Abstract P1-11-01: Effectiveness, safety and quality of life (QoL) results from the German multicenter AVANTI study of 1st-line bevacizumab (BEV)-containing therapy in &gt;2000 patients (pts) with advanced breast cancer (aBC)
Authors: Müller V , Jakob A , Aktas B , Grafe A , März W , Fett W , Bruch H-R , Klare P , Hoefflin S , Schneeweiss A 
Published: February 2018

Abstract
Background: In Europe, BEV is approved with either paclitaxel (PAC) or capecitabine (CAP) as 1st-line therapy for HER2-negative aBC. These regimens are being evaluated in routine oncology practice in the German AVANTI (ML22452) observational study.
Methods: Eligible pts had received no prior chemotherapy (CT) for aBC and had no BEV contraindications. CT schedule, diagnostics and frequency of follow-up are at the physician's discretion. Data are collected for 1 y after starting BEV, with 6-monthly follow-up for 1.5 y thereafter. QoL is assessed using EORTC QLQ-C30. Data cutoff for the 3rd interim analysis was Dec 1, 2016.
Results: Between Oct 2009 and Feb 2015, 2056 eligible pts at &gt;300 centers began treatment with BEV+PAC (n=1658) or BEV+CAP (n=398). Median follow-up was 12.7 (range &lt;0.1–50.9) mo. Median treatment duration was 4.4 (95% CI 4.2–4.6) mo for CT and 6.0 (95% CI 5.8–6.5) mo for BEV. Table 1 summarizes PFS. In the overall population, grade 3/4 AEs were reported in 20% of pts (20% BEV+PAC; 22% BEV+CAP) and led to treatment discontinuation in 5% (5% and 5%, respectively). Mean QLQ-C30 scores were relatively stable over time both overall and in subgroups aged &lt;65 vs ≥65 y, indicating maintained QoL during therapy; no relevant QoL differences between age groups were seen (Table 2). To characterize 'long responders', we identified 459 pts with PFS ≥15 mo (410 BEV+PAC; 49 BEV+CAP). Of these, 33% were aged ≥65 y, 15% had triple-negative aBC (TNBC) and 25% had ≥3 metastatic sites. Median treatment duration was 5.1 mo for CT and 10.8 mo for BEV.
Table 1. PFS by subgroupPtsNo. of events/pts (%)Median PFS (95% CI), moAll1121/2042 (55)14.2 (13.5–15.3)BEV+PAC902/1646 (55)15.2 (14.0–16.2)BEV+CAP219/396 (55)10.9 (10.1–13.4)TNBC187/429 (44)12.6 (10.7–14.3)Non-TNBC677/1486 (46)14.7 (13.6–16.1)&lt;65 y577/1325 (44)15.1 (13.6–16.2)≥65 y344/717 (48)13.5 (12.5–14.9)&lt;3 metastatic sites678/1522 (45)14.4 (13.6–15.8)≥3 metastatic sites254/534 (48)13.5 (11.7–15.5)
Table 2. Mean QoL scores over time, selected scalesScaleTimepointAll pts&lt;65 y≥65 y nMean scorenMean scorenMean scoreGlobal health statusaBL84046.555747.128345.4 Wk 986744.057044.229743.7 Wk 3352043.335543.716542.4 Wk 5434244.622845.111443.6Physical functioningaBL83668.555570.328164.7 Wk 986360.956864.329554.4 Wk 3351360.335263.316153.8 Wk 5434161.622862.411359.9Social functioningaBL82761.455559.727264.8 Wk 985654.456655.429052.5 Wk 3351455.435156.516353.2 Wk 5433758.122555.811262.8FatiguebBL83548.955548.128050.6 Wk 986059.156756.329364.6 Wk 3351656.135254.516459.7 Wk 5434055.822855.711255.9PainbBL83537.855638.027937.2 Wk 986438.556937.029541.3 Wk 3351746.935345.616449.8 Wk 5434046.922848.111244.5BL=baseline. aHigher score=better QoL/functioning. bHigher score=greater symptom burden.
Conclusions: More mature results from AVANTI show median PFS of 14.2 mo, favorable tolerability and maintained QoL, supporting 1st-line use of BEV for aBC. The subgroup with prolonged disease control (PFS &gt;15 mo) was heterogeneous; further analyses of these pts are ongoing.
Citation Format: Müller V, Jakob A, Aktas B, Grafe A, März W, Fett W, Bruch H-R, Klare P, Hoefflin S, Schneeweiss A. Effectiveness, safety and quality of life (QoL) results from the German multicenter AVANTI study of 1st-line bevacizumab (BEV)-containing therapy in &gt;2000 patients (pts) with advanced breast cancer (aBC) [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P1-11-01.