For patients with untreated metastatic colorectal cancer, chemotherapy with fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) plus bevacizumab improves outcome versus fluorouracil, leucovorin, and irinotecan (FOLFIRI) plus bevacizumab, according to a study published in the New England Journal of Medicine.

Fotios Loupakis, M.D., Ph.D., from the Università di Pisa in Italy, and colleagues randomized 508 patients with untreated metastatic colorectal cancer to receive FOLFIRI plus bevacizumab (control group) or FOLFOXIRI plus bevacizumab (experimental group). Up to 12 cycles were administered, and fluorouracil plus bevacizumab was continued until disease progression.

The researchers found that the median progression-free survival was 12.1 and 9.7 months in the experimental and control groups, respectively (hazard ratio for progression, 0.75; P = 0.003). In the experimental and control groups, the objective response rate was 65 and 53 percent, respectively (P = 0.006).

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The experimental group had a trend toward longer overall survival (31.0 versus 25.8 months; hazard ratio for death, 0.79; 95 percent confidence interval, 0.63 to 1.00; P = 0.054). The experimental group had significantly higher incidences of grade 3 and 4 neurotoxicity, stomatitis, diarrhea, and neutropenia.

“FOLFOXIRI plus bevacizumab, as compared with FOLFIRI plus bevacizumab, improved the outcome in patients with metastatic colorectal cancer and increased the incidence of some adverse events,” the authors write.

A research grant was provided by F. Hoffmann-La Roche.


  1. Loupakis, Fotios, MD, PhD, et al. “Initial Therapy with FLOFOXIRI and Bevacizumab for Metastatic Colorectal Cancer.” The New England Journal of Medicine. DOI: 10.1056/NEJMoa1403108. October 23, 2014.