Dr. Mitchell on Survival and Safety of the VELOUR Trial
Edith Mitchell, MD, FACP, clinical professor, director, Center to Eliminate Cancer Disparities Program Leader, Thomas Jefferson University, discusses an analysis of the VELOUR trial. This analysis looked at overall survival and safety during the course of the phase III trial comparing FOLFIRI and ziv-aflibercept or placebo in patients with metastatic colorectal cancer (mCRC) who progressed on prior oxaliplatin treatment.
With any new drug, Mitchell says, it takes time for physicians to learn about the toxicities and how to manage symptoms. Patients who remain on an agent can have side effects that are easier to manage and receive benefit.
This analysis showed that hazard ratio improved over time, consistent with survival curves that continue to separate past the median time point, which indicated that the magnitude of ziv-aflibercept treatment effect continues to increase over time. The analysis also showed that the majority of grade 3/4 adverse events occurred in early treatment (first 3-4 cycles) and the majority of grade 3/4 events were single-episode in nature.