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 Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Metastatic
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.