Journal
DIGESTIVE AND LIVER DISEASE
Volume 46, Issue 2, Pages 182-186Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.dld.2013.09.020
Keywords
Cisplatin; Gemcitabine; Pancreatic cancer; Phase II study; Sorafenib
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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.
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