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Randomised phase II trial of S-1 plus oxaliplatin vs S-1 in patients with gemcitabine-refractory pancreatic cancer

BACKGROUND: This randomised, open-label, multicenter phase II study compared progression-free survival (PFS) of S-1 plus oxaliplatin (SOX) with that of S-1 alone in patients with gemcitabine-refractory pancreatic cancer. METHODS: Patients with confirmed progressive disease following the first-line t...

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Detalles Bibliográficos
Autores principales: Ohkawa, S, Okusaka, T, Isayama, H, Fukutomi, A, Yamaguchi, K, Ikeda, M, Funakoshi, A, Nagase, M, Hamamoto, Y, Nakamori, S, Tsuchiya, Y, Baba, H, Ishii, H, Omuro, Y, Sho, M, Matsumoto, S, Yamada, N, Yanagimoto, H, Unno, M, Ichikawa, Y, Takahashi, S, Watanabe, G, Wakabayashi, G, Egawa, N, Tsuda, M, Hosotani, R, Hamada, C, Hyodo, I
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4453667/
https://www.ncbi.nlm.nih.gov/pubmed/25880004
http://dx.doi.org/10.1038/bjc.2015.103
Descripción
Sumario:BACKGROUND: This randomised, open-label, multicenter phase II study compared progression-free survival (PFS) of S-1 plus oxaliplatin (SOX) with that of S-1 alone in patients with gemcitabine-refractory pancreatic cancer. METHODS: Patients with confirmed progressive disease following the first-line treatment with a gemcitabine-based regimen were randomised to receive either S-1 (80/100/120 mg day(−1) based on body surface area (BSA), orally, days 1–28, every 6 weeks) or SOX (S-1 80/100/120 mg day(−1) based on BSA, orally, days 1–14, plus oxaliplatin 100 mg m(−2), intravenously, day 1, every 3 weeks). The primary end point was PFS. RESULTS: Between January 2009 and July 2010, 271 patients were randomly allocated to either S-1 (n=135) or SOX (n=136). Median PFS for S-1 and SOX were 2.8 and 3.0 months, respectively (hazard ratio (HR)=0.84; 95% confidence interval (CI), 0.65–1.08; stratified log-rank test P=0.18). Median overall survival (OS) was 6.9 vs 7.4 months (HR=1.03; 95% CI, 0.79–1.34; stratified log-rank test P=0.82). The response rate (RR) was 11.5% vs 20.9% (P=0.04). The major grade 3/4 toxicities (S-1 and SOX) were neutropenia (11.4% and 8.1%), thrombocytopenia (4.5% and 10.3%) and anorexia (12.9% and 14.7%). CONCLUSIONS: Although SOX showed an advantage in RR, it provided no significant improvement in PFS or OS compared with S-1 alone.