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

S. Ohkawa, T. Okusaka, H. Isayama, A. Fukutomi, K. Yamaguchi, M. Ikeda, A. Funakoshi, M. Nagase, Y. Hamamoto, S. Nakamori, Y. Tsuchiya, H. Baba, H. Ishii, Y. Omuro, M. Sho, S. Matsumoto, N. Yamada, H. Yanagimoto, M. Unno, Y. IchikawaS. Takahashi, G. Watanabe, G. Wakabayashi, N. Egawa, M. Tsuda, R. Hosotani, C. Hamada, I. Hyodo

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48 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)1428-1434
Number of pages7
JournalBritish Journal of Cancer
Issue number9
Publication statusPublished - 2015 Apr 28


  • S-1
  • SOX
  • chemotherapy
  • oxaliplatin
  • pancreatic cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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