Real-world data exploring effectiveness of treatments following demonstrated efficacy in phase III trials are becoming increasingly important, especially for regulatory bodies and payers. Pooling outcome and adverse-event (AE) data from non-interventional studies enables more accurate estimation of real-world effectiveness and safety in clinically important subgroups.
Individual pt data from pts receiving first-line BEV + PAC with no additional chemotherapy agent for HER2-negative mBC in three non-interventional studies (ML21165 [Germany], AVANTI [Germany] and AVAREG [Hungary]) were extracted and pooled. Progression-free survival (PFS) and overall survival (OS) were estimated in the BEV + PAC population and subgroups of clinical interest by Kaplan-Meier methodology. Safety was analysed descriptively.
The analysis population included 2135 pts. The median duration of follow-up was 13.1 (range
Results from >2000 pts treated in the real-world setting indicate effectiveness of first-line BEV + PAC in HER2-negative mBC. The main limitation of this analysis is the inconsistent data collection and recording between studies. Nevertheless, this approach provides insight into effectiveness of BEV + PAC in the real-world setting.
Clinical trial identification
Legal entity responsible for the study
F Hoffmann-La Roche
F Hoffmann-La Roche
V. Mueller: VM has received speaker honoraria from Amgen, AstraZeneca, Celgene, Eisai, GlaxoSmithKline, Pfizer, Pierre-Fabre, Novartis, Roche, Teva and Janssen-Cilag, and consultancy honoraria from Roche, Pierre Fabre, Amgen and Eisai. S. de Ducla: SdD is an employee of Roche and holds shares in Roche. L. Mitchell: LM is a full-time employee of Roche with all conditions/benefits under Roche's contract. A. Schneeweiss: AS has received honoraria from Roche and Celgene for several talks and research funding from Celgene. All other authors have declared no conflicts of interest.