Oncologist Patricia LoRusso, DO, associate director of innovative medicine at Yale Medicine, has expertise in testing new treatments on patient volunteers who have advanced stages of cancer. Her passion is bringing research breakthroughs into the clinic to help patients with different types and stages of cancer.

The clinical trials at Yale Cancer Center offer access to experimental drugs that are sometimes a patient’s last and best hope, says Dr. LoRusso. Therapies that prove successful can advance through the U.S. Food and Drug Administration approval process. “Many of the drugs tested here will help generations of cancer patients,” says Dr. LoRusso. In her career, 14 cancer drugs she has performed clinical trials on, which she refers to as her “children,” have gone on to gain FDA approval.

Dr. LoRusso leads the Phase I clinical trials infusion center at Smilow Cancer Hospital at Yale New Haven. She infuses the center with a warm, team-focused approach that puts patients at the center of care. “We’re improving patients’ lives in Connecticut and beyond,” says Dr. LoRusso.

Titles

Amy and Joseph Perella Professor of Medicine (Medical Oncology)
Chief, Experimental Therapeutics
Associate Cancer Center Director, Experimental Therapeutics

Education & Training

MA
Yale University (2015)
Fellowship
Wayne State University (1988)
Residency
Riverside Osteopathic Hospital (1984)
Internship
Riverside Osteopathic Hospital (1982)
DO
Michigan State University (1981)
BS
Marygrove College (1977)

Additional Information

Honors & Recognitions

Board Certifications

Publications

Targeted therapy for DNA damage response and homologous recombination repair defects: The Olaparib Combinations trial
Doroshow D, Shapiro G, Do K, Keedy V, Mahdi H, Sohal D, Hafez N, LoRusso P, Cecchini M, Sklar J, Mortimer P, Glover C, Moses J, Jürgensmeier J, Eder J. Targeted therapy for DNA damage response and homologous recombination repair defects: The Olaparib Combinations trial. Cancer 2026, 132: e70332. PMID: 41808580, DOI: 10.1002/cncr.70332.
FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational Trials.
Shord S, Chen C, Jin J, Van Wart S, Martin S, Davidson B, Liu J, LoRusso P, Oxnard G. FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational Trials. Clinical Cancer Research 2025, 31: 4891-4898. PMID: 41036557, PMCID: PMC12536354, DOI: 10.1158/1078-0432.ccr-25-0098.
FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Early Phase Trials Using Innovative Trial Designs and Biomarkers
Okusanya O, Patilea-Vrana G, Sireci A, Iasonos A, Davidson B, Liu J, Shord S, LoRusso P, Yap T. FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Early Phase Trials Using Innovative Trial Designs and Biomarkers. Clinical Cancer Research 2025, 31: 4882-4890. PMID: 41036631, PMCID: PMC12614637, DOI: 10.1158/1078-0432.ccr-25-1918.
FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Dosages for First-in-Human Trials.
Zhu H, Phipps A, Yuan Y, Davidson B, Shord S, Liu J, LoRusso P. FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Dosages for First-in-Human Trials. Clinical Cancer Research 2025, 31: 4872-4881. PMID: 41036712, DOI: 10.1158/1078-0432.ccr-25-0095.
High MGMT expression identifies aggressive colorectal cancer with distinct genomic features and immune evasion properties
Zhang J, Rajendran B, Desai S, Gibson J, DiPalermo J, LoRusso P, Kong Y, Zhao H, Cecchini M, Schalper K. High MGMT expression identifies aggressive colorectal cancer with distinct genomic features and immune evasion properties. Journal For ImmunoTherapy Of Cancer 2025, 13: e011653. PMID: 40935566, PMCID: PMC12506448, DOI: 10.1136/jitc-2025-011653.
First-in-Human Phase I/II Study of INCAGN01876, a Glucocorticoid-Induced Tumor Necrosis Factor Receptor Agonist, in Patients with Advanced or Metastatic Solid Tumors
Hamid O, Cardin D, Hodi F, LoRusso P, Merghoub T, Zappasodi R, Maniyar R, Janik J, van der Velden M, Zhou F, Dong Z, Chen X, Harding J. First-in-Human Phase I/II Study of INCAGN01876, a Glucocorticoid-Induced Tumor Necrosis Factor Receptor Agonist, in Patients with Advanced or Metastatic Solid Tumors. Clinical Cancer Research 2025, 31: 4089-4100. PMID: 40711469, PMCID: PMC12485371, DOI: 10.1158/1078-0432.ccr-24-4141.
Myeloid targeting antibodies PY159 and PY314 for platinum-resistant ovarian cancer
Yeku O, Barve M, Tan W, Wang J, Patnaik A, LoRusso P, Richardson D, Naqash A, Lynam S, Fu S, Gordon M, Hubbard J, Kummar S, Kyriakopoulos C, Dowlati A, Chamberlain M, Winer I. Myeloid targeting antibodies PY159 and PY314 for platinum-resistant ovarian cancer. Journal For ImmunoTherapy Of Cancer 2025, 13: e010959. PMID: 40081941, PMCID: PMC11907075, DOI: 10.1136/jitc-2024-010959.
Phase I dose-escalation and pharmacodynamic study of STING agonist E7766 in advanced solid tumors
Luke J, Pinato D, Juric D, LoRusso P, Hosein P, Desai A, Haddad R, de Miguel M, Cervantes A, Kim W, Marabelle A, Zhang Y, Rong Y, Yuan X, Champiat S. Phase I dose-escalation and pharmacodynamic study of STING agonist E7766 in advanced solid tumors. Journal For ImmunoTherapy Of Cancer 2025, 13: e010511. PMID: 39979069, PMCID: PMC11842995, DOI: 10.1136/jitc-2024-010511.
Nanrilkefusp alfa (SOT101), an IL-15 receptor βγ superagonist, as a single agent or with anti-PD-1 in patients with advanced cancers
Champiat S, Garralda E, Galvao V, Cassier P, Gomez-Roca C, Korakis I, Grell P, Naing A, LoRusso P, Mikyskova R, Podzimkova N, Reinis M, Ouali K, Schoenenberger A, Kiemle-Kallee J, Tillmanns S, Sachse R, Moebius U, Spisek R, Bechard D, Jelinkova L, Adkins I, Marabelle A. Nanrilkefusp alfa (SOT101), an IL-15 receptor βγ superagonist, as a single agent or with anti-PD-1 in patients with advanced cancers. Cell Reports Medicine 2025, 6: 101967. PMID: 39933529, PMCID: PMC11866505, DOI: 10.1016/j.xcrm.2025.101967.
Olaparib in treatment‐refractory isocitrate dehydrogenase 1 (IDH1)– and IDH2‐mutant cholangiocarcinoma: Safety and antitumor activity from the phase 2 National Cancer Institute 10129 trial
Cecchini M, Pilat M, Uboha N, Azad N, Cho M, Davis E, Ahnert J, Tinoco G, Shapiro G, Khagi S, Powers B, Spencer K, Groisberg R, Drappatz J, Chen L, Das B, Bao X, Li J, Narayan A, Vu D, Patel A, Niger M, Doroshow D, Durecki D, Boerner S, Bindra R, Ivy P, Shyr D, Shyr Y, LoRusso P. Olaparib in treatment‐refractory isocitrate dehydrogenase 1 (IDH1)– and IDH2‐mutant cholangiocarcinoma: Safety and antitumor activity from the phase 2 National Cancer Institute 10129 trial. Cancer 2025, 131: e35755-e35755. PMID: 39917990, PMCID: PMC11949439, DOI: 10.1002/cncr.35755.
Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial
Lopez J, Powles T, Braiteh F, Siu L, LoRusso P, Friedman C, Balmanoukian A, Gordon M, Yachnin J, Rottey S, Karydis I, Fisher G, Schmidt M, Schuler M, Sullivan R, Burris H, Galvao V, Henick B, Dirix L, Jaeger D, Ott P, Wong K, Jerusalem G, Schiza A, Fong L, Steeghs N, Leidner R, Rittmeyer A, Laurie S, Gort E, Aljumaily R, Melero I, Sabado R, Rhee I, Mancuso M, Muller L, Fine G, Yadav M, Kim L, Leveque V, Robert A, Darwish M, Qi T, Zhu J, Zhang J, Twomey P, Rao G, Low D, Petry C, Lo A, Schartner J, Delamarre L, Mellman I, Löwer M, Müller F, Derhovanessian E, Cortini A, Manning L, Maurus D, Brachtendorf S, Lörks V, Omokoko T, Godehardt E, Becker D, Hawner C, Wallrapp C, Albrecht C, Kröner C, Tadmor A, Diekmann J, Vormehr M, Jork A, Paruzynski A, Lang M, Blake J, Hennig O, Kuhn A, Sahin U, Türeci Ö, Camidge D. Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial. Nature Medicine 2025, 31: 152-164. PMID: 39762422, PMCID: PMC11750724, DOI: 10.1038/s41591-024-03334-7.
Financial Toxicity Among Patients With Advanced Solid Tumors Participating in Early-Phase Clinical Trials
Blanter J, Van Hyfte G, Ahmad M, Xu S, Hapanowicz O, Fazilov G, Lu A, Lucas N, Wu K, Shelton G, DeMerchant M, Lachowicz M, Kier M, Werner M, Eder J, Galsky M, Marron T, Smith C, LoRusso P, Hofstatter E, Doroshow D. Financial Toxicity Among Patients With Advanced Solid Tumors Participating in Early-Phase Clinical Trials. JCO Oncology Practice 2024, 21: 862-875. PMID: 39661920, PMCID: PMC12508792, DOI: 10.1200/op.24.00293.
First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP:TGF-ß1 complex, as monotherapy and in combination with the anti–PD-1 antibody budigalimab in patients with advanced solid tumors
Shimizu T, Powderly J, Razak A, LoRusso P, Miller K, Kao S, Kongpachith S, Tribouley C, Graham M, Stoll B, Patel M, Sahtout M, Blaney M, Leibman R, Golan T, Tolcher A. First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP:TGF-ß1 complex, as monotherapy and in combination with the anti–PD-1 antibody budigalimab in patients with advanced solid tumors. Frontiers In Oncology 2024, 14: 1376551. PMID: 39534099, PMCID: PMC11555770, DOI: 10.3389/fonc.2024.1376551.
Circulating Tumor DNA Dynamics Reveal KRAS G12C Mutation Heterogeneity and Response to Treatment with the KRAS G12C Inhibitor Divarasib in Solid Tumors
Choi Y, Dharia N, Jun T, Chang J, Royer-Joo S, Yau K, Assaf Z, Aimi J, Sivakumar S, Montesion M, Sacher A, LoRusso P, Desai J, Schutzman J, Shi Z, group A. Circulating Tumor DNA Dynamics Reveal KRAS G12C Mutation Heterogeneity and Response to Treatment with the KRAS G12C Inhibitor Divarasib in Solid Tumors. Clinical Cancer Research 2024, 30: of1-of10. PMID: 38995268, PMCID: PMC11369623, DOI: 10.1158/1078-0432.ccr-24-0255.
A Phase II Trial of the WEE1 Inhibitor Adavosertib in SETD2-Altered Advanced Solid Tumor Malignancies (NCI 10170)
Maldonado E, Rathmell W, Shapiro G, Takebe N, Rodon J, Mahalingam D, Trikalinos N, Kalebasty A, Parikh M, Boerner S, Balido C, Krings G, Burns T, Bergsland E, Munster P, Ashworth A, LoRusso P, Aggarwal R. A Phase II Trial of the WEE1 Inhibitor Adavosertib in SETD2-Altered Advanced Solid Tumor Malignancies (NCI 10170). Cancer Research Communications 2024, 4: 1793-1801. PMID: 38920407, PMCID: PMC11264598, DOI: 10.1158/2767-9764.crc-24-0213.
Author Correction: Inhibition of lysine acetyltransferase KAT6 in ER+HER2− metastatic breast cancer: a phase 1 trial
Mukohara T, Park Y, Sommerhalder D, Yonemori K, Hamilton E, Kim S, Kim J, Iwata H, Yamashita T, Layman R, Mita M, Clay T, Chae Y, Oakman C, Yan F, Kim G, Im S, Lindeman G, Rugo H, Liyanage M, Saul M, Le Corre C, Skoura A, Liu L, Li M, LoRusso P. Author Correction: Inhibition of lysine acetyltransferase KAT6 in ER+HER2− metastatic breast cancer: a phase 1 trial. Nature Medicine 2024, 30: 2371-2371. PMID: 38914862, PMCID: PMC11333270, DOI: 10.1038/s41591-024-03129-w.
Unlocking the Potential: Biomarkers of Response to Antibody-Drug Conjugates.
Ascione L, Guidi L, Prakash A, Trapani D, LoRusso P, Lou E, Curigliano G. Unlocking the Potential: Biomarkers of Response to Antibody-Drug Conjugates. American Society Of Clinical Oncology Educational Book 2024, 44: e431766. PMID: 38828973, DOI: 10.1200/edbk_431766.
Inhibition of lysine acetyltransferase KAT6 in ER+HER2− metastatic breast cancer: a phase 1 trial
Mukohara T, Park Y, Sommerhalder D, Yonemori K, Hamilton E, Kim S, Kim J, Iwata H, Yamashita T, Layman R, Mita M, Clay T, Chae Y, Oakman C, Yan F, Kim G, Im S, Lindeman G, Rugo H, Liyanage M, Saul M, Le Corre C, Skoura A, Liu L, Li M, LoRusso P. Inhibition of lysine acetyltransferase KAT6 in ER+HER2− metastatic breast cancer: a phase 1 trial. Nature Medicine 2024, 30: 2242-2250. PMID: 38824244, PMCID: PMC11333285, DOI: 10.1038/s41591-024-03060-0.
Efficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series
Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Macarulla T, Geng J, Li J, Teufel M, Märten A, LoRusso P. Efficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series. OncoTargets And Therapy 2024, 17: 267-280. PMID: 38567193, PMCID: PMC10986405, DOI: 10.2147/ott.s440979.
Circulating Tumor DNA Dynamics Fail to Predict Efficacy of Poly(ADP-ribose) Polymerase/VEGFR Inhibition in Patients With Heavily Pretreated Advanced Solid Tumors
Hu Y, Narayan A, Xu Y, Wolfe J, Vu D, Trinh T, Kantak C, Ivy S, Eder J, Deng Y, LoRusso P, Kim J, Patel A. Circulating Tumor DNA Dynamics Fail to Predict Efficacy of Poly(ADP-ribose) Polymerase/VEGFR Inhibition in Patients With Heavily Pretreated Advanced Solid Tumors. JCO Precision Oncology 2024, 8: e2300289. PMID: 38412387, PMCID: PMC10914240, DOI: 10.1200/po.23.00289.
Entinostat, nivolumab and ipilimumab for women with advanced HER2-negative breast cancer: a phase Ib trial
Roussos Torres E, Ho W, Danilova L, Tandurella J, Leatherman J, Rafie C, Wang C, Brufsky A, LoRusso P, Chung V, Yuan Y, Downs M, O’Connor A, Shin S, Hernandez A, Engle E, Piekarz R, Streicher H, Talebi Z, Rudek M, Zhu Q, Anders R, Cimino-Mathews A, Fertig E, Jaffee E, Stearns V, Connolly R. Entinostat, nivolumab and ipilimumab for women with advanced HER2-negative breast cancer: a phase Ib trial. Nature Cancer 2024, 5: 866-879. PMID: 38355777, PMCID: PMC11552660, DOI: 10.1038/s43018-024-00729-w.
Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103)
Garralda E, Oh Y, Italiano A, Bedard P, Delord J, Calvo E, LoRusso P, Wainberg Z, Cervantes A, Rodriguez‐Vida A, Shemesh C, Sane R, Mendus D, Ding H, Hendricks R, Meng R, Cho B, Kim T, Wu B. Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103). The Journal Of Clinical Pharmacology 2024, 64: 544-554. PMID: 38105505, DOI: 10.1002/jcph.2397.
The HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results
Lewis G, Li G, Guo J, Yu S, Fields C, Lee G, Zhang D, Dragovich P, Pillow T, Wei B, Sadowsky J, Leipold D, Wilson T, Kamath A, Mamounas M, Lee M, Saad O, Choeurng V, Ungewickell A, Monemi S, Crocker L, Kalinsky K, Modi S, Jung K, Hamilton E, LoRusso P, Krop I, Schutten M, Commerford R, Sliwkowski M, Cho E. The HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results. Nature Communications 2024, 15: 466. PMID: 38212321, PMCID: PMC10784567, DOI: 10.1038/s41467-023-44533-z.
NCI10066: a Phase 1/2 study of olaparib in combination with ramucirumab in previously treated metastatic gastric and gastroesophageal junction adenocarcinoma
Cecchini M, Cleary J, Shyr Y, Chao J, Uboha N, Cho M, Shields A, Pant S, Goff L, Spencer K, Kim E, Stein S, Kortmansky J, Canosa S, Sklar J, Swisher E, Radke M, Ivy P, Boerner S, Durecki D, Hsu C, LoRusso P, Lacy J. NCI10066: a Phase 1/2 study of olaparib in combination with ramucirumab in previously treated metastatic gastric and gastroesophageal junction adenocarcinoma. British Journal Of Cancer 2023, 130: 476-482. PMID: 38135713, PMCID: PMC10844282, DOI: 10.1038/s41416-023-02534-1.
Divarasib plus cetuximab in KRAS G12C-positive colorectal cancer: a phase 1b trial
Desai J, Alonso G, Kim S, Cervantes A, Karasic T, Medina L, Shacham-Shmueli E, Cosman R, Falcon A, Gort E, Guren T, Massarelli E, Miller W, Paz-Ares L, Prenen H, Amatu A, Cremolini C, Kim T, Moreno V, Ou S, Passardi A, Sacher A, Santoro A, Stec R, Ulahannan S, Arbour K, Lorusso P, Luo J, Patel M, Choi Y, Shi Z, Mandlekar S, Lin M, Royer-Joo S, Chang J, Jun T, Dharia N, Schutzman J, Han S. Divarasib plus cetuximab in KRAS G12C-positive colorectal cancer: a phase 1b trial. Nature Medicine 2023, 30: 271-278. PMID: 38052910, PMCID: PMC10803265, DOI: 10.1038/s41591-023-02696-8.
Anti-TIGIT Antibody Tiragolumab Alone or With Atezolizumab in Patients With Advanced Solid Tumors
Kim T, Bedard P, LoRusso P, Gordon M, Bendell J, Oh D, Ahn M, Garralda E, D’Angelo S, Desai J, Hodi F, Wainberg Z, Delord J, Cassier P, Cervantes A, Gil-Martin M, Wu B, Patil N, Jin Y, Hoang T, Mendus D, Wen X, Meng R, Cho B. Anti-TIGIT Antibody Tiragolumab Alone or With Atezolizumab in Patients With Advanced Solid Tumors. JAMA Oncology 2023, 9: 1574-1582. PMID: 37768658, PMCID: PMC10540058, DOI: 10.1001/jamaoncol.2023.3867.
Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation
Sacher A, LoRusso P, Patel M, Miller W, Garralda E, Forster M, Santoro A, Falcon A, Kim T, Paz-Ares L, Bowyer S, de Miguel M, Han S, Krebs M, Lee J, Cheng M, Arbour K, Massarelli E, Choi Y, Shi Z, Mandlekar S, Lin M, Royer-Joo S, Chang J, Dharia N, Schutzman J, Desai J. Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation. The New England Journal Of Medicine 2023, 389: 710-721. PMID: 37611121, DOI: 10.1056/nejmoa2303810.
Platinum Sensitivity in IDH1/2 Mutated Intrahepatic Cholangiocarcinoma: Not All “BRCAness” Is Created Equal
Doroshow D, Wei W, Mehrotra M, Sia D, Eder J, Bindra R, Houldsworth J, LoRusso P, Walther Z. Platinum Sensitivity in IDH1/2 Mutated Intrahepatic Cholangiocarcinoma: Not All “BRCAness” Is Created Equal. Cancer Investigation 2023, 41: 646-655. PMID: 37505929, DOI: 10.1080/07357907.2023.2242957.
A Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors
Garralda E, Schram A, Bedard P, Schwartz G, Yuen E, McNeely S, Ribeiro S, Cunningham J, Wang Y, Urunuela A, Xu X, LoRusso P. A Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors. The Oncologist 2023, 29: e131-e140. PMID: 37531083, PMCID: PMC10769797, DOI: 10.1093/oncolo/oyad215.
A pilot study of volumetric and density tumor analysis of ACC patients treated with vorinostat in a phase II clinical trial
Malarkey M, Toscano A, Bagheri M, Solomon J, Machado L, LoRusso P, Chen A, Folio L, Goncalves P. A pilot study of volumetric and density tumor analysis of ACC patients treated with vorinostat in a phase II clinical trial. Heliyon 2023, 9: e18680. PMID: 37593628, PMCID: PMC10428039, DOI: 10.1016/j.heliyon.2023.e18680.
Quantitative DNA Repair Biomarkers and Immune Profiling for Temozolomide and Olaparib in Metastatic Colorectal Cancer
Cecchini M, Zhang J, Wei W, Sklar J, Lacy J, Zhong M, Kong Y, Zhao H, DiPalermo J, Devine L, Stein S, Kortmansky J, Johung K, Bindra R, LoRusso P, Schalper K. Quantitative DNA Repair Biomarkers and Immune Profiling for Temozolomide and Olaparib in Metastatic Colorectal Cancer. Cancer Research Communications 2023, 3: 1132-1139. PMID: 37387791, PMCID: PMC10305782, DOI: 10.1158/2767-9764.crc-23-0045.
NCI 7977: A Phase I Dose-Escalation Study of Intermittent Oral ABT-888 (Veliparib) Plus Intravenous Irinotecan Administered in Patients with Advanced Solid Tumors
Cecchini M, Walther Z, Wei W, Hafez N, Pilat M, Boerner S, Durecki D, Eder J, Schalper K, Chen A, LoRusso P. NCI 7977: A Phase I Dose-Escalation Study of Intermittent Oral ABT-888 (Veliparib) Plus Intravenous Irinotecan Administered in Patients with Advanced Solid Tumors. Cancer Research Communications 2023, 3: 1113-1117. PMID: 37377610, PMCID: PMC10292219, DOI: 10.1158/2767-9764.crc-22-0485.
The MDM2–p53 antagonist BI 907828 in patients with advanced or metastatic solid tumors: results of a phase Ia, first-in-human, dose-escalation study
LoRusso P, Yamamoto N, Patel M, Laurie S, Bauer T, Geng J, Davenport T, Teufel M, Li J, Lahmar M, Gounder M. The MDM2–p53 antagonist BI 907828 in patients with advanced or metastatic solid tumors: results of a phase Ia, first-in-human, dose-escalation study. Cancer Discovery 2023, 13: 1802-1813. PMID: 37269344, PMCID: PMC10401071, DOI: 10.1158/2159-8290.cd-23-0153.
First-in-human study of oleclumab, a potent, selective anti-CD73 monoclonal antibody, alone or in combination with durvalumab in patients with advanced solid tumors
Bendell J, LoRusso P, Overman M, Noonan A, Kim D, Strickler J, Kim S, Clarke S, George T, Grimison P, Barve M, Amin M, Desai J, Wise-Draper T, Eck S, Jiang Y, Khan A, Wu Y, Martin P, Cooper Z, Elgeioushi N, Mueller N, Kumar R, Patel S. First-in-human study of oleclumab, a potent, selective anti-CD73 monoclonal antibody, alone or in combination with durvalumab in patients with advanced solid tumors. Cancer Immunology, Immunotherapy 2023, 72: 2443-2458. PMID: 37016126, PMCID: PMC10264501, DOI: 10.1007/s00262-023-03430-6.
Multicenter Phase 2 Trial of the PARP Inhibitor Olaparib in Recurrent IDH1 and IDH2-Mutant Glioma
Fanucci K, Pilat M, Shyr D, Shyr Y, Boerner S, Li J, Durecki D, Drappatz J, Puduvalli V, Lieberman F, Gonzalez J, Giglio P, Ivy S, Bindra R, Omuro A, LoRusso P. Multicenter Phase 2 Trial of the PARP Inhibitor Olaparib in Recurrent IDH1 and IDH2-Mutant Glioma. Cancer Research Communications 2023, 3: 192-201. PMID: 36968138, PMCID: PMC10035510, DOI: 10.1158/2767-9764.crc-22-0436.
Phase Ia/Ib Study of BAY1895344 Plus Topoisomerase I Inhibitors with a Focus on Poorly Differentiated Neuroendocrine Carcinomas and Pancreatic Adenocarcinoma
Stockton S, Dan A, Cecchini M, Ajumaily R, Whisenant J, Gore S, Ivy P, LoRusso P, Berlin J, Das S. Phase Ia/Ib Study of BAY1895344 Plus Topoisomerase I Inhibitors with a Focus on Poorly Differentiated Neuroendocrine Carcinomas and Pancreatic Adenocarcinoma. Endocrine Abstracts 2023 DOI: 10.1530/endoabs.89.t1.
A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients With Advanced Liposarcoma, Solid Tumors, or Lymphomas
Gounder M, Bauer T, Schwartz G, Weise A, LoRusso P, Kumar P, Tao B, Hong Y, Patel P, Lu Y, Lesegretain A, Tirunagaru V, Xu F, Doebele R, Hong D. A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients With Advanced Liposarcoma, Solid Tumors, or Lymphomas. Journal Of Clinical Oncology 2023, 41: 1714-1724. PMID: 36669146, PMCID: PMC10022862, DOI: 10.1200/jco.22.01285.
Genome-wide analysis of aberrant position and sequence of plasma DNA fragment ends in patients with cancer
Budhraja K, McDonald B, Stephens M, Contente-Cuomo T, Markus H, Farooq M, Favaro P, Connor S, Byron S, Egan J, Ernst B, McDaniel T, Sekulic A, Tran N, Prados M, Borad M, Berens M, Pockaj B, LoRusso P, Bryce A, Trent J, Murtaza M. Genome-wide analysis of aberrant position and sequence of plasma DNA fragment ends in patients with cancer. Science Translational Medicine 2023, 15: eabm6863. PMID: 36630480, PMCID: PMC10080578, DOI: 10.1126/scitranslmed.abm6863.
Interplay of Immunosuppression and Immunotherapy Among Patients With Cancer and COVID-19
Bakouny Z, Labaki C, Grover P, Awosika J, Gulati S, Hsu C, Alimohamed S, Bashir B, Berg S, Bilen M, Bowles D, Castellano C, Desai A, Elkrief A, Eton O, Fecher L, Flora D, Galsky M, Gatti-Mays M, Gesenhues A, Glover M, Gopalakrishnan D, Gupta S, Halfdanarson T, Hayes-Lattin B, Hendawi M, Hsu E, Hwang C, Jandarov R, Jani C, Johnson D, Joshi M, Khan H, Khan S, Knox N, Koshkin V, Kulkarni A, Kwon D, Matar S, McKay R, Mishra S, Moria F, Nizam A, Nock N, Nonato T, Panasci J, Pomerantz L, Portuguese A, Provenzano D, Puc M, Rao Y, Rhodes T, Riely G, Ripp J, Rivera A, Ruiz-Garcia E, Schmidt A, Schoenfeld A, Schwartz G, Shah S, Shaya J, Subbiah S, Tachiki L, Tucker M, Valdez-Reyes M, Weissmann L, Wotman M, Wulff-Burchfield E, Xie Z, Yang Y, Thompson M, Shah D, Warner J, Shyr Y, Choueiri T, Wise-Draper T, Fromowitz A, Gandhi R, Gartrell B, Goel S, Halmos B, Makower D, O' Sullivan D, Ohri N, Portes M, Shapiro L, Shastri A, Sica R, Verma A, Butt O, Campian J, Fiala M, Henderson J, Monahan R, Stockerl-Goldstein K, Zhou A, Bitran J, Hallmeyer S, Mundt D, Pandravada S, Papaioannou P, Patel M, Streckfuss M, Tadesse E, Gatson N, Kundranda M, Lammers P, Loree J, Yu I, Bindal P, Lam B, Peters M, Piper-Vallillo A, Egan P, Farmakiotis D, Arvanitis P, Klein E, Olszewski A, Vieira K, Angevine A, Bar M, Del Prete S, Fiebach M, Gulati A, Hatton E, Houston K, Rose S, Steve Lo K, Stratton J, Weinstein P, Garcia J, Routy B, Hoyo-Ulloa I, Dawsey S, Lemmon C, Pennell N, Sharifi N, Painter C, Granada C, Hoppenot C, Li A, Bitterman D, Connors J, Demetri G, Florez (Duma) N, Freeman D, Giordano A, Morgans A, Nohria A, Saliby R, Tolaney S, Van Allen E, Xu W, Zon R, Halabi S, Zhang T, Dzimitrowicz H, Leighton J, Graber J, Grivas P, Hawley J, Loggers E, Lyman G, Lynch R, Nakasone E, Schweizer M, Vinayak S, Wagner M, Yeh A, Dansoa Y, Makary M, Manikowski J, Vadakara J, Yossef K, Beckerman J, Goyal S, Messing I, Rosenstein L, Steffes D, Alsamarai S, Clement J, Cosin J, Daher A, Dailey M, Elias R, Fein J, Hosmer W, Jayaraj A, Mather J, Menendez A, Nadkarni R, Serrano O, Yu P, Balanchivadze N, Gadgeel S, Accordino M, Bhutani D, Bodin B, Hershman D, Masson C, Alexander M, Mushtaq S, Reuben D, Bernicker E, Deeken J, Jeffords K, Shafer D, Cárdenas A, Cuervo Campos R, De-la-Rosa-Martinez D, Ramirez A, Vilar-Compte D, Gill D, Lewis M, Low C, Jones M, Mansoor A, Mashru S, Werner M, Cohen A, McWeeney S, Nemecek E, Williamson S, Peters S, Smith S, Lewis G, Zaren H, Akhtari M, Castillo D, Cortez K, Lau E, Nagaraj G, Park K, Reeves M, O'Connor T, Altman J, Gurley M, Mulcahy M, Wehbe F, Durbin E, Nelson H, Ramesh V, Sachs Z, Wilson G, Bardia A, Boland G, Gainor J, Peppercorn J, Reynolds K, Rosovsky R, Zubiri L, Bekaii-Saab T, Joyner M, Riaz I, Senefeld J, Shah S, Ayre S, Bonnen M, Mahadevan D, McKeown C, Mesa R, Ramirez A, Salazar M, Shah P, Wang C, Bouganim N, Papenburg J, Sabbah A, Tagalakis V, Vinh D, Nanchal R, Singh H, Bahadur N, Bao T, Belenkaya R, Nambiar P, O’Cearbhaill R, Papadopoulos E, Philip J, Robson M, Rosenberg J, Wilkins C, Tamimi R, Cerrone K, Dill J, Faller B, Alomar M, Chandrasekhar S, Hume E, Islam J, Ajmera A, Brouha S, Cabal A, Choi S, Hsiao A, Jiang J, Kligerman S, Park J, Razavi P, Reid E, Bhatt P, Mariano M, Thomson C, Glace M, Knoble J, Rink C, Zacks R, Blau S, Brown C, Cantrell A, Namburi S, Polimera H, Rovito M, Edwin N, Herz K, Kennecke H, Monfared A, Sautter R, Cronin T, Elshoury A, Fleissner B, Griffiths E, Hernandez-Ilizaliturri F, Jain P, Kariapper A, Levine E, Moffitt M, O'Connor T, Smith L, Wicher C, Zsiros E, Jabbour S, Misdary C, Shah M, Batist G, Cook E, Ferrario C, Lau S, Miller W, Rudski L, Santos Dutra M, Wilchesky M, Mahmood S, McNair C, Mico V, Dixon B, Kloecker G, Logan B, Mandapakala C, Cabebe E, Jha A, Khaki A, Nagpal S, Schapira L, Wu J, Whaley D, Lopes G, de Cardenas K, Russell K, Stith B, Taylor S, Klamerus J, Revankar S, Addison D, Chen J, Haynam M, Jhawar S, Karivedu V, Palmer J, Pillainayagam C, Stover D, Wall S, Williams N, Abbasi S, Annis S, Balmaceda N, Greenland S, Kasi A, Rock C, Luders M, Smits M, Weiss M, Chism D, Owenby S, Ang C, Doroshow D, Metzger M, Berenberg J, Uyehara C, Fazio A, Huber K, Lashley L, Sueyoshi M, Patel K, Riess J, Borno H, Small E, Zhang S, Andermann T, Jensen C, Rubinstein S, Wood W, Ahmad S, Brownfield L, Heilman H, Kharofa J, Latif T, Marcum M, Shaikh H, Sohal D, Abidi M, Geiger C, Markham M, Russ A, Saker H, Acoba J, Choi H, Rho Y, Feldman L, Gantt G, Hoskins K, Khan M, Liu L, Nguyen R, Pasquinelli M, Schwartz C, Venepalli N, Vikas P, Zakharia Y, Friese C, Boldt A, Gonzalez C, Su C, Su C, Yoon J, Bijjula R, Mavromatis B, Seletyn M, Wood B, Zaman Q, Kaklamani V, Beeghly A, Brown A, Charles L, Cheng A, Crispens M, Croessmann S, Davis E, Ding T, Duda S, Enriquez K, French B, Gillaspie E, Hausrath D, Hennessy C, Lewis J, Li X, Prescott L, Reid S, Saif S, Slosky D, Solorzano C, Sun T, Vega-Luna K, Wang L, Aboulafia D, Carducci T, Goldsmith K, Van Loon S, Topaloglu U, Moore J, Rice R, Cabalona W, Cyr S, Barrow McCollough B, Peddi P, Rosen L, Ravindranathan D, Hafez N, Herbst R, LoRusso P, Lustberg M, Masters T, Stratton C. Interplay of Immunosuppression and Immunotherapy Among Patients With Cancer and COVID-19. JAMA Oncology 2023, 9: 128-134. PMID: 36326731, PMCID: PMC9634600, DOI: 10.1001/jamaoncol.2022.5357.
Improving precision oncology through better designs and reporting of biomarker-driven randomized clinical trials
LoRusso P, Freidlin B. Improving precision oncology through better designs and reporting of biomarker-driven randomized clinical trials. Journal Of The National Cancer Institute 2022, 115: 122-124. PMID: 36448688, PMCID: PMC9905964, DOI: 10.1093/jnci/djac212.
A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance.
Yap T, LoRusso P, Wong D, Hu-Lieskovan S, Papadopoulos K, Holz J, Grabowska U, Gradinaru C, Leung K, Marshall S, Reader C, Russell R, Sainson R, Seal C, Shepherd C, Germaschewski F, Gliddon D, Stern O, Young L, Brewis N, Kayitalire L, Morrow M. A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance. Clinical Cancer Research 2022, 29: 888-898. PMID: 36342102, DOI: 10.1158/1078-0432.ccr-22-1449.
First in Human Phase 1/2 ICONIC Trial of the ICOS agonist vopratelimab alone and with nivolumab: ICOS high CD4 T cell populations and predictors of response
Yap TA, Gainor JF, Callahan MK, Falchook GS, Pachynski RK, LoRusso P, Kummar S, Gibney GT, Burris HA, Tykodi SS, Rahma OE, Seiwert TY, Papadopoulos KP, Murphy M, Park H, Hanson A, Hashambhoy-Ramsay Y, McGrath L, Hooper E, Xiao X, Cohen H, Fan M, Felitsky D, Hart C, McComb R, Brown K, Sepahi A, Jimenez J, Zhang W, Baeck J, Laken H, Murray R, Trehu E, Harvey CJ. First in Human Phase 1/2 ICONIC Trial of the ICOS agonist vopratelimab alone and with nivolumab: ICOS high CD4 T cell populations and predictors of response. Clinical Cancer Research 2022, 28: 3695-3708. PMID: 35511938, PMCID: PMC9433959, DOI: 10.1158/1078-0432.ccr-21-4256.
Racial Disparities in COVID-19 Outcomes Among Black and White Patients With Cancer
Fu J, Reid S, French B, Hennessy C, Hwang C, Gatson N, Duma N, Mishra S, Nguyen R, Hawley J, Singh S, Chism D, Venepalli N, Warner J, Choueiri T, Schmidt A, Fecher L, Girard J, Bilen M, Ravindranathan D, Goyal S, Wise-Draper T, Park C, Painter C, McGlown S, de Lima Lopes G, Serrano O, Shah D, Halmos B, Verma A, Gartrell B, Goel S, Ohri N, Sica R, Thakkar A, Stockerl-Goldstein K, Butt O, Campian J, Fiala M, Monahan R, Zhou A, Patel J, Piper-Vallillo A, Bindal P, Thompson M, Bohachek P, Mundt D, Streckfuss M, Tadesse E, Lammers P, Panagiotou O, Egan P, Farmakiotis D, Khan H, Olszewski A, Loaiza-Bonilla A, Del Prete S, Angevine A, Bar M, Gulati A, Steve Lo K, Stratton J, Weinstein P, Caimi P, Barnholtz-Sloan J, Garcia J, Nakayama J, Gupta S, Pennell N, Ahluwalia M, Dawsey S, Lemmon C, Nizam A, Hoppenot C, Li A, Bakouny Z, Bouchard G, Busser F, Connors J, Curran C, Demetri G, Giordano A, Kelleher K, Nohria A, Shaw G, Van Allen E, Nuzzo P, Xu V, Zon R, Zhang T, Halabi S, Leighton J, Lyman G, Graber J, Grivas P, Khaki A, Loggers E, Lynch R, Nakasone E, Schweizer M, Tachiki L, Vinayak S, Wagner M, Yeh A, Huynh-Le M, Rosenstein L, Yu P, Clement J, Daher A, Dailey M, Elias R, Jayaraj A, Hsu E, Menendez A, Rathmann J, Gadgeel S, Hershman D, Accordino M, Bhutani D, Schwartz G, Reuben D, Mushtaq S, Bernicker E, Deeken J, Shafer D, Lewis M, Rhodes T, Gill D, Low C, Mashru S, Mansoor A, Zaren H, Smith S, Nagaraj G, Akhtari M, Lau E, Reeves M, Berg S, Elms D, Morgans A, Wehbe F, Altman J, Gurley M, Mulcahy M, Durbin E, Kulkarni A, Nelson H, Shah S, Rosovsky R, Reynolds K, Bardia A, Boland G, Gainor J, Zubiri L, Halfdanarson T, Bekaii-Saab T, Desai A, Xie Z, Mesa R, Bonnen M, Mahadevan D, Ramirez A, Salazar M, Shah P, Faller B, McKay R, Ajmera A, Cabal A, Shaya J, Weissmann L, Jani C, Knoble J, Glace M, Rink C, Stauffer K, Zacks R, Joshi M, Menon H, Rovito M, Griffiths E, Elshoury A, Jabbour S, Shah M, Bashir B, McNair C, Mahmood S, Mico V, Miller C, Rivera A, Flora D, Logan B, Kloecker G, Mandapakala C, Shah S, Cabebe E, Glover M, Jha A, Schapira L, Wu J, Subbiah S, Revankar S, Stover D, Addison D, Chen J, Gatti-Mays M, Jhawar S, Karivedu V, Lustberg M, Palmer J, Pillainayagam C, Wall S, Williams N, Wulff-Burchfield E, Kasi A, Edwin N, Smits M, Owenby S, Doroshow D, Galsky M, Wotman M, Zhu H, Fazio A, Riess J, Patel K, Rubinstein S, Wood W, Islam J, Kumar V, Ahmad S, Grover P, Gulati S, Kharofa J, Marcum M, Bowles D, Geiger C, Markham M, Bishnoi R, Russ A, Shah C, Acoba J, Rho Y, Feldman L, Hoskins K, Gantt G, Khan M, Pasquinelli M, Schwartz C, Vikas P, Friese C, Mavromatis B, Bijjula R, Zaman Q, Cheng A, Davis E, Duda S, Enriquez K, Gillaspie E, Hausrath D, Hsu C, Johnson D, Li X, Rini B, Slosky D, Shyr Y, Solorzano C, Sun T, Tucker M, Vega-Luna K, Wang L, Puc M, Carducci T, Goldsmith K, Van Loon S, Topaloglu U, Alimohamed S, Rice R, Cabalona W, Pilar C, Peddi P, Rosen L, McCollough B, Hafez N, Herbst R, LoRusso P, Masters T, Stratton C, Koshkin V, Kwon D, Peters S. Racial Disparities in COVID-19 Outcomes Among Black and White Patients With Cancer. JAMA Network Open 2022, 5: e224304. PMID: 35344045, PMCID: PMC8961318, DOI: 10.1001/jamanetworkopen.2022.4304.
Praluzatamab Ravtansine, a CD166-Targeting Antibody–Drug Conjugate, in Patients with Advanced Solid Tumors: An Open-Label Phase I/II Trial
Boni V, Fidler MJ, Arkenau HT, Spira A, Meric-Bernstam F, Uboha N, Sanborn RE, Sweis RF, LoRusso P, Nagasaka M, Garcia-Corbacho J, Jalal S, Harding JJ, Kim SK, Miedema IHC, Vugts DJ, Huisman MC, Zwezerijnen GJC, van Dongen GAMS, van Oordt C, Wang S, Dang T, Zein IA, Vasiljeva O, Lyman SK, Paton V, Hannah A, Liu JF. Praluzatamab Ravtansine, a CD166-Targeting Antibody–Drug Conjugate, in Patients with Advanced Solid Tumors: An Open-Label Phase I/II Trial. Clinical Cancer Research 2022, 28: 2020-2029. PMID: 35165101, PMCID: PMC9365353, DOI: 10.1158/1078-0432.ccr-21-3656.
Assessment of Regional Variability in COVID-19 Outcomes Among Patients With Cancer in the United States
Hawley J, Sun T, Chism D, Duma N, Fu J, Gatson N, Mishra S, Nguyen R, Reid S, Serrano O, Singh S, Venepalli N, Bakouny Z, Bashir B, Bilen M, Caimi P, Choueiri T, Dawsey S, Fecher L, Flora D, Friese C, Glover M, Gonzalez C, Goyal S, Halfdanarson T, Hershman D, Khan H, Labaki C, Lewis M, McKay R, Messing I, Pennell N, Puc M, Ravindranathan D, Rhodes T, Rivera A, Roller J, Schwartz G, Shah S, Shaya J, Streckfuss M, Thompson M, Wulff-Burchfield E, Xie Z, Yu P, Warner J, Shah D, French B, Hwang C, Halmos B, Verma A, Gartrell B, Goel S, Ohri N, Sica R, Thakkar A, Stockerl-Goldstein K, Butt O, Campian J, Fiala M, Henderson J, Monahan R, Zhou A, Thompson M, Bohachek P, Mundt D, Streckfuss M, Tadesse E, Lammers P, Panagiotou O, Egan P, Farmakiotis D, Khan H, Olszewski A, Loaiza-Bonilla A, Del Prete S, Bar M, Gulati A, Steve Lo K, Rose S, Stratton J, Weinstein P, Caimi P, Barnholtz-Sloan J, Garcia J, Nakayama J, Gupta S, Pennell N, Ahluwalia M, Dawsey S, Lemmon C, Nizam A, Hoppenot C, Li A, Choueiri T, Bakouny Z, Bouchard G, Busser F, Connors J, Curran C, Demetri G, Giordano A, Kelleher K, Nohria A, Schmidt A, Shaw G, Van Allen E, Nuzzo P, Xu V, Zon R, Zhang T, Halabi S, Leighton J, Lyman G, Graber J, Grivas P, Khaki A, Loggers E, Lynch R, Nakasone E, Schweizer M, Tachiki L, Vinayak S, Wagner M, Yeh A, Gatson N, Goyal S, Huynh-Le M, Rosenstein L, Yu P, Clement J, Daher A, Dailey M, Elias R, Jayaraj A, Hsu E, Menendez A, Rathmann J, Serrano O, Hwang C, Gadgeel S, Singh S, Hawley J, Hershman D, Accordino M, Bhutani D, Schwartz G, Reuben D, Alexander M, Mushtaq S, Bernicker E, Deeken J, Shafer D, Lewis M, Rhodes T, Gill D, Low C, Mashru S, Mansoor A, Zaren H, Smith S, Nagaraj G, Akhtari M, Lau E, Reeves M, Berg S, Elms D, Morgans A, Wehbe F, Altman J, Gurley M, Mulcahy M, Durbin E, Kulkarni A, Nelson H, Sachs Z, Shah S, Rosovsky R, Reynolds K, Bardia A, Boland G, Gainor J, Zubiri L, Halfdanarson T, Bekaii-Saab T, Desai A, Xie Z, Mesa R, Bonnen M, Mahadevan D, Ramirez A, Salazar M, Shah D, Shah P, Faller B, McKay R, Ajmera A, Brouha S, Cabal A, Hsiao A, Kligerman S, Shaya J, Weissmann L, Jani C, Thomson C, Knoble J, Glace M, Rink C, Stauffer K, Zacks R, Blau S, Joshi M, Menon H, Rovito M, Griffiths E, Elshoury A, Jabbour S, Misdary C, Shah M, Bashir B, McNair C, Mahmood S, Mico V, Rivera A, Flora D, Logan B, Kloecker G, Mandapakala C, Shah S, Cabebe E, Glover M, Jha A, Schapira L, Wu J, Subbiah S, Lopes G, Revankar S, Stover D, Addison D, Chen J, Gatti-Mays M, Jhawar S, Karivedu V, Lustberg M, Palmer J, Wall S, Williams N, Wulff-Burchfield E, Kasi A, Edwin N, Smits M, Chism D, Owenby S, Doroshow D, Galsky M, Wotman M, Zhu H, Fu J, Fazio A, Sueyoshi M, Huber K, Riess J, Patel K, Rubinstein S, Wood W, Jensen C, Kumar V, Wise-Draper T, Ahmad S, Grover P, Gulati S, Kharofa J, Latif T, Marcum M, Park C, Shaikh H, Bowles D, Geiger C, Markham M, Bishnoi R, Russ A, Shah C, Acoba J, Rho Y, Feldman L, Hoskins K, Gantt G, Liu L, Khan M, Nguyen R, Pasquinelli M, Schwartz C, Venepalli N, Vikas P, Friese C, Fecher L, Mavromatis B, Bijjula R, Zaman Q, Warner J, Cheng A, Davis E, Duda S, Enriquez K, French B, Gillaspie E, Hennessy C, Hausrath D, Hsu C, Johnson D, Li X, Mishra S, Reid S, Rini B, Slosky D, Shyr Y, Solorzano C, Sun T, Tucker M, Vega-Luna K, Wang L, Kennecke H, Aboulafia D, Schroeder B, Puc M, Carducci T, Goldsmith K, Van Loon S, Topaloglu U, Alimohamed S, Rice R, Cabalona W, Pilar C, Peddi P, Rosen L, McCollough B, Bilen M, Ravindranathan D, Hafez N, Herbst R, LoRusso P, Masters T, Stratton C. Assessment of Regional Variability in COVID-19 Outcomes Among Patients With Cancer in the United States. JAMA Network Open 2022, 5: e2142046. PMID: 34982158, PMCID: PMC8728628, DOI: 10.1001/jamanetworkopen.2021.42046.
The impact of COVID-19 on cancer care and oncology clinical research: an experts’ perspective
Sessa C, Cortes J, Conte P, Cardoso F, Choueiri T, Dummer R, Lorusso P, Ottmann O, Ryll B, Mok T, Tempero M, Comis S, Oliva C, Peters S, Tabernero J. The impact of COVID-19 on cancer care and oncology clinical research: an experts’ perspective. ESMO Open 2021, 7: 100339. PMID: 34953404, PMCID: PMC8608656, DOI: 10.1016/j.esmoop.2021.100339.
Association Between Androgen Deprivation Therapy and Mortality Among Patients With Prostate Cancer and COVID-19
Schmidt A, Tucker M, Bakouny Z, Labaki C, Hsu C, Shyr Y, Armstrong A, Beer T, Bijjula R, Bilen M, Connell C, Dawsey S, Faller B, Gao X, Gartrell B, Gill D, Gulati S, Halabi S, Hwang C, Joshi M, Khaki A, Menon H, Morris M, Puc M, Russell K, Shah D, Shah N, Sharifi N, Shaya J, Schweizer M, Steinharter J, Wulff-Burchfield E, Xu W, Zhu J, Mishra S, Grivas P, Rini B, Warner J, Zhang T, Choueiri T, Gupta S, McKay R, Desai A, Cohen A, Olszewski A, Bardia A, Daher A, Brown A, Yeh A, Hsiao A, Cheng A, Zhou A, Beeghly-Fadiel A, Morgans A, Jha A, Menendez A, Fazio A, Nizam A, Ramirez A, Kulkarni A, Verma A, Elshoury A, Rivera A, Walden A, Piper-Vallillo A, Cook A, Li A, Cantrell A, Cabal A, Nohria A, Angevine A, Gulati A, Giordano A, Kasi A, Ajmera A, Elkrief A, Kariapper A, Loaiza-Bonilla A, Jayaraj A, Thakkar A, Russ A, Bashir B, Halmos B, Logan B, Wood B, Slawik B, Dixon B, French B, Routy B, Mavromatis B, Hayes-Lattin B, Barrow McCollough B, Fleissner B, Stith B, Wicher C, Schwartz C, Thomson C, Solorzano C, Granada C, Brown C, Hennessy C, Stratton C, Castellano C, Ang C, Mandapakala C, Wang C, Jani C, Su C, Misdary C, Chapman C, McNair C, Lemmon C, Geiger C, Friese C, Su C, McKeown C, Hoppenot C, Low C, Pillainayagam C, Ferrario C, Rock C, Gonzalez Gomez C, Masson C, Mundt D, Addison D, Flora D, Stover D, Kwon D, Hausrath D, Bowles D, Reuben D, Shafer D, Bitterman D, O' Sullivan D, Mahadevan D, Sohal D, Whaley D, Slosky D, Chism D, Hershman D, Doroshow D, Ravindranathan D, Farmakiotis D, Bhutani D, Vinh D, Freeman D, Johnson D, Hatton E, Van Allen E, Griffiths E, Davis E, Nakasone E, Loggers E, Robilotti E, Levine E, Cabebe E, Hsu E, Powell E, Nemecek E, Lau E, Durbin E, Bernicker E, Small E, Cook E, Gillaspie E, Reid E, Papadopoulos E, Tadesse E, Wehbe F, Lyman G, Schwartz G, Nagaraj G, Boland G, Demetri G, Batist G, Gantt Jr. G, Kloecker G, Shaw G, Riely G, Borno H, Saker H, Dzimitrowicz H, Nelson H, Khan H, Shaikh H, Polimera H, Chen J, Stratton J, Acoba J, Patel J, Connors J, Mather J, Henderson J, Dill J, Girard J, Warner J, Graber J, Papenburg J, Altman J, Hawley J, Clement J, Park J, Campian J, Philip J, Deeken J, Riess J, Rosenberg J, Loree J, Senefeld J, Kharofa J, Garcia J, Palmer J, Lewis J, Guido J, Fu J, Wu J, Jiang J, Gainor J, Klamerus J, Steve Lo K, Patel K, de Cardenas K, Vega-Luna K, Goldsmith K, Hansen K, Huber K, Stockerl-Goldstein K, Jeffords K, Hoskins K, Reynolds K, Cerrone K, Cortez K, Enriquez K, Rosen L, Lashley L, Pomerantz L, Smith L, Feldman L, Fecher L, Zubiri L, Liu L, Schapira L, Tachiki L, Weissmann L, Rosenstein L, Wang L, Tomasini M, Abidi M, Khan M, Shah M, Rovito M, Gatti-Mays M, Escobedo M, Alexander M, Bonnen M, Fiala M, Lewis M, Dailey M, Reeves M, Sueyoshi M, Portes M, Salazar M, Mulcahy M, Pasquinelli M, Lustberg M, Fiebach M, Luders M, Galsky M, Weiss M, Clark M, Smits M, Accordino M, Markham M, Gurley M, Thompson M, Bar M, Wagner M, Joyner M, Glover M, Wotman M, Braccioforte M, Marcum M, Seletyn M, Huynh-Le M, Santos Dutra M, Streckfuss M, Akhtari M, Gatson N, Bahadur N, Knox N, Edwin N, Pennell N, Bouganim N, Hafez N, Venepalli N, Williams N, Balanchivadze N, Ohri N, Butt O, Panagiotou O, Serrano O, Bohachek P, Egan P, Shah P, Caimi P, LoRusso P, Weinstein P, Yu P, Lammers P, Nuzzo P, Bindal P, Peddi P, Grover P, Zaman Q, Sica R, Rosovsky R, Elias R, Zon R, Gandhi R, Belenkaya R, Rice R, Buerki R, Herbst R, Mesa R, Lynch R, Nguyen R, Monahan R, Jhawar S, Alimohamed S, Jabbour S, Del Prete S, Mahmood S, Goel S, Revankar S, Matar S, Saif S, Mushtaq S, Wall S, Croessman S, Kligerman S, McWeeney S, Goyal S, Choi S, Brouha S, Taylor S, Vinayak S, Gadgeel S, Blau S, Hallmeyer S, Reid S, Williamson S, Fry S, May S, Berg S, Duda S, Greenland S, Murdock S, Subbiah S, Shah S, Shah S, Van Loon S, Ayre S, Owenby S, Rose S, Ahmad S, Zhang S, Latif T, Bekaii-Saab T, Cronin T, Nonato T, Rhodes T, Carducci T, Halfdanarson T, Sun T, Wise-Draper T, Masters T, Topaloglu U, Koshkin V, Mico V, Karivedu V, Walters W, Miller Jr. W, Li X, Rho Y, Xie Z, Sachs Z. Association Between Androgen Deprivation Therapy and Mortality Among Patients With Prostate Cancer and COVID-19. JAMA Network Open 2021, 4: e2134330. PMID: 34767021, PMCID: PMC8590166, DOI: 10.1001/jamanetworkopen.2021.34330.
Association of Convalescent Plasma Therapy With Survival in Patients With Hematologic Cancers and COVID-19
Thompson M, Henderson J, Shah P, Rubinstein S, Joyner M, Choueiri T, Flora D, Griffiths E, Gulati A, Hwang C, Koshkin V, Papadopoulos E, Robilotti E, Su C, Wulff-Burchfield E, Xie Z, Yu P, Mishra S, Senefeld J, Shah D, Warner J, Halmos B, Verma A, Gartrell B, Goel S, Ohri N, Sica R, Thakkar A, Stockerl-Goldstein K, Butt O, Campian J, Fiala M, Monahan R, Zhou A, Bohachek P, Mundt D, Streckfuss M, Tadesse E, Lammers P, Revankar S, Panagiotou O, Egan P, Farmakiotis D, Khan H, Olszewski A, Loaiza-Bonilla A, Del Prete S, Angevine A, Bar M, Lo K, Stratton J, Weinstein P, Caimi P, Barnholtz-Sloan J, Garcia J, Nakayama J, Gupta S, Pennell N, Ahluwalia M, Dawsey S, Nizam A, Lemmon C, Hoppenot C, Li A, Bakouny Z, Bouchard G, Busser F, Conners J, Curran C, Demetri G, Giordano A, Kelleher K, Nohria A, Schmidt A, Shaw G, Van Allen E, Nuzzo P, Xu W, Zon R, Zhang T, Halabi S, Lyman G, Graber J, Grivas P, Khaki A, Loggers E, Lynch R, Nakasone E, Schweizer M, Tachiki L, Vinayak S, Wagner M, Yeh A, Gatson N, Goyal S, Huynh-Le M, Rosenstein L, Clement J, Daher A, Dailey M, Elias R, Hsu E, Menendez A, Rathmann J, Serrano O, Jayaraj A, Gadgeel S, Hawley J, Hershman D, Accordino M, Bhutani D, Schwartz G, Reuben D, Mushtaq S, Bernicker E, Deeken J, Shafer D, Lewis M, Rhodes T, Gill D, Low C, Nagle S, Hayes-Lattin B, McWeeney S, Nemecek E, Zaren H, Smith S, Nagaraj G, Akhtari M, Lau E, Reeves M, Berg S, Elms D, Morgans A, Wehbe F, Altman J, Gurley M, Mulcahy M, Durbin E, Kulkarni A, Nelson H, Shah S, Rosovsky R, Reynolds K, Bardia A, Boland G, Gainor J, Zubiri L, Halfdanarson T, Bekaii-Saab T, Desai A, Mesa R, Bonnen M, Mahadevan D, Ramirez A, Salazar M, Belenkaya R, Philip J, Riely G, Faller B, McKay R, Ajmera A, Cabal A, Shaya J, Weissmann L, Jani C, Chen J, Gatti-Mays M, Jhawar S, Lustberg M, Palmer J, Pillainayagam C, Stover D, Wall S, Williams N, Karivedu V, Addison D, Joshi M, Menon H, Rovito M, Elshoury A, Jabbour S, Shah M, Bashir B, Mahmood S, McNair C, Mico V, Rivera A, Miller C, Cabebe E, Glover M, Jha A, Schapira L, Shah S, Wu J, Subbiah S, Logan B, Kloecker G, Lopes G, Russell K, Stith B, Smits M, Edwin N, Chism D, Owenby S, Doroshow D, Galsky M, Zhu H, Fu J, Fazio A, Patel K, Riess J, Kwon D, Kumar V, Islam J, Wood W, Ahmad S, Grover P, Gulati S, Kharofa J, Marcum M, Park C, Wise-Draper T, Bowles D, Geiger C, Bishnoi R, Markham M, Shah C, Acoba J, Rho Y, Feldman L, Hoskins K, Gantt G, Khan M, Nguyen R, Pasquinelli M, Schwartz C, Venepalli N, Vikas P, Kasi A, Fecher L, Friese C, Mavromatis B, Zaman Q, Bijjula R, Cheng A, Davis E, French B, Gillaspie E, Hausrath D, Hennessy C, Hsu C, Johnson D, Li X, Reid S, Rini B, Shyr Y, Slosky D, Solorzano C, Tucker M, Vega-Luna K, Wang L, Enriquez K, Sun T, Carducci T, Puc M, Van Loon S, Goldsmith K, Rice R, Cabalona W, Pilar C, Barrow McCollough B, Peddi P, Rosen L, Bilen M, Ravindranathan D, Hafez N, Herbst R, LoRusso P, Masters T, Stratton C. Association of Convalescent Plasma Therapy With Survival in Patients With Hematologic Cancers and COVID-19. JAMA Oncology 2021, 7: 1167-1175. PMID: 34137799, PMCID: PMC8377563, DOI: 10.1001/jamaoncol.2021.1799.
Phase 1 Study of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (ETCTN-9844)
Roussos Torres ET, Rafie C, Wang C, Lim D, Brufsky A, LoRusso P, Eder JP, Chung V, Downs M, Geare M, Piekarz R, Streicher H, Anforth L, Rudek MA, Zhu Q, Besharati S, Cimino-Mathews A, Anders RA, Stearns V, Jaffee EM, Connolly RM. Phase 1 Study of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (ETCTN-9844). Clinical Cancer Research 2021, 27: clincanres.5017.2021. PMID: 34135021, PMCID: PMC8563383, DOI: 10.1158/1078-0432.ccr-20-5017.
Improved methods for RNAseq-based alternative splicing analysis
Halperin RF, Hegde A, Lang JD, Raupach EA, Legendre C, Liang W, LoRusso P, Sekulic A, Sosman J, Trent J, Rangasamy S, Pirrotte P, Schork N. Improved methods for RNAseq-based alternative splicing analysis. Scientific Reports 2021, 11: 10740. PMID: 34031440, PMCID: PMC8144374, DOI: 10.1038/s41598-021-89938-2.
Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation
Kim J, Cardin DB, Vaishampayan UN, Kato S, Grossman SR, Glazer P, Shyr Y, Ivy SP, LoRusso P. Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation. The Oncologist 2021, 26: e1104-e1109. PMID: 33742489, PMCID: PMC8265343, DOI: 10.1002/onco.13758.
A Systematic Framework to Rapidly Obtain Data on Patients with Cancer and COVID-19:CCC19 Governance, Protocol, and Quality Assurance
Abidi M, Aboulafia D, Accordino M, Acoba J, Ahluwalia M, Ahmad S, Ajmera A, Alimohamed S, Altman J, Angevine A, Bakouny Z, Bar M, Bardia A, Barnholtz-Sloan J, Barrow McCollough B, Bashir B, Batist G, Bekaii-Saab T, Berg S, Bernicker E, Bhutani D, Bilen M, Bindal P, Bishnoi R, Blau S, Bohachek P, Boland G, Bonnen M, Bouchard G, Bouganim N, Bowles D, Busser F, Butt O, Cabal A, Cabalona W, Cabebe E, Caimi P, Campian J, Carducci T, Chen J, Cheng A, Chism D, Choueiri T, Clark M, Clement J, Connors J, Cook E, Curran C, Daher A, Dailey M, Davis E, Dawsey S, Deeken J, Del Prete S, Demetri G, Desai A, Doroshow D, Durbin E, Egan P, Elias R, Elkrief A, Elms D, Elshoury A, Faller B, Farmakiotis D, Fecher L, Feldman L, Ferrario C, Fiala M, Flora D, French B, Friese C, Fu J, Gadgeel S, Gainor J, Galsky M, Gantt G, Garcia J, Gartrell B, Gatti-Mays M, Gill D, Gillaspie E, Giordano A, Glace (, Glover M, Goel S, Graber J, Griffiths E, Grivas P, Grover P, Gulati A, Gulati S, Gupta S, Gurley M, Hafez N, Halabi S, Halfdanarson T, Halmos B, Hausrath D, Hawley J, Hennessy C, Herbst R, Hershman D, Hoppenot C, Hoskins K, Hoyo-Ulloa I, Hsu E, Hsu C, Hwang C, Islam J, Jabbour S, Jani C, Jha A, Jhawar S, Johnson D, Joshi M, Kasi A, Kelleher K, Kennecke H, Khaki A, Khan H, Khan M, Kharofa J, Kloecker G, Knoble J, Kulkarni A, Kumar V, Lammers P, Leighton J, Lemmon C, Lewis M, Li A, Li X, Liu S, Lo K, Loaiza-Bonilla A, Logan B, Loggers E, de Lima Lopes G, Loree J, LoRusso P, Low C, Lustberg M, Lyman G, Lynch R, Madhavan S, Mahadevan D, Mahmood S, Mansoor A, Marcum M, Markham M, Mashru S, Masters T, Mavromatis B, McKay R, McNair C, McWeeney S, Menendez A, Menon H, Mesa R, Mico V, Miller C, Mishra S, Monahan R, Morgans A, Mulcahy M, Mundt D, Mushtaq S, Nagaraj G, Nagle S, Nakasone E, Nakayama J, Nelson H, Nemecek E, Nguyen R, Nizam A, Nohria A, Nuzzo P, Ohri N, Olszewski A, Owenby S, Painter C, Palmer J, Panagiotou O, Park C, Pasquinelli M, Patel J, Patel K, Peddi P, Pennell N, Peters S, Pilar C, Pillainayagam C, Puc M, Ramirez A, Rathmann J, Ravindranathan D, Reid S, Reuben D, Revankar S, Reynolds K, Rho Y, Rhodes T, Rice R, Riess J, Rini B, Rink C, Rosen L, Rosenstein L, Rosovsky R, Routy B, Rovito M, Rubinstein S, Saif M, Salazar M, Santos Dutra M, Schapira L, Schmidt A, Schroeder B, Schwartz G, Schwartz C, Schweizer M, Serrano O, Shafer D, Shah P, Shah D, Shah M, Shah S, Shah C, Shaw G, Shaya J, Shyr Y, Slosky D, Smits M, Solorzano C, Stauffer K, Stockerl-Goldstein K, Stover D, Stratton J, Stratton C, Streckfuss M, Subbiah S, Tachiki L, Tadesse E, Thompson M, Topaloglu U, Tucker M, Van Allen E, Van Loon S, Vega-Luna K, Venepalli N, Verma A, Vikas P, Vinayak S, Vinh D, Wagner M, Wall S, Wang L, Warner J, Wehbe F, Weinstein P, Weiss M, Weissmann L, Wildes T, Williams N, Wise-Draper T, Wood W, Wu J, Wulff-Burchfield E, Xie Z, Xu W, Yeh A, Yu I, Yu P, Zacks R, Zaman Q, Zaren H, Zhang T, Zhou A, Zhu H, Zon R, Zubiri L. A Systematic Framework to Rapidly Obtain Data on Patients with Cancer and COVID-19:CCC19 Governance, Protocol, and Quality Assurance. Cancer Cell 2020, 38: 761-766. PMID: 33176160, PMCID: PMC7598547, DOI: 10.1016/j.ccell.2020.10.022.
7LBA Late Breaking Milademetan, an oral MDM2 inhibitor, in well-differentiated/ dedifferentiated liposarcoma: results from a phase 1 study in patients with solid tumors or lymphomas
Gounder M, Bauer T, Schwartz G, LoRusso P, Kumar P, Kato K, Tao B, Hong Y, Patel P, Hong D. 7LBA Late Breaking Milademetan, an oral MDM2 inhibitor, in well-differentiated/ dedifferentiated liposarcoma: results from a phase 1 study in patients with solid tumors or lymphomas. European Journal Of Cancer 2020, 138: s3-s4. DOI: 10.1016/s0959-8049(20)31080-7.
Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center
Hong D, Marcelo-Lewis K, LoRusso P. Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center. 2020, 71-83. DOI: 10.1007/978-3-030-47682-3_4.
Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study
Kuderer NM, Choueiri TK, Shah DP, Shyr Y, Rubinstein SM, Rivera DR, Shete S, Hsu CY, Desai A, de Lima Lopes G, Grivas P, Painter CA, Peters S, Thompson MA, Bakouny Z, Batist G, Bekaii-Saab T, Bilen MA, Bouganim N, Larroya MB, Castellano D, Del Prete SA, Doroshow DB, Egan PC, Elkrief A, Farmakiotis D, Flora D, Galsky MD, Glover MJ, Griffiths EA, Gulati AP, Gupta S, Hafez N, Halfdanarson TR, Hawley JE, Hsu E, Kasi A, Khaki AR, Lemmon CA, Lewis C, Logan B, Masters T, McKay RR, Mesa RA, Morgans AK, Mulcahy MF, Panagiotou OA, Peddi P, Pennell NA, Reynolds K, Rosen LR, Rosovsky R, Salazar M, Schmidt A, Shah SA, Shaya JA, Steinharter J, Stockerl-Goldstein KE, Subbiah S, Vinh DC, Wehbe FH, Weissmann LB, Wu JT, Wulff-Burchfield E, Xie Z, Yeh A, Yu PP, Zhou AY, Zubiri L, Mishra S, Lyman GH, Rini BI, Warner JL, Consortium C, Abidi M, Acoba J, Agarwal N, Ahmad S, Ajmera A, Altman J, Angevine A, Azad N, Bar M, Bardia A, Barnholtz-Sloan J, Barrow B, Bashir B, Belenkaya R, Berg S, Bernicker E, Bestvina C, Bishnoi R, Boland G, Bonnen M, Bouchard G, Bowles D, Busser F, Cabal A, Caimi P, Carducci T, Casulo C, Chen J, Clement J, Chism D, Cook E, Curran C, Daher A, Dailey M, Dahiya S, Deeken J, Demetri G, DiLullo S, Duma N, Elias R, Faller B, Fecher L, Feldman L, Friese C, Fu P, Fu J, Futreal A, Gainor J, Garcia J, Gill D, Gillaspie E, Giordano A, Glace G, Grothey A, Gulati S, Gurley M, Halmos B, Herbst R, Hershman D, Hoskins K, Jain R, Jabbour S, Jha A, Johnson D, Joshi M, Kelleher K, Kharofa J, Khan H, Knoble J, Koshkin V, Kulkarni A, Lammers P, Leighton J, Lewis M, Li X, Li A, Lo K, Loaiza-Bonilla A, LoRusso P, Low C, Lustberg M, Mahadevan D, Mansoor A, Marcum M, Markham M, Marshall C, Mashru S, Matar S, McNair C, McWeeney S, Mehnert J, Menendez A, Menon H, Messmer M, Monahan R, Mushtaq S, Nagaraj G, Nagle S, Naidoo J, Nakayama J, Narayan V, Nelson H, Nemecek E, Nguyen R, Nuzzo P, Oberstein P, Olszewski A, Owenby S, Pasquinelli M, Philip J, Prabhakaran S, Puc M, Ramirez A, Rathmann J, Revankar S, Rho Y, Rhodes T, Rice R, Riely G, Riess J, Rink C, Robilotti E, Rosenstein L, Routy B, Rovito M, Saif M, Sanyal A, Schapira L, Schwartz C, Serrano O, Shah M, Shah C, Shaw G, Shergill A, Shouse G, Soares H, Solorzano C, Srivastava P, Stauffer K, Stover D, Stratton J, Stratton C, Subbiah V, Tamimi R, Tannir N, Topaloglu U, Van Allen E, Van Loon S, Vega-Luna K, Venepalli N, Verma A, Vikas P, Wall S, Weinstein P, Weiss M, Wise-Draper T, Wood W, Xu W, Yackzan S, Zacks R, Zhang T, Zimmer A, West J. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. The Lancet 2020, 395: 1907-1918. PMID: 32473681, PMCID: PMC7255743, DOI: 10.1016/s0140-6736(20)31187-9.
Phase I Dose-Escalation and -Expansion Study of Telisotuzumab (ABT-700), an Anti–c-Met Antibody, in Patients with Advanced Solid Tumors
Strickler JH, LoRusso P, Salgia R, Kang YK, Yen C, Lin CC, Ansell P, Motwani M, Wong S, Yue H, Wang L, Reilly E, Afar D, Naumovski L, Ramanathan RK. Phase I Dose-Escalation and -Expansion Study of Telisotuzumab (ABT-700), an Anti–c-Met Antibody, in Patients with Advanced Solid Tumors. Molecular Cancer Therapeutics 2020, 19: 1210-1217. PMID: 32127466, DOI: 10.1158/1535-7163.mct-19-0529.
Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies
Falchook G, Rosen S, LoRusso P, Watts J, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita M, Cassaday R, Harb W, Peguero J, Smith DC, Piha-Paul SA, Szmulewitz R, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta A. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies. Clinical Cancer Research 2020, 26: 1247-1257. PMID: 31527168, PMCID: PMC7528620, DOI: 10.1158/1078-0432.ccr-18-4071.
A First-in-Human Phase I Study to Evaluate the ERK1/2 Inhibitor GDC-0994 in Patients with Advanced Solid Tumors
Varga A, Soria JC, Hollebecque A, LoRusso P, Bendell J, Huang SA, Wagle MC, Okrah K, Liu L, Murray E, Sanabria-Bohorquez SM, Tagen M, Dokainish H, Mueller L, Burris H. A First-in-Human Phase I Study to Evaluate the ERK1/2 Inhibitor GDC-0994 in Patients with Advanced Solid Tumors. Clinical Cancer Research 2020, 26: 1229-1236. PMID: 31848189, DOI: 10.1158/1078-0432.ccr-19-2574.
First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors
Piha-Paul SA, Sachdev JC, Barve M, LoRusso P, Szmulewitz R, Patel SP, Lara PN, Chen X, Hu B, Freise KJ, Modi D, Sood A, Hutti JE, Wolff J, O'Neil BH. First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors. Clinical Cancer Research 2019, 25: 6309-6319. PMID: 31420359, DOI: 10.1158/1078-0432.ccr-19-0578.
Phase I Study of the Indoleamine 2,3-Dioxygenase 1 (IDO1) Inhibitor Navoximod (GDC-0919) Administered with PD-L1 Inhibitor (Atezolizumab) in Advanced Solid Tumors
Jung KH, LoRusso P, Burris H, Gordon M, Bang YJ, Hellmann MD, Cervantes A, de Olza M, Marabelle A, Hodi FS, Ahn MJ, Emens LA, Barlesi F, Hamid O, Calvo E, McDermott D, Soliman H, Rhee I, Lin R, Pourmohamad T, Suchomel J, Tsuhako A, Morrissey K, Mahrus S, Morley R, Pirzkall A, Davis SL. Phase I Study of the Indoleamine 2,3-Dioxygenase 1 (IDO1) Inhibitor Navoximod (GDC-0919) Administered with PD-L1 Inhibitor (Atezolizumab) in Advanced Solid Tumors. Clinical Cancer Research 2019, 25: 3220-3228. PMID: 30770348, PMCID: PMC7980952, DOI: 10.1158/1078-0432.ccr-18-2740.
Phase I Study of AMG 337, a Highly Selective Small-molecule MET Inhibitor, in Patients with Advanced Solid Tumors
Hong DS, LoRusso P, Hamid O, Janku F, Kittaneh M, Catenacci DVT, Chan E, Bekaii-Saab T, Gadgeel S, Loberg RD, Amore BM, Hwang YC, Tang R, Ngarmchamnanrith G, Kwak EL. Phase I Study of AMG 337, a Highly Selective Small-molecule MET Inhibitor, in Patients with Advanced Solid Tumors. Clinical Cancer Research 2019, 25: 2403-2413. PMID: 30425090, PMCID: PMC6892342, DOI: 10.1158/1078-0432.ccr-18-1341.
A phase I dose-escalation and dose-expansion study of brontictuzumab in subjects with selected solid tumors
Ferrarotto R, Eckhardt G, Patnaik A, LoRusso P, Faoro L, Heymach J, Kapoun A, Xu L, Munster P. A phase I dose-escalation and dose-expansion study of brontictuzumab in subjects with selected solid tumors. Annals Of Oncology 2018, 29: 1561-1568. PMID: 29726923, DOI: 10.1093/annonc/mdy171.
A Phase I/Ib Study of Enzalutamide Alone and in Combination with Endocrine Therapies in Women with Advanced Breast Cancer
Schwartzberg LS, Yardley D, Elias A, Patel M, LoRusso P, Burris HA, Gucalp A, Peterson A, Blaney M, Steinberg J, Gibbons J, Traina TA. A Phase I/Ib Study of Enzalutamide Alone and in Combination with Endocrine Therapies in Women with Advanced Breast Cancer. Clinical Cancer Research 2017, 23: 4046-4054. PMID: 28280092, DOI: 10.1158/1078-0432.ccr-16-2339.
A Phase I–II Study of the Oral PARP Inhibitor Rucaparib in Patients with Germline BRCA1/2-Mutated Ovarian Carcinoma or Other Solid Tumors
Kristeleit R, Shapiro GI, Burris HA, Oza AM, LoRusso P, Patel MR, Domchek SM, Balmaña J, Drew Y, Chen LM, Safra T, Montes A, Giordano H, Maloney L, Goble S, Isaacson J, Xiao J, Borrow J, Rolfe L, Shapira-Frommer R. A Phase I–II Study of the Oral PARP Inhibitor Rucaparib in Patients with Germline BRCA1/2-Mutated Ovarian Carcinoma or Other Solid Tumors. Clinical Cancer Research 2017, 23: 4095-4106. PMID: 28264872, DOI: 10.1158/1078-0432.ccr-16-2796.
A Phase I Pharmacokinetic Study of Trastuzumab Emtansine (T-DM1) in Patients with Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
Li C, Agarwal P, Gibiansky E, Jin J, Dent S, Gonçalves A, Nijem I, Strasak A, Harle-Yge M, Chernyukhin N, LoRusso P, Girish S. A Phase I Pharmacokinetic Study of Trastuzumab Emtansine (T-DM1) in Patients with Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function. Clinical Pharmacokinetics 2016, 56: 1069-1080. PMID: 27995530, DOI: 10.1007/s40262-016-0496-y.
Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study
Nogova L, Sequist LV, Garcia J, Andre F, Delord JP, Hidalgo M, Schellens JH, Cassier PA, Camidge DR, Schuler M, Vaishampayan U, Burris H, Tian GG, Campone M, Wainberg ZA, Lim WT, LoRusso P, Shapiro GI, Parker K, Chen X, Choudhury S, Ringeisen F, Graus-Porta D, Porter D, Isaacs R, Buettner R, Wolf J. Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study. Journal Of Clinical Oncology 2016, 35: 157-165. PMID: 27870574, PMCID: PMC6865065, DOI: 10.1200/jco.2016.67.2048.
Antibody–Drug Conjugates (ADCs) in Clinical Development
McLaughlin J, LoRusso P. Antibody–Drug Conjugates (ADCs) in Clinical Development. 2016, 321-344. DOI: 10.1002/9781119060727.ch13.
Preclinical and first‐in‐human phase I studies of KW‐2450, an oral tyrosine kinase inhibitor with insulin‐like growth factor receptor‐1/insulin receptor selectivity
Schwartz GK, Dickson MA, LoRusso P, Sausville EA, Maekawa Y, Watanabe Y, Kashima N, Nakashima D, Akinaga S. Preclinical and first‐in‐human phase I studies of KW‐2450, an oral tyrosine kinase inhibitor with insulin‐like growth factor receptor‐1/insulin receptor selectivity. Cancer Science 2016, 107: 499-506. PMID: 26850678, PMCID: PMC4832855, DOI: 10.1111/cas.12906.
Clinical development of antibody–drug conjugates
Sewald N, Ramchandren R, LoRusso P. Clinical development of antibody–drug conjugates. 2015, 136-148. DOI: 10.4155/fseb2013.14.341.
48 Phase I Trials Today
Morgensztern D, LoRusso P, Boerner S, Herbst R, Eder J. 48 Phase I Trials Today. 2015, 661-676.e2. DOI: 10.1016/b978-1-4557-4066-6.00048-2.
AN INTEGRATED FRAMEWORK FOR REPORTING CLINICALLY RELEVANT BIOMARKERS FROM PAIRED TUMOR/NORMAL GENOMIC AND TRANSCRIPTOMIC SEQUENCING DATA IN SUPPORT OF CLINICAL TRIALS IN PERSONALIZED MEDICINE
Altman R, Dunker A, Hunter L, Ritchie M, Murray T, Klein T, NASSER S, KURDOGLU A, IZATT T, ALDRICH J, RUSSELL M, CHRISTOFORIDES A, TEMBE W, KIEFER J, CORNEVEAUX J, BYRON S, FORMAN K, ZUCCARO C, KEATS J, LORUSSO P, CARPTEN J, TRENT J, CRAIG D. AN INTEGRATED FRAMEWORK FOR REPORTING CLINICALLY RELEVANT BIOMARKERS FROM PAIRED TUMOR/NORMAL GENOMIC AND TRANSCRIPTOMIC SEQUENCING DATA IN SUPPORT OF CLINICAL TRIALS IN PERSONALIZED MEDICINE. Pacific Symposium On Biocomputing Pacific Symposium On Biocomputing 2014, 56-67. PMID: 25592568, DOI: 10.1142/9789814644730_0007.
Erratum to: Phase I study of PF-04691502, a small-molecule, oral, dual inhibitor of PI3K and mTOR, in patients with advanced cancer
Britten C, Adjei A, Millham R, Houk B, Borzillo G, Pierce K, Wainberg Z, LoRusso P. Erratum to: Phase I study of PF-04691502, a small-molecule, oral, dual inhibitor of PI3K and mTOR, in patients with advanced cancer. Investigational New Drugs 2014, 32: 575-575. DOI: 10.1007/s10637-014-0069-6.
Insulin growth factor receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic adrenocortical carcinoma
Naing A, LoRusso P, Fu S, Hong D, Chen H, Doyle L, Phan A, Habra M, Kurzrock R. Insulin growth factor receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic adrenocortical carcinoma. British Journal Of Cancer 2013, 108: 826-830. PMID: 23412108, PMCID: PMC3590681, DOI: 10.1038/bjc.2013.46.
Phase I study of humanized monoclonal antibody AVE1642 directed against the type 1 insulin-like growth factor receptor (IGF-1R), administered in combination with anticancer therapies to patients with advanced solid tumors
Macaulay V, Middleton M, Protheroe A, Tolcher A, Dieras V, Sessa C, Bahleda R, Blay J, LoRusso P, Mery-Mignard D, Soria J. Phase I study of humanized monoclonal antibody AVE1642 directed against the type 1 insulin-like growth factor receptor (IGF-1R), administered in combination with anticancer therapies to patients with advanced solid tumors. Annals Of Oncology 2012, 24: 784-791. PMID: 23104723, PMCID: PMC3574548, DOI: 10.1093/annonc/mds511.
Oral Chemotherapeutic Agents
Ogita S, LoRusso P, Li J. Oral Chemotherapeutic Agents. 2012, 1-37. DOI: 10.1002/9780470921920.edm132.
Reply to E.S. Wang et al
LoRusso P, Boerner S, Evelhoch J, Evelhoch J. Reply to E.S. Wang et al. Journal Of Clinical Oncology 2012, 30: 762-763. DOI: 10.1200/jco.2011.39.6895.
C-MET as a Novel Target for the Treatment of Renal Cell Carcinoma
Vankayala H, LoRusso P, Vaishampayan U. C-MET as a Novel Target for the Treatment of Renal Cell Carcinoma. 2012, 213-238. DOI: 10.1007/978-1-4614-2400-0_10.
Phase I dose-escalation study to determine the safety, pharmacokinetics and pharmacodynamics of brivanib alaninate in combination with full-dose cetuximab in patients with advanced gastrointestinal malignancies who have failed prior therapy
Garrett C, Siu L, El-Khoueiry A, Buter J, Rocha-Lima C, Marshall J, LoRusso P, Major P, Chemidlin J, Mokliatchouk O, Velasquez L, Hayes W, Feltquate D, Syed S, Ford S, Kollia G, Galbraith S, Nuyten D. Phase I dose-escalation study to determine the safety, pharmacokinetics and pharmacodynamics of brivanib alaninate in combination with full-dose cetuximab in patients with advanced gastrointestinal malignancies who have failed prior therapy. British Journal Of Cancer 2011, 105: 44-52. PMID: 21629245, PMCID: PMC3137402, DOI: 10.1038/bjc.2011.182.
Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study
Leal T, Remick S, Takimoto C, Ramanathan R, Davies A, Egorin M, Hamilton A, LoRusso P, Shibata S, Lenz H, Mier J, Sarantopoulos J, Mani S, Wright J, Ivy S, Neuwirth R, von Moltke L, Venkatakrishnan K, Mulkerin D. Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study. Cancer Chemotherapy And Pharmacology 2011, 68: 1439-1447. PMID: 21479634, PMCID: PMC3481841, DOI: 10.1007/s00280-011-1637-5.
Breast Cancer Rationally Designed Therapies
Burger A, LoRusso P. Breast Cancer Rationally Designed Therapies. 2011, 537-546. DOI: 10.1007/978-3-642-16483-5_6746.
A Phase I Study of the Pharmacokinetic and Safety Profiles of Oral Pazopanib With a High‐Fat or Low‐Fat Meal in Patients With Advanced Solid Tumors
Heath E, Chiorean E, Sweeney C, Hodge J, Lager J, Forman K, Malburg L, Arumugham T, Dar M, Suttle A, Gainer S, LoRusso P. A Phase I Study of the Pharmacokinetic and Safety Profiles of Oral Pazopanib With a High‐Fat or Low‐Fat Meal in Patients With Advanced Solid Tumors. Clinical Pharmacology & Therapeutics 2010, 88: 818-823. PMID: 20980999, DOI: 10.1038/clpt.2010.199.
Phase I Dose-Escalation and Pharmacokinetic Study of Dasatinib in Patients with Advanced Solid Tumors
Demetri G, Russo P, MacPherson I, Wang D, Morgan J, Brunton V, Paliwal P, Agrawal S, Voi M, Evans T. Phase I Dose-Escalation and Pharmacokinetic Study of Dasatinib in Patients with Advanced Solid Tumors. Clinical Cancer Research 2009, 15: 6232-6240. PMID: 19789325, DOI: 10.1158/1078-0432.ccr-09-0224.
In Reply
LoRusso P, Burris H, Jones S, Fleming R, Koch K. In Reply. Journal Of Clinical Oncology 2009, 27: 316-317. DOI: 10.1200/jco.2008.20.0758.
Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group
Ramanathan R, Egorin M, Takimoto C, Remick S, Doroshow J, LoRusso P, Mulkerin D, Grem J, Hamilton A, Murgo A, Potter D, Belani C, Hayes M, Peng B, Ivy S. Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group. Journal Of Clinical Oncology 2008, 26: 563-569. PMID: 18235115, DOI: 10.1200/jco.2007.11.0304.
Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group
Gibbons J, Egorin M, Ramanathan R, Fu P, Mulkerin D, Shibata S, Takimoto C, Mani S, LoRusso P, Grem J, Pavlick A, Lenz H, Flick S, Reynolds S, Lagattuta T, Parise R, Wang Y, Murgo A, Ivy S, Remick S. Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group. Journal Of Clinical Oncology 2008, 26: 570-576. PMID: 18235116, DOI: 10.1200/jco.2007.13.3819.
Chapter 47 Phase 1 Trials Today
LoRusso P, Bekele B, Boerner S, Davis D, Evelhoch J, Herbst R. Chapter 47 Phase 1 Trials Today. 2008, 553-570. DOI: 10.1016/b978-141603703-3.10047-0.
List of Contributing Authors
Aaronson S, Abbruzzese J, Abel E, Anderson K, Arrick B, Bafico A, Barbash O, Bast R, Baylin S, Bekele B, Bertino J, Boerner S, Bommer G, Borden E, Buchstaller J, Buetow K, Burman K, Calin G, Campisi J, Caprioli R, Carroll P, Chaurand P, Ashley J, Cleveland J, Collins J, Cortes J, Costello J, Cox J, Croce C, D'Andrea A, Davis D, Deberardinis R, Demasi J, Diehl J, Digiovanni J, Dorsey F, Egeblad M, Ekmekcioglu S, Evelhoch J, Fearon E, Febbo P, Feng Z, Fletcher C, Frankel A, Friedman D, Fury M, Gambhir S, Gazdar A, Girard L, Glick A, Gonzalez-Angulo A, Gray J, Greene K, Grimm E, Grumolato L, Guertin D, Hait W, Havrda M, Hennessy B, Herbst R, Houghton A, Houghton P, Howley P, Hu W, Hwu P, Israel M, Jacks T, Jorgensen C, Kantarjian H, Keith B, Kelsen D, Korn W, Kundra P, Kurzrock R, Lee J, Levine A, Li L, Lippman S, Littlepage L, Liu Y, Look T, Lorusso P, Malkin D, Margolin J, Matrisian L, Mccormick F, Mendelsohn J, Merghoub T, Mills G, Minna J, Morrison S, Morton C, Neckers L, Nevins J, Okino S, Pardoll D, Pawson T, Payne E, Pfister D, Polsky D, Poplack D, Posada J, Powis G, Quintana E, Quintás-Cardama A, Rabin K, Reimann J, Rubin E, Sabatini D, Sato M, Sausville E, Sen G, Shah M, Shames D, Shoemaker R, Sikic B, Silverman R, Simon M, Spellman P, Steeves M, Thompson C, Tonon G, Weinberg R, Welch D, Werb Z, Winslow M, Woodward W, Xiong H, Yaghoubi S, Yuspa S. List of Contributing Authors. 2008, vii-xiii. DOI: 10.1016/b978-141603703-3.10061-5.
Angiogenesis pathway inhibitors.
Herbst RS, LoRusso P, Isobe T, Hurwitz HI. Angiogenesis pathway inhibitors. Cancer Chemotherapy And Biological Response Modifiers 2005, 22: 225-45. PMID: 16110614, DOI: 10.1016/s0921-4410(04)22010-5.
The Role of Bisphosphonates in the Treatment of Skeletal Complications of Breast Cancer
El-Rayes B, LoRusso P. The Role of Bisphosphonates in the Treatment of Skeletal Complications of Breast Cancer. American Journal Of Cancer 2004, 3: 369-375. DOI: 10.2165/00024669-200403060-00004.
Clinical Development Issues
Averbuch S, Wolf M, El‐Rayes B, LoRusso P. Clinical Development Issues. 2004, 287-306. DOI: 10.1002/047165616x.ch13.
In Vivo Methods for Screening and Preclinical Testing
Corbett T, Polin L, LoRusso P, Valeriote F, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lisow L. In Vivo Methods for Screening and Preclinical Testing. Cancer Drug Discovery And Development 2004, 99-123. DOI: 10.1007/978-1-59259-739-0_6.
Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition.
Albanell J, Rojo F, Averbuch S, Feyereislova A, Mascaro J, Herbst R, LoRusso P, Rischin D, Sauleda S, Gee J, Nicholson R, Baselga J. Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition. Journal Of Clinical Oncology 2002, 20: 110-24. PMID: 11773160, DOI: 10.1200/jco.2002.20.1.110.
Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients
Blum J, Dieras V, Russo P, Horton J, Rutman O, Buzdar A, Osterwalder B. Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients. Cancer 2001, 92: 1759-1768. PMID: 11745247, DOI: 10.1002/1097-0142(20011001)92:7<1759::aid-cncr1691>3.0.co;2-a.
Analysis of skeletal-related events in breast cancer and response to therapy
LoRusso P. Analysis of skeletal-related events in breast cancer and response to therapy. Seminars In Oncology 2001, 28: 22-27. PMID: 11544572, DOI: 10.1016/s0093-7754(01)90228-3.
Analysis of skeletal-related events in breast cancer and response to therapy
LoRusso P. Analysis of skeletal-related events in breast cancer and response to therapy. Seminars In Oncology 2001, 28: 22-27. DOI: 10.1053/sonc.2001.25437.
Chronic Oral Administration of CI-994: A Phase I Study
Prakash S, Foster B, Meyer M, Wozniak A, Heilbrun L, Flaherty L, Zalupski M, Radulovic L, Valdivieso M, LoRusso P. Chronic Oral Administration of CI-994: A Phase I Study. Investigational New Drugs 2001, 19: 1-11. PMID: 11291827, DOI: 10.1023/a:1006489328324.
Preclinical efficacy of thioxanthone SR271425 against transplanted solid tumors of mouse and human origin
Corbett T, Panchapor C, Polin L, Lowichik N, Pugh S, White K, Kushner J, Meyer J, Czarnecki J, Chinnukroh S, Edelstein M, LoRusso P, Heilbrun L, Horwitz J, Grieshaber C, Perni R, Wentland M, Coughlin S, Elenbaas S, Philion R, Rake J. Preclinical efficacy of thioxanthone SR271425 against transplanted solid tumors of mouse and human origin. Investigational New Drugs 1999, 17: 17-27. PMID: 10555119, DOI: 10.1023/a:1006267517726.
Accrual to Breast Cancer Clinical Trials at a University-Affiliated Hospital in Metropolitan Detroit
Simon M, Brown D, Du W, LoRusso P, Kellogg C. Accrual to Breast Cancer Clinical Trials at a University-Affiliated Hospital in Metropolitan Detroit. American Journal Of Clinical Oncology 1999, 22: 42-46. PMID: 10025379, DOI: 10.1097/00000421-199902000-00011.
Phase II study of CI-958 in colorectal cancer
Shields A, Philip P, LoRusso P, Ferris A, Zalupski M. Phase II study of CI-958 in colorectal cancer. Cancer Chemotherapy And Pharmacology 1999, 43: 162-164. PMID: 9923823, DOI: 10.1007/s002800050878.
Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer.
Blum J, Jones S, Buzdar A, LoRusso P, Kuter I, Vogel C, Osterwalder B, Burger H, Brown C, Griffin T. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. Journal Of Clinical Oncology 1999, 17: 485-93. PMID: 10080589, DOI: 10.1200/jco.1999.17.2.485.
Controlled‐release oxycodone compared with controlled‐release morphine in the treatment of cancer pain: A randomized, double‐blind, parallel‐group study
Mucci‐LoRusso P, Berman B, Silberstein P, Citron M, Bressler L, Weinstein S, Kaiko R, Buckley B, Reder R. Controlled‐release oxycodone compared with controlled‐release morphine in the treatment of cancer pain: A randomized, double‐blind, parallel‐group study. European Journal Of Pain 1998, 2: 239-249. PMID: 15102384, DOI: 10.1016/s1090-3801(98)90020-9.
Preclinical antitumor efficacy of analogs of XK469: sodium-(2-[4-(7-chloro-2-quinoxalinyloxy)phenoxy]propionate
Corbett T, LoRusso P, Demchick L, Simpson C, Pugh S, White K, Kushner J, Polin L, Meyer J, Czarnecki J, Heilbrun L, Horwitz J, Gross J, Behrens C, Harrison B, McRipley R, Trainor G. Preclinical antitumor efficacy of analogs of XK469: sodium-(2-[4-(7-chloro-2-quinoxalinyloxy)phenoxy]propionate. Investigational New Drugs 1998, 16: 129-139. PMID: 9848576, DOI: 10.1023/a:1006174622061.
Evaluation of pyrazoloacridine in patients with advanced pancreatic carcinoma
Zalupski M, Shields A, Philip P, Kraut M, LoRusso P, Heilbrun L, Vaitkevicius V. Evaluation of pyrazoloacridine in patients with advanced pancreatic carcinoma. Investigational New Drugs 1998, 16: 93-96. PMID: 9740550, DOI: 10.1023/a:1006087114621.
Treatment of human prostate tumors PC-3 and TSU-PR1 with standard and investigational agents in SCID mice
Polin L, Valeriote F, White K, Panchapor C, Pugh S, Knight J, LoRusso P, Hussain M, Liversidge E, Peltier N, Golakoti T, Patterson G, Moore R, Corbett T. Treatment of human prostate tumors PC-3 and TSU-PR1 with standard and investigational agents in SCID mice. Investigational New Drugs 1997, 15: 99-108. PMID: 9220288, DOI: 10.1023/a:1005856605726.
Phase II study of pyrazoloacridine in patients with advanced colorectal carcinoma
Zalupski M, Philip P, LoRusso P, Shields A. Phase II study of pyrazoloacridine in patients with advanced colorectal carcinoma. Cancer Chemotherapy And Pharmacology 1997, 40: 225-227. PMID: 9219505, DOI: 10.1007/s002800050650.
In Vivo Methods for Screening and Preclinical Testing
Corbett T, Valeriote F, LoRusso P, Polin L, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lisow L. In Vivo Methods for Screening and Preclinical Testing. Cancer Drug Discovery And Development 1997, 75-99. DOI: 10.1007/978-1-4615-8152-9_5.
Preclinical antitumor activity of CI-994
LoRusso P, Demchik L, Foster B, Knight J, Bissery M, Polin L, Leopold W, Corbett T. Preclinical antitumor activity of CI-994. Investigational New Drugs 1996, 14: 349-356. PMID: 9157069, DOI: 10.1007/bf00180810.
Preclinical anticancer activity of cryptophycin-8.
Corbett T, Valeriote F, Demchik L, Polin L, Panchapor C, Pugh S, White K, Knight J, Jones J, Jones L, LoRusso P, Foster B, Wiegand R, Lisow L, Golakoti T, Heltzel C, Ogino J, Patterson G, Moore R. Preclinical anticancer activity of cryptophycin-8. Journal Of Experimental Therapeutics And Oncology 1996, 1: 95-108. PMID: 9414393.
Levels of 5‐hydroxymethyl‐2′‐deoxyuridine in DNA from blood as a marker of breast cancer
Djuric Z, Heilbrun L, Simon M, Smith D, Luongo D, LoRusso P, Martino S. Levels of 5‐hydroxymethyl‐2′‐deoxyuridine in DNA from blood as a marker of breast cancer. Cancer 1996, 77: 691-696. PMID: 8616761, DOI: 10.1002/(sici)1097-0142(19960215)77:4<691::aid-cncr15>3.0.co;2-w.
Phase I clinical trial of pyrazoloacridine NSC366140 (PD115934).
LoRusso P, Foster B, Poplin E, McCormick J, Kraut M, Flaherty L, Heilbrun L, Valdivieso M, Baker L. Phase I clinical trial of pyrazoloacridine NSC366140 (PD115934). Clinical Cancer Research 1995, 1: 1487-93. PMID: 9815948.
Phase I trial of Adozelesin using the treatment schedule of daily × 5 every 3 weeks
Foster B, LoRusso P, Poplin E, Zalupski M, Valdivieso M, Wozniak A, Flaherty L, Kasunic D, Earhart R, Baker L. Phase I trial of Adozelesin using the treatment schedule of daily × 5 every 3 weeks. Investigational New Drugs 1995, 13: 321-326. PMID: 8824350, DOI: 10.1007/bf00873138.
Comparative efficacy of DMP 840 against mouse and human solid tumor models
LoRusso P, Demchik L, Dan M, Polin L, Gross J, Corbett T. Comparative efficacy of DMP 840 against mouse and human solid tumor models. Investigational New Drugs 1995, 13: 195-203. PMID: 8729946, DOI: 10.1007/bf00873800.
Tumor Models and the Discovery and Secondary Evaluation of Solid Tumor Active Agents
Corbett T, Valeriote F, Lorusso P, Polin L, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lowichik N, Biernat L, Foster B, Wozniak A, Lisow L, Valdivieso M, Baker L, Leopold W, Sebolt J, Bissery M, Mattes K, Dzubow J, Rake J, Perni R, Wentland M, Coughlin S, Shaw J, Liversidge G, Liversidge E, Bruno J, Sarpotdar P, Moore R, Patterson G. Tumor Models and the Discovery and Secondary Evaluation of Solid Tumor Active Agents. Pharmaceutical Biology 1995, 33: 102-122. DOI: 10.3109/13880209509067092.
Discovery of Anticancer Agents from Natural Products
Valeriote F, Corbett T, Lorusso P, Moore R, Scheuer P, Patterson G, Paul V, Grindey G, Bonjouklian R, Pearce H, Suffness M. Discovery of Anticancer Agents from Natural Products. Pharmaceutical Biology 1995, 33: 59-66. DOI: 10.3109/13880209509067088.
Antitumour activity of N-[[1-[[2-(diethylamino)ethyl]amino]-9-oxo-9H-thioxanthen-4-yl]methyl]methanesulfonamide (WIN33377) and analogues
Corbett T, Lowichik N, Pugh S, Polin L, Panchapor C, White K, Knight J, Demchik L, Jones J, Jones L, Biernat L, Lorusso P, Foster B, Heilbrun L, Rake J, Mattes K, Perni R, Powles R, Hlavac A, Wentland M, Coughlin S, Baker L, Valeriote F. Antitumour activity of N-[[1-[[2-(diethylamino)ethyl]amino]-9-oxo-9H-thioxanthen-4-yl]methyl]methanesulfonamide (WIN33377) and analogues. Expert Opinion On Investigational Drugs 1994, 3: 1281-1292. DOI: 10.1517/13543784.3.12.1281.
Randomized clinical trial of mitomycin-C with or without pretreatment with WR-2721 in patients with advanced colorectal cancer
Poplin E, LoRusso P, Lokich J, Gullo J, Leming P, Schulz J, Veach S, McCulloch W, Baker L, Schein P. Randomized clinical trial of mitomycin-C with or without pretreatment with WR-2721 in patients with advanced colorectal cancer. Cancer Chemotherapy And Pharmacology 1994, 33: 415-419. PMID: 8306416, DOI: 10.1007/bf00686271.
Immunohistologic evaluation of invasion-associated proteases in breast carcinoma.
Visscher D, Sarkar F, LoRusso P, Sakr W, Ottosen S, Wykes S, Crissman J. Immunohistologic evaluation of invasion-associated proteases in breast carcinoma. Modern Pathology 1993, 6: 302-6. PMID: 8346178.
Discovery of Solid Tumor Active Agents Using a Soft-Agar-Colony-Formation Disk-Diffusion-Assay
Corbett T, Valeriote F, Polin L, Panchapor C, Pugh S, White K, Lowichik N, Knight J, Bissery M, Wozniak A, LoRusso P, Biernat L, Polin D, Knight L, Biggar S, Looney D, Demchik L, Jones J, Jones L, Blair S, Palmer K, Essenmacher S, Lisow L, Mattes K, Cavanaugh P, Rake J, Baker L. Discovery of Solid Tumor Active Agents Using a Soft-Agar-Colony-Formation Disk-Diffusion-Assay. Developments In Oncology 1992, 35-87. DOI: 10.1007/978-1-4615-3492-1_3.
Antitumor efficacy of PD115934 (NSC 366140) against solid tumors of mice.
LoRusso P, Wozniak A, Polin L, Capps D, Leopold W, Werbel L, Biernat L, Dan M, Corbett T. Antitumor efficacy of PD115934 (NSC 366140) against solid tumors of mice. Cancer Research 1990, 50: 4900-5. PMID: 2165850.
Activity of datelliptium acetate (NSC 311152; SR 95156A) against solid tumors of mice
Mucci-LoRusso P, Polin L, Biernat L, Valeriote F, Corbett T. Activity of datelliptium acetate (NSC 311152; SR 95156A) against solid tumors of mice. Investigational New Drugs 1990, 8: 253-261. PMID: 2177044, DOI: 10.1007/bf00171834.
Low-Dose Continuous Infusion 5-Fluorouracil and Cisplatin
LoRusso P, Pazdur R, Redman B, Kinzie J, Vaitkevicius V. Low-Dose Continuous Infusion 5-Fluorouracil and Cisplatin. American Journal Of Clinical Oncology 1989, 12: 486-490. PMID: 2686394, DOI: 10.1097/00000421-198912000-00005.
Activity of batracylin (NSC-320846) against solid tumors of mice
Mucci-LoRusso P, Polin L, Bissery M, Valeriote F, Plowman J, Luk G, Corbettv T. Activity of batracylin (NSC-320846) against solid tumors of mice. Investigational New Drugs 1989, 7: 295-306. PMID: 2557298, DOI: 10.1007/bf00173759.
5-Fluorouracil containing combinations in murine tumor systems
Corbett T, Bissery M, Mucci-LoRusso P, Polin L. 5-Fluorouracil containing combinations in murine tumor systems. Investigational New Drugs 1989, 7: 37-49. PMID: 2661481, DOI: 10.1007/bf00178190.
Chemotherapy for paranasal sinus carcinoma. A 10‐year experience at Wayne state university
Lorusso P, Tapazoglou E, Kish J, Ensley J, Cummings G, Kelly J, Al‐Sarraf M. Chemotherapy for paranasal sinus carcinoma. A 10‐year experience at Wayne state university. Cancer 1988, 62: 1-5. PMID: 2454717, DOI: 10.1002/1097-0142(19880701)62:1<1::aid-cncr2820620102>3.0.co;2-f.

Departments and Programs

Locations

Smilow Cancer Hospital Phase I Unit

55 Park Street

Ste First Floor

New Haven, CT 06511

Directions

Smilow Cancer Hospital Phase I Unit
55 Park Street
Ste First Floor
New Haven, CT 06511
- Directions

View Academic Profile

Click here to view more about this specialist's research and educational efforts on https://medicine.yale.edu

Click here to view more about this specialist's research and educational efforts onhttps://medicine.yale.edu

Biography

Titles

Amy and Joseph Perella Professor of Medicine (Medical Oncology)
Chief, Experimental Therapeutics
Associate Cancer Center Director, Experimental Therapeutics

Education & Training

MA
Yale University (2015)
Fellowship
Wayne State University (1988)
Residency
Riverside Osteopathic Hospital (1984)
Internship
Riverside Osteopathic Hospital (1982)
DO
Michigan State University (1981)
BS
Marygrove College (1977)

Additional Information

Honors & Recognitions

Board Certifications

Publications

Targeted therapy for DNA damage response and homologous recombination repair defects: The Olaparib Combinations trial
Doroshow D, Shapiro G, Do K, Keedy V, Mahdi H, Sohal D, Hafez N, LoRusso P, Cecchini M, Sklar J, Mortimer P, Glover C, Moses J, Jürgensmeier J, Eder J. Targeted therapy for DNA damage response and homologous recombination repair defects: The Olaparib Combinations trial. Cancer 2026, 132: e70332. PMID: 41808580, DOI: 10.1002/cncr.70332.
FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational Trials.
Shord S, Chen C, Jin J, Van Wart S, Martin S, Davidson B, Liu J, LoRusso P, Oxnard G. FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational Trials. Clinical Cancer Research 2025, 31: 4891-4898. PMID: 41036557, PMCID: PMC12536354, DOI: 10.1158/1078-0432.ccr-25-0098.
FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Early Phase Trials Using Innovative Trial Designs and Biomarkers
Okusanya O, Patilea-Vrana G, Sireci A, Iasonos A, Davidson B, Liu J, Shord S, LoRusso P, Yap T. FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Early Phase Trials Using Innovative Trial Designs and Biomarkers. Clinical Cancer Research 2025, 31: 4882-4890. PMID: 41036631, PMCID: PMC12614637, DOI: 10.1158/1078-0432.ccr-25-1918.
FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Dosages for First-in-Human Trials.
Zhu H, Phipps A, Yuan Y, Davidson B, Shord S, Liu J, LoRusso P. FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Dosages for First-in-Human Trials. Clinical Cancer Research 2025, 31: 4872-4881. PMID: 41036712, DOI: 10.1158/1078-0432.ccr-25-0095.
High MGMT expression identifies aggressive colorectal cancer with distinct genomic features and immune evasion properties
Zhang J, Rajendran B, Desai S, Gibson J, DiPalermo J, LoRusso P, Kong Y, Zhao H, Cecchini M, Schalper K. High MGMT expression identifies aggressive colorectal cancer with distinct genomic features and immune evasion properties. Journal For ImmunoTherapy Of Cancer 2025, 13: e011653. PMID: 40935566, PMCID: PMC12506448, DOI: 10.1136/jitc-2025-011653.
First-in-Human Phase I/II Study of INCAGN01876, a Glucocorticoid-Induced Tumor Necrosis Factor Receptor Agonist, in Patients with Advanced or Metastatic Solid Tumors
Hamid O, Cardin D, Hodi F, LoRusso P, Merghoub T, Zappasodi R, Maniyar R, Janik J, van der Velden M, Zhou F, Dong Z, Chen X, Harding J. First-in-Human Phase I/II Study of INCAGN01876, a Glucocorticoid-Induced Tumor Necrosis Factor Receptor Agonist, in Patients with Advanced or Metastatic Solid Tumors. Clinical Cancer Research 2025, 31: 4089-4100. PMID: 40711469, PMCID: PMC12485371, DOI: 10.1158/1078-0432.ccr-24-4141.
Myeloid targeting antibodies PY159 and PY314 for platinum-resistant ovarian cancer
Yeku O, Barve M, Tan W, Wang J, Patnaik A, LoRusso P, Richardson D, Naqash A, Lynam S, Fu S, Gordon M, Hubbard J, Kummar S, Kyriakopoulos C, Dowlati A, Chamberlain M, Winer I. Myeloid targeting antibodies PY159 and PY314 for platinum-resistant ovarian cancer. Journal For ImmunoTherapy Of Cancer 2025, 13: e010959. PMID: 40081941, PMCID: PMC11907075, DOI: 10.1136/jitc-2024-010959.
Phase I dose-escalation and pharmacodynamic study of STING agonist E7766 in advanced solid tumors
Luke J, Pinato D, Juric D, LoRusso P, Hosein P, Desai A, Haddad R, de Miguel M, Cervantes A, Kim W, Marabelle A, Zhang Y, Rong Y, Yuan X, Champiat S. Phase I dose-escalation and pharmacodynamic study of STING agonist E7766 in advanced solid tumors. Journal For ImmunoTherapy Of Cancer 2025, 13: e010511. PMID: 39979069, PMCID: PMC11842995, DOI: 10.1136/jitc-2024-010511.
Nanrilkefusp alfa (SOT101), an IL-15 receptor βγ superagonist, as a single agent or with anti-PD-1 in patients with advanced cancers
Champiat S, Garralda E, Galvao V, Cassier P, Gomez-Roca C, Korakis I, Grell P, Naing A, LoRusso P, Mikyskova R, Podzimkova N, Reinis M, Ouali K, Schoenenberger A, Kiemle-Kallee J, Tillmanns S, Sachse R, Moebius U, Spisek R, Bechard D, Jelinkova L, Adkins I, Marabelle A. Nanrilkefusp alfa (SOT101), an IL-15 receptor βγ superagonist, as a single agent or with anti-PD-1 in patients with advanced cancers. Cell Reports Medicine 2025, 6: 101967. PMID: 39933529, PMCID: PMC11866505, DOI: 10.1016/j.xcrm.2025.101967.
Olaparib in treatment‐refractory isocitrate dehydrogenase 1 (IDH1)– and IDH2‐mutant cholangiocarcinoma: Safety and antitumor activity from the phase 2 National Cancer Institute 10129 trial
Cecchini M, Pilat M, Uboha N, Azad N, Cho M, Davis E, Ahnert J, Tinoco G, Shapiro G, Khagi S, Powers B, Spencer K, Groisberg R, Drappatz J, Chen L, Das B, Bao X, Li J, Narayan A, Vu D, Patel A, Niger M, Doroshow D, Durecki D, Boerner S, Bindra R, Ivy P, Shyr D, Shyr Y, LoRusso P. Olaparib in treatment‐refractory isocitrate dehydrogenase 1 (IDH1)– and IDH2‐mutant cholangiocarcinoma: Safety and antitumor activity from the phase 2 National Cancer Institute 10129 trial. Cancer 2025, 131: e35755-e35755. PMID: 39917990, PMCID: PMC11949439, DOI: 10.1002/cncr.35755.
Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial
Lopez J, Powles T, Braiteh F, Siu L, LoRusso P, Friedman C, Balmanoukian A, Gordon M, Yachnin J, Rottey S, Karydis I, Fisher G, Schmidt M, Schuler M, Sullivan R, Burris H, Galvao V, Henick B, Dirix L, Jaeger D, Ott P, Wong K, Jerusalem G, Schiza A, Fong L, Steeghs N, Leidner R, Rittmeyer A, Laurie S, Gort E, Aljumaily R, Melero I, Sabado R, Rhee I, Mancuso M, Muller L, Fine G, Yadav M, Kim L, Leveque V, Robert A, Darwish M, Qi T, Zhu J, Zhang J, Twomey P, Rao G, Low D, Petry C, Lo A, Schartner J, Delamarre L, Mellman I, Löwer M, Müller F, Derhovanessian E, Cortini A, Manning L, Maurus D, Brachtendorf S, Lörks V, Omokoko T, Godehardt E, Becker D, Hawner C, Wallrapp C, Albrecht C, Kröner C, Tadmor A, Diekmann J, Vormehr M, Jork A, Paruzynski A, Lang M, Blake J, Hennig O, Kuhn A, Sahin U, Türeci Ö, Camidge D. Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial. Nature Medicine 2025, 31: 152-164. PMID: 39762422, PMCID: PMC11750724, DOI: 10.1038/s41591-024-03334-7.
Financial Toxicity Among Patients With Advanced Solid Tumors Participating in Early-Phase Clinical Trials
Blanter J, Van Hyfte G, Ahmad M, Xu S, Hapanowicz O, Fazilov G, Lu A, Lucas N, Wu K, Shelton G, DeMerchant M, Lachowicz M, Kier M, Werner M, Eder J, Galsky M, Marron T, Smith C, LoRusso P, Hofstatter E, Doroshow D. Financial Toxicity Among Patients With Advanced Solid Tumors Participating in Early-Phase Clinical Trials. JCO Oncology Practice 2024, 21: 862-875. PMID: 39661920, PMCID: PMC12508792, DOI: 10.1200/op.24.00293.
First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP:TGF-ß1 complex, as monotherapy and in combination with the anti–PD-1 antibody budigalimab in patients with advanced solid tumors
Shimizu T, Powderly J, Razak A, LoRusso P, Miller K, Kao S, Kongpachith S, Tribouley C, Graham M, Stoll B, Patel M, Sahtout M, Blaney M, Leibman R, Golan T, Tolcher A. First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP:TGF-ß1 complex, as monotherapy and in combination with the anti–PD-1 antibody budigalimab in patients with advanced solid tumors. Frontiers In Oncology 2024, 14: 1376551. PMID: 39534099, PMCID: PMC11555770, DOI: 10.3389/fonc.2024.1376551.
Circulating Tumor DNA Dynamics Reveal KRAS G12C Mutation Heterogeneity and Response to Treatment with the KRAS G12C Inhibitor Divarasib in Solid Tumors
Choi Y, Dharia N, Jun T, Chang J, Royer-Joo S, Yau K, Assaf Z, Aimi J, Sivakumar S, Montesion M, Sacher A, LoRusso P, Desai J, Schutzman J, Shi Z, group A. Circulating Tumor DNA Dynamics Reveal KRAS G12C Mutation Heterogeneity and Response to Treatment with the KRAS G12C Inhibitor Divarasib in Solid Tumors. Clinical Cancer Research 2024, 30: of1-of10. PMID: 38995268, PMCID: PMC11369623, DOI: 10.1158/1078-0432.ccr-24-0255.
A Phase II Trial of the WEE1 Inhibitor Adavosertib in SETD2-Altered Advanced Solid Tumor Malignancies (NCI 10170)
Maldonado E, Rathmell W, Shapiro G, Takebe N, Rodon J, Mahalingam D, Trikalinos N, Kalebasty A, Parikh M, Boerner S, Balido C, Krings G, Burns T, Bergsland E, Munster P, Ashworth A, LoRusso P, Aggarwal R. A Phase II Trial of the WEE1 Inhibitor Adavosertib in SETD2-Altered Advanced Solid Tumor Malignancies (NCI 10170). Cancer Research Communications 2024, 4: 1793-1801. PMID: 38920407, PMCID: PMC11264598, DOI: 10.1158/2767-9764.crc-24-0213.
Author Correction: Inhibition of lysine acetyltransferase KAT6 in ER+HER2− metastatic breast cancer: a phase 1 trial
Mukohara T, Park Y, Sommerhalder D, Yonemori K, Hamilton E, Kim S, Kim J, Iwata H, Yamashita T, Layman R, Mita M, Clay T, Chae Y, Oakman C, Yan F, Kim G, Im S, Lindeman G, Rugo H, Liyanage M, Saul M, Le Corre C, Skoura A, Liu L, Li M, LoRusso P. Author Correction: Inhibition of lysine acetyltransferase KAT6 in ER+HER2− metastatic breast cancer: a phase 1 trial. Nature Medicine 2024, 30: 2371-2371. PMID: 38914862, PMCID: PMC11333270, DOI: 10.1038/s41591-024-03129-w.
Unlocking the Potential: Biomarkers of Response to Antibody-Drug Conjugates.
Ascione L, Guidi L, Prakash A, Trapani D, LoRusso P, Lou E, Curigliano G. Unlocking the Potential: Biomarkers of Response to Antibody-Drug Conjugates. American Society Of Clinical Oncology Educational Book 2024, 44: e431766. PMID: 38828973, DOI: 10.1200/edbk_431766.
Inhibition of lysine acetyltransferase KAT6 in ER+HER2− metastatic breast cancer: a phase 1 trial
Mukohara T, Park Y, Sommerhalder D, Yonemori K, Hamilton E, Kim S, Kim J, Iwata H, Yamashita T, Layman R, Mita M, Clay T, Chae Y, Oakman C, Yan F, Kim G, Im S, Lindeman G, Rugo H, Liyanage M, Saul M, Le Corre C, Skoura A, Liu L, Li M, LoRusso P. Inhibition of lysine acetyltransferase KAT6 in ER+HER2− metastatic breast cancer: a phase 1 trial. Nature Medicine 2024, 30: 2242-2250. PMID: 38824244, PMCID: PMC11333285, DOI: 10.1038/s41591-024-03060-0.
Efficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series
Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Macarulla T, Geng J, Li J, Teufel M, Märten A, LoRusso P. Efficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series. OncoTargets And Therapy 2024, 17: 267-280. PMID: 38567193, PMCID: PMC10986405, DOI: 10.2147/ott.s440979.
Circulating Tumor DNA Dynamics Fail to Predict Efficacy of Poly(ADP-ribose) Polymerase/VEGFR Inhibition in Patients With Heavily Pretreated Advanced Solid Tumors
Hu Y, Narayan A, Xu Y, Wolfe J, Vu D, Trinh T, Kantak C, Ivy S, Eder J, Deng Y, LoRusso P, Kim J, Patel A. Circulating Tumor DNA Dynamics Fail to Predict Efficacy of Poly(ADP-ribose) Polymerase/VEGFR Inhibition in Patients With Heavily Pretreated Advanced Solid Tumors. JCO Precision Oncology 2024, 8: e2300289. PMID: 38412387, PMCID: PMC10914240, DOI: 10.1200/po.23.00289.
Entinostat, nivolumab and ipilimumab for women with advanced HER2-negative breast cancer: a phase Ib trial
Roussos Torres E, Ho W, Danilova L, Tandurella J, Leatherman J, Rafie C, Wang C, Brufsky A, LoRusso P, Chung V, Yuan Y, Downs M, O’Connor A, Shin S, Hernandez A, Engle E, Piekarz R, Streicher H, Talebi Z, Rudek M, Zhu Q, Anders R, Cimino-Mathews A, Fertig E, Jaffee E, Stearns V, Connolly R. Entinostat, nivolumab and ipilimumab for women with advanced HER2-negative breast cancer: a phase Ib trial. Nature Cancer 2024, 5: 866-879. PMID: 38355777, PMCID: PMC11552660, DOI: 10.1038/s43018-024-00729-w.
Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103)
Garralda E, Oh Y, Italiano A, Bedard P, Delord J, Calvo E, LoRusso P, Wainberg Z, Cervantes A, Rodriguez‐Vida A, Shemesh C, Sane R, Mendus D, Ding H, Hendricks R, Meng R, Cho B, Kim T, Wu B. Pharmacokinetics (PK) of Tiragolumab in First‐in‐Human Study in Patients with Mixed Solid Tumors (GO30103). The Journal Of Clinical Pharmacology 2024, 64: 544-554. PMID: 38105505, DOI: 10.1002/jcph.2397.
The HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results
Lewis G, Li G, Guo J, Yu S, Fields C, Lee G, Zhang D, Dragovich P, Pillow T, Wei B, Sadowsky J, Leipold D, Wilson T, Kamath A, Mamounas M, Lee M, Saad O, Choeurng V, Ungewickell A, Monemi S, Crocker L, Kalinsky K, Modi S, Jung K, Hamilton E, LoRusso P, Krop I, Schutten M, Commerford R, Sliwkowski M, Cho E. The HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results. Nature Communications 2024, 15: 466. PMID: 38212321, PMCID: PMC10784567, DOI: 10.1038/s41467-023-44533-z.
NCI10066: a Phase 1/2 study of olaparib in combination with ramucirumab in previously treated metastatic gastric and gastroesophageal junction adenocarcinoma
Cecchini M, Cleary J, Shyr Y, Chao J, Uboha N, Cho M, Shields A, Pant S, Goff L, Spencer K, Kim E, Stein S, Kortmansky J, Canosa S, Sklar J, Swisher E, Radke M, Ivy P, Boerner S, Durecki D, Hsu C, LoRusso P, Lacy J. NCI10066: a Phase 1/2 study of olaparib in combination with ramucirumab in previously treated metastatic gastric and gastroesophageal junction adenocarcinoma. British Journal Of Cancer 2023, 130: 476-482. PMID: 38135713, PMCID: PMC10844282, DOI: 10.1038/s41416-023-02534-1.
Divarasib plus cetuximab in KRAS G12C-positive colorectal cancer: a phase 1b trial
Desai J, Alonso G, Kim S, Cervantes A, Karasic T, Medina L, Shacham-Shmueli E, Cosman R, Falcon A, Gort E, Guren T, Massarelli E, Miller W, Paz-Ares L, Prenen H, Amatu A, Cremolini C, Kim T, Moreno V, Ou S, Passardi A, Sacher A, Santoro A, Stec R, Ulahannan S, Arbour K, Lorusso P, Luo J, Patel M, Choi Y, Shi Z, Mandlekar S, Lin M, Royer-Joo S, Chang J, Jun T, Dharia N, Schutzman J, Han S. Divarasib plus cetuximab in KRAS G12C-positive colorectal cancer: a phase 1b trial. Nature Medicine 2023, 30: 271-278. PMID: 38052910, PMCID: PMC10803265, DOI: 10.1038/s41591-023-02696-8.
Anti-TIGIT Antibody Tiragolumab Alone or With Atezolizumab in Patients With Advanced Solid Tumors
Kim T, Bedard P, LoRusso P, Gordon M, Bendell J, Oh D, Ahn M, Garralda E, D’Angelo S, Desai J, Hodi F, Wainberg Z, Delord J, Cassier P, Cervantes A, Gil-Martin M, Wu B, Patil N, Jin Y, Hoang T, Mendus D, Wen X, Meng R, Cho B. Anti-TIGIT Antibody Tiragolumab Alone or With Atezolizumab in Patients With Advanced Solid Tumors. JAMA Oncology 2023, 9: 1574-1582. PMID: 37768658, PMCID: PMC10540058, DOI: 10.1001/jamaoncol.2023.3867.
Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation
Sacher A, LoRusso P, Patel M, Miller W, Garralda E, Forster M, Santoro A, Falcon A, Kim T, Paz-Ares L, Bowyer S, de Miguel M, Han S, Krebs M, Lee J, Cheng M, Arbour K, Massarelli E, Choi Y, Shi Z, Mandlekar S, Lin M, Royer-Joo S, Chang J, Dharia N, Schutzman J, Desai J. Single-Agent Divarasib (GDC-6036) in Solid Tumors with a KRAS G12C Mutation. The New England Journal Of Medicine 2023, 389: 710-721. PMID: 37611121, DOI: 10.1056/nejmoa2303810.
Platinum Sensitivity in IDH1/2 Mutated Intrahepatic Cholangiocarcinoma: Not All “BRCAness” Is Created Equal
Doroshow D, Wei W, Mehrotra M, Sia D, Eder J, Bindra R, Houldsworth J, LoRusso P, Walther Z. Platinum Sensitivity in IDH1/2 Mutated Intrahepatic Cholangiocarcinoma: Not All “BRCAness” Is Created Equal. Cancer Investigation 2023, 41: 646-655. PMID: 37505929, DOI: 10.1080/07357907.2023.2242957.
A Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors
Garralda E, Schram A, Bedard P, Schwartz G, Yuen E, McNeely S, Ribeiro S, Cunningham J, Wang Y, Urunuela A, Xu X, LoRusso P. A Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors. The Oncologist 2023, 29: e131-e140. PMID: 37531083, PMCID: PMC10769797, DOI: 10.1093/oncolo/oyad215.
A pilot study of volumetric and density tumor analysis of ACC patients treated with vorinostat in a phase II clinical trial
Malarkey M, Toscano A, Bagheri M, Solomon J, Machado L, LoRusso P, Chen A, Folio L, Goncalves P. A pilot study of volumetric and density tumor analysis of ACC patients treated with vorinostat in a phase II clinical trial. Heliyon 2023, 9: e18680. PMID: 37593628, PMCID: PMC10428039, DOI: 10.1016/j.heliyon.2023.e18680.
Quantitative DNA Repair Biomarkers and Immune Profiling for Temozolomide and Olaparib in Metastatic Colorectal Cancer
Cecchini M, Zhang J, Wei W, Sklar J, Lacy J, Zhong M, Kong Y, Zhao H, DiPalermo J, Devine L, Stein S, Kortmansky J, Johung K, Bindra R, LoRusso P, Schalper K. Quantitative DNA Repair Biomarkers and Immune Profiling for Temozolomide and Olaparib in Metastatic Colorectal Cancer. Cancer Research Communications 2023, 3: 1132-1139. PMID: 37387791, PMCID: PMC10305782, DOI: 10.1158/2767-9764.crc-23-0045.
NCI 7977: A Phase I Dose-Escalation Study of Intermittent Oral ABT-888 (Veliparib) Plus Intravenous Irinotecan Administered in Patients with Advanced Solid Tumors
Cecchini M, Walther Z, Wei W, Hafez N, Pilat M, Boerner S, Durecki D, Eder J, Schalper K, Chen A, LoRusso P. NCI 7977: A Phase I Dose-Escalation Study of Intermittent Oral ABT-888 (Veliparib) Plus Intravenous Irinotecan Administered in Patients with Advanced Solid Tumors. Cancer Research Communications 2023, 3: 1113-1117. PMID: 37377610, PMCID: PMC10292219, DOI: 10.1158/2767-9764.crc-22-0485.
The MDM2–p53 antagonist BI 907828 in patients with advanced or metastatic solid tumors: results of a phase Ia, first-in-human, dose-escalation study
LoRusso P, Yamamoto N, Patel M, Laurie S, Bauer T, Geng J, Davenport T, Teufel M, Li J, Lahmar M, Gounder M. The MDM2–p53 antagonist BI 907828 in patients with advanced or metastatic solid tumors: results of a phase Ia, first-in-human, dose-escalation study. Cancer Discovery 2023, 13: 1802-1813. PMID: 37269344, PMCID: PMC10401071, DOI: 10.1158/2159-8290.cd-23-0153.
First-in-human study of oleclumab, a potent, selective anti-CD73 monoclonal antibody, alone or in combination with durvalumab in patients with advanced solid tumors
Bendell J, LoRusso P, Overman M, Noonan A, Kim D, Strickler J, Kim S, Clarke S, George T, Grimison P, Barve M, Amin M, Desai J, Wise-Draper T, Eck S, Jiang Y, Khan A, Wu Y, Martin P, Cooper Z, Elgeioushi N, Mueller N, Kumar R, Patel S. First-in-human study of oleclumab, a potent, selective anti-CD73 monoclonal antibody, alone or in combination with durvalumab in patients with advanced solid tumors. Cancer Immunology, Immunotherapy 2023, 72: 2443-2458. PMID: 37016126, PMCID: PMC10264501, DOI: 10.1007/s00262-023-03430-6.
Multicenter Phase 2 Trial of the PARP Inhibitor Olaparib in Recurrent IDH1 and IDH2-Mutant Glioma
Fanucci K, Pilat M, Shyr D, Shyr Y, Boerner S, Li J, Durecki D, Drappatz J, Puduvalli V, Lieberman F, Gonzalez J, Giglio P, Ivy S, Bindra R, Omuro A, LoRusso P. Multicenter Phase 2 Trial of the PARP Inhibitor Olaparib in Recurrent IDH1 and IDH2-Mutant Glioma. Cancer Research Communications 2023, 3: 192-201. PMID: 36968138, PMCID: PMC10035510, DOI: 10.1158/2767-9764.crc-22-0436.
Phase Ia/Ib Study of BAY1895344 Plus Topoisomerase I Inhibitors with a Focus on Poorly Differentiated Neuroendocrine Carcinomas and Pancreatic Adenocarcinoma
Stockton S, Dan A, Cecchini M, Ajumaily R, Whisenant J, Gore S, Ivy P, LoRusso P, Berlin J, Das S. Phase Ia/Ib Study of BAY1895344 Plus Topoisomerase I Inhibitors with a Focus on Poorly Differentiated Neuroendocrine Carcinomas and Pancreatic Adenocarcinoma. Endocrine Abstracts 2023 DOI: 10.1530/endoabs.89.t1.
A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients With Advanced Liposarcoma, Solid Tumors, or Lymphomas
Gounder M, Bauer T, Schwartz G, Weise A, LoRusso P, Kumar P, Tao B, Hong Y, Patel P, Lu Y, Lesegretain A, Tirunagaru V, Xu F, Doebele R, Hong D. A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients With Advanced Liposarcoma, Solid Tumors, or Lymphomas. Journal Of Clinical Oncology 2023, 41: 1714-1724. PMID: 36669146, PMCID: PMC10022862, DOI: 10.1200/jco.22.01285.
Genome-wide analysis of aberrant position and sequence of plasma DNA fragment ends in patients with cancer
Budhraja K, McDonald B, Stephens M, Contente-Cuomo T, Markus H, Farooq M, Favaro P, Connor S, Byron S, Egan J, Ernst B, McDaniel T, Sekulic A, Tran N, Prados M, Borad M, Berens M, Pockaj B, LoRusso P, Bryce A, Trent J, Murtaza M. Genome-wide analysis of aberrant position and sequence of plasma DNA fragment ends in patients with cancer. Science Translational Medicine 2023, 15: eabm6863. PMID: 36630480, PMCID: PMC10080578, DOI: 10.1126/scitranslmed.abm6863.
Interplay of Immunosuppression and Immunotherapy Among Patients With Cancer and COVID-19
Bakouny Z, Labaki C, Grover P, Awosika J, Gulati S, Hsu C, Alimohamed S, Bashir B, Berg S, Bilen M, Bowles D, Castellano C, Desai A, Elkrief A, Eton O, Fecher L, Flora D, Galsky M, Gatti-Mays M, Gesenhues A, Glover M, Gopalakrishnan D, Gupta S, Halfdanarson T, Hayes-Lattin B, Hendawi M, Hsu E, Hwang C, Jandarov R, Jani C, Johnson D, Joshi M, Khan H, Khan S, Knox N, Koshkin V, Kulkarni A, Kwon D, Matar S, McKay R, Mishra S, Moria F, Nizam A, Nock N, Nonato T, Panasci J, Pomerantz L, Portuguese A, Provenzano D, Puc M, Rao Y, Rhodes T, Riely G, Ripp J, Rivera A, Ruiz-Garcia E, Schmidt A, Schoenfeld A, Schwartz G, Shah S, Shaya J, Subbiah S, Tachiki L, Tucker M, Valdez-Reyes M, Weissmann L, Wotman M, Wulff-Burchfield E, Xie Z, Yang Y, Thompson M, Shah D, Warner J, Shyr Y, Choueiri T, Wise-Draper T, Fromowitz A, Gandhi R, Gartrell B, Goel S, Halmos B, Makower D, O' Sullivan D, Ohri N, Portes M, Shapiro L, Shastri A, Sica R, Verma A, Butt O, Campian J, Fiala M, Henderson J, Monahan R, Stockerl-Goldstein K, Zhou A, Bitran J, Hallmeyer S, Mundt D, Pandravada S, Papaioannou P, Patel M, Streckfuss M, Tadesse E, Gatson N, Kundranda M, Lammers P, Loree J, Yu I, Bindal P, Lam B, Peters M, Piper-Vallillo A, Egan P, Farmakiotis D, Arvanitis P, Klein E, Olszewski A, Vieira K, Angevine A, Bar M, Del Prete S, Fiebach M, Gulati A, Hatton E, Houston K, Rose S, Steve Lo K, Stratton J, Weinstein P, Garcia J, Routy B, Hoyo-Ulloa I, Dawsey S, Lemmon C, Pennell N, Sharifi N, Painter C, Granada C, Hoppenot C, Li A, Bitterman D, Connors J, Demetri G, Florez (Duma) N, Freeman D, Giordano A, Morgans A, Nohria A, Saliby R, Tolaney S, Van Allen E, Xu W, Zon R, Halabi S, Zhang T, Dzimitrowicz H, Leighton J, Graber J, Grivas P, Hawley J, Loggers E, Lyman G, Lynch R, Nakasone E, Schweizer M, Vinayak S, Wagner M, Yeh A, Dansoa Y, Makary M, Manikowski J, Vadakara J, Yossef K, Beckerman J, Goyal S, Messing I, Rosenstein L, Steffes D, Alsamarai S, Clement J, Cosin J, Daher A, Dailey M, Elias R, Fein J, Hosmer W, Jayaraj A, Mather J, Menendez A, Nadkarni R, Serrano O, Yu P, Balanchivadze N, Gadgeel S, Accordino M, Bhutani D, Bodin B, Hershman D, Masson C, Alexander M, Mushtaq S, Reuben D, Bernicker E, Deeken J, Jeffords K, Shafer D, Cárdenas A, Cuervo Campos R, De-la-Rosa-Martinez D, Ramirez A, Vilar-Compte D, Gill D, Lewis M, Low C, Jones M, Mansoor A, Mashru S, Werner M, Cohen A, McWeeney S, Nemecek E, Williamson S, Peters S, Smith S, Lewis G, Zaren H, Akhtari M, Castillo D, Cortez K, Lau E, Nagaraj G, Park K, Reeves M, O'Connor T, Altman J, Gurley M, Mulcahy M, Wehbe F, Durbin E, Nelson H, Ramesh V, Sachs Z, Wilson G, Bardia A, Boland G, Gainor J, Peppercorn J, Reynolds K, Rosovsky R, Zubiri L, Bekaii-Saab T, Joyner M, Riaz I, Senefeld J, Shah S, Ayre S, Bonnen M, Mahadevan D, McKeown C, Mesa R, Ramirez A, Salazar M, Shah P, Wang C, Bouganim N, Papenburg J, Sabbah A, Tagalakis V, Vinh D, Nanchal R, Singh H, Bahadur N, Bao T, Belenkaya R, Nambiar P, O’Cearbhaill R, Papadopoulos E, Philip J, Robson M, Rosenberg J, Wilkins C, Tamimi R, Cerrone K, Dill J, Faller B, Alomar M, Chandrasekhar S, Hume E, Islam J, Ajmera A, Brouha S, Cabal A, Choi S, Hsiao A, Jiang J, Kligerman S, Park J, Razavi P, Reid E, Bhatt P, Mariano M, Thomson C, Glace M, Knoble J, Rink C, Zacks R, Blau S, Brown C, Cantrell A, Namburi S, Polimera H, Rovito M, Edwin N, Herz K, Kennecke H, Monfared A, Sautter R, Cronin T, Elshoury A, Fleissner B, Griffiths E, Hernandez-Ilizaliturri F, Jain P, Kariapper A, Levine E, Moffitt M, O'Connor T, Smith L, Wicher C, Zsiros E, Jabbour S, Misdary C, Shah M, Batist G, Cook E, Ferrario C, Lau S, Miller W, Rudski L, Santos Dutra M, Wilchesky M, Mahmood S, McNair C, Mico V, Dixon B, Kloecker G, Logan B, Mandapakala C, Cabebe E, Jha A, Khaki A, Nagpal S, Schapira L, Wu J, Whaley D, Lopes G, de Cardenas K, Russell K, Stith B, Taylor S, Klamerus J, Revankar S, Addison D, Chen J, Haynam M, Jhawar S, Karivedu V, Palmer J, Pillainayagam C, Stover D, Wall S, Williams N, Abbasi S, Annis S, Balmaceda N, Greenland S, Kasi A, Rock C, Luders M, Smits M, Weiss M, Chism D, Owenby S, Ang C, Doroshow D, Metzger M, Berenberg J, Uyehara C, Fazio A, Huber K, Lashley L, Sueyoshi M, Patel K, Riess J, Borno H, Small E, Zhang S, Andermann T, Jensen C, Rubinstein S, Wood W, Ahmad S, Brownfield L, Heilman H, Kharofa J, Latif T, Marcum M, Shaikh H, Sohal D, Abidi M, Geiger C, Markham M, Russ A, Saker H, Acoba J, Choi H, Rho Y, Feldman L, Gantt G, Hoskins K, Khan M, Liu L, Nguyen R, Pasquinelli M, Schwartz C, Venepalli N, Vikas P, Zakharia Y, Friese C, Boldt A, Gonzalez C, Su C, Su C, Yoon J, Bijjula R, Mavromatis B, Seletyn M, Wood B, Zaman Q, Kaklamani V, Beeghly A, Brown A, Charles L, Cheng A, Crispens M, Croessmann S, Davis E, Ding T, Duda S, Enriquez K, French B, Gillaspie E, Hausrath D, Hennessy C, Lewis J, Li X, Prescott L, Reid S, Saif S, Slosky D, Solorzano C, Sun T, Vega-Luna K, Wang L, Aboulafia D, Carducci T, Goldsmith K, Van Loon S, Topaloglu U, Moore J, Rice R, Cabalona W, Cyr S, Barrow McCollough B, Peddi P, Rosen L, Ravindranathan D, Hafez N, Herbst R, LoRusso P, Lustberg M, Masters T, Stratton C. Interplay of Immunosuppression and Immunotherapy Among Patients With Cancer and COVID-19. JAMA Oncology 2023, 9: 128-134. PMID: 36326731, PMCID: PMC9634600, DOI: 10.1001/jamaoncol.2022.5357.
Improving precision oncology through better designs and reporting of biomarker-driven randomized clinical trials
LoRusso P, Freidlin B. Improving precision oncology through better designs and reporting of biomarker-driven randomized clinical trials. Journal Of The National Cancer Institute 2022, 115: 122-124. PMID: 36448688, PMCID: PMC9905964, DOI: 10.1093/jnci/djac212.
A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance.
Yap T, LoRusso P, Wong D, Hu-Lieskovan S, Papadopoulos K, Holz J, Grabowska U, Gradinaru C, Leung K, Marshall S, Reader C, Russell R, Sainson R, Seal C, Shepherd C, Germaschewski F, Gliddon D, Stern O, Young L, Brewis N, Kayitalire L, Morrow M. A Phase 1 First-in-Human Study of FS118, a Tetravalent Bispecific Antibody Targeting LAG-3 and PD-L1 in Patients with Advanced Cancer and PD-L1 Resistance. Clinical Cancer Research 2022, 29: 888-898. PMID: 36342102, DOI: 10.1158/1078-0432.ccr-22-1449.
First in Human Phase 1/2 ICONIC Trial of the ICOS agonist vopratelimab alone and with nivolumab: ICOS high CD4 T cell populations and predictors of response
Yap TA, Gainor JF, Callahan MK, Falchook GS, Pachynski RK, LoRusso P, Kummar S, Gibney GT, Burris HA, Tykodi SS, Rahma OE, Seiwert TY, Papadopoulos KP, Murphy M, Park H, Hanson A, Hashambhoy-Ramsay Y, McGrath L, Hooper E, Xiao X, Cohen H, Fan M, Felitsky D, Hart C, McComb R, Brown K, Sepahi A, Jimenez J, Zhang W, Baeck J, Laken H, Murray R, Trehu E, Harvey CJ. First in Human Phase 1/2 ICONIC Trial of the ICOS agonist vopratelimab alone and with nivolumab: ICOS high CD4 T cell populations and predictors of response. Clinical Cancer Research 2022, 28: 3695-3708. PMID: 35511938, PMCID: PMC9433959, DOI: 10.1158/1078-0432.ccr-21-4256.
Racial Disparities in COVID-19 Outcomes Among Black and White Patients With Cancer
Fu J, Reid S, French B, Hennessy C, Hwang C, Gatson N, Duma N, Mishra S, Nguyen R, Hawley J, Singh S, Chism D, Venepalli N, Warner J, Choueiri T, Schmidt A, Fecher L, Girard J, Bilen M, Ravindranathan D, Goyal S, Wise-Draper T, Park C, Painter C, McGlown S, de Lima Lopes G, Serrano O, Shah D, Halmos B, Verma A, Gartrell B, Goel S, Ohri N, Sica R, Thakkar A, Stockerl-Goldstein K, Butt O, Campian J, Fiala M, Monahan R, Zhou A, Patel J, Piper-Vallillo A, Bindal P, Thompson M, Bohachek P, Mundt D, Streckfuss M, Tadesse E, Lammers P, Panagiotou O, Egan P, Farmakiotis D, Khan H, Olszewski A, Loaiza-Bonilla A, Del Prete S, Angevine A, Bar M, Gulati A, Steve Lo K, Stratton J, Weinstein P, Caimi P, Barnholtz-Sloan J, Garcia J, Nakayama J, Gupta S, Pennell N, Ahluwalia M, Dawsey S, Lemmon C, Nizam A, Hoppenot C, Li A, Bakouny Z, Bouchard G, Busser F, Connors J, Curran C, Demetri G, Giordano A, Kelleher K, Nohria A, Shaw G, Van Allen E, Nuzzo P, Xu V, Zon R, Zhang T, Halabi S, Leighton J, Lyman G, Graber J, Grivas P, Khaki A, Loggers E, Lynch R, Nakasone E, Schweizer M, Tachiki L, Vinayak S, Wagner M, Yeh A, Huynh-Le M, Rosenstein L, Yu P, Clement J, Daher A, Dailey M, Elias R, Jayaraj A, Hsu E, Menendez A, Rathmann J, Gadgeel S, Hershman D, Accordino M, Bhutani D, Schwartz G, Reuben D, Mushtaq S, Bernicker E, Deeken J, Shafer D, Lewis M, Rhodes T, Gill D, Low C, Mashru S, Mansoor A, Zaren H, Smith S, Nagaraj G, Akhtari M, Lau E, Reeves M, Berg S, Elms D, Morgans A, Wehbe F, Altman J, Gurley M, Mulcahy M, Durbin E, Kulkarni A, Nelson H, Shah S, Rosovsky R, Reynolds K, Bardia A, Boland G, Gainor J, Zubiri L, Halfdanarson T, Bekaii-Saab T, Desai A, Xie Z, Mesa R, Bonnen M, Mahadevan D, Ramirez A, Salazar M, Shah P, Faller B, McKay R, Ajmera A, Cabal A, Shaya J, Weissmann L, Jani C, Knoble J, Glace M, Rink C, Stauffer K, Zacks R, Joshi M, Menon H, Rovito M, Griffiths E, Elshoury A, Jabbour S, Shah M, Bashir B, McNair C, Mahmood S, Mico V, Miller C, Rivera A, Flora D, Logan B, Kloecker G, Mandapakala C, Shah S, Cabebe E, Glover M, Jha A, Schapira L, Wu J, Subbiah S, Revankar S, Stover D, Addison D, Chen J, Gatti-Mays M, Jhawar S, Karivedu V, Lustberg M, Palmer J, Pillainayagam C, Wall S, Williams N, Wulff-Burchfield E, Kasi A, Edwin N, Smits M, Owenby S, Doroshow D, Galsky M, Wotman M, Zhu H, Fazio A, Riess J, Patel K, Rubinstein S, Wood W, Islam J, Kumar V, Ahmad S, Grover P, Gulati S, Kharofa J, Marcum M, Bowles D, Geiger C, Markham M, Bishnoi R, Russ A, Shah C, Acoba J, Rho Y, Feldman L, Hoskins K, Gantt G, Khan M, Pasquinelli M, Schwartz C, Vikas P, Friese C, Mavromatis B, Bijjula R, Zaman Q, Cheng A, Davis E, Duda S, Enriquez K, Gillaspie E, Hausrath D, Hsu C, Johnson D, Li X, Rini B, Slosky D, Shyr Y, Solorzano C, Sun T, Tucker M, Vega-Luna K, Wang L, Puc M, Carducci T, Goldsmith K, Van Loon S, Topaloglu U, Alimohamed S, Rice R, Cabalona W, Pilar C, Peddi P, Rosen L, McCollough B, Hafez N, Herbst R, LoRusso P, Masters T, Stratton C, Koshkin V, Kwon D, Peters S. Racial Disparities in COVID-19 Outcomes Among Black and White Patients With Cancer. JAMA Network Open 2022, 5: e224304. PMID: 35344045, PMCID: PMC8961318, DOI: 10.1001/jamanetworkopen.2022.4304.
Praluzatamab Ravtansine, a CD166-Targeting Antibody–Drug Conjugate, in Patients with Advanced Solid Tumors: An Open-Label Phase I/II Trial
Boni V, Fidler MJ, Arkenau HT, Spira A, Meric-Bernstam F, Uboha N, Sanborn RE, Sweis RF, LoRusso P, Nagasaka M, Garcia-Corbacho J, Jalal S, Harding JJ, Kim SK, Miedema IHC, Vugts DJ, Huisman MC, Zwezerijnen GJC, van Dongen GAMS, van Oordt C, Wang S, Dang T, Zein IA, Vasiljeva O, Lyman SK, Paton V, Hannah A, Liu JF. Praluzatamab Ravtansine, a CD166-Targeting Antibody–Drug Conjugate, in Patients with Advanced Solid Tumors: An Open-Label Phase I/II Trial. Clinical Cancer Research 2022, 28: 2020-2029. PMID: 35165101, PMCID: PMC9365353, DOI: 10.1158/1078-0432.ccr-21-3656.
Assessment of Regional Variability in COVID-19 Outcomes Among Patients With Cancer in the United States
Hawley J, Sun T, Chism D, Duma N, Fu J, Gatson N, Mishra S, Nguyen R, Reid S, Serrano O, Singh S, Venepalli N, Bakouny Z, Bashir B, Bilen M, Caimi P, Choueiri T, Dawsey S, Fecher L, Flora D, Friese C, Glover M, Gonzalez C, Goyal S, Halfdanarson T, Hershman D, Khan H, Labaki C, Lewis M, McKay R, Messing I, Pennell N, Puc M, Ravindranathan D, Rhodes T, Rivera A, Roller J, Schwartz G, Shah S, Shaya J, Streckfuss M, Thompson M, Wulff-Burchfield E, Xie Z, Yu P, Warner J, Shah D, French B, Hwang C, Halmos B, Verma A, Gartrell B, Goel S, Ohri N, Sica R, Thakkar A, Stockerl-Goldstein K, Butt O, Campian J, Fiala M, Henderson J, Monahan R, Zhou A, Thompson M, Bohachek P, Mundt D, Streckfuss M, Tadesse E, Lammers P, Panagiotou O, Egan P, Farmakiotis D, Khan H, Olszewski A, Loaiza-Bonilla A, Del Prete S, Bar M, Gulati A, Steve Lo K, Rose S, Stratton J, Weinstein P, Caimi P, Barnholtz-Sloan J, Garcia J, Nakayama J, Gupta S, Pennell N, Ahluwalia M, Dawsey S, Lemmon C, Nizam A, Hoppenot C, Li A, Choueiri T, Bakouny Z, Bouchard G, Busser F, Connors J, Curran C, Demetri G, Giordano A, Kelleher K, Nohria A, Schmidt A, Shaw G, Van Allen E, Nuzzo P, Xu V, Zon R, Zhang T, Halabi S, Leighton J, Lyman G, Graber J, Grivas P, Khaki A, Loggers E, Lynch R, Nakasone E, Schweizer M, Tachiki L, Vinayak S, Wagner M, Yeh A, Gatson N, Goyal S, Huynh-Le M, Rosenstein L, Yu P, Clement J, Daher A, Dailey M, Elias R, Jayaraj A, Hsu E, Menendez A, Rathmann J, Serrano O, Hwang C, Gadgeel S, Singh S, Hawley J, Hershman D, Accordino M, Bhutani D, Schwartz G, Reuben D, Alexander M, Mushtaq S, Bernicker E, Deeken J, Shafer D, Lewis M, Rhodes T, Gill D, Low C, Mashru S, Mansoor A, Zaren H, Smith S, Nagaraj G, Akhtari M, Lau E, Reeves M, Berg S, Elms D, Morgans A, Wehbe F, Altman J, Gurley M, Mulcahy M, Durbin E, Kulkarni A, Nelson H, Sachs Z, Shah S, Rosovsky R, Reynolds K, Bardia A, Boland G, Gainor J, Zubiri L, Halfdanarson T, Bekaii-Saab T, Desai A, Xie Z, Mesa R, Bonnen M, Mahadevan D, Ramirez A, Salazar M, Shah D, Shah P, Faller B, McKay R, Ajmera A, Brouha S, Cabal A, Hsiao A, Kligerman S, Shaya J, Weissmann L, Jani C, Thomson C, Knoble J, Glace M, Rink C, Stauffer K, Zacks R, Blau S, Joshi M, Menon H, Rovito M, Griffiths E, Elshoury A, Jabbour S, Misdary C, Shah M, Bashir B, McNair C, Mahmood S, Mico V, Rivera A, Flora D, Logan B, Kloecker G, Mandapakala C, Shah S, Cabebe E, Glover M, Jha A, Schapira L, Wu J, Subbiah S, Lopes G, Revankar S, Stover D, Addison D, Chen J, Gatti-Mays M, Jhawar S, Karivedu V, Lustberg M, Palmer J, Wall S, Williams N, Wulff-Burchfield E, Kasi A, Edwin N, Smits M, Chism D, Owenby S, Doroshow D, Galsky M, Wotman M, Zhu H, Fu J, Fazio A, Sueyoshi M, Huber K, Riess J, Patel K, Rubinstein S, Wood W, Jensen C, Kumar V, Wise-Draper T, Ahmad S, Grover P, Gulati S, Kharofa J, Latif T, Marcum M, Park C, Shaikh H, Bowles D, Geiger C, Markham M, Bishnoi R, Russ A, Shah C, Acoba J, Rho Y, Feldman L, Hoskins K, Gantt G, Liu L, Khan M, Nguyen R, Pasquinelli M, Schwartz C, Venepalli N, Vikas P, Friese C, Fecher L, Mavromatis B, Bijjula R, Zaman Q, Warner J, Cheng A, Davis E, Duda S, Enriquez K, French B, Gillaspie E, Hennessy C, Hausrath D, Hsu C, Johnson D, Li X, Mishra S, Reid S, Rini B, Slosky D, Shyr Y, Solorzano C, Sun T, Tucker M, Vega-Luna K, Wang L, Kennecke H, Aboulafia D, Schroeder B, Puc M, Carducci T, Goldsmith K, Van Loon S, Topaloglu U, Alimohamed S, Rice R, Cabalona W, Pilar C, Peddi P, Rosen L, McCollough B, Bilen M, Ravindranathan D, Hafez N, Herbst R, LoRusso P, Masters T, Stratton C. Assessment of Regional Variability in COVID-19 Outcomes Among Patients With Cancer in the United States. JAMA Network Open 2022, 5: e2142046. PMID: 34982158, PMCID: PMC8728628, DOI: 10.1001/jamanetworkopen.2021.42046.
The impact of COVID-19 on cancer care and oncology clinical research: an experts’ perspective
Sessa C, Cortes J, Conte P, Cardoso F, Choueiri T, Dummer R, Lorusso P, Ottmann O, Ryll B, Mok T, Tempero M, Comis S, Oliva C, Peters S, Tabernero J. The impact of COVID-19 on cancer care and oncology clinical research: an experts’ perspective. ESMO Open 2021, 7: 100339. PMID: 34953404, PMCID: PMC8608656, DOI: 10.1016/j.esmoop.2021.100339.
Association Between Androgen Deprivation Therapy and Mortality Among Patients With Prostate Cancer and COVID-19
Schmidt A, Tucker M, Bakouny Z, Labaki C, Hsu C, Shyr Y, Armstrong A, Beer T, Bijjula R, Bilen M, Connell C, Dawsey S, Faller B, Gao X, Gartrell B, Gill D, Gulati S, Halabi S, Hwang C, Joshi M, Khaki A, Menon H, Morris M, Puc M, Russell K, Shah D, Shah N, Sharifi N, Shaya J, Schweizer M, Steinharter J, Wulff-Burchfield E, Xu W, Zhu J, Mishra S, Grivas P, Rini B, Warner J, Zhang T, Choueiri T, Gupta S, McKay R, Desai A, Cohen A, Olszewski A, Bardia A, Daher A, Brown A, Yeh A, Hsiao A, Cheng A, Zhou A, Beeghly-Fadiel A, Morgans A, Jha A, Menendez A, Fazio A, Nizam A, Ramirez A, Kulkarni A, Verma A, Elshoury A, Rivera A, Walden A, Piper-Vallillo A, Cook A, Li A, Cantrell A, Cabal A, Nohria A, Angevine A, Gulati A, Giordano A, Kasi A, Ajmera A, Elkrief A, Kariapper A, Loaiza-Bonilla A, Jayaraj A, Thakkar A, Russ A, Bashir B, Halmos B, Logan B, Wood B, Slawik B, Dixon B, French B, Routy B, Mavromatis B, Hayes-Lattin B, Barrow McCollough B, Fleissner B, Stith B, Wicher C, Schwartz C, Thomson C, Solorzano C, Granada C, Brown C, Hennessy C, Stratton C, Castellano C, Ang C, Mandapakala C, Wang C, Jani C, Su C, Misdary C, Chapman C, McNair C, Lemmon C, Geiger C, Friese C, Su C, McKeown C, Hoppenot C, Low C, Pillainayagam C, Ferrario C, Rock C, Gonzalez Gomez C, Masson C, Mundt D, Addison D, Flora D, Stover D, Kwon D, Hausrath D, Bowles D, Reuben D, Shafer D, Bitterman D, O' Sullivan D, Mahadevan D, Sohal D, Whaley D, Slosky D, Chism D, Hershman D, Doroshow D, Ravindranathan D, Farmakiotis D, Bhutani D, Vinh D, Freeman D, Johnson D, Hatton E, Van Allen E, Griffiths E, Davis E, Nakasone E, Loggers E, Robilotti E, Levine E, Cabebe E, Hsu E, Powell E, Nemecek E, Lau E, Durbin E, Bernicker E, Small E, Cook E, Gillaspie E, Reid E, Papadopoulos E, Tadesse E, Wehbe F, Lyman G, Schwartz G, Nagaraj G, Boland G, Demetri G, Batist G, Gantt Jr. G, Kloecker G, Shaw G, Riely G, Borno H, Saker H, Dzimitrowicz H, Nelson H, Khan H, Shaikh H, Polimera H, Chen J, Stratton J, Acoba J, Patel J, Connors J, Mather J, Henderson J, Dill J, Girard J, Warner J, Graber J, Papenburg J, Altman J, Hawley J, Clement J, Park J, Campian J, Philip J, Deeken J, Riess J, Rosenberg J, Loree J, Senefeld J, Kharofa J, Garcia J, Palmer J, Lewis J, Guido J, Fu J, Wu J, Jiang J, Gainor J, Klamerus J, Steve Lo K, Patel K, de Cardenas K, Vega-Luna K, Goldsmith K, Hansen K, Huber K, Stockerl-Goldstein K, Jeffords K, Hoskins K, Reynolds K, Cerrone K, Cortez K, Enriquez K, Rosen L, Lashley L, Pomerantz L, Smith L, Feldman L, Fecher L, Zubiri L, Liu L, Schapira L, Tachiki L, Weissmann L, Rosenstein L, Wang L, Tomasini M, Abidi M, Khan M, Shah M, Rovito M, Gatti-Mays M, Escobedo M, Alexander M, Bonnen M, Fiala M, Lewis M, Dailey M, Reeves M, Sueyoshi M, Portes M, Salazar M, Mulcahy M, Pasquinelli M, Lustberg M, Fiebach M, Luders M, Galsky M, Weiss M, Clark M, Smits M, Accordino M, Markham M, Gurley M, Thompson M, Bar M, Wagner M, Joyner M, Glover M, Wotman M, Braccioforte M, Marcum M, Seletyn M, Huynh-Le M, Santos Dutra M, Streckfuss M, Akhtari M, Gatson N, Bahadur N, Knox N, Edwin N, Pennell N, Bouganim N, Hafez N, Venepalli N, Williams N, Balanchivadze N, Ohri N, Butt O, Panagiotou O, Serrano O, Bohachek P, Egan P, Shah P, Caimi P, LoRusso P, Weinstein P, Yu P, Lammers P, Nuzzo P, Bindal P, Peddi P, Grover P, Zaman Q, Sica R, Rosovsky R, Elias R, Zon R, Gandhi R, Belenkaya R, Rice R, Buerki R, Herbst R, Mesa R, Lynch R, Nguyen R, Monahan R, Jhawar S, Alimohamed S, Jabbour S, Del Prete S, Mahmood S, Goel S, Revankar S, Matar S, Saif S, Mushtaq S, Wall S, Croessman S, Kligerman S, McWeeney S, Goyal S, Choi S, Brouha S, Taylor S, Vinayak S, Gadgeel S, Blau S, Hallmeyer S, Reid S, Williamson S, Fry S, May S, Berg S, Duda S, Greenland S, Murdock S, Subbiah S, Shah S, Shah S, Van Loon S, Ayre S, Owenby S, Rose S, Ahmad S, Zhang S, Latif T, Bekaii-Saab T, Cronin T, Nonato T, Rhodes T, Carducci T, Halfdanarson T, Sun T, Wise-Draper T, Masters T, Topaloglu U, Koshkin V, Mico V, Karivedu V, Walters W, Miller Jr. W, Li X, Rho Y, Xie Z, Sachs Z. Association Between Androgen Deprivation Therapy and Mortality Among Patients With Prostate Cancer and COVID-19. JAMA Network Open 2021, 4: e2134330. PMID: 34767021, PMCID: PMC8590166, DOI: 10.1001/jamanetworkopen.2021.34330.
Association of Convalescent Plasma Therapy With Survival in Patients With Hematologic Cancers and COVID-19
Thompson M, Henderson J, Shah P, Rubinstein S, Joyner M, Choueiri T, Flora D, Griffiths E, Gulati A, Hwang C, Koshkin V, Papadopoulos E, Robilotti E, Su C, Wulff-Burchfield E, Xie Z, Yu P, Mishra S, Senefeld J, Shah D, Warner J, Halmos B, Verma A, Gartrell B, Goel S, Ohri N, Sica R, Thakkar A, Stockerl-Goldstein K, Butt O, Campian J, Fiala M, Monahan R, Zhou A, Bohachek P, Mundt D, Streckfuss M, Tadesse E, Lammers P, Revankar S, Panagiotou O, Egan P, Farmakiotis D, Khan H, Olszewski A, Loaiza-Bonilla A, Del Prete S, Angevine A, Bar M, Lo K, Stratton J, Weinstein P, Caimi P, Barnholtz-Sloan J, Garcia J, Nakayama J, Gupta S, Pennell N, Ahluwalia M, Dawsey S, Nizam A, Lemmon C, Hoppenot C, Li A, Bakouny Z, Bouchard G, Busser F, Conners J, Curran C, Demetri G, Giordano A, Kelleher K, Nohria A, Schmidt A, Shaw G, Van Allen E, Nuzzo P, Xu W, Zon R, Zhang T, Halabi S, Lyman G, Graber J, Grivas P, Khaki A, Loggers E, Lynch R, Nakasone E, Schweizer M, Tachiki L, Vinayak S, Wagner M, Yeh A, Gatson N, Goyal S, Huynh-Le M, Rosenstein L, Clement J, Daher A, Dailey M, Elias R, Hsu E, Menendez A, Rathmann J, Serrano O, Jayaraj A, Gadgeel S, Hawley J, Hershman D, Accordino M, Bhutani D, Schwartz G, Reuben D, Mushtaq S, Bernicker E, Deeken J, Shafer D, Lewis M, Rhodes T, Gill D, Low C, Nagle S, Hayes-Lattin B, McWeeney S, Nemecek E, Zaren H, Smith S, Nagaraj G, Akhtari M, Lau E, Reeves M, Berg S, Elms D, Morgans A, Wehbe F, Altman J, Gurley M, Mulcahy M, Durbin E, Kulkarni A, Nelson H, Shah S, Rosovsky R, Reynolds K, Bardia A, Boland G, Gainor J, Zubiri L, Halfdanarson T, Bekaii-Saab T, Desai A, Mesa R, Bonnen M, Mahadevan D, Ramirez A, Salazar M, Belenkaya R, Philip J, Riely G, Faller B, McKay R, Ajmera A, Cabal A, Shaya J, Weissmann L, Jani C, Chen J, Gatti-Mays M, Jhawar S, Lustberg M, Palmer J, Pillainayagam C, Stover D, Wall S, Williams N, Karivedu V, Addison D, Joshi M, Menon H, Rovito M, Elshoury A, Jabbour S, Shah M, Bashir B, Mahmood S, McNair C, Mico V, Rivera A, Miller C, Cabebe E, Glover M, Jha A, Schapira L, Shah S, Wu J, Subbiah S, Logan B, Kloecker G, Lopes G, Russell K, Stith B, Smits M, Edwin N, Chism D, Owenby S, Doroshow D, Galsky M, Zhu H, Fu J, Fazio A, Patel K, Riess J, Kwon D, Kumar V, Islam J, Wood W, Ahmad S, Grover P, Gulati S, Kharofa J, Marcum M, Park C, Wise-Draper T, Bowles D, Geiger C, Bishnoi R, Markham M, Shah C, Acoba J, Rho Y, Feldman L, Hoskins K, Gantt G, Khan M, Nguyen R, Pasquinelli M, Schwartz C, Venepalli N, Vikas P, Kasi A, Fecher L, Friese C, Mavromatis B, Zaman Q, Bijjula R, Cheng A, Davis E, French B, Gillaspie E, Hausrath D, Hennessy C, Hsu C, Johnson D, Li X, Reid S, Rini B, Shyr Y, Slosky D, Solorzano C, Tucker M, Vega-Luna K, Wang L, Enriquez K, Sun T, Carducci T, Puc M, Van Loon S, Goldsmith K, Rice R, Cabalona W, Pilar C, Barrow McCollough B, Peddi P, Rosen L, Bilen M, Ravindranathan D, Hafez N, Herbst R, LoRusso P, Masters T, Stratton C. Association of Convalescent Plasma Therapy With Survival in Patients With Hematologic Cancers and COVID-19. JAMA Oncology 2021, 7: 1167-1175. PMID: 34137799, PMCID: PMC8377563, DOI: 10.1001/jamaoncol.2021.1799.
Phase 1 Study of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (ETCTN-9844)
Roussos Torres ET, Rafie C, Wang C, Lim D, Brufsky A, LoRusso P, Eder JP, Chung V, Downs M, Geare M, Piekarz R, Streicher H, Anforth L, Rudek MA, Zhu Q, Besharati S, Cimino-Mathews A, Anders RA, Stearns V, Jaffee EM, Connolly RM. Phase 1 Study of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (ETCTN-9844). Clinical Cancer Research 2021, 27: clincanres.5017.2021. PMID: 34135021, PMCID: PMC8563383, DOI: 10.1158/1078-0432.ccr-20-5017.
Improved methods for RNAseq-based alternative splicing analysis
Halperin RF, Hegde A, Lang JD, Raupach EA, Legendre C, Liang W, LoRusso P, Sekulic A, Sosman J, Trent J, Rangasamy S, Pirrotte P, Schork N. Improved methods for RNAseq-based alternative splicing analysis. Scientific Reports 2021, 11: 10740. PMID: 34031440, PMCID: PMC8144374, DOI: 10.1038/s41598-021-89938-2.
Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation
Kim J, Cardin DB, Vaishampayan UN, Kato S, Grossman SR, Glazer P, Shyr Y, Ivy SP, LoRusso P. Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation. The Oncologist 2021, 26: e1104-e1109. PMID: 33742489, PMCID: PMC8265343, DOI: 10.1002/onco.13758.
A Systematic Framework to Rapidly Obtain Data on Patients with Cancer and COVID-19:CCC19 Governance, Protocol, and Quality Assurance
Abidi M, Aboulafia D, Accordino M, Acoba J, Ahluwalia M, Ahmad S, Ajmera A, Alimohamed S, Altman J, Angevine A, Bakouny Z, Bar M, Bardia A, Barnholtz-Sloan J, Barrow McCollough B, Bashir B, Batist G, Bekaii-Saab T, Berg S, Bernicker E, Bhutani D, Bilen M, Bindal P, Bishnoi R, Blau S, Bohachek P, Boland G, Bonnen M, Bouchard G, Bouganim N, Bowles D, Busser F, Butt O, Cabal A, Cabalona W, Cabebe E, Caimi P, Campian J, Carducci T, Chen J, Cheng A, Chism D, Choueiri T, Clark M, Clement J, Connors J, Cook E, Curran C, Daher A, Dailey M, Davis E, Dawsey S, Deeken J, Del Prete S, Demetri G, Desai A, Doroshow D, Durbin E, Egan P, Elias R, Elkrief A, Elms D, Elshoury A, Faller B, Farmakiotis D, Fecher L, Feldman L, Ferrario C, Fiala M, Flora D, French B, Friese C, Fu J, Gadgeel S, Gainor J, Galsky M, Gantt G, Garcia J, Gartrell B, Gatti-Mays M, Gill D, Gillaspie E, Giordano A, Glace (, Glover M, Goel S, Graber J, Griffiths E, Grivas P, Grover P, Gulati A, Gulati S, Gupta S, Gurley M, Hafez N, Halabi S, Halfdanarson T, Halmos B, Hausrath D, Hawley J, Hennessy C, Herbst R, Hershman D, Hoppenot C, Hoskins K, Hoyo-Ulloa I, Hsu E, Hsu C, Hwang C, Islam J, Jabbour S, Jani C, Jha A, Jhawar S, Johnson D, Joshi M, Kasi A, Kelleher K, Kennecke H, Khaki A, Khan H, Khan M, Kharofa J, Kloecker G, Knoble J, Kulkarni A, Kumar V, Lammers P, Leighton J, Lemmon C, Lewis M, Li A, Li X, Liu S, Lo K, Loaiza-Bonilla A, Logan B, Loggers E, de Lima Lopes G, Loree J, LoRusso P, Low C, Lustberg M, Lyman G, Lynch R, Madhavan S, Mahadevan D, Mahmood S, Mansoor A, Marcum M, Markham M, Mashru S, Masters T, Mavromatis B, McKay R, McNair C, McWeeney S, Menendez A, Menon H, Mesa R, Mico V, Miller C, Mishra S, Monahan R, Morgans A, Mulcahy M, Mundt D, Mushtaq S, Nagaraj G, Nagle S, Nakasone E, Nakayama J, Nelson H, Nemecek E, Nguyen R, Nizam A, Nohria A, Nuzzo P, Ohri N, Olszewski A, Owenby S, Painter C, Palmer J, Panagiotou O, Park C, Pasquinelli M, Patel J, Patel K, Peddi P, Pennell N, Peters S, Pilar C, Pillainayagam C, Puc M, Ramirez A, Rathmann J, Ravindranathan D, Reid S, Reuben D, Revankar S, Reynolds K, Rho Y, Rhodes T, Rice R, Riess J, Rini B, Rink C, Rosen L, Rosenstein L, Rosovsky R, Routy B, Rovito M, Rubinstein S, Saif M, Salazar M, Santos Dutra M, Schapira L, Schmidt A, Schroeder B, Schwartz G, Schwartz C, Schweizer M, Serrano O, Shafer D, Shah P, Shah D, Shah M, Shah S, Shah C, Shaw G, Shaya J, Shyr Y, Slosky D, Smits M, Solorzano C, Stauffer K, Stockerl-Goldstein K, Stover D, Stratton J, Stratton C, Streckfuss M, Subbiah S, Tachiki L, Tadesse E, Thompson M, Topaloglu U, Tucker M, Van Allen E, Van Loon S, Vega-Luna K, Venepalli N, Verma A, Vikas P, Vinayak S, Vinh D, Wagner M, Wall S, Wang L, Warner J, Wehbe F, Weinstein P, Weiss M, Weissmann L, Wildes T, Williams N, Wise-Draper T, Wood W, Wu J, Wulff-Burchfield E, Xie Z, Xu W, Yeh A, Yu I, Yu P, Zacks R, Zaman Q, Zaren H, Zhang T, Zhou A, Zhu H, Zon R, Zubiri L. A Systematic Framework to Rapidly Obtain Data on Patients with Cancer and COVID-19:CCC19 Governance, Protocol, and Quality Assurance. Cancer Cell 2020, 38: 761-766. PMID: 33176160, PMCID: PMC7598547, DOI: 10.1016/j.ccell.2020.10.022.
7LBA Late Breaking Milademetan, an oral MDM2 inhibitor, in well-differentiated/ dedifferentiated liposarcoma: results from a phase 1 study in patients with solid tumors or lymphomas
Gounder M, Bauer T, Schwartz G, LoRusso P, Kumar P, Kato K, Tao B, Hong Y, Patel P, Hong D. 7LBA Late Breaking Milademetan, an oral MDM2 inhibitor, in well-differentiated/ dedifferentiated liposarcoma: results from a phase 1 study in patients with solid tumors or lymphomas. European Journal Of Cancer 2020, 138: s3-s4. DOI: 10.1016/s0959-8049(20)31080-7.
Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center
Hong D, Marcelo-Lewis K, LoRusso P. Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center. 2020, 71-83. DOI: 10.1007/978-3-030-47682-3_4.
Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study
Kuderer NM, Choueiri TK, Shah DP, Shyr Y, Rubinstein SM, Rivera DR, Shete S, Hsu CY, Desai A, de Lima Lopes G, Grivas P, Painter CA, Peters S, Thompson MA, Bakouny Z, Batist G, Bekaii-Saab T, Bilen MA, Bouganim N, Larroya MB, Castellano D, Del Prete SA, Doroshow DB, Egan PC, Elkrief A, Farmakiotis D, Flora D, Galsky MD, Glover MJ, Griffiths EA, Gulati AP, Gupta S, Hafez N, Halfdanarson TR, Hawley JE, Hsu E, Kasi A, Khaki AR, Lemmon CA, Lewis C, Logan B, Masters T, McKay RR, Mesa RA, Morgans AK, Mulcahy MF, Panagiotou OA, Peddi P, Pennell NA, Reynolds K, Rosen LR, Rosovsky R, Salazar M, Schmidt A, Shah SA, Shaya JA, Steinharter J, Stockerl-Goldstein KE, Subbiah S, Vinh DC, Wehbe FH, Weissmann LB, Wu JT, Wulff-Burchfield E, Xie Z, Yeh A, Yu PP, Zhou AY, Zubiri L, Mishra S, Lyman GH, Rini BI, Warner JL, Consortium C, Abidi M, Acoba J, Agarwal N, Ahmad S, Ajmera A, Altman J, Angevine A, Azad N, Bar M, Bardia A, Barnholtz-Sloan J, Barrow B, Bashir B, Belenkaya R, Berg S, Bernicker E, Bestvina C, Bishnoi R, Boland G, Bonnen M, Bouchard G, Bowles D, Busser F, Cabal A, Caimi P, Carducci T, Casulo C, Chen J, Clement J, Chism D, Cook E, Curran C, Daher A, Dailey M, Dahiya S, Deeken J, Demetri G, DiLullo S, Duma N, Elias R, Faller B, Fecher L, Feldman L, Friese C, Fu P, Fu J, Futreal A, Gainor J, Garcia J, Gill D, Gillaspie E, Giordano A, Glace G, Grothey A, Gulati S, Gurley M, Halmos B, Herbst R, Hershman D, Hoskins K, Jain R, Jabbour S, Jha A, Johnson D, Joshi M, Kelleher K, Kharofa J, Khan H, Knoble J, Koshkin V, Kulkarni A, Lammers P, Leighton J, Lewis M, Li X, Li A, Lo K, Loaiza-Bonilla A, LoRusso P, Low C, Lustberg M, Mahadevan D, Mansoor A, Marcum M, Markham M, Marshall C, Mashru S, Matar S, McNair C, McWeeney S, Mehnert J, Menendez A, Menon H, Messmer M, Monahan R, Mushtaq S, Nagaraj G, Nagle S, Naidoo J, Nakayama J, Narayan V, Nelson H, Nemecek E, Nguyen R, Nuzzo P, Oberstein P, Olszewski A, Owenby S, Pasquinelli M, Philip J, Prabhakaran S, Puc M, Ramirez A, Rathmann J, Revankar S, Rho Y, Rhodes T, Rice R, Riely G, Riess J, Rink C, Robilotti E, Rosenstein L, Routy B, Rovito M, Saif M, Sanyal A, Schapira L, Schwartz C, Serrano O, Shah M, Shah C, Shaw G, Shergill A, Shouse G, Soares H, Solorzano C, Srivastava P, Stauffer K, Stover D, Stratton J, Stratton C, Subbiah V, Tamimi R, Tannir N, Topaloglu U, Van Allen E, Van Loon S, Vega-Luna K, Venepalli N, Verma A, Vikas P, Wall S, Weinstein P, Weiss M, Wise-Draper T, Wood W, Xu W, Yackzan S, Zacks R, Zhang T, Zimmer A, West J. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study. The Lancet 2020, 395: 1907-1918. PMID: 32473681, PMCID: PMC7255743, DOI: 10.1016/s0140-6736(20)31187-9.
Phase I Dose-Escalation and -Expansion Study of Telisotuzumab (ABT-700), an Anti–c-Met Antibody, in Patients with Advanced Solid Tumors
Strickler JH, LoRusso P, Salgia R, Kang YK, Yen C, Lin CC, Ansell P, Motwani M, Wong S, Yue H, Wang L, Reilly E, Afar D, Naumovski L, Ramanathan RK. Phase I Dose-Escalation and -Expansion Study of Telisotuzumab (ABT-700), an Anti–c-Met Antibody, in Patients with Advanced Solid Tumors. Molecular Cancer Therapeutics 2020, 19: 1210-1217. PMID: 32127466, DOI: 10.1158/1535-7163.mct-19-0529.
Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies
Falchook G, Rosen S, LoRusso P, Watts J, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita M, Cassaday R, Harb W, Peguero J, Smith DC, Piha-Paul SA, Szmulewitz R, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta A. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies. Clinical Cancer Research 2020, 26: 1247-1257. PMID: 31527168, PMCID: PMC7528620, DOI: 10.1158/1078-0432.ccr-18-4071.
A First-in-Human Phase I Study to Evaluate the ERK1/2 Inhibitor GDC-0994 in Patients with Advanced Solid Tumors
Varga A, Soria JC, Hollebecque A, LoRusso P, Bendell J, Huang SA, Wagle MC, Okrah K, Liu L, Murray E, Sanabria-Bohorquez SM, Tagen M, Dokainish H, Mueller L, Burris H. A First-in-Human Phase I Study to Evaluate the ERK1/2 Inhibitor GDC-0994 in Patients with Advanced Solid Tumors. Clinical Cancer Research 2020, 26: 1229-1236. PMID: 31848189, DOI: 10.1158/1078-0432.ccr-19-2574.
First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors
Piha-Paul SA, Sachdev JC, Barve M, LoRusso P, Szmulewitz R, Patel SP, Lara PN, Chen X, Hu B, Freise KJ, Modi D, Sood A, Hutti JE, Wolff J, O'Neil BH. First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors. Clinical Cancer Research 2019, 25: 6309-6319. PMID: 31420359, DOI: 10.1158/1078-0432.ccr-19-0578.
Phase I Study of the Indoleamine 2,3-Dioxygenase 1 (IDO1) Inhibitor Navoximod (GDC-0919) Administered with PD-L1 Inhibitor (Atezolizumab) in Advanced Solid Tumors
Jung KH, LoRusso P, Burris H, Gordon M, Bang YJ, Hellmann MD, Cervantes A, de Olza M, Marabelle A, Hodi FS, Ahn MJ, Emens LA, Barlesi F, Hamid O, Calvo E, McDermott D, Soliman H, Rhee I, Lin R, Pourmohamad T, Suchomel J, Tsuhako A, Morrissey K, Mahrus S, Morley R, Pirzkall A, Davis SL. Phase I Study of the Indoleamine 2,3-Dioxygenase 1 (IDO1) Inhibitor Navoximod (GDC-0919) Administered with PD-L1 Inhibitor (Atezolizumab) in Advanced Solid Tumors. Clinical Cancer Research 2019, 25: 3220-3228. PMID: 30770348, PMCID: PMC7980952, DOI: 10.1158/1078-0432.ccr-18-2740.
Phase I Study of AMG 337, a Highly Selective Small-molecule MET Inhibitor, in Patients with Advanced Solid Tumors
Hong DS, LoRusso P, Hamid O, Janku F, Kittaneh M, Catenacci DVT, Chan E, Bekaii-Saab T, Gadgeel S, Loberg RD, Amore BM, Hwang YC, Tang R, Ngarmchamnanrith G, Kwak EL. Phase I Study of AMG 337, a Highly Selective Small-molecule MET Inhibitor, in Patients with Advanced Solid Tumors. Clinical Cancer Research 2019, 25: 2403-2413. PMID: 30425090, PMCID: PMC6892342, DOI: 10.1158/1078-0432.ccr-18-1341.
A phase I dose-escalation and dose-expansion study of brontictuzumab in subjects with selected solid tumors
Ferrarotto R, Eckhardt G, Patnaik A, LoRusso P, Faoro L, Heymach J, Kapoun A, Xu L, Munster P. A phase I dose-escalation and dose-expansion study of brontictuzumab in subjects with selected solid tumors. Annals Of Oncology 2018, 29: 1561-1568. PMID: 29726923, DOI: 10.1093/annonc/mdy171.
A Phase I/Ib Study of Enzalutamide Alone and in Combination with Endocrine Therapies in Women with Advanced Breast Cancer
Schwartzberg LS, Yardley D, Elias A, Patel M, LoRusso P, Burris HA, Gucalp A, Peterson A, Blaney M, Steinberg J, Gibbons J, Traina TA. A Phase I/Ib Study of Enzalutamide Alone and in Combination with Endocrine Therapies in Women with Advanced Breast Cancer. Clinical Cancer Research 2017, 23: 4046-4054. PMID: 28280092, DOI: 10.1158/1078-0432.ccr-16-2339.
A Phase I–II Study of the Oral PARP Inhibitor Rucaparib in Patients with Germline BRCA1/2-Mutated Ovarian Carcinoma or Other Solid Tumors
Kristeleit R, Shapiro GI, Burris HA, Oza AM, LoRusso P, Patel MR, Domchek SM, Balmaña J, Drew Y, Chen LM, Safra T, Montes A, Giordano H, Maloney L, Goble S, Isaacson J, Xiao J, Borrow J, Rolfe L, Shapira-Frommer R. A Phase I–II Study of the Oral PARP Inhibitor Rucaparib in Patients with Germline BRCA1/2-Mutated Ovarian Carcinoma or Other Solid Tumors. Clinical Cancer Research 2017, 23: 4095-4106. PMID: 28264872, DOI: 10.1158/1078-0432.ccr-16-2796.
A Phase I Pharmacokinetic Study of Trastuzumab Emtansine (T-DM1) in Patients with Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
Li C, Agarwal P, Gibiansky E, Jin J, Dent S, Gonçalves A, Nijem I, Strasak A, Harle-Yge M, Chernyukhin N, LoRusso P, Girish S. A Phase I Pharmacokinetic Study of Trastuzumab Emtansine (T-DM1) in Patients with Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function. Clinical Pharmacokinetics 2016, 56: 1069-1080. PMID: 27995530, DOI: 10.1007/s40262-016-0496-y.
Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study
Nogova L, Sequist LV, Garcia J, Andre F, Delord JP, Hidalgo M, Schellens JH, Cassier PA, Camidge DR, Schuler M, Vaishampayan U, Burris H, Tian GG, Campone M, Wainberg ZA, Lim WT, LoRusso P, Shapiro GI, Parker K, Chen X, Choudhury S, Ringeisen F, Graus-Porta D, Porter D, Isaacs R, Buettner R, Wolf J. Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study. Journal Of Clinical Oncology 2016, 35: 157-165. PMID: 27870574, PMCID: PMC6865065, DOI: 10.1200/jco.2016.67.2048.
Antibody–Drug Conjugates (ADCs) in Clinical Development
McLaughlin J, LoRusso P. Antibody–Drug Conjugates (ADCs) in Clinical Development. 2016, 321-344. DOI: 10.1002/9781119060727.ch13.
Preclinical and first‐in‐human phase I studies of KW‐2450, an oral tyrosine kinase inhibitor with insulin‐like growth factor receptor‐1/insulin receptor selectivity
Schwartz GK, Dickson MA, LoRusso P, Sausville EA, Maekawa Y, Watanabe Y, Kashima N, Nakashima D, Akinaga S. Preclinical and first‐in‐human phase I studies of KW‐2450, an oral tyrosine kinase inhibitor with insulin‐like growth factor receptor‐1/insulin receptor selectivity. Cancer Science 2016, 107: 499-506. PMID: 26850678, PMCID: PMC4832855, DOI: 10.1111/cas.12906.
Clinical development of antibody–drug conjugates
Sewald N, Ramchandren R, LoRusso P. Clinical development of antibody–drug conjugates. 2015, 136-148. DOI: 10.4155/fseb2013.14.341.
48 Phase I Trials Today
Morgensztern D, LoRusso P, Boerner S, Herbst R, Eder J. 48 Phase I Trials Today. 2015, 661-676.e2. DOI: 10.1016/b978-1-4557-4066-6.00048-2.
AN INTEGRATED FRAMEWORK FOR REPORTING CLINICALLY RELEVANT BIOMARKERS FROM PAIRED TUMOR/NORMAL GENOMIC AND TRANSCRIPTOMIC SEQUENCING DATA IN SUPPORT OF CLINICAL TRIALS IN PERSONALIZED MEDICINE
Altman R, Dunker A, Hunter L, Ritchie M, Murray T, Klein T, NASSER S, KURDOGLU A, IZATT T, ALDRICH J, RUSSELL M, CHRISTOFORIDES A, TEMBE W, KIEFER J, CORNEVEAUX J, BYRON S, FORMAN K, ZUCCARO C, KEATS J, LORUSSO P, CARPTEN J, TRENT J, CRAIG D. AN INTEGRATED FRAMEWORK FOR REPORTING CLINICALLY RELEVANT BIOMARKERS FROM PAIRED TUMOR/NORMAL GENOMIC AND TRANSCRIPTOMIC SEQUENCING DATA IN SUPPORT OF CLINICAL TRIALS IN PERSONALIZED MEDICINE. Pacific Symposium On Biocomputing Pacific Symposium On Biocomputing 2014, 56-67. PMID: 25592568, DOI: 10.1142/9789814644730_0007.
Erratum to: Phase I study of PF-04691502, a small-molecule, oral, dual inhibitor of PI3K and mTOR, in patients with advanced cancer
Britten C, Adjei A, Millham R, Houk B, Borzillo G, Pierce K, Wainberg Z, LoRusso P. Erratum to: Phase I study of PF-04691502, a small-molecule, oral, dual inhibitor of PI3K and mTOR, in patients with advanced cancer. Investigational New Drugs 2014, 32: 575-575. DOI: 10.1007/s10637-014-0069-6.
Insulin growth factor receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic adrenocortical carcinoma
Naing A, LoRusso P, Fu S, Hong D, Chen H, Doyle L, Phan A, Habra M, Kurzrock R. Insulin growth factor receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic adrenocortical carcinoma. British Journal Of Cancer 2013, 108: 826-830. PMID: 23412108, PMCID: PMC3590681, DOI: 10.1038/bjc.2013.46.
Phase I study of humanized monoclonal antibody AVE1642 directed against the type 1 insulin-like growth factor receptor (IGF-1R), administered in combination with anticancer therapies to patients with advanced solid tumors
Macaulay V, Middleton M, Protheroe A, Tolcher A, Dieras V, Sessa C, Bahleda R, Blay J, LoRusso P, Mery-Mignard D, Soria J. Phase I study of humanized monoclonal antibody AVE1642 directed against the type 1 insulin-like growth factor receptor (IGF-1R), administered in combination with anticancer therapies to patients with advanced solid tumors. Annals Of Oncology 2012, 24: 784-791. PMID: 23104723, PMCID: PMC3574548, DOI: 10.1093/annonc/mds511.
Oral Chemotherapeutic Agents
Ogita S, LoRusso P, Li J. Oral Chemotherapeutic Agents. 2012, 1-37. DOI: 10.1002/9780470921920.edm132.
Reply to E.S. Wang et al
LoRusso P, Boerner S, Evelhoch J, Evelhoch J. Reply to E.S. Wang et al. Journal Of Clinical Oncology 2012, 30: 762-763. DOI: 10.1200/jco.2011.39.6895.
C-MET as a Novel Target for the Treatment of Renal Cell Carcinoma
Vankayala H, LoRusso P, Vaishampayan U. C-MET as a Novel Target for the Treatment of Renal Cell Carcinoma. 2012, 213-238. DOI: 10.1007/978-1-4614-2400-0_10.
Phase I dose-escalation study to determine the safety, pharmacokinetics and pharmacodynamics of brivanib alaninate in combination with full-dose cetuximab in patients with advanced gastrointestinal malignancies who have failed prior therapy
Garrett C, Siu L, El-Khoueiry A, Buter J, Rocha-Lima C, Marshall J, LoRusso P, Major P, Chemidlin J, Mokliatchouk O, Velasquez L, Hayes W, Feltquate D, Syed S, Ford S, Kollia G, Galbraith S, Nuyten D. Phase I dose-escalation study to determine the safety, pharmacokinetics and pharmacodynamics of brivanib alaninate in combination with full-dose cetuximab in patients with advanced gastrointestinal malignancies who have failed prior therapy. British Journal Of Cancer 2011, 105: 44-52. PMID: 21629245, PMCID: PMC3137402, DOI: 10.1038/bjc.2011.182.
Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study
Leal T, Remick S, Takimoto C, Ramanathan R, Davies A, Egorin M, Hamilton A, LoRusso P, Shibata S, Lenz H, Mier J, Sarantopoulos J, Mani S, Wright J, Ivy S, Neuwirth R, von Moltke L, Venkatakrishnan K, Mulkerin D. Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study. Cancer Chemotherapy And Pharmacology 2011, 68: 1439-1447. PMID: 21479634, PMCID: PMC3481841, DOI: 10.1007/s00280-011-1637-5.
Breast Cancer Rationally Designed Therapies
Burger A, LoRusso P. Breast Cancer Rationally Designed Therapies. 2011, 537-546. DOI: 10.1007/978-3-642-16483-5_6746.
A Phase I Study of the Pharmacokinetic and Safety Profiles of Oral Pazopanib With a High‐Fat or Low‐Fat Meal in Patients With Advanced Solid Tumors
Heath E, Chiorean E, Sweeney C, Hodge J, Lager J, Forman K, Malburg L, Arumugham T, Dar M, Suttle A, Gainer S, LoRusso P. A Phase I Study of the Pharmacokinetic and Safety Profiles of Oral Pazopanib With a High‐Fat or Low‐Fat Meal in Patients With Advanced Solid Tumors. Clinical Pharmacology & Therapeutics 2010, 88: 818-823. PMID: 20980999, DOI: 10.1038/clpt.2010.199.
Phase I Dose-Escalation and Pharmacokinetic Study of Dasatinib in Patients with Advanced Solid Tumors
Demetri G, Russo P, MacPherson I, Wang D, Morgan J, Brunton V, Paliwal P, Agrawal S, Voi M, Evans T. Phase I Dose-Escalation and Pharmacokinetic Study of Dasatinib in Patients with Advanced Solid Tumors. Clinical Cancer Research 2009, 15: 6232-6240. PMID: 19789325, DOI: 10.1158/1078-0432.ccr-09-0224.
In Reply
LoRusso P, Burris H, Jones S, Fleming R, Koch K. In Reply. Journal Of Clinical Oncology 2009, 27: 316-317. DOI: 10.1200/jco.2008.20.0758.
Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group
Ramanathan R, Egorin M, Takimoto C, Remick S, Doroshow J, LoRusso P, Mulkerin D, Grem J, Hamilton A, Murgo A, Potter D, Belani C, Hayes M, Peng B, Ivy S. Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group. Journal Of Clinical Oncology 2008, 26: 563-569. PMID: 18235115, DOI: 10.1200/jco.2007.11.0304.
Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group
Gibbons J, Egorin M, Ramanathan R, Fu P, Mulkerin D, Shibata S, Takimoto C, Mani S, LoRusso P, Grem J, Pavlick A, Lenz H, Flick S, Reynolds S, Lagattuta T, Parise R, Wang Y, Murgo A, Ivy S, Remick S. Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group. Journal Of Clinical Oncology 2008, 26: 570-576. PMID: 18235116, DOI: 10.1200/jco.2007.13.3819.
Chapter 47 Phase 1 Trials Today
LoRusso P, Bekele B, Boerner S, Davis D, Evelhoch J, Herbst R. Chapter 47 Phase 1 Trials Today. 2008, 553-570. DOI: 10.1016/b978-141603703-3.10047-0.
List of Contributing Authors
Aaronson S, Abbruzzese J, Abel E, Anderson K, Arrick B, Bafico A, Barbash O, Bast R, Baylin S, Bekele B, Bertino J, Boerner S, Bommer G, Borden E, Buchstaller J, Buetow K, Burman K, Calin G, Campisi J, Caprioli R, Carroll P, Chaurand P, Ashley J, Cleveland J, Collins J, Cortes J, Costello J, Cox J, Croce C, D'Andrea A, Davis D, Deberardinis R, Demasi J, Diehl J, Digiovanni J, Dorsey F, Egeblad M, Ekmekcioglu S, Evelhoch J, Fearon E, Febbo P, Feng Z, Fletcher C, Frankel A, Friedman D, Fury M, Gambhir S, Gazdar A, Girard L, Glick A, Gonzalez-Angulo A, Gray J, Greene K, Grimm E, Grumolato L, Guertin D, Hait W, Havrda M, Hennessy B, Herbst R, Houghton A, Houghton P, Howley P, Hu W, Hwu P, Israel M, Jacks T, Jorgensen C, Kantarjian H, Keith B, Kelsen D, Korn W, Kundra P, Kurzrock R, Lee J, Levine A, Li L, Lippman S, Littlepage L, Liu Y, Look T, Lorusso P, Malkin D, Margolin J, Matrisian L, Mccormick F, Mendelsohn J, Merghoub T, Mills G, Minna J, Morrison S, Morton C, Neckers L, Nevins J, Okino S, Pardoll D, Pawson T, Payne E, Pfister D, Polsky D, Poplack D, Posada J, Powis G, Quintana E, Quintás-Cardama A, Rabin K, Reimann J, Rubin E, Sabatini D, Sato M, Sausville E, Sen G, Shah M, Shames D, Shoemaker R, Sikic B, Silverman R, Simon M, Spellman P, Steeves M, Thompson C, Tonon G, Weinberg R, Welch D, Werb Z, Winslow M, Woodward W, Xiong H, Yaghoubi S, Yuspa S. List of Contributing Authors. 2008, vii-xiii. DOI: 10.1016/b978-141603703-3.10061-5.
Angiogenesis pathway inhibitors.
Herbst RS, LoRusso P, Isobe T, Hurwitz HI. Angiogenesis pathway inhibitors. Cancer Chemotherapy And Biological Response Modifiers 2005, 22: 225-45. PMID: 16110614, DOI: 10.1016/s0921-4410(04)22010-5.
The Role of Bisphosphonates in the Treatment of Skeletal Complications of Breast Cancer
El-Rayes B, LoRusso P. The Role of Bisphosphonates in the Treatment of Skeletal Complications of Breast Cancer. American Journal Of Cancer 2004, 3: 369-375. DOI: 10.2165/00024669-200403060-00004.
Clinical Development Issues
Averbuch S, Wolf M, El‐Rayes B, LoRusso P. Clinical Development Issues. 2004, 287-306. DOI: 10.1002/047165616x.ch13.
In Vivo Methods for Screening and Preclinical Testing
Corbett T, Polin L, LoRusso P, Valeriote F, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lisow L. In Vivo Methods for Screening and Preclinical Testing. Cancer Drug Discovery And Development 2004, 99-123. DOI: 10.1007/978-1-59259-739-0_6.
Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition.
Albanell J, Rojo F, Averbuch S, Feyereislova A, Mascaro J, Herbst R, LoRusso P, Rischin D, Sauleda S, Gee J, Nicholson R, Baselga J. Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition. Journal Of Clinical Oncology 2002, 20: 110-24. PMID: 11773160, DOI: 10.1200/jco.2002.20.1.110.
Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients
Blum J, Dieras V, Russo P, Horton J, Rutman O, Buzdar A, Osterwalder B. Multicenter, Phase II study of capecitabine in taxane‐pretreated metastatic breast carcinoma patients. Cancer 2001, 92: 1759-1768. PMID: 11745247, DOI: 10.1002/1097-0142(20011001)92:7<1759::aid-cncr1691>3.0.co;2-a.
Analysis of skeletal-related events in breast cancer and response to therapy
LoRusso P. Analysis of skeletal-related events in breast cancer and response to therapy. Seminars In Oncology 2001, 28: 22-27. PMID: 11544572, DOI: 10.1016/s0093-7754(01)90228-3.
Analysis of skeletal-related events in breast cancer and response to therapy
LoRusso P. Analysis of skeletal-related events in breast cancer and response to therapy. Seminars In Oncology 2001, 28: 22-27. DOI: 10.1053/sonc.2001.25437.
Chronic Oral Administration of CI-994: A Phase I Study
Prakash S, Foster B, Meyer M, Wozniak A, Heilbrun L, Flaherty L, Zalupski M, Radulovic L, Valdivieso M, LoRusso P. Chronic Oral Administration of CI-994: A Phase I Study. Investigational New Drugs 2001, 19: 1-11. PMID: 11291827, DOI: 10.1023/a:1006489328324.
Preclinical efficacy of thioxanthone SR271425 against transplanted solid tumors of mouse and human origin
Corbett T, Panchapor C, Polin L, Lowichik N, Pugh S, White K, Kushner J, Meyer J, Czarnecki J, Chinnukroh S, Edelstein M, LoRusso P, Heilbrun L, Horwitz J, Grieshaber C, Perni R, Wentland M, Coughlin S, Elenbaas S, Philion R, Rake J. Preclinical efficacy of thioxanthone SR271425 against transplanted solid tumors of mouse and human origin. Investigational New Drugs 1999, 17: 17-27. PMID: 10555119, DOI: 10.1023/a:1006267517726.
Accrual to Breast Cancer Clinical Trials at a University-Affiliated Hospital in Metropolitan Detroit
Simon M, Brown D, Du W, LoRusso P, Kellogg C. Accrual to Breast Cancer Clinical Trials at a University-Affiliated Hospital in Metropolitan Detroit. American Journal Of Clinical Oncology 1999, 22: 42-46. PMID: 10025379, DOI: 10.1097/00000421-199902000-00011.
Phase II study of CI-958 in colorectal cancer
Shields A, Philip P, LoRusso P, Ferris A, Zalupski M. Phase II study of CI-958 in colorectal cancer. Cancer Chemotherapy And Pharmacology 1999, 43: 162-164. PMID: 9923823, DOI: 10.1007/s002800050878.
Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer.
Blum J, Jones S, Buzdar A, LoRusso P, Kuter I, Vogel C, Osterwalder B, Burger H, Brown C, Griffin T. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. Journal Of Clinical Oncology 1999, 17: 485-93. PMID: 10080589, DOI: 10.1200/jco.1999.17.2.485.
Controlled‐release oxycodone compared with controlled‐release morphine in the treatment of cancer pain: A randomized, double‐blind, parallel‐group study
Mucci‐LoRusso P, Berman B, Silberstein P, Citron M, Bressler L, Weinstein S, Kaiko R, Buckley B, Reder R. Controlled‐release oxycodone compared with controlled‐release morphine in the treatment of cancer pain: A randomized, double‐blind, parallel‐group study. European Journal Of Pain 1998, 2: 239-249. PMID: 15102384, DOI: 10.1016/s1090-3801(98)90020-9.
Preclinical antitumor efficacy of analogs of XK469: sodium-(2-[4-(7-chloro-2-quinoxalinyloxy)phenoxy]propionate
Corbett T, LoRusso P, Demchick L, Simpson C, Pugh S, White K, Kushner J, Polin L, Meyer J, Czarnecki J, Heilbrun L, Horwitz J, Gross J, Behrens C, Harrison B, McRipley R, Trainor G. Preclinical antitumor efficacy of analogs of XK469: sodium-(2-[4-(7-chloro-2-quinoxalinyloxy)phenoxy]propionate. Investigational New Drugs 1998, 16: 129-139. PMID: 9848576, DOI: 10.1023/a:1006174622061.
Evaluation of pyrazoloacridine in patients with advanced pancreatic carcinoma
Zalupski M, Shields A, Philip P, Kraut M, LoRusso P, Heilbrun L, Vaitkevicius V. Evaluation of pyrazoloacridine in patients with advanced pancreatic carcinoma. Investigational New Drugs 1998, 16: 93-96. PMID: 9740550, DOI: 10.1023/a:1006087114621.
Treatment of human prostate tumors PC-3 and TSU-PR1 with standard and investigational agents in SCID mice
Polin L, Valeriote F, White K, Panchapor C, Pugh S, Knight J, LoRusso P, Hussain M, Liversidge E, Peltier N, Golakoti T, Patterson G, Moore R, Corbett T. Treatment of human prostate tumors PC-3 and TSU-PR1 with standard and investigational agents in SCID mice. Investigational New Drugs 1997, 15: 99-108. PMID: 9220288, DOI: 10.1023/a:1005856605726.
Phase II study of pyrazoloacridine in patients with advanced colorectal carcinoma
Zalupski M, Philip P, LoRusso P, Shields A. Phase II study of pyrazoloacridine in patients with advanced colorectal carcinoma. Cancer Chemotherapy And Pharmacology 1997, 40: 225-227. PMID: 9219505, DOI: 10.1007/s002800050650.
In Vivo Methods for Screening and Preclinical Testing
Corbett T, Valeriote F, LoRusso P, Polin L, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lisow L. In Vivo Methods for Screening and Preclinical Testing. Cancer Drug Discovery And Development 1997, 75-99. DOI: 10.1007/978-1-4615-8152-9_5.
Preclinical antitumor activity of CI-994
LoRusso P, Demchik L, Foster B, Knight J, Bissery M, Polin L, Leopold W, Corbett T. Preclinical antitumor activity of CI-994. Investigational New Drugs 1996, 14: 349-356. PMID: 9157069, DOI: 10.1007/bf00180810.
Preclinical anticancer activity of cryptophycin-8.
Corbett T, Valeriote F, Demchik L, Polin L, Panchapor C, Pugh S, White K, Knight J, Jones J, Jones L, LoRusso P, Foster B, Wiegand R, Lisow L, Golakoti T, Heltzel C, Ogino J, Patterson G, Moore R. Preclinical anticancer activity of cryptophycin-8. Journal Of Experimental Therapeutics And Oncology 1996, 1: 95-108. PMID: 9414393.
Levels of 5‐hydroxymethyl‐2′‐deoxyuridine in DNA from blood as a marker of breast cancer
Djuric Z, Heilbrun L, Simon M, Smith D, Luongo D, LoRusso P, Martino S. Levels of 5‐hydroxymethyl‐2′‐deoxyuridine in DNA from blood as a marker of breast cancer. Cancer 1996, 77: 691-696. PMID: 8616761, DOI: 10.1002/(sici)1097-0142(19960215)77:4<691::aid-cncr15>3.0.co;2-w.
Phase I clinical trial of pyrazoloacridine NSC366140 (PD115934).
LoRusso P, Foster B, Poplin E, McCormick J, Kraut M, Flaherty L, Heilbrun L, Valdivieso M, Baker L. Phase I clinical trial of pyrazoloacridine NSC366140 (PD115934). Clinical Cancer Research 1995, 1: 1487-93. PMID: 9815948.
Phase I trial of Adozelesin using the treatment schedule of daily × 5 every 3 weeks
Foster B, LoRusso P, Poplin E, Zalupski M, Valdivieso M, Wozniak A, Flaherty L, Kasunic D, Earhart R, Baker L. Phase I trial of Adozelesin using the treatment schedule of daily × 5 every 3 weeks. Investigational New Drugs 1995, 13: 321-326. PMID: 8824350, DOI: 10.1007/bf00873138.
Comparative efficacy of DMP 840 against mouse and human solid tumor models
LoRusso P, Demchik L, Dan M, Polin L, Gross J, Corbett T. Comparative efficacy of DMP 840 against mouse and human solid tumor models. Investigational New Drugs 1995, 13: 195-203. PMID: 8729946, DOI: 10.1007/bf00873800.
Tumor Models and the Discovery and Secondary Evaluation of Solid Tumor Active Agents
Corbett T, Valeriote F, Lorusso P, Polin L, Panchapor C, Pugh S, White K, Knight J, Demchik L, Jones J, Jones L, Lowichik N, Biernat L, Foster B, Wozniak A, Lisow L, Valdivieso M, Baker L, Leopold W, Sebolt J, Bissery M, Mattes K, Dzubow J, Rake J, Perni R, Wentland M, Coughlin S, Shaw J, Liversidge G, Liversidge E, Bruno J, Sarpotdar P, Moore R, Patterson G. Tumor Models and the Discovery and Secondary Evaluation of Solid Tumor Active Agents. Pharmaceutical Biology 1995, 33: 102-122. DOI: 10.3109/13880209509067092.
Discovery of Anticancer Agents from Natural Products
Valeriote F, Corbett T, Lorusso P, Moore R, Scheuer P, Patterson G, Paul V, Grindey G, Bonjouklian R, Pearce H, Suffness M. Discovery of Anticancer Agents from Natural Products. Pharmaceutical Biology 1995, 33: 59-66. DOI: 10.3109/13880209509067088.
Antitumour activity of N-[[1-[[2-(diethylamino)ethyl]amino]-9-oxo-9H-thioxanthen-4-yl]methyl]methanesulfonamide (WIN33377) and analogues
Corbett T, Lowichik N, Pugh S, Polin L, Panchapor C, White K, Knight J, Demchik L, Jones J, Jones L, Biernat L, Lorusso P, Foster B, Heilbrun L, Rake J, Mattes K, Perni R, Powles R, Hlavac A, Wentland M, Coughlin S, Baker L, Valeriote F. Antitumour activity of N-[[1-[[2-(diethylamino)ethyl]amino]-9-oxo-9H-thioxanthen-4-yl]methyl]methanesulfonamide (WIN33377) and analogues. Expert Opinion On Investigational Drugs 1994, 3: 1281-1292. DOI: 10.1517/13543784.3.12.1281.
Randomized clinical trial of mitomycin-C with or without pretreatment with WR-2721 in patients with advanced colorectal cancer
Poplin E, LoRusso P, Lokich J, Gullo J, Leming P, Schulz J, Veach S, McCulloch W, Baker L, Schein P. Randomized clinical trial of mitomycin-C with or without pretreatment with WR-2721 in patients with advanced colorectal cancer. Cancer Chemotherapy And Pharmacology 1994, 33: 415-419. PMID: 8306416, DOI: 10.1007/bf00686271.
Immunohistologic evaluation of invasion-associated proteases in breast carcinoma.
Visscher D, Sarkar F, LoRusso P, Sakr W, Ottosen S, Wykes S, Crissman J. Immunohistologic evaluation of invasion-associated proteases in breast carcinoma. Modern Pathology 1993, 6: 302-6. PMID: 8346178.
Discovery of Solid Tumor Active Agents Using a Soft-Agar-Colony-Formation Disk-Diffusion-Assay
Corbett T, Valeriote F, Polin L, Panchapor C, Pugh S, White K, Lowichik N, Knight J, Bissery M, Wozniak A, LoRusso P, Biernat L, Polin D, Knight L, Biggar S, Looney D, Demchik L, Jones J, Jones L, Blair S, Palmer K, Essenmacher S, Lisow L, Mattes K, Cavanaugh P, Rake J, Baker L. Discovery of Solid Tumor Active Agents Using a Soft-Agar-Colony-Formation Disk-Diffusion-Assay. Developments In Oncology 1992, 35-87. DOI: 10.1007/978-1-4615-3492-1_3.
Antitumor efficacy of PD115934 (NSC 366140) against solid tumors of mice.
LoRusso P, Wozniak A, Polin L, Capps D, Leopold W, Werbel L, Biernat L, Dan M, Corbett T. Antitumor efficacy of PD115934 (NSC 366140) against solid tumors of mice. Cancer Research 1990, 50: 4900-5. PMID: 2165850.
Activity of datelliptium acetate (NSC 311152; SR 95156A) against solid tumors of mice
Mucci-LoRusso P, Polin L, Biernat L, Valeriote F, Corbett T. Activity of datelliptium acetate (NSC 311152; SR 95156A) against solid tumors of mice. Investigational New Drugs 1990, 8: 253-261. PMID: 2177044, DOI: 10.1007/bf00171834.
Low-Dose Continuous Infusion 5-Fluorouracil and Cisplatin
LoRusso P, Pazdur R, Redman B, Kinzie J, Vaitkevicius V. Low-Dose Continuous Infusion 5-Fluorouracil and Cisplatin. American Journal Of Clinical Oncology 1989, 12: 486-490. PMID: 2686394, DOI: 10.1097/00000421-198912000-00005.
Activity of batracylin (NSC-320846) against solid tumors of mice
Mucci-LoRusso P, Polin L, Bissery M, Valeriote F, Plowman J, Luk G, Corbettv T. Activity of batracylin (NSC-320846) against solid tumors of mice. Investigational New Drugs 1989, 7: 295-306. PMID: 2557298, DOI: 10.1007/bf00173759.
5-Fluorouracil containing combinations in murine tumor systems
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Chemotherapy for paranasal sinus carcinoma. A 10‐year experience at Wayne state university
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Departments and Programs

Locations

Smilow Cancer Hospital Phase I Unit

55 Park Street

Ste First Floor

New Haven, CT 06511

Directions

Smilow Cancer Hospital Phase I Unit
55 Park Street
Ste First Floor
New Haven, CT 06511
- Directions

Smilow Cancer Hospital Phase I Unit

55 Park Street

Ste First Floor

New Haven, CT 06511

Directions

Smilow Cancer Hospital Phase I Unit
55 Park Street
Ste First Floor
New Haven, CT 06511
- Directions