The anti-angiogenic fusion protein Aflibercept targets VEGF-A, VEGF-B and PlGF. Aflibercept in combination with FOLFIRI is approved in patients with mCRC that is resistant or has progressed after oxaliplatin-containing therapy.
QoLiTrap (AIO-LQ-0113) is an international (Austria, Germany, Switzerland) non-interventional study with a recruitment target of 1500 patients. Primary goal is to evaluate Quality-of-life (QoL) in mCRC patients treated with aflibercept + FOLFIRI using the EORTC-QLQ C30 questionnaire at baseline and before every cycle.
For this interim analysis (data cut-off: 02 March 2017) 576 patients (mean age: 64.7 ± 10 years; 65.1% male, 50.5% with documented RAS mutation, ECOG 0-1: 85.6% of patients) who completed the baseline and at least 2 post-baseline EORTC-QLQ C30 questionnaires were evaluated. Aflibercept was administered for a median number of 6 (and up to 55) cycles. Patients had a median global health score of 58.3 which decreased moderately (mean change -4.0, p
The current interim analysis indicates that aflibercept + FOLFIRI in mCRC patients under routine conditions was accompanied by a moderate decline in global health status. Preliminary efficacy results are encouraging, also for patients pretreated with anti-EGFR antibody and/or bevacizumab, who showed a disease control rate of 73% in second line aflibercept therapy. This study is supported by Sanofi-Aventis Deutschland GmbH.
Clinical trial identification
Legal entity responsible for the study
Sanofi Aventis GmbH
Sanofi Aventis Deutschland GmbH
R. von Moos: Advisory board: Sanofi, Roche, Merck. Research grant: Amgen, Merck. G. Derigs: Advisory activities: Janssen, Roche, Clegene. F. Scholten: Advisory activities: BMS, Celgene. Honorarium: Janssen, Sanofi. Poster creation: Sanofi. R.D. Hofheinz: Advisory Board: Sanofi. Honorarium: Sanofi. All other authors have declared no conflicts of interest.