Real-World Evaluation of Quality of Life, Effectiveness, and Safety of Aflibercept Plus FOLFIRI in Patients with Metastatic Colorectal Cancer: The Prospective QoLiTrap Study.

Abstract

Simple SummaryColorectal cancer (CRC) is the third most frequently diagnosed malignancy worldwide and the second leading cause of cancer-related mortality. In VELOUR phase III trial, aflibercept combined with FOLFIRI has been shown to prolong overall survival versus FOLFIRI plus placebo in metastatic CRC (mCRC) patients previously treated with an oxaliplatin-based regimen. However, VELOUR did not evaluate patient quality of life and, outcomes following treatment with epidermal growth factor receptor inhibitors (EGFR-I) were unknown. In this prospective study conducted in daily practice, mCRC patients treated with aflibercept plus FOLFIRI maintained their quality of life as assessed by the EORTC QLQ-C30 questionnaire. Aflibercept plus FOLFIRI was also associated with a high objective tumor response and retained its activity regardless of sex, RAS status, and prior targeted therapy, especially after EGFR-I. Adverse events were consistent with the known safety profile of aflibercept plus FOLFIRI.Aflibercept plus FOLFIRI prolongs overall survival (OS) in patients with metastatic colorectal cancer after the failure of oxaliplatin-containing therapy. QoLiTrap prospectively evaluated the quality of life (QoL) and effectiveness of this regimen in daily clinical practice, according to RAS status, sex, and prior targeted therapy, especially epidermal growth factor receptor inhibitors (EGFR-I). The primary endpoint was the percentage of patients whose EORTC QLQ-C30 global health status (GHS) improved or reduced by <5% from baseline during the first 12 weeks of therapy. Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. One thousand two hundred and seventy-seven patients were treated with aflibercept plus FOLFIRI and 872 were evaluable for QoL. GHS improved or decreased by <5% in 40.3% of cases. The ORR was 20.8%, the median PFS was 7.8 months (95% confidence interval (CI), 7.3–8.3), and the median OS was 14.4 months (95% CI, 13.1–18.1). After prior EGFR-I, the ORR was 23.7%, median PFS was 9.4 months (95% CI, 6.5–12.9), and median OS was 17.4 months (95% CI, 10.5–33.7). The safety profile was consistent with previously reported data. Aflibercept plus FOLFIRI given in daily practice maintained QoL in mCRC patients, was associated with a high objective tumor response, and retained its activity regardless of sex, RAS status, and prior EGFR-I therapy.