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Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients

International Journal of Clinical Oncology volume 18, pages 254–259 (2013)Cite this article

Abstract

Background

A prospective feasibility study was planned to clarify the proportion of compliance and adverse events in the administration of capecitabine as adjuvant chemotherapy for colon cancer in Japanese patients.

Methods

We aimed initially to register 92 cases of R0 stage III colon cancer. Capecitabine (2,500 mg/m2/day) was given orally on days 1–14 every 3 weeks for 8 cycles. The proportion of treatments completed as planned was selected as the primary endpoint.

Results

Ninety-seven cases were registered and treated between September 2008 and August 2009. The proportion of treatments completed in the full analysis set was 64/97 [66.0%; 95% confidence interval (CI), 55.7–75.3%] and in the per protocol set was 64/91 (70.3%; 95% CI, 59.8–79.5%). Adverse events which led to treatment discontinuation included hand–foot syndrome (HFS) (7), haematotoxicity (5) and increased hepatic damage (4). The proportions of patients with major grade 3/4 adverse events were HFS 22.7%, neutropenia 7.2%, diarrhoea 2.1%, and increased bilirubin 0.0%.

Conclusions

This collaborative multi-facility study, the first of its kind in Japan, presented results of a safety confirmation experiment on capecitabine as adjuvant chemotherapy for stage III colon cancer. The results suggest that capecitabine may be administered safely to Japanese patients.

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Acknowledgments

We are indebted to the physicians and all other co-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.

Conflict of interest

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

Author information

Affiliations

  1. Department of Surgery, Saiseikai Fukuoka General Hospital, 1-3-46 Tenjin, Chuou-ku, Fukuoka, 810-0001, Japan

    Yasunori Emi

  2. Department of Gastroenterological Surgery, National Kyushu Cancer Center, Fukuoka, Japan

    Yoshihisa Sakaguchi & Masaru Morita

  3. Department of Surgery, University of the Ryukyus Hospital, Nishihara, Japan

    Hironori Samura

  4. Department of Surgery, Kurume Medical Center, Kurume, Japan

    Yutaka Ogata

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

    Masaki Kitazono, Yoshito Akagi & Kazuo Shirouzu

  6. Department of Gastrointestinal Surgery, Kagoshima University, Kagoshima, Japan

    Shoji Natsugoe

  7. Department of Medical Informatics, Kyushu University Hospital, Fukuoka, Japan

    Shoji Tokunaga

  8. F. Hoffmann-La Roche Ltd, Basel, Switzerland

    Florin Sirzen

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

    Yoshihiro Kakeji, Eiji Oki, Hiroshi Saeki, Koji Ando & Yoshihiko Maehara

Authors
  1. Yasunori Emi
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  2. Yoshihiro Kakeji
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  3. Eiji Oki
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  4. Hiroshi Saeki
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  5. Koji Ando
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  6. Masaki Kitazono
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  7. Yoshihisa Sakaguchi
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  8. Masaru Morita
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  9. Hironori Samura
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  10. Yutaka Ogata
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  11. Yoshito Akagi
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  12. Shoji Natsugoe
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  13. Kazuo Shirouzu
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  14. Shoji Tokunaga
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  15. Florin Sirzen
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  16. Yoshihiko Maehara
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Consortia

Kyushu Study Group of Clinical Cancer (KSCC)

Corresponding author

Correspondence to Yasunori Emi.

Additional information

YM was the principal investigator. YE, YK, YA, and ST were responsible for the study concept and design. YK, YS, HS, YO, SN, KA, MM, and KS provided patients. YK, HS and YO did the review. YE and YK collected and collated data. ST and YE analyzed the data. ST, YO, YK and YM interpreted the data. YE wrote the manuscript, which was approved by all authors.

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Cite this article

Emi, Y., Kakeji, Y., Oki, E. et al. Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients. Int J Clin Oncol 18, 254–259 (2013). https://doi.org/10.1007/s10147-011-0371-7

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  • DOI: https://doi.org/10.1007/s10147-011-0371-7

Keywords

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