Adding bevacizumab to FOLFOXIRI (5-fluorouracil, leucovorin, oxaliplatin, irinotecan) provided significant benefit in progression-free and overall survival compared with FOLFOXIRI alone as frontline treatment for patients with metastatic colorectal cancer (mCRC), a propensity score-adjusted analysis published in the journal Annals of Oncology has shown.1

Although FOLFOXIRI plus bevacizumab is a valid option as upfront treatment for patients with mCRC, there are no randomized head-to-head trials evaluating the impact of adding immunotherapy to the chemotherapy regimen. Therefore, researchers sought to conduct a propensity score-adjusted analysis from 2 randomized clinical trials.

For the study, researchers analyzed data from 122 patients with mCRC who received first-line FOLFOXIRI in the phase 3 trial and 252 patients who received first-line FOLFOXIRI plus bevacizumab.

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Of note, patients in the FOLFOXIRI group were more likely to have had an ECOG performance status of 1 or 2, a high Köhne score, metachronous and liver-limited disease, previously received adjuvant treatments, and their primary tumors resected.

Results showed that median progression-free survival was 12.3 months in the chemoimmunotherapy group compared with 10.0 months in the chemotherapy alone group (propensity score-adjusted HR, 0.74; 95% CI, 0.59 – 0.94; P = .013).

Median overall survival was 29.8 months and 23.6 months, respectively (propensity score-adjusted HR, 0.72; 95% CI, 0.56 – 0.93; P = .014). Multivariate analyses also demonstrated a significantly longer overall and progression-free survival with FOLFOXIRI plus bevacizumab compared with FOLFOXIRI (P = .030 and P = .013, respectively).

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However, researchers found no significant differences in response rate, early response rate, or median depth of response.

The findings ultimately support the use of FOLFOXIRI plus bevacizumab as first-line treatment for patients with mCRC.


  1. Cremolini C, Loupakis F, Masi G, et al. FOLFOXIRI or FOLFOXIRI plus bevacizumab as first-line treatment of metastatic colorectal cancer: a propensity score-adjusted analysis from two randomized clinical trials [published online ahead of print February 9, 2016]. Ann Oncol. doi: 10.1093/annonc/mdw052.