Sorafenib does not improve efficacy of chemotherapy in advanced pancreatic cancer : a GISCAD randomized phase II study
Articolo
Data di Pubblicazione:
2014
Citazione:
Sorafenib does not improve efficacy of chemotherapy in advanced pancreatic cancer : a GISCAD randomized phase II study / S. Cascinu, R. Berardi, A. Sobrero, P. Bidoli, R. Labianca, S. Siena, D. Ferrari, S. Barni, E. Aitini, V. Zagonel, F. Caprioni, F. Villa, S. Mosconi, L. Faloppi, G. Tonini, C. Boni, P. Conte, F. Di Costanzo, M. Cinquini. - In: DIGESTIVE AND LIVER DISEASE. - ISSN 1590-8658. - 46:2(2014 Feb), pp. 182-186. [10.1016/j.dld.2013.09.020]
Abstract:
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.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
Cisplatin; Gemcitabine; Pancreatic cancer; Phase II study; Sorafenib; Adenocarcinoma; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Deoxycytidine; Disease-Free Survival; Female; Humans; Male; Middle Aged; Niacinamide; Pancreatic Neoplasms; Phenylurea Compounds; Treatment Outcome; Gastroenterology; Hepatology
Elenco autori:
S. Cascinu, R. Berardi, A. Sobrero, P. Bidoli, R. Labianca, S. Siena, D. Ferrari, S. Barni, E. Aitini, V. Zagonel, F. Caprioni, F. Villa, S. Mosconi, L. Faloppi, G. Tonini, C. Boni, P. Conte, F. Di Costanzo, M. Cinquini
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