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

Cancer Chemotherapy and Pharmacology volume 71, pages 973–979 (2013)Cite this article

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.

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Acknowledgments

We thank all the patients participated in this study, their families, and the investigators.

Conflict of interest

None.

Author information

Affiliations

  1. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan

    Takashi Sasaki, Hiroyuki Isayama, Yousuke Nakai & Kazuhiko Koike

  2. Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo, Japan

    Yukiko Ito

  3. First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan

    Ichiro Yasuda

  4. Department of Gastroenterology, Mitsui Memorial Hospital, Tokyo, Japan

    Nobuo Toda

  5. Department of Gastroenterology, Kanto Central Hospital, Tokyo, Japan

    Hirofumi Kogure

  6. Center for Gastroendoscopy, Onomichi General Hospital, Onomichi, Japan

    Keiji Hanada

  7. Center for Gastroenterology, Teine-Keijinkai Hospital, Sapporo, Japan

    Hiroyuki Maguchi

  8. Department of Gastroenterology, JR Tokyo General Hospital, Tokyo, Japan

    Naoki Sasahira

  9. Department of Gastroenterology and Neurology, Kagawa University School of Medicine, Takamatsu, Japan

    Hideki Kamada

  10. Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan

    Tsuyoshi Mukai

  11. Department of Gastroenterology, Osaka Red Cross Hospital, Osaka, Japan

    Yoshihiro Okabe

  12. Department of Gastroenterology, Nagano Municipal Hospital, Nagano, Japan

    Osamu Hasebe

  13. Department of Gastroenterology, Toho University Ohashi Medical Center, Tokyo, Japan

    Iruru Maetani

Authors
  1. Takashi Sasaki
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  2. Hiroyuki Isayama
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  3. Yousuke Nakai
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  4. Yukiko Ito
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  5. Ichiro Yasuda
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  6. Nobuo Toda
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  7. Hirofumi Kogure
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  8. Keiji Hanada
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  9. Hiroyuki Maguchi
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  10. Naoki Sasahira
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  11. Hideki Kamada
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  12. Tsuyoshi Mukai
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  13. Yoshihiro Okabe
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  14. Osamu Hasebe
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  15. Iruru Maetani
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  16. Kazuhiko Koike
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Corresponding author

Correspondence to Hiroyuki Isayama.

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Cite this article

Sasaki, T., Isayama, H., Nakai, Y. et al. A randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine monotherapy for advanced biliary tract cancer. Cancer Chemother Pharmacol 71, 973–979 (2013). https://doi.org/10.1007/s00280-013-2090-4

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  • DOI: https://doi.org/10.1007/s00280-013-2090-4

Keywords

  • Biliary tract cancer
  • Gemcitabine
  • S-1
  • Chemotherapy
  • Randomized control study