Cancer Chemotherapy and Pharmacology

, Volume 71, Issue 4, pp 973–979

A randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine monotherapy for advanced biliary tract cancer

Authors

  • Takashi Sasaki
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
  • Yousuke Nakai
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
  • Yukiko Ito
    • Department of GastroenterologyJapanese Red Cross Medical Center
  • Ichiro Yasuda
    • First Department of Internal MedicineGifu University Hospital
  • Nobuo Toda
    • Department of GastroenterologyMitsui Memorial Hospital
  • Hirofumi Kogure
    • Department of GastroenterologyKanto Central Hospital
  • Keiji Hanada
    • Center for GastroendoscopyOnomichi General Hospital
  • Hiroyuki Maguchi
    • Center for GastroenterologyTeine-Keijinkai Hospital
  • Naoki Sasahira
    • Department of GastroenterologyJR Tokyo General Hospital
  • Hideki Kamada
    • Department of Gastroenterology and NeurologyKagawa University School of Medicine
  • Tsuyoshi Mukai
    • Department of GastroenterologyGifu Municipal Hospital
  • Yoshihiro Okabe
    • Department of GastroenterologyOsaka Red Cross Hospital
  • Osamu Hasebe
    • Department of GastroenterologyNagano Municipal Hospital
  • Iruru Maetani
    • Department of GastroenterologyToho University Ohashi Medical Center
  • Kazuhiko Koike
    • Department of Gastroenterology, Graduate School of MedicineThe University of Tokyo
Original Article

DOI: 10.1007/s00280-013-2090-4

Cite this article as:
Sasaki, T., Isayama, H., Nakai, Y. et al. Cancer Chemother Pharmacol (2013) 71: 973. doi:10.1007/s00280-013-2090-4

Abstract

Purpose

In order to confirm the impact of adding S-1 to gemcitabine, we conducted a randomized phase II study to compare the combination therapy of gemcitabine plus S-1 to gemcitabine monotherapy in patients with advanced biliary tract cancer.

Methods

Sixty-two patients with advanced cholangiocarcinoma or gallbladder cancer were randomized to either the combination therapy of gemcitabine and S-1 (gemcitabine 1,000 mg/m2 on days 1 and 15 and S-1 40 mg/m2 b.i.d. on days 1–14, repeated every 4 weeks) or gemcitabine monotherapy (gemcitabine 1,000 mg/m2 on days 1, 8, and 15, repeated every 4 weeks). The primary endpoint of this study was response rate, and the regimen which showed the better response rate was selected as a candidate of phase III study. Tumor response was assessed every two cycles using Response Evaluation Criteria in Solid Tumors criteria version 1.0.

Results

The response rates of the combination therapy and the monotherapy were 20.0 and 9.4 %, respectively. The median time-to-progressions and overall survivals of these two treatments were nearly the same (5.6 vs. 4.3 months; 8.9 vs. 9.2 months). Adverse events occurred more frequently in the combination arm.

Conclusions

The combination therapy of gemcitabine and S-1 showed the better response rate, but the superiority of this combination therapy was not clear in total. Because the standard of care changed to the combination therapy with gemcitabine and cisplatin during this study, it is difficult to select this combination therapy with a 4-week regimen as a candidate of phase III study.

Keywords

Biliary tract cancerGemcitabineS-1ChemotherapyRandomized control study

Copyright information

© Springer-Verlag Berlin Heidelberg 2013