Department of Hepato-Gastroenterology and Digestive Oncology, Hôpital Européen Georges Pompidou, Paris, France.
Eur J Cancer. 2013 Aug;49(12):2633-42. doi: 10.1016/j.ejca.2013.04.002. Epub 2013 Apr 30.
This phase III study investigated the addition of aflibercept to gemcitabine, in patients with advanced pancreatic cancer.
Patients with metastatic pancreatic cancer were randomly assigned to receive either intravenous (i.v.) aflibercept, 4 mg/kg every 2 weeks, or matching placebo combined with gemcitabine, 1000 mg/m(2) i.v. weekly for 7 weeks out of 8, then weekly for 3 weeks out of 4 until progressive disease, unacceptable toxicity or withdrawal of consent. The primary objective was to demonstrate an improvement in overall survival (OS) between the treatment arms.
The study was stopped for futility following a planned interim analysis of OS in 427 randomised patients. With a median follow-up of 7.9 months, based on the 546 patients at study termination, median OS was 7.8 months in the gemcitabine plus placebo arm (n=275) versus 6.5 months in the gemcitabine plus aflibercept arm (n=271), which was not significant (hazard ratio 1.165, 95% confidence interval (CI) 0.921-1.473, p=0.2034). Median progression-free survival was 3.7 months in both arms. Treatment discontinuations due to adverse events were more frequent in the aflibercept than in the placebo-containing arm (23% versus 12%).
Adding aflibercept to gemcitabine did not improve OS in patients with metastatic pancreatic cancer.
这项 III 期研究旨在探讨阿柏西普联合吉西他滨治疗晚期胰腺癌患者的疗效。
转移性胰腺癌患者被随机分为静脉注射（IV）阿柏西普 4 mg/kg，每 2 周 1 次，或匹配的安慰剂联合吉西他滨 1000 mg/m² IV 每周 7 周，然后每 4 周 3 周，直至疾病进展、不可接受的毒性或退出同意。主要目的是证明治疗组之间总生存期（OS）的改善。
在对 427 例随机患者的 OS 进行计划的中期分析后，该研究因无效而停止。根据研究结束时的 546 例患者，中位随访 7.9 个月，吉西他滨联合安慰剂组（n=275）的中位 OS 为 7.8 个月，吉西他滨联合阿柏西普组（n=271）为 6.5 个月，无显著差异（风险比 1.165，95%置信区间（CI）0.921-1.473，p=0.2034）。中位无进展生存期在两组均为 3.7 个月。由于不良事件而停止治疗的患者在阿柏西普组比安慰剂组更常见（23%比 12%）。
在转移性胰腺癌患者中，阿柏西普联合吉西他滨并未改善 OS。
