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Gemcitabine and S-1 versus gemcitabine and cisplatin treatment in patients with advanced biliary tract cancer: a multicenter retrospective study

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Summary

Objective This study aimed to compare the safety and efficacy of the combination therapy of gemcitabine and S-1 (GS) versus gemcitabine and cisplatin (GC) in patients with advanced biliary tract cancer (BTC). Methods In this multicenter retrospective cohort study, a total of 212 patients with advanced BTC receiving GS (n = 125) or GC (n = 87) between July 2006 and August 2015 were analyzed. The primary endpoint was overall survival (OS). The secondary endpoints were progression-free survival (PFS), objective tumor response, and safety. Results Patient characteristics were well balanced between the two groups, except for tumor size (the baseline sum of the largest diameter of the tumor: 6.3 cm in the GS group vs. 8.6 cm in the GC group, p = 0.01). Although the response rate was higher in the GS group than in the GC group (28.8% vs. 10.3%, p = 0.01), the median PFS and OS were comparable between the two groups (PFS of 5.6 vs. 7.6 months, p = 0.74; OS of 12.4 vs. 9.2 months, p = 0.20, respectively). Stomatitis and skin rash were more frequently observed in the GS group, whereas anemia, thrombocytopenia, nausea, and renal toxicity were more commonly observed in the GC group. Conclusion This study demonstrates that GS and GC are similar with regard to their safety and efficacy in patients with advanced BTC. GS could serve as an alternative treatment for advanced BTC as a first-line chemotherapy.

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Abbreviations

BTC:

Biliary tract cancer

GS:

Gemcitabine and S-1 combination therapy

GC:

Gemcitabine and cisplatin combination therapy

OS:

Overall survival

PFS:

Progression-free survival

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Acknowledgements

We thank all participating patients and their families, as well as the investigators Drs. Ryunosuke Hakuta, Gyotane Umefune, Tomotaka Saito, Takeo Watanabe, and Kaoru Takagi, and the research coordinators Miyuki Tsuchida and Chiho Takeda (Department of Gastroenterology, the University of Tokyo Hospital).

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Authors and Affiliations

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

    Naminatsu Takahara, Hiroyuki Isayama, Yousuke Nakai, Kazunaga Ishigaki, Kei Saito, Rie Uchino, Suguru Mizuno, Hirofumi Kogure, Saburo Matsubara, Minoru Tada & Kazuhiko Koike

  2. Department of Gastroenterology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan

    Takashi Sasaki

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

    Dai Akiyama

  4. Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo, Japan

    Hiroshi Yagioka

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

    Osamu Togawa

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

    Yukiko Ito

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

    Nobuo Toda

Authors
  1. Naminatsu Takahara
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  2. Hiroyuki Isayama
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  3. Yousuke Nakai
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  4. Takashi Sasaki
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  5. Kazunaga Ishigaki
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  6. Kei Saito
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  7. Dai Akiyama
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  8. Rie Uchino
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  9. Suguru Mizuno
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  10. Hiroshi Yagioka
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  11. Hirofumi Kogure
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  12. Osamu Togawa
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  13. Saburo Matsubara
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  14. Yukiko Ito
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  15. Nobuo Toda
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  16. Minoru Tada
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  17. Kazuhiko Koike
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Corresponding author

Correspondence to Hiroyuki Isayama.

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The authors declare no conflict of interest related to this article.

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None.

Ethical approval

This study was performed in accordance with the Declaration of Helsinki and was approved by each institutional review board.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Takahara, N., Isayama, H., Nakai, Y. et al. Gemcitabine and S-1 versus gemcitabine and cisplatin treatment in patients with advanced biliary tract cancer: a multicenter retrospective study. Invest New Drugs 35, 269–276 (2017). https://doi.org/10.1007/s10637-017-0430-7

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  • DOI: https://doi.org/10.1007/s10637-017-0430-7

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