Published in:
01-04-2013 | Original Article
Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients
Published in: International Journal of Clinical Oncology | Issue 2/2013
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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.