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Feasibility study of postoperative adjuvant chemotherapy with S-1 in patients with biliary tract cancer

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Abstract

Background

The role of adjuvant chemotherapy has not yet been established for patients with resected biliary tract cancer. S-1 has been shown to exert activity against advanced biliary tract cancer. Therefore, we evaluated the feasibility of adjuvant chemotherapy with S-1 in patients with resected biliary tract cancer.

Methods

Patients with complete macroscopic resection of intrahepatic/extrahepatic bile duct, gall bladder, or ampullary cancer were eligible. S-1 was administered orally twice daily for 4 weeks every 6 weeks, up to 4 cycles. The treatment was continued up to 24 weeks or until recurrence/appearance of unacceptable toxicity. The primary endpoint was the treatment completion rate, which was defined as the percentage of patients who received a relative dose intensity of ≥ 75%. This trial was registered as UMIN000004051.

Results

Thirty-three patients were enrolled between June 2010 and March 2011. The relative dose intensity was ≥ 75% in 27 patients representing a treatment completion rate of 81.8%. The most common grade 3/4 adverse event was neutropenia (18%). Grade 2 nausea or diarrhea was observed in 12%. The 3-year relapse-free survival rate was 39.4%. The 3-year survival rate was 54.5%.

Conclusion

Adjuvant chemotherapy with S-1 is feasible treatment in patients with resected biliary tract cancer. It is necessary to conduct a phase III study to confirm the efficacy of adjuvant therapy of S-1 in patients with resected BTC.

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Acknowledgements

We thank Shinichi Ohkawa, Shoji Nakamori and Yasuo Hamamoto for audit. This study was supported by Ministry of Health, Labour and Welfare of Japan (Grant Number: 22–50).

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Authors and Affiliations

  1. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

    Kohei Nakachi & Masafumi Ikeda

  2. Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

    Masaru Konishi

  3. Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

    Kazuaki Shimada

  4. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

    Takuji Okusaka

  5. Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan

    Akio Saiura

  6. Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan

    Hiroshi Ishii

  7. Department of Surgery, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka, Tokyo, 181-8611, Japan

    Masanori Sugiyama

  8. Department of Medical Oncology, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka, Tokyo, 181-8611, Japan

    Junji Furuse

  9. Department of Gastroenterological Surgery, Saitama Cancer Center, 780 Komuro, Ina, Kitaadachi-gun, Saitama, 362-0806, Japan

    Hirohiko Sakamoto

  10. Department of Gastroenterology, Saitama Cancer Center, 780 Komuro, Ina, Kitaadachi-gun, Saitama, 362-0806, Japan

    Tomotaka Shimamura

  11. Department of Surgery, Institute of Gastroenterology, Tokyo Women’s Medical University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan

    Takehiro Ohta

  12. Otaru General Hospital, 1-1-1, Wakamatsu, Otaru, Hokkaido, 047-8550, Japan

    Kohei Nakachi

Authors
  1. Kohei Nakachi
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  2. Masaru Konishi
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  3. Masafumi Ikeda
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  4. Kazuaki Shimada
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  5. Takuji Okusaka
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  6. Akio Saiura
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  7. Hiroshi Ishii
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  8. Masanori Sugiyama
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  9. Junji Furuse
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  10. Hirohiko Sakamoto
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  11. Tomotaka Shimamura
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  12. Takehiro Ohta
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Corresponding author

Correspondence to Kohei Nakachi.

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Conflict of interest

Masafumi Ikeda received honoraria from Taiho Pharmaceutical; Takuji Okusaka received research funding, consulting fee, and honoraria from Taiho Pharmaceutical; Hiroshi Ishii received research funding and honoraria from Taiho Pharmaceutical; Junji Furuse received research funding, consulting fee, and honoraria from Taiho Pharmaceutical; other authors have no conflict of interest.

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Nakachi, K., Konishi, M., Ikeda, M. et al. Feasibility study of postoperative adjuvant chemotherapy with S-1 in patients with biliary tract cancer. Int J Clin Oncol 23, 894–899 (2018). https://doi.org/10.1007/s10147-018-1283-6

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  • DOI: https://doi.org/10.1007/s10147-018-1283-6

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