A phase II Japanese study of a modified capecitabine regimen for advanced or metastatic colorectal cancer.

This phase II study evaluated a modified Japanese capecitabine regimen as first-line treatment for advanced/metastatic colorectal cancer. Sixty patients received oral capecitabine 828 mg/m(2) twice daily for 3 weeks every 4 weeks. In the 56 efficacy-evaluable patients, the overall response rate was 26.8% (95% CI 15.8-40.3%) and 21 patients (37.5%) had stable disease. The median duration of response and overall survival times were 7.4 months (range 4.3-13.8) and 17.6 months (95% CI 14.1-20.5), respectively. The most frequent non-hematological treatment-related adverse events (all grades) were hand-foot syndrome (62.7%), anorexia (28.8%), diarrhea (22.0%) and fever (22.0%). There was no grade 3/4 diarrhea. The most common grade 3/4 laboratory abnormalities were lymphocytopenia (30.5%) and hyperbilirubinemia (35.6%). We conclude that the modified Japanese intermittent regimen of capecitabine is effective and well tolerated as first-line treatment for advanced colorectal cancer, and is worthy of further study in larger phase III studies.