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

Yasunori Emi, Yoshihiro Kakeji, Eiji Oki, Hiroshi Saeki, Koji Ando, Masaki Kitazono, Yoshihisa Sakaguchi, Masaru Morita, Hironori Samura, Yutaka Ogata, Yoshito Akagi, Shoji Natsugoe, Kazuo Shirouzu, Shoji Tokunaga, Florin Sirzen, Yoshihiko Maehara

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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.

Original languageEnglish
Pages (from-to)254-259
Number of pages6
JournalInternational Journal of Clinical Oncology
Volume18
Issue number2
DOIs
Publication statusPublished - Apr 2013

All Science Journal Classification (ASJC) codes

  • Surgery
  • Hematology
  • Oncology

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    Emi, Y., Kakeji, Y., Oki, E., Saeki, H., Ando, K., Kitazono, M., Sakaguchi, Y., Morita, M., Samura, H., Ogata, Y., Akagi, Y., Natsugoe, S., Shirouzu, K., Tokunaga, S., Sirzen, F., & Maehara, Y. (2013). Initial report of KSCC0803: Feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients. International Journal of Clinical Oncology, 18(2), 254-259. https://doi.org/10.1007/s10147-011-0371-7