Efficacy and Safety of First-Line Bevacizumab (BEV) Combined with Paclitaxel (PAC) According to Age: Subpopulation Analysis of a Large, Multicenter, Non-Interventional Study in Patients (Pts) with HER2-Negative Metastatic Breast Cancer (MBC).
Authors: Geberth M. , Foerster F. , Klare P. , Schneeweiss A. , Schumacher C. , Hahn L. , Tesch H. , Hertz-Eichenrode M. , Weinberg R. , Gluz O. , Kuemmel S. , Strumberg D. , Wuelfing P. , Schmidt M. 
Published: December 2010

Abstract
Background: In three randomized phase III trials (E2100, AVADO, RIBBON-1), the combination of Bev with taxane-based therapy significantly improved PFS and response rate versus taxane alone in HER2-negative MBC. Subpopulation analysis of AVADO suggested that the magnitude of the benefit derived from Bev was similar in older and younger pts (≥65 vs &lt;65 years). To gain further information on the safety and efficacy of first-line Bev–pac in older pts treated in the real-life setting, we conducted a subpopulation analysis of data from an ongoing multicenter non-interventional study initiated after the approval of Bev in Germany. Materials and methods: Pts who had received no prior chemotherapy for their MBC were treated with Bev–pac according to the European indication. Efficacy and safety data were collected for up to 1 year (or until progression, death, or discontinuation of Bev if earlier).Results: Safety and efficacy data are currently available for 307 pts, of whom 102 (33%) are ≥65 years and 56 (18%) are ≥70 years (Table). Mean duration of documented Bev therapy was 7.0 months in pts &lt;65 years and 6.4 months in those ≥65 years. &lt;65 years (n=205)≥65 years (n=102)Mean disease-free interval, years ± SD3.8 ± 3.56.8 ± 5.8Tumor grade, %1212476034929Unknown311Metastatic sites, %Liver4347Lung3537Bone5556CNS21Receptor status, %ER and/or PgR positive6673Triple (ER, PgR, HER2) negative2514ECOG performance status, %040321485521010322(Neo)adjuvant chemotherapy, %7052Taxane and anthracycline239Anthracycline, no taxane3427Taxane, no anthracycline40Other715Missing&lt;11Endocrine therapy for MBC, %2531Grade ≥3 Bev-related AEs of special interest, %Hemorrhage/bleeding1.01.0Hypertension2.9a2.0aThrombosis/embolism2.42.0Arterial thrombotic event0.5a1.0aGastrointestinal perforation1.00Proteinuria00Overall response rate, %6047Stable disease, %2223Not evaluable/unknown816PFS events, n (%)106 (52)51 (50)6-month PFS rate, % (95% CI)70 (63–77)63 (53–74)baNo grade 4b69% (95% CI: 56–84) in pts aged ≥70 yearsConclusions: In this study in pts representing real-life practice, the efficacy and safety profile of Bev–pac supports results from prospective randomized clinical trials of Bev combined with taxane-based therapy. Although differences in baseline characteristics complicate interpretation of this analysis, there appeared to be no increase in the incidence of Bev-related AEs of special interest in pts ≥65 versus &lt;65 years. Efficacy was broadly similar irrespective of age; of note, in the small subgroup of pts ≥70 years, the 6-month PFS rate was very similar to that in pts ≤65 years. These data support findings of subpopulation analyses of older pts treated in the AVADO and MO19391 trials. First-line Bev combined with pac in this elderly pt population offers a highly active and well-tolerated treatment, especially when considering that many of these pts may not be candidates for combination chemotherapy.
Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 6085.