e12022^ Background: First-line bevacizumab (Bev) combined with paclitaxel (Pac) significantly improves progression-free survival (PFS) and response rate vs. Pac alone in HER2-negative metastatic breast cancer (mBC), as shown in the E2100 study. The efficacy and safety of first-line Bev-Pac treatment was investigated in a non-interventional study in routine oncology practice in Hungary. Methods: Patients (pts) who had received no prior chemotherapy for mBC received Bev–Pac combination therapy according to the EU label. The primary endpoint was PFS. Efficacy and safety were documented until progression, death, or Bev discontinuation, whichever occurred first. Subgroup analyses of efficacy were conducted in pts with triple-negative mBC (TNBC). Results: Efficacy and safety data were available from 220 treated pts. Baseline characteristics were: median age 56 years (range 30–79; 13% ≥65 years; 4% ≥70 years); 18%/23% stage III/IV disease at first diagnosis; 36% disease-free interval ≤2 years; 46%/44%/30% bone/lung/liver metastases; 75%/21%/3% ECOG status 0/1/2; 45% ER positive; 48% TNBC. The Bev schedule was 10 mg/kg q2w (median 14 q2w Bev cycles) in 51% of pts and 15 mg/kg q3w (median 10 q3w Bev cycles) in 49%. The median duration of follow-up was 12.2 months (range: 0.9–36.5). Median PFS was 9.3 months (95% CI 7.8–10.8) in the total population (events in 63%), 8.3 months (95% CI 7.8–8.8) in the TNBC subgroup, and 13.3 months (95% CI 10.9–15.6) in the non-TNBC subgroup (log-rank p=0.001 between the TNBC and non-TNBC subgroups). Median time to treatment failure was 7.0 months (95% CI 6.1–8.0). The 1-year survival rate was 68%. Median OS was not reached. Adverse events (AEs) occurred in 36% of pts, and were classified as serious in 8% (20 events). The most common AEs (any grade) were hypertension, neuropathy, proteinuria, and anemia. There were three deaths, from pulmonary embolism, venous thromboembolism, and cardiomyopathy, on Bev therapy. No new safety signals were seen. Conclusions: These data in the real-life setting reconfirm that first-line Bev–Pac therapy is an effective and well-tolerated treatment option for mBC pts, with notable activity in pts with TNBC. Clinical trial information: NCT01777932.

Due to the limited experience with capecitabine plus docetaxel (XT) combination in the first-line treatment of metastatic breast cancer in Hungary, the main objective of the study was to analyze the effectiveness and tolerability of XT therapy. A prospective, open-label, non-randomized, single-arm, multicenter, observational study was designed. All female patients were eligible whose metastatic breast cancer could be treated with the XT protocol according to the summary of product characteristics of the drugs. The median progression free survival was 9.9 ± 3.0 months. Time to treatment failure was 4.6 ± 5.1 months on average. The overall response rate was 28.9 %, the clinical benefit rate was 73.3 %. The treatment was discontinued in 35.6 % of patients due to disease progression and in 20.0 % due to adverse events (AE). 33 patients with a total of 73 AEs have been reported, and 13 of them had serious adverse events (SAE). The efficacy and the safety profile of XT chemotherapy proven in the study are consistent with the results demonstrated in randomized trials. First-line XT chemotherapy effectively improves the PFS in metastatic breast cancer.

Background Bevacizumab (BV) plus paclitaxel (PTX) is a treatment option in patients with HER2-negative metastatic breast cancer (mBC). We conducted an international pooled analysis with individual patient data to evaluate the effectiveness of BV + PTX as a first-line treatment for HER2-negative mBC patients under routine practice. Methods A total of 2,474 mBC patients treated with BV + PTX from four prospective observational studies were analyzed. The primary endpoint was overall survival (OS). The other endpoints including identifying independent prognostic factors and validation of the modified Prognostic Factor Index (PFI) developed in the ATHENA trial. Results Median follow-up time was 10.9 months (M). Median OS were 21.4 M (95% confidential interval 19.8–22.7 M). The seven independent prognostic factors (tumor subtype, age, ECOG performance status (PS), disease-free interval (DFI), liver metastases, number of metastatic organs, and prior anthracycline and/or taxane treatment) for OS found in this analysis included the five risk factors (RFs [DFI < 24 months, ECOG PS 2, liver metastases and/or > 3 metastasis organ sites, TNBC, prior anthracycline and/or taxane therapy]). High- (> 3 RFs [median OS 12.6 M]) and intermediate-risk groups (2 RFs [median OS 18.0 M]) had a significantly worse prognosis than the low-risk group (< 1 RF [median OS 27.4 M]), (p < 0.0001). Conclusions This international pooled analysis showed the effectiveness of first-line BV + PTX for HER2-negative mBC patients identifying seven independent prognostic factors as real-world evidence. The usefulness of the modified PFI developed in the ATHENA trial in predicting OS among patients receiving BV + PTX was also verified.

Background: This international pooled analysis was conducted to examine the effectiveness and the safety of bevacizumab (BV) plus paclitaxel (PTX) as the 1 st line treatment for HER2 negative metastatic breast cancer (MBC) with real-world data. Using the data from this pooled analysis, we tried to verify the usefulness of the prognostic index (PI) for MBC treated with BV-containing regimen previously shown in the ATENA trial. abstracts Annals of Oncology Volume 31 -Issue S4 -2020 S367