Sorafenib does not improve efficacy of chemotherapy in advanced pancreatic cancer: A GISCAD randomized phase II study |
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| Affiliation: | 1. Medical Oncology Unit, Università Politecnica delle Marche, Ospedali Riuniti di Ancona, Ancona, Italy;2. Medical Oncology Unit, Ospedale S. Martino, Genova, Italy;3. Medical Oncology Unit, Ospedale S. Gerardo, Monza, Italy;4. Medical Oncology Unit, Ospedali Riuniti, Bergamo, Italy;5. Niguarda Cancer Center, Ospedale Niguarda Ca’ Granda, Milan, Italy;6. Medical Oncology Unit, Ospedale S. Paolo, Milano, Italy;7. Medical Oncology Unit, Treviglio Hospital, Treviglio, Italy;8. Medical Oncology Unit, C. Poma Hospital, Mantova, Italy;9. Medical Oncology Unit, Istituto Oncologico Veneto, Padova, Italy;10. Medical Oncology Unit, University Campus Bio-Medico, Rome, Italy;11. Medical Oncology Unit, Arcispedale S. Maria Nuova IRCCS, Reggio Emilia, Italy;12. Medical Oncology Unit, Policlinico Universitario, Modena, Italy;13. Medical Oncology Unit Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy;14. New Drug Development Strategies Laboratory, Mario Negri Institute, Milano, Italy |
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| Abstract: | BackgroundThe 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.MethodsLocally 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).ResultsOne 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.ConclusionsSorafenib does not significantly enhance activity of chemotherapy in advanced pancreatic cancer patients, and therefore should not be assessed in phase III trials. |
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| Keywords: | Cisplatin Gemcitabine Pancreatic cancer Phase II study Sorafenib |
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