Sorafenib does not improve efficacy of chemotherapy in advanced pancreatic cancer: A GISCAD randomized phase II study
Sorafenib does not improve efficacy of chemotherapy in advanced pancreatic cancer: A GISCAD randomized phase II study
复制标题
DOI：
10.1016/j.dld.2013.09.020
复制
发表时间：
2014-02-01
影响因子：
4.5
通讯作者：
Cinquini, Michela
中科院分区：
文献类型：
--
作者：
Cascinu, Stefano;Berardi, Rossana;Cinquini, Michela
背景：由于KRAS-BRAF突变的高频率，RAF-MEK-ERK通路在胰腺癌中通常被激活。一项II期随机试验旨在研究索拉非尼联合化疗治疗晚期胰腺癌的活性。方法：局部晚期或转移性胰腺腺癌患者以1:1的比例随机接受顺铂+吉西他滨联合索拉非尼400mg bid （a组）或不使用索拉非尼（B组）。结果：入组114例患者；其中，A组有43例（74.6%）患者进展，b组有44例（82.4%）患者进展。中位无进展生存期分别为4.3个月（95% CI: 2.7-6.5）和4.5个月（95% CI: 2.5-5.2） （HR = 0.92; 95% CI: 0.62-1.35）。中位总生存期分别为7.5个月（95% CI: 5.6-9.7）和8.3个月（95% CI: 6.2-8.7） （HR = 0.95; 95% CI: 0.62-1.48）。A组有效率为3.4%，b组有效率为3.6%。结论：索拉非尼不能显著增强晚期胰腺癌患者化疗活性，因此不应在III期试验中进行评估。(C) 2013 Editrice gastroenteritaliana S.r.l, Elsevier Ltd.出版版权所有。
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.