5-fluorouracil, leucovorin and oxaliplatin plus bevacizumab in the first-line treatment of metastatic colorectal cancer: a single-institute study.

BACKGROUND: The addition of bevacizumab to 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX) improved the time-to-progression (TTP) and overall survival (OS) in comparison to FOLFOX in the second-line treatment of metastatic colorectal cancer (MCRC). However, limited survival data are available to support FOLFOX plus bevacizumab in a first-line setting. We conducted a retrospective study of first-line FOLFOX plus bevacizumab to better characterize the safety and efficacy of this regimen in the first-line treatment of MCRC.

METHODS: Records of patients treated with first-line FOLFOX plus bevacizumab between January 2003 and March 2006 were reviewed. Grade 3 and 4 toxicity as well as efficacy data were collected. TTP and OS analyses were done using the Kaplan-Meier method.

RESULTS: 51 patients were treated with FOLFOX plus bevacizumab. Oxaliplatin treatment was interrupted prior to progression in 67% of patients. Grade 3 neuropathy, neutropenia and diarrhea occurred in 16, 8, and 8% of patients, respectively. The overall response rate, median TTP and median OS were 41%, 9.9 months and 23.2 months, respectively.

CONCLUSIONS: First-line FOLFOX plus bevacizumab is associated with favorable TTP and OS. The definitive role of bevacizumab in the first-line setting in combination with FOLFOX chemotherapy should be explored further in randomized clinical trials.