Capecitabine/irinotecan or capecitabine/oxaliplatinin combination with bevacizumab is effective andsafe as first-line therapy for metastatic colorectalcancer: A randomized phase II study of the AIOcolorectal study group

Abstract

Background: This randomized phase II trial investigated the efficacy and safety of capecitabine/oxaliplatin (CapOx)plus bevacizumab and dose-modified capecitabine/irinotecan (mCapIri) plus bevacizumab as first-line therapyin patients with metastatic colorectal cancer (mCRC).Patients and methods: Patients received bevacizumab 7.5 mg/kg with oxaliplatin 130 mg/m2/day 1 pluscapecitabine 1000 mg/m2 bid/days 1-14 or with irinotecan 200 mg/m2/day 1 plus capecitabine 800 mg/m2 bid/days1-14 both every 21 days. The primary end point was 6 months progression-free survival (PFS).Results: A total of 255 patients were enrolled. The intent-to-treat population comprised 247 patients (CapOx-bevacizumab: n = 127; mCapIri-bevacizumab: n = 120). The six-month PFS rates were 76% (95% CI, 69%-84%) and84% (95% CI, 77%-90%). Median PFS and OS were 10.4 months (95% CI, 9.0-12.0) and 24.4 months (95% CI,19.3-30.7) with CapOx-bevacizumab, and 12.1 months (95% CI, 10.8-13.2) and 25.5 months (95% CI, 21.0-31.0)with mCapIri-bevacizumab. Grade 3/4 diarrhea as predominant toxic effect occurred in 22% of patients withCapOx-bevacizumab and in 16% with mCapIri-bevacizumab.Conclusions: Both, CapOx-bevacizumab and mCapIri-bevacizumab, show promising activity and an excellent toxic effect profile. Efficacy is in the range of other bevacizumab-containing combination regimen although lower doses of irinotecan and capecitabine were selected for mCapIri. © The Author 2013. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.