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Phase III Trial of Bevacizumab in Combination With Gemcitabine and Erlotinib in Patients With Metastatic Pancreatic Cancer

吉西他滨 埃罗替尼 贝伐单抗 医学 胰腺癌 内科学 肿瘤科 盐酸厄洛替尼 安慰剂 临床终点 胃肠病学 癌症 化疗 随机对照试验 表皮生长因子受体 病理 替代医学
作者
Eric Van Cutsem,Walter L. Vervenne,Jaafar Bennouna,Yves Humblet,Sharlene Gill,Jean‐Luc Van Laethem,Chris Verslype,Werner Scheithauer,Aijing Shang,Jan Cosaert,Malcolm J. Moore
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:27 (13): 2231-2237 被引量:640
标识
DOI:10.1200/jco.2008.20.0238
摘要

Treatment with gemcitabine provides modest benefits in patients with metastatic pancreatic cancer. The addition of erlotinib to gemcitabine shows a small but significant improvement in overall survival (OS) versus gemcitabine alone. Phase II results for bevacizumab plus gemcitabine provided the rationale for a phase III trial of gemcitabine-erlotinib plus bevacizumab or placebo.Patients with metastatic pancreatic adenocarcinoma were randomly assigned to receive gemcitabine (1,000 mg/m(2)/week), erlotinib (100 mg/day), and bevacizumab (5 mg/kg every 2 weeks) or gemcitabine, erlotinib, and placebo in this double-blind, phase III trial. Primary end point was OS; secondary end points included progression-free survival (PFS), disease control rate, and safety.A total of 301 patients were randomly assigned to the placebo group and 306 to the bevacizumab group. Median OS was 7.1 and 6.0 months in the bevacizumab and placebo arms, respectively (hazard ratio [HR], 0.89; 95% CI, 0.74 to 1.07; P = .2087); this difference was not statistically significant. Adding bevacizumab to gemcitabine-erlotinib significantly improved PFS (HR, 0.73; 95% CI, 0.61 to 0.86; P = .0002). Treatment with bevacizumab plus gemcitabine-erlotinib was well tolerated: safety data did not differ from previously described safety profiles for individual drugs.The primary objective was not met. The addition of bevacizumab to gemcitabine-erlotinib did not lead to a statistically significant improvement in OS in patients with metastatic pancreatic cancer. PFS, however, was significantly longer in the bevacizumab group compared with placebo. No unexpected safety events were observed from adding bevacizumab to gemcitabine-erlotinib.
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