期刊
DIGESTIVE AND LIVER DISEASE
卷 46, 期 2, 页码 182-186出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.dld.2013.09.020
关键词
Cisplatin; Gemcitabine; Pancreatic cancer; Phase II study; Sorafenib
Background: The RAF-MEK-ERK pathway is commonly activated in pancreatic cancer because of a high frequency of KRAS-BRAF mutations. A phase II randomized trial was designed to investigate the activity of sorafenib in combination with chemotherapy in advanced pancreatic cancer. Methods: Locally advanced or metastatic pancreatic adenocarcinoma patients were randomized in a 1: 1 ratio to receive cisplatin plus gemcitabine with sorafenib 400 mg bid (arm A) or without sorafenib (arm B). Results: One hundred and fourteen patients were enrolled; of these, 43 (74.6%) patients progressed in arm A and 44 (82.4%) in arm B. Median progression-free survival was 4.3 months (95% CI: 2.7-6.5) and 4.5 months (95% CI: 2.5-5.2), respectively (HR = 0.92; 95% CI: 0.62-1.35). Median overall survival was 7.5 (95% CI: 5.6-9.7) and 8.3 months (95% CI: 6.2-8.7), respectively (HR = 0.95; 95% CI: 0.62-1.48). Response rates were 3.4% in arm A and 3.6% in arm B. Conclusions: Sorafenib does not significantly enhance activity of chemotherapy in advanced pancreatic cancer patients, and therefore should not be assessed in phase III trials. (C) 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据