237P - Real-world effectiveness and safety of first-line bevacizumab (BEV) + paclitaxel (PAC) in >2000 patients (pts) with HER2-negative metastatic breast...

Date 10 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Anticancer agents
Breast Cancer
Therapy
Biological Therapy
Presenter Volkmar Mueller
Citation Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365
Authors V. Mueller1, M. Dank2, S. de Ducla3, L. Mitchell4, A. Schneeweiss5
  • 1Department Of Gynecology, University Medical Center Hamburg-Eppendorf, 20246 - Hamburg/DE
  • 2Oncology Division, Semmelweis University Cancer Center, Budapest/HU
  • 3Pharma Development Medical Affairs, F. Hoffmann-La Roche Ltd, Basel/CH
  • 4Pharma Development Medical Affairs Biometrics, F. Hoffmann-La Roche Ltd, Basel/CH
  • 5Division Gynecologic Oncology, National Center for Tumor Diseases, University Hospital, Heidelberg/DE

Abstract

Background

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.

Methods

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.

Results

The analysis population included 2135 pts. The median duration of follow-up was 13.1 (range

Conclusions

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

N/A

Legal entity responsible for the study

F Hoffmann-La Roche

Funding

F Hoffmann-La Roche

Disclosure

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.