Bevacizumab 10mg/kg plus FOLFIRI (leucovorin, fluorouracil, irinotecan) as second-line treatment after first-line bevacizumab plus oxaliplatin-based therapy did not prolong progression-free survival compared with bevacizumab 5mg/kg plus FOLFIRI in patients with metastatic colorectal cancer (mCRC), a recent study published online first in the journal Annals of Oncology has shown.
For the phase III study, researchers enrolled 387 patients between September 2009 and January 2012 from 100 institutions in Japan and randomly assigned them to receive FOLFIRI plus bevacizumab 5mg/kg or 10mg/kg in 2-week cycles until disease progression.
Results showed that among the 369 evaluable patients for efficacy, the median progression-free survival was 6.1 months in the 5mg/kg group and 6.4 months in the 10mg/kg group (HR = 0.95; 95% CI: 0.75-1.21; P = 0.676).
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Median time to treatment failure was 5.2 months in both groups (HR = 1.01; 95% CI: 0.81-1.25; P = 0.967). Data for overall survival is not yet mature.
In regard to safety, adverse event rates were similar in both groups
The findings suggest that if bevacizumab is continued after first-line therapy in patients with mCRC, a 5mg/kg-dose is appropriate for second-line therapy.
- Iwamoto S, Takahashi T, Tamagawa H, et al. FOLFIRI plus bevacizumab as second-line therapy in patients with metastatic colorectal cancer after first-line bevacizumab plus oxaliplatin-based therapy: the randomized phase III EAGLE study. Ann Oncol. 2015. [Epub ahead of print]. doi: 10.1093/annonc/mdv197.