The addition of ziv-aflibercept to FOLFIRI chemotherapy was associated with durable improvements in survival among patients with metastatic colorectal cancer who underwent prior treatment with oxaliplatin, according to study results.
Paul Ruff, MD, director of medical oncology at the University of Witwatersrand in Johannesburg, South Africa, and colleagues assessed the efficacy and safety of ziv-aflibercept (Zaltrap, Sanofi-Aventis) plus FOLFIRI — which consists of fluorouracil, leucovorin and irinotecan — in 1,226 patients with colorectal cancer who progressed after treatment with oxaliplatin.
Researchers randomly assigned 612 of them to FOLFIRI plus ziv-aflibercept. The other 614 received FOLFIRI plus placebo.
Results showed patients who received ziv-aflibercept demonstrated higher rates of OS at 18 months (38.5% vs. 30.9%), 24 months (28% vs. 18.7%) and 30 months (22.3% vs. 12%) than those who received placebo.
Researchers determined the proportional improvement in HRs over time were consistent with results of survival probability, as they demonstrated ziv-aflibercept was associated with a 50% improvement in survival at 2 years and a near-doubling of survival at 30 months.
Researchers reported higher rates of grade 3 and grade 4 adverse events in the ziv-aflibercept arm. However, those events occurred early in treatment cycles and decreased considerably after initial presentation, researchers wrote. The majority of adverse events were reversible.
Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.