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Phase III Randomized Clinical Trial Comparing Tremelimumab With Standard-of-Care Chemotherapy in Patients With Advanced Melanoma

银耳霉素 医学 达卡巴嗪 内科学 皮疹 危险系数 化疗 替莫唑胺 肿瘤科 外科 易普利姆玛 免疫疗法 癌症 置信区间
作者
Antoni Ribas,Richard Kefford,Margaret Marshall,Cornelis J.A. Punt,John B.A.G. Haanen,Maribel Mármol,Claus Garbe,Helen Gogas,Jacob Schachter,Gerald P. Linette,Paul Lorigan,Kari Kendra,Michele Maio,Uwe Trefzer,Michael Smylie,Grant A. McArthur,Brigitte Dréno,Paul Nathan,Jacek Mackiewicz,John M. Kirkwood
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:31 (5): 616-622 被引量:809
标识
DOI:10.1200/jco.2012.44.6112
摘要

Purpose In phase I/II trials, the cytotoxic T lymphocyte–associated antigen-4–blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy. Patients and Methods Patients with treatment-naive, unresectable stage IIIc or IV melanoma were randomly assigned at a ratio of one to one to tremelimumab (15 mg/kg once every 90 days) or physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine). Results In all, 655 patients were enrolled and randomly assigned. The test statistic crossed the prespecified futility boundary at second interim analysis after 340 deaths, but survival follow-up continued. At final analysis with 534 events, median OS by intent to treat was 12.6 months (95% CI, 10.8 to 14.3) for tremelimumab and 10.7 months (95% CI, 9.36 to 11.96) for chemotherapy (hazard ratio, 0.88; P = .127). Objective response rates were similar in the two arms: 10.7% in the tremelimumab arm and 9.8% in the chemotherapy arm. However, response duration (measured from date of random assignment) was significantly longer after tremelimumab (35.8 v 13.7 months; P = .0011). Diarrhea, pruritus, and rash were the most common treatment-related adverse events in the tremelimumab arm; 7.4% had endocrine toxicities. Seven deaths in the tremelimumab arm and one in the chemotherapy arm were considered treatment related by either investigators or sponsor. Conclusion This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over standard-of-care chemotherapy in first-line treatment of patients with metastatic melanoma.
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