781 Background: The aim of this randomized, multicenter, non-comparative phase II trial was to investigate the efficacy and safety of capecitabine/oxaliplatin (CapOX) plus bevacizumab (BEV) and capecitabine/irinotecan (CapIRI) plus BEV as a first-line treatment in Japanese patients with metastatic colorectal cancer (mCRC). Methods: Patients with untreated mCRC were randomly assigned to the following treatment arms; CapOX/BEV arm (bevacizumab 7.5mg/kg and oxaliplatin 130 mg/m2 on day 1, and oral capecitabine 1000 mg/m2 bid on day 1-14, every 3 weeks) and CapIRI/BEV arm (bevacizumab 7.5mg/kg and irinotecan 200 mg/m2 on day 1, and capecitabine 800 mg/m2 bid on day 1-14, every 3 weeks). The primary endpoint was overall response rate (ORR), and secondary end points included progression-free survival (PFS), overall survival (OS), and safety. Results: A total of 107 patients were enrolled. The intent-to-treat population comprised 52 patients in CapOX/BEV arm and 51 patients in CapIRI/BEV arm. The ORR was 58% in CapOX/BEV arm and 57% in CapIRI/BEV arm ( p= 0.545). The median tumor shrinkage rate (DpR) was 36.0% (range, -24.0 to 100%) and 36.7% (range, -26.0 to 100%), respectively (p = 0.399). Median PFS was 12.4 months (95% confidence interval [CI], 10.6–14.3 months) in CapOX/BEV arm and 11.5 months (95% CI, 9.6–13.4 months) in CapIRI/BEV arm (hazard ratio [HR], 1.145; 95% CI, 0.760–1.725; p= 0.517). The median OS was 26.6 months (95% CI, 21.5–31.8 months) and 28.7 months (95% CI, 19.6–37.9), respectively (HR, 1.206; 95% CI, 0.0.733–1.907; p= 0.461). The frequency of hematological and non-hematological adverse events (≥grade3) were 10% and 27% in CapOX/BEV arm, and 16% and 27% in CapIRI/BEV arm, respectively. Conclusions: Both regimens, CapOX plus BEV and CapIRI plus BEV, could be equally feasible first-line treatment for Japanese patients with mCRC. Clinical trial information: UMIN_000007545.
Phase II trial of aflibercept with FOLFIRI as a second-line treatment for Japanese patients with metastatic colorectal cancer
