Aflibercept in combination with FOLFIRI for the second-line treatment of patients with metastatic colorectal cancer: First interim safety data from AFEQT trial.

661 Background: In the randomized phase 3 VELOUR trial, aflibercept + FOLFIRI demonstrated a statistically significant overall survival benefit compared with FOLFIRI alone in metastatic colorectal cancer (mCRC) patients (pts) previously treated with an oxaliplatin-based regimen. Evidence from the VELOUR trial supported the initiation of a French clinical trial; AFEQT [NCT01670721] to capture utility values from QoL instruments and collect safety data from a target population similar to that in VELOUR. Interim data collected by French investigators are reported. Methods: AFEQT is single-arm, open-label trial evaluating safety and health-related QoL of aflibercept in mCRC pts previously treated with an oxaliplatin-based regimen. Estimated total enrollment is 200 mCRC pts. Eligible pts received aflibercept (4 mg/kg) q2wks on day 1 of each cycle followed by FOLFIRI up to disease progression, unacceptable toxicity, death, or investigator/patient decision, whichever occurred first. FOLFIRI starting dose and subsequent additional dose modifications were at the discretion of the treating physician. Safety assessments followed each cycle and continued until 30 days after last drug administration. The percentage of pts with grade 3/4 adverse events (G3/4 AEs) in the safety population of AFEQT was compared with that of VELOUR. Results: At data cut-off, the safety population comprised 123 pts with at least 1 completed cycle of treatment. Median age of pts was 64.6 vs. 61 years in VELOUR. At least 1 G3/4 AE was experienced by 67.5% of pts vs. 83.5% in VELOUR. Most reported G3/4 AEs were G3. There were no reports of G4 hypertension or diarrhea. Additional data will be reported during the meeting. Conclusions: In VELOUR, AEs occurred early in treatment, were often of single occurrence, generally reversible, and consistent with AEs commonly seen by oncologists. Interim safety analysis from AFEQT did not identify any new safety signal. Clinical trial information: NCT01670721. [Table: see text]