This single-arm, non-interventional study ML28306 aimed at evaluating the effectiveness and safety of 1L Bevacizumab (BEV) treatment, focusing on 4 defined age groups, with platinum-based chemotherapy in patients with unresectable advanced, metastatic or recurrent adenocarcinoma of the lung in routine practice.
The study is fully recruited with 1107 patients in 174 centers. 990 patients who received ≥1 BEV-dose to date are included in the present analysis. Enrollment started 02/2013; last patient out is expected 06/2017. Baseline characteristics, treatment regimen, effectiveness and safety data are documented for each patient. Primary endpoint is progression-free survival (PFS).
In terms of age, 34% of patients were
Effectiveness and safety data of the 2. interim analysis is in line with results of the 1. analysis and other real-world data on BEV. The mPFS of the present study is comparable to the mPFS of 6.6m of the controlled E4599 trial, while the mOS is slightly lower (12.5m vs 14.2m). The safety profile is similar across age groups. No new safety signals were observed. Elderly patients seem to benefit in the same way as younger ones.
Clinical trial identification
AVAdeno Study: An Observational Study of First-Line Avastin (Bevacizumab) in Patients With Adenocarcinoma of the Lung ClinicalTrials.gov Identifier: NCT01827852
Legal entity responsible for the study
Roche Pharma AG
Roche Pharma AG
H.R. Wirtz: Membership on an advisory board or board of directors: MSD, Roche, Boehringer Ingelheim Corporate-sponsored research: TNI Medical. S. Lang, S. Hammerschmidt: Membership on an advisory board or board of directors: Roche. M. Reck: Membership on an advisory board or board of directors: Hoffmann-La Roche, Lilly, MSD, Astra Zeneca, BMS, Pfizer, Novartis, Celgene, Boehringer Ingelheim. All other authors have declared no conflicts of interest.