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

T. Ioka, Y. Komatsu, N. Mizuno, A. Tsuji, S. Ohkawa, M. Tanaka, H. Iguchi, A. Ishiguro, M. Kitano, T. Satoh, T. Yamaguchi, K. Takeda, M. Kida, K. Eguchi, T. Ito, M. Munakata, T. Itoi, J. Furuse, C. Hamada, Y. Sakata

Research output: Contribution to journalArticlepeer-review

19 Citations (Scopus)


Background:We aimed to compare the efficacy and safety of irinotecan/S-1 (IRIS) therapy with S-1 monotherapy in patients with gemcitabine-refractory pancreatic cancer.Methods:Patients were treated with oral S-1 (80-120 mg for 14 days every 4 weeks) plus intravenous irinotecan (100 mg m -2 on days 1 and 15 every 4 weeks; IRIS group) or oral S-1 group (80-120 mg daily for 28 days every 6 weeks). The primary endpoint was progression-free survival (PFS).Results:Of 137 patients enrolled, 127 were eligible for efficacy. The median PFS in the IRIS group and S-1 monotherapy group were 3.5 and 1.9 months, respectively (hazard ratio (HR)=0.77; 95% confidence interval (CI), 0.53-1.11; P=0.18), while the median overall survival (OS) were 6.8 and 5.8 months, respectively (HR=0.75; 95% CI, 0.51-1.09; P=0.13). Response rate was significantly higher in the IRIS group than in the S-1 monotherapy group (18.3% vs 6.0%, P=0.03). Grade 3 or higher neutropenia and anorexia occurred more frequently in the IRIS group.Conclusions:There was a trend for better PFS and OS in the IRIS group that could be a treatment arm in the clinical trials for gemcitabine-refractory pancreatic cancer.

Original languageEnglish
Pages (from-to)464-471
Number of pages8
JournalBritish journal of cancer
Issue number4
Publication statusPublished - Feb 14 2017

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research


Dive into the research topics of 'Randomised phase II trial of irinotecan plus S-1 in patients with gemcitabine-refractory pancreatic cancer'. Together they form a unique fingerprint.

Cite this