(CHICAGO, IL) – Despite a high incidence of adverse events, adding aflibercept to FOLFIRI chemotherapy is associated with “a consistent trend” of increased survival among metastatic colorectal cancer (mCRC) patients, regardless of patients’ previous bevacizumab treatment status, according to the stratified phase 3 VELOUR study presented at the 2012 American Society of Clinical Oncology Annual Meeting.

“Prior treatment with bevacizumab did not appear to impact the safety profile of aflibercept,” said lead author Carmen Joseph Allegra, MD, Division of Hematology/Oncology, University of Florida Shands Cancer Center, Gainesville, FL.

Aflibercept, also known as VEGF Trap, is a recombinant human fusion protein that inhibits vascular endothelial growth factor (VEGF-A, VEGF-B) and placental growth factor (PIGF) receptor binding. 

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In the study, patients with mCRC that had progressed after oxaliplatin therapy were randomized to receive either FOLIFIRI (leucovorin, 5-fluorouracil, irinotecan) plus placebo or FOLFIRI plus aflibercept 4 mg/kg IV every 2 weeks. Patients were stratified by ECOG performance score (PS, 0 v 1 v 2) and prior bevacizumab treatment. Of 1,226 patients enrolled in the study, 187 placebo-arm patients and 186 aflibercept patients had previously been administered bevacizumab. The most common anti-VEGF-associated grade 3/4 adverse event were proteinuria (afilbercept/FOLFIRI: 9.4% vs placebo: 0.6%; prior bevacizumab) compared to (afilbercept/FOLFIRI: 7.3% vs placebo: 1.4%; no prior bevacizumab) and hypertension (afilbercept/FOLFIRI: 16.4% vs placebo: 0.6%; prior bevacizumab) compared to (afilbercept/FOLFIRI: 20.5% vs placebo: 1.8%; no prior bevacizumab)

Although the study was not statistically powered to assess survival, aflibercept patients exhibited a consistent trend toward prolonged overall survival (HR=0.817; 95% CI=0.713-0.937; Log-rank P=0.0032). The trend was not affected by prior bevacizumab history, Dr. Allegra concluded.