- 作者：Stefano Cascinu ; Rossana Berardi ; Alberto Sobrero ; Paolo Bidoli ; Roberto Labianca ; Salvatore Siena ; Daris Ferrari ; S ; ro Barni ; Enrico Aitini ; Vittorina Zagonel ; Francesco Caprioni ; Federica Villa ; Stefania Mosconi ; Luca Faloppi ; Giuseppe Tonini ; Corrado Boni ; Pierfranco Conte ; Francesco Di Costanzo ; Michela Cinquini ; on behalf of the Italian Group for the Study of Digestive Tract Cancer (GISCAD)
- 关键词：Cisplatin ; Gemcitabine ; Pancreatic cancer ; Phase II study ; Sorafenib
- 刊名：Digestive and Liver Disease
- 出版年：February, 2014
- 年：2014
- 卷：46
- 期：2
- 页码：182-186
- 全文大小：736 K
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.