According to a new study published online in the journal Annals of Oncology, researchers have found that the addition of bevcizumab to standard first-line chemotherapy did not improve outcomes in patients with metastatic colorectal cancer.
For the phase 3 clinical trial, researchers sought to evaluate the effectiveness of adding bevacizumab to first-line FOLFIRI (fluorouracil, leucovorin, irinotecan) and FOLFOX4 (fluorouracil, leucovorin, oxaliplatin) in patients with metastatic colorectal cancer.
Between November 2007 and March 2012, researchers enrolled 376 patients and randomly assigned them to receive FOLFIRI or FOLFOX4 plus bevacizumab (arm A) or standard first-line chemotherapy only (arm B). Of those in arm A, about 40% received FOLFIRI and 60% received FOLFOX4.
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After a median follow-up of 36 months, researchers had observed 343 progressions and 275 deaths in the overall population. Results showed that the median progression-free survival was 9.6 months (95% CI: 8.2 – 10.3) for arm A and 8.4 months (95% CI: 7.2 – 9.0) for arm B (HR = 0.86; 95% CI: 0.70 – 1.07; P = 0.182).
Researchers found no statistical differences in overall survival or overall response rate. In regard to safety, arm A was associated with more frequent asthenia, bleeding, hypertension, and proteinuria.
- Passardi A, Nanni O, Turci D, et al. Effectiveness of bevacizumab added to standard chemotherapy in metastatic colorectal colorectal cancer: final results for first-line treatment from ITACa randomized clinical trial. Ann Oncol. 2015. [Epub ahead of print]. doi: 10.1093/annonc/mdv130.