Multicenter, randomized, open-label Phase II study comparing S-1 alternate-day oral therapy with the standard daily regimen as a first-line treatment in patients with unresectable advanced pancreatic cancer

Hiroki Yamaue, Atsushi Shimizu, Yasuhiro Hagiwara, Masayuki Sho, Hiroaki Yanagimoto, Shoji Nakamori, Hideki Ueno, Hiroshi Ishii, Masayuki Kitano, Kazuya Sugimori, Hiroyuki Maguchi, Shinichi Ohkawa, Hiroshi Imaoka, Daisuke Hashimoto, Kazuki Ueda, Hiroko Nebiki, Tatsuya Nagakawa, Hiroyuki Isayama, Isao Yokota, Yasuo OhashiTetsuhiko Shirasaka

Research output: Contribution to journalArticlepeer-review

16 Scopus citations

Abstract

Purpose: Non-inferiority for overall survival (OS) following alternate-day treatment with the oral anticancer drug S-1 compared with standard daily treatment was assessed in Japanese patients with unresectable advanced pancreatic cancer in a multicenter, randomized, phase II study. This trial was registered at the UMIN Clinical Trials Registry (no. 000008604). Methods: Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned 2:1 to treatment with alternate-day (twice daily on alternate days from days 1 through 42 of a 42-day cycle) or daily (twice daily on days 1 through 28 of a 42-day cycle) treatment with S-1. The primary endpoint was OS. Secondary endpoints were progression-free survival (PFS), time to treatment failure, response rate, quality of life assessments, and safety. Results: A total of 190 patients were enrolled, of which 185 were included in the final analysis (alternate-day: 121; daily: 64). Median OS was 9.4 for the alternate-day group and 10.4 months for the daily group [hazard ratio (HR), 1.19; 95% credible interval, 0.86 to 1.64], indicating that non-inferiority of alternate-day treatment to daily treatment was not demonstrated. Median PFS was 3.0 for the alternate-day group and 4.2 months for the daily group (HR, 1.65; 95% credible interval, 1.20–2.29). The incidence of anorexia, fatigue, neutrophils, pigmentation, and pneumonitis was lower in alternate-day treatment compared with daily treatment. Conclusion: S-1 for advanced pancreatic cancer should be taken daily as recommended, based on the decreased OS and PFS and marginal improvement in safety observed in the alternate-day group.

Original languageEnglish
Pages (from-to)813-823
Number of pages11
JournalCancer Chemotherapy and Pharmacology
Volume79
Issue number4
DOIs
StatePublished - 1 Apr 2017
Externally publishedYes

Keywords

  • Alternate-day treatment
  • EORTC QLQ-30
  • EQ-5D
  • S-1
  • Unresectable pancreatic cancer

Fingerprint

Dive into the research topics of 'Multicenter, randomized, open-label Phase II study comparing S-1 alternate-day oral therapy with the standard daily regimen as a first-line treatment in patients with unresectable advanced pancreatic cancer'. Together they form a unique fingerprint.

Cite this