Phase II Trial of Cediranib in Combination With Cisplatin and Pemetrexed in Chemotherapy-Naïve Patients With Unresectable Malignant Pleural Mesothelioma (SWOG S0905)

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Anne S TsaoKaren Kelly

Abstract

Antiangiogenic agents combined with chemotherapy have efficacy in the treatment of unresectable malignant pleural mesothelioma (MPM). Cediranib (AstraZeneca, Cheshire, United Kingdom), a vascular endothelial growth factor receptor and platelet-derived growth factor receptor inhibitor, demonstrated therapeutic potential in a prior phase I trial. We evaluated a phase II trial for efficacy. SWOG S0905 (ClinicalTrials.gov identifier: NCT01064648) randomly assigned cediranib or placebo with platinum-pemetrexed for six cycles followed by maintenance cediranib or placebo in unresectable chemotherapy-naïve patients with MPM of any histologic subtype. Primary end point was Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 progression-free survival (PFS). Secondary end points included overall survival, PFS by modified RECIST v1.1, response (modified RECIST and RECIST v1.1), disease control, and safety/toxicity. The trial was designed to detect a difference in RECIST v1.1 PFS at the one-sided 0.1 level using a stratified log-rank test. Ninety-two eligible patients were enrolled (75% epithelioid and 25% biphasic or sarcomatoid). The cediranib arm had more grade 3 and 4 diarrhea, dehydration, hypertension, and weight loss. C...Continue Reading

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Citations

Feb 11, 2020·Frontiers in Oncology·Fabio NicoliniMassimiliano Mazza
Mar 7, 2020·Frontiers in Oncology·Anna K NowakGérard Zalcman
Jun 3, 2021·Journal of Clinical Medicine·Emanuele VitaEmilio Bria
Jul 9, 2021·Apoptosis : an International Journal on Programmed Cell Death·Xiaofeng DaiJianying Zhang
Aug 17, 2021·Cancer Treatment Reviews·Wanyuan Cui, Sanjay Popat
Aug 24, 2021·Current Treatment Options in Oncology·Elizabeth DudnikLiran Holtzman
Jul 7, 2021·British Journal of Cancer·Joanna ObaczStefan J Marciniak

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