A phase II study of capecitabine, irinotecan, and bevacizumab in patients with previously untreated metastatic colorectal cancer.

BACKGROUND

Previous phase III studies raised concern about the safety of the combination of capecitabine and irinotecan in patients with metastatic colorectal cancer (mCRC). We conducted a single arm phase II study to evaluate the safety and efficacy of bevacizumab in combination with dose-reduced capecitabine and irinotecan in patients with previously untreated mCRC.

PATIENTS AND METHODS

Patients with previously untreated mCRC were eligible. Capecitabine was given at 1,000 mg/m2 orally twice daily for 14 days and dose was reduced to 750 mg/m2 for patients over 65. Irinotecan was given at 200 mg/m2 and bevacizumab was given at 7.5 mg/kg intravenously on day 1. The treatment cycle was repeated every 21 days. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival, response rate, and toxicity.

RESULTS

Fifty patients were enrolled, the median age was 58, and 54% were ECOG 0. The most common grade 3/4 adverse events included hand-foot syndrome (14%), neutropenia (12%), and diarrhea (10%). Response rate was 51% and disease control rate (response and stable disease) was 98%. Median PFS was 11.5 months (95% CI: 9.2-13.7), and 6 month PFS was 90% (95% CI: 77-98%).

CONCLUSION

With modest dose reductions, the combination of capecitabine, irinotecan, and bevacizumab was well tolerated and resulted in favorable outcomes for patients with previously untreated mCRC.