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.
Efficacy and safety of everolimus and exemestane for metastatic breast cancer patients: a real-life experience of three Oncology Departments