Randomized phase iii study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: Gest study

Hideki Ueno, Tatsuya Ioka, Masafumi Ikeda, Shinichi Ohkawa, Hiroaki Yanagimoto, Narikazu Boku, Akira Fukutomi, Kazuya Sugimori, Hideo Baba, Kenji Yamao, Tomotaka Shimamura, Masayuki Sho, Masayuki Kitano, Ann Lii Cheng, Kazuhiro Mizumoto, Jen Shi Chen, Junji Furuse, Akihiro Funakoshi, Takashi Hatori, Taketo YamaguchiShinichi Egawa, Atsushi Sato, Yasuo Ohashi, Takuji Okusaka, Masao Tanaka

Research output: Contribution to journalArticle

356 Citations (Scopus)

Abstract

Purpose The present phase III study was designed to investigate the noninferiority of S-1 alone and superiority of gemcitabine plus S-1 compared with gemcitabine alone with respect to overall survival. Patients and Methods The participants were chemotherapy-naive patients with locally advanced or metastatic pancreatic cancer. Patients were randomly assigned to receive only gemcitabine (1,000 mg/m2 on days 1, 8, and 15 of a 28-day cycle), only S-1 (80, 100, or 120 mg/d according to body-surface area on days 1 through 28 of a 42-day cycle), or gemcitabine plus S-1 (gemcitabine 1,000 mg/m2 on days 1 and 8 plus S-1 60, 80, or 100 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle). Results In the total of 834 enrolled patients, median overall survival was 8.8 months in the gemcitabine group, 9.7 months in the S-1 group, and 10.1 months in the gemcitabine plus S-1 group. The noninferiority of S-1 to gemcitabine was demonstrated (hazard ratio, 0.96; 97.5% CI, 0.78 to 1.18; P - .001 for noninferiority), whereas the superiority of gemcitabine plus S-1 was not (hazard ratio, 0.88; 97.5% CI, 0.71 to 1.08; Pgt; .15). All treatments were generally well tolerated, although hematologic and GI toxicities were more severe in the gemcitabine plus S-1 group than in the gemcitabine group. Conclusion Monotherapy with S-1 demonstrated noninferiority to gemcitabine in overall survival with good tolerability and presents a convenient oral alternative for locally advanced and metastatic pancreatic cancer.

Original languageEnglish
Pages (from-to)1640-1648
Number of pages9
JournalJournal of Clinical Oncology
Volume31
Issue number13
DOIs
Publication statusPublished - May 1 2013

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Fingerprint Dive into the research topics of 'Randomized phase iii study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: Gest study'. Together they form a unique fingerprint.

  • Cite this

    Ueno, H., Ioka, T., Ikeda, M., Ohkawa, S., Yanagimoto, H., Boku, N., Fukutomi, A., Sugimori, K., Baba, H., Yamao, K., Shimamura, T., Sho, M., Kitano, M., Cheng, A. L., Mizumoto, K., Chen, J. S., Furuse, J., Funakoshi, A., Hatori, T., ... Tanaka, M. (2013). Randomized phase iii study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: Gest study. Journal of Clinical Oncology, 31(13), 1640-1648. https://doi.org/10.1200/JCO.2012.43.3680