Dr. Ruff Analyzes Overall Survival in the VELOUR Trial

Paul Ruff, MD, director of Medical Oncology at the University of Witwatersrand, Johannesburg, South Africa, discusses a time-course analysis of overall survival (OS) following treatment with ziv-aflibercept (Zaltrap) in patients with metastatic colorectal cancer (mCRC), as observed in the VELOUR trial.

The phase III VELOUR trial examined FOLFIRI alone or in combination with the VEGF-targeted fusion protein aflibercept, following progression on an oxaliplatin-based regimen. The trial included 1226 patients with mCRC and the results were the basis for the FDA approval of aflibercept in early August 2012 (Read About the Approval).

The median OS for patients receiving the combination was 13.5 months compared to 12.1 for FOLFIRI alone (HR=0.82, P = .0032). This is equivalent to an approximate 18% reduction in the risk of dying, Ruff explains.

Furthermore, Ruff adds, the survival advantage with aflibercept appears to be sustained over the course of the trial. At 18 months, aflibercept increased survival by 2.6 months, and by 24 months, survival was prolonged by 4.4 months.