First-line systemic therapy with FOLFIRI (fluorouracil, leucovorin, irinotecan) plus bevacizumab was non-inferior in terms of progression-free survival as compared with mFOLFOX6 (fluorouracil, leucovorin, oxaliplatin) plus bevacizumab for patients with metastatic colorectal cancer (mCRC), a study published in the journal Annals of Oncology has shown.1
Although FOLFIRI and FOLFOX have demonstrated equivalent efficacy for mCRC, their effectiveness with bevacizumab has not been compared. For the open-label, phase 3 trial, researchers in Japan enrolled 402 patients with previously untreated mCRC. Participants were randomly assigned 1:1 to receive FOLFIRI plus bevacizumab or mFOLFOX6 plus bevacizumab.
Results showed that among the 395 evaluable patients, median progression-free survival was 12.1 months with FOLFIRI plus bevacizumab and 10.7 months with mFOLFOX6 plus bevacizumab (HR, 0.905; 95% CI, 0.723-1.133; P=.003), suggesting that FOLFIRI plus bevacizumab is non-inferior to mFOLFOX6 plus bevacizumab. Median overall survival was 31.4 months and 30.1 months, respectively (HR, 0.990; 95% CI, 0.785-1.249).
Researchers also found that 64% of patients in the irinotecan arm achieved a response vs 62% of patients who received oxaliplatin.
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In regard to safety, the most frequently reported grade 3 or higher adverse events with FOLFIRI plus bevacizumab were neutropenia (46%), leukopenia (11%), diarrhea (9%), venous thromboembolism (6%), and febrile neutropenia (5%). The most common grade 3 or higher adverse reactions in the mFOLFOX6 plus bevacizumab arm were neutropenia (35%), peripheral neuropathy (22%), and diarrhea (5%).
The study further demonstrated that during 18 months of therapy, quality of life was better with FOLFIRI than with mFOLFOX6.
- Yamazaki K, Nagase M, Tamagawa H, et al. Randomized phase III study of bevacizumab plus FOLFIRI and bevacizumab plus mFOLFOX6 as first-line treatment for patients with metastatic colorectal cancer (WJOG4407G) [published online ahead of print May 13, 2016]. Ann Oncol. doi: 10.1093/annonc/mdw206.