Ziv-aflibercept in combination with FOLFIRI for second-line treatment of patients with metastatic colorectal cancer (mCRC): Interim safety data from the global aflibercept safety and quality-of-life program (ASQoP and AFEQT studies) in patients ≥65.

Abstract

545 Background: The prespecified analysis of patients ≥65 years of age in the VELOUR study demonstrated a safety profile similar to that of ziv-aflibercept (Z) (known as aflibercept outside the United States) plus FOLFIRI in the overall VELOUR study. Results from VELOUR supported the initiation of the global Aflibercept Safety and Quality-of-Life (QoL) Program composed of two clinical studies (ASQoP [NCT01571284]; AFEQT [NCT01670721]) to capture QoL and safety data from a target population similar to that of VELOUR in a real-life setting. We report early safety data from this interim analysis for patients ≥65 y. Methods: ASQoP and AFEQT are single-arm, open-label trials evaluating safety and QoL of Z in mCRC patients previously treated with an oxaliplatin-containing regimen. Eligible patients received Z (4 mg/kg) q2wks on day 1 of each cycle followed by FOLFIRI until disease progression, unacceptable toxicity, death, or investigator/patient decision. Initial starting doses and subsequent dose modifications are at the treating physician’s discretion. The percentage of patients ≥65 y with grade (G) 3/4 adverse events (AEs) in the combined safety population of ASQoP and AFEQT are compared with that of the prespecified analysis in patients ≥65 y from VELOUR. Results: At data cut-off, the safety population comprised 116 patients with at least 1 completed cycle of treatment; 53 (45.7%) were ≥65 y. At least 1 G3/4 AE was experienced by 64.2% of patients vs 89.3% in VELOUR. Most reported G3/4 AEs were G3. There were no reports of G4 hypertension, diarrhea, stomatitis, or proteinuria. Conclusions: Thisinterim safety analysis from ASQoP and AFEQT in patients ≥65 y has identified no new safety signals. The early interim analysis provides additional safety data and suggests an acceptable toxicity profile in this real-life setting. Clinical trial information: NCT01571284. [Table: see text]