Sorafenib does not improve efficacy of chemotherapy in advanced pancreatic cancer: A GISCAD randomized phase II study

Stefano Cascinu, Rossana Berardi, Alberto Sobrero, Paolo Bidoli, Roberto Labianca, Salvatore Siena, Daris Ferrari, Sandro Barni, Enrico Aitini, Vittorina Zagonel, Francesco Caprioni, Federica Villa, Stefania Mosconi, Luca Faloppi, Giuseppe Tonini, Corrado Boni, Pierfranco Conte, Francesco Di Costanzo, Michela Cinquini

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)182-186
Number of pages5
JournalDigestive and Liver Disease
Issue number2
Publication statusPublished - Feb 2014


  • Cisplatin
  • Gemcitabine
  • Pancreatic cancer
  • Phase II study
  • Sorafenib

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology


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