A. Grafe (Nordhausen, Germany)
Praxis Dr Grafe/Brustzentrum der Frauenklinik, Su¨dharz-Klinikum Nordhausen gGmbhAuthor Of 1 Presentation
98P - Final results from AVANTI, a multicentre German observational study of 1st-line bevacizumab (BEV) + chemotherapy (CT) in >2000 patients (pts) with advanced breast cancer (aBC)
Abstract
Background
In Europe, BEV is approved in combination with paclitaxel (PAC) or capecitabine (CAP) as 1st-line therapy for HER2-negative aBC. AVANTI (ML22452) assessed safety, effectiveness and pt-reported outcomes (EORTC QLQ-C30) with these regimens in German routine oncology practice.
Methods
Eligible pts had HER2-negative aBC, no BEV contraindications and had received no prior CT for aBC. CT schedule, diagnostics and follow-up visits were at the physician’s discretion. Data were collected for 1 y after starting BEV, then every 6 mo for 1.5 y (max follow-up: 2.5 y). Treatment satisfaction was rated by pts and physicians. Subgroup analysis was prespecified in clinically relevant subgroups, including triple-negative breast cancer (TNBC).
Results
Between 1 Nov 2009 and 30 Apr 2016, 2065 eligible pts at 346 centres received ≥1 dose of BEV with PAC (n=1821) or CAP (n=295); 51 switched CT and were analysed in both subgroups. Data cut-off for the final analysis was 3 Feb 2020. Median age was 60 y, 21% had TNBC, 56% prior (neo)adjuvant CT and 29% de novo metastatic disease. Pts receiving BEV + CAP were less likely to have de novo disease and more likely to have TNBC, age ≥60 y and prior CT and endocrine therapy (ET). The median treatment duration was 6.0 mo (95% CI 5.6–6.3) for BEV and 4.2 mo (4.0–4.2) for CT. Overall (complete or partial) response rate was 49% (95% CI 46–51%). Median PFS was 12.6 (95% CI 11.9–13.2) mo (12.8 with BEV + PAC, 10.5 with BEV + CAP); median OS was 23.9 (22.2–25.1) mo. PFS and OS were worse in pts with TNBC, prior CT or prior ET (Table). Grade 3/4 AEs were reported in 27% of pts and led to treatment discontinuation in 15%. Treatment satisfaction was rated as good or better by 304/394 (77%) responding pts at week 54 and in 1393/2065 pts (67%) by physicians across the study. aUnknown in 127 pts. CI = confidence interval; HR = hazard ratio; OS = overall survival; PFS = progression-free survival.
Subgroup PFS OS Median, mo HR (95% CI) Median, mo HR (95% CI) Baseline hypertension Hypertensive v normotensive 13.6 v 11.9 0.88 (0.77–1.00) 25.1 v 23.2 0.88 (0.76–1.01) TNBCa Yes v no 10.3 v 12.9 1.44 (1.24–1.67) 16.8 v 25.2 1.53 (1.30–1.80) Age ≥60 v <60 y 12.8 v 12.3 1.09 (0.96–1.23) 21.9 v 25.4 1.26 (1.11–1.44) Metastatic sites ≥3 v <3 11.6 v 12.8 1.06 (0.88–1.28) 19.3 v 24.9 1.15 (0.96–1.39) Prior anthracycline/ taxane Yes v no 11.5 v 14.3 1.32 (1.16–1.50) 20.8 v 27.4 1.25 (1.09–1.43) Prior ET Yes v no 10.7 v 13.2 1.56 (1.33–1.82) 17.6 v 25.1 1.56 (1.33–1.82)
Conclusions
Final results from AVANTI show median PFS of 12.6 mo and a safety profile consistent with phase III experience.
Clinical trial identification
ML22452, 13th May 2015.
Editorial acknowledgement
Medical writing assistance: Jennifer Kelly (Medi-Kelsey Ltd.).
Legal entity responsible for the study
Roche Pharma AG.
Funding
Roche Pharma AG.
Disclosure
V. Mueller: Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Daiichi Sankyo; Honoraria (self), Advisory/Consultancy: Eisai; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy: Teva; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Seattle Genetics; Honoraria (self), Advisory/Consultancy: Genomic Health; Honoraria (self), Advisory/Consultancy: Hexal; Honoraria (self), Advisory/Consultancy: Pierre Fabre; Honoraria (self), Advisory/Consultancy: ClinSol; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Tesaro; Honoraria (self), Advisory/Consultancy: Nektar; Research grant/Funding (institution): Genentech. O. Hoffmann: Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Daiichi Sankyo; Honoraria (self): AstraZeneca; Honoraria (self), Travel/Accommodation/Expenses: Eisai; Honoraria (self), Travel/Accommodation/Expenses: Amgen; Honoraria (self): Riemser Pharma; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Hexal. A-K. Sommer: Full/Part-time employment: Roche Pharma AG; Shareholder/Stockholder/Stock options: Roche. A. Schneeweiss: Honoraria (self), Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Speaker Bureau/Expert testimony: AstraZeneca; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Celgene; Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self): Novartis; Honoraria (self): MSD; Honoraria (self): Tesaro; Honoraria (self): Lilly; Research grant/Funding (institution): AbbVie. All other authors have declared no conflicts of interest.