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Final report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japan

International Journal of Clinical Oncology volume 22, pages 505–510 (2017)Cite this article

Abstract

Background

The impact of oral capecitabine as adjuvant chemotherapy for Japanese patients with resected colon cancer was unclear. We previously planned and conducted a prospective feasibility study (KSCC0803) and reported on the safety of oral capecitabine as adjuvant chemotherapy for Japanese patients with resected stage III colon cancer. The purpose of the current study was to assess the survival results from that study.

Methods

The study subjects were Japanese patients with resected stage III colon cancer. The protocol adjuvant regimen consisted of oral capecitabine 1250 mg/m2 twice daily on days 1–14 of a 3-week cycle for a total of eight cycles. The 3- and 5-year disease free survival (DFS) rates and overall survival (OS) rates were analyzed in the eligible cohort.

Results

Ninety-seven patients were registered between September 2008 and August 2009 and treated with the protocol regimen. The median follow-up time was 60.7 months. The 3- and 5-year DFS rates were 71.2% [95% confidence interval (CI): 61.7–79.8%] and 69.7% (95% CI: 59.4–77.8%), respectively. The 3- and 5-year OS rates were 92.6% (95% CI: 85.2–96.4%) and 84.5% (95% CI: 75.1–90.5%), respectively.

Conclusions

The survival results in this study are in line with those of previously reported, reliable, studies. The safety and tolerability of the protocol regimen have already been confirmed. Oral capecitabine is acceptable as adjuvant chemotherapy for Japanese patients with resected stage III colon cancer.

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Acknowledgements

We are indebted to the physicians and all of the other medical staff who contributed to this study. We also thank Ms. Taniguchi, Ms. Kozuru, and Ms. Kasamoto at the Clinical Research Support Center Kyushu (CReS Kyushu) for their excellent data management and secretarial assistance.

Author information

Affiliations

  1. Department of Gastroenterological Surgery, National Kyushu Cancer Center, Notame 3-1-1, Minami-ku, Fukuoka, 811-1395, Japan

    Kazuhito Minami & Masaru Morita

  2. Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan

    Yasunori Emi

  3. Department of Surgery, Oita Red Cross Hospital, Oita, Japan

    Masahiro Okamoto

  4. Department of Surgery, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan

    Eiji Tanaka

  5. Department of Surgery, Nakatsu Municipal Hospital, Oita, Japan

    Shigeyuki Nagata

  6. Department of Surgery, Nakagami Hospital, Okinawa, Japan

    Tetsuo Touyama

  7. Department of Gastrointestinal Surgery, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan

    Kippei Ohgaki

  8. Department of Surgery, Social Insurance Tagawa Hospital, Fukuoka, Japan

    Takaho Tanaka

  9. Department of Surgery, Kagoshima Kouseiren Hospital, Kagoshima, Japan

    Hiroshi Okumura

  10. Department of Surgery, Nanpuh Hospital, Kagoshima, Japan

    Toyokuni Suenaga

  11. Medical Information Center, Kyushu University Hospital, Fukuoka, Japan

    Shoji Tokunaga

  12. Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan

    Eiji Oki & Yoshihiko Maehara

  13. Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, Kobe, Japan

    Yoshihiro Kakeji

  14. Department of Surgery, Kurume University School of Medicine, Kurume, Japan

    Yoshito Akagi

  15. Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan

    Hideo Baba

  16. Department of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan

    Shoji Natsugoe

Authors
  1. Kazuhito Minami
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  2. Masaru Morita
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  3. Yasunori Emi
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  4. Masahiro Okamoto
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  5. Eiji Tanaka
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  6. Shigeyuki Nagata
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  7. Tetsuo Touyama
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  8. Kippei Ohgaki
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  9. Takaho Tanaka
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  10. Hiroshi Okumura
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  11. Toyokuni Suenaga
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  12. Shoji Tokunaga
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  13. Eiji Oki
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  14. Yoshihiro Kakeji
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  15. Yoshito Akagi
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  16. Hideo Baba
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  17. Shoji Natsugoe
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  18. Yoshihiko Maehara
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Consortia

Kyushu Study Group of Clinical Cancer (KSCC)

Corresponding author

Correspondence to Kazuhito Minami.

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Conflict of interest

Yoshihiko Maehara has received research funding from Chugai Pharmaceutical. All other authors declare no conflicts of interest.

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Minami, K., Morita, M., Emi, Y. et al. Final report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japan. Int J Clin Oncol 22, 505–510 (2017). https://doi.org/10.1007/s10147-017-1088-z

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  • DOI: https://doi.org/10.1007/s10147-017-1088-z

Keywords

  • Capecitabine
  • Adjuvant chemotherapy
  • Colon cancer
  • Japanese
  • Feasibility study
  • X-ACT trial