| Abstract
| - Background: A pilot phase II study was conducted to evaluate the Japanese intermittent regimen of capecitabine in patients with advanced/recurrent colorectal cancer. Methods: Twenty-two patients received oral capecitabine in a dose of 828 mg/m2 twice daily for 3 weeks every 4 weeks. Results: In the 20 patients evaluable for efficacy, the overall response rate was 25.0% (95% CI, 8.7-49.1%), rising to 33.0% in the subset of patients previously untreated for metastatic disease (n = 9). A further nine patients had stable disease. The median duration of response was 7.0 months. Five patients (22.7%) experienced grade 3/4 treatment-related adverse events, the most common being a bullous rash observed in two patients (9.1%). Conclusions: The 3 weeks out of 4 intermittent regimen of capecitabine demonstrated good antitumor activity and tolerability in patients with advanced/refractory colorectal cancer, providing a clear rationale for conducting a larger phase II study in patients with advanced disease.
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