Abstract P4-14-04: AVANTI: A non-interventional study examining the combination of bevacizumab with paclitaxel or capecitabine in metastatic breast cancer
Authors: Schneeweiss A , Fett W , Aktas B , Fruehauf S , Grafe A , Jakob A , Foerster F , Müller V 
Published: August 2014

Abstract
Background: We initiated a large, multicentre, non-interventional study (NIS) to determine the safety and efficacy of treatment, as well as the selection criteria that influence choice of therapy (bevacizumab plus paclitaxel or capecitabine), for patients with metastatic breast cancer (MBC) treated in the context of routine oncology practice in Germany. The study also aimed to gather information on patient-reported quality of life and treatment satisfaction. Here we present an interim analysis of the safety and efficacy data.
Methods: Pre- or postmenopausal female patients aged ≥18 years with previously untreated locally advanced, recurrent, or MBC were enrolled if they were considered eligible for treatment with a combination of bevacizumab and either paclitaxel or capecitabine. Endocrine pretreatment was allowed. Patients with contraindications to bevacizumab were excluded. Kaplan-Meier estimates and Cox-regression were used to model survival data.
Results: Since October 2009, 1,807 patients have been recruited; this analysis includes data for 1,464 patients with a median age of 60.4 years (range: 23.6–86.4). Most patients had a performance status of 1 (43.1%) and HER2-negative (83.5%), hormone receptor-positive (70.2%) disease. The most common sites of metastasis were bone (52.3%), liver (39.3%) and lungs (33.4%); 736 patients (50.3%) had at least two documented metastatic sites. Bevacizumab plus paclitaxel (68.5% of patients) and bevacizumab plus capecitabine (12.0%) were the most frequently prescribed therapies. Other bevacizumab-containing combination regimens were prescribed to the remaining 19.5% of patients. The treatment decision factors cited most often were efficacy of therapy (62.4%), therapy guidelines (49.7%), tolerability of therapy (40.6%) and HER2 status (38.1%). The overall response rate (complete response [CR] + partial response [PR]) was 48.5% with 5.9% of patients achieving a CR. The disease control rate (CR + PR + stable disease) was 72.7%. At the time of data cut-off, 414 patients (28.3%) had experienced a progression-free survival (PFS) event. Median PFS was 9.5 months (95% CI: 8.8–10.1). Adverse events (AEs) and serious AEs were reported in 457 (31.2%) and 109 patients (7.4%), respectively. The most frequently reported AEs were hypertension (6.1% of patients), fatigue (5.5%), sensory neuropathy (4.6%), leukopenia (4.0%), nausea (4.2%) and diarrhoea (3.6%). Treatment was discontinued due to AEs in 72 patients (4.9%).
Conclusions: Interim results of this large NIS demonstrate that bevacizumab plus either paclitaxel or capecitabine combination therapy is well tolerated and active in patients with MBC representative of those treated in routine oncology practice. Follow-up is ongoing and final results of this interim analysis, as well as subgroup analyses, will be reported at the meeting.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-14-04.