Randomized phase II study of consecutive-day versus alternate-day treatment with S-1 as second-line chemotherapy in advanced pancreatic cancer

Takuya Ishikawa, Hiroki Kawashima, Eizaburo Ohno, Hiroshi Matsubara, Yoji Sasaki, Koichi Achiwa, Akira Kanamori, Hajime Sumi, Takanori Hirai, Koji Nonogaki, Tomoyuki Tsuzuki, Masanori Kuroiwa, Masashi Hattori, Shinya Maruta, Takeshi Hiramatsu, Masahiko Ando, Senju Hashimoto, Yoshiki Hirooka

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Abstract

Objective: To evaluate the efficacy and safety of alternate-day administration of S-1 as second-line chemotherapy for unresectable pancreatic cancer in a multicenter, randomized, phase II study. Methods: Patients with histologically proven, unresectable pancreatic cancer treated with chemotherapy not including S-1 as first-line therapy were randomly assigned to receive either daily or alternate-day treatment with S-1. The primary end point was overall survival (OS), and the secondary end points were progression-free survival (PFS), time to treatment failure (TTF), response rate, and adverse events. Results: A total of 77 patients were enrolled, of which 75 were included in the final analysis. The median OS was 4.5 months in the daily group and 4.4 months in the alternate-day group (HR 1.178; 95% CI 0.741-1.875), with no significance in PFS and TTF. The response rate was 2.8% in the daily group and 0% in the alternate-day group. Grade 3 or higher adverse events occurred with significantly higher incidence in the daily group (47.2 vs. 25.6%, p = 0.044). Conclusion: As a second-line chemotherapy for unresectable pancreatic cancer, although the efficacy in both groups was comparable and we can expect fewer toxicities with alternate-day administration of S-1, the noninferiority of alternate-day treatment to daily treatment with S-1 was not verified.

Original languageEnglish
Pages (from-to)1-7
Number of pages7
JournalOncology (Switzerland)
Volume96
Issue number1
DOIs
Publication statusPublished - 01-12-2018
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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