Efficacy and safety of first-line bevacizumab combined with paclitaxel in 220 patients with metastatic breast cancer: The Hungarian AVAREG observational study.

Abstract

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.

Combination of pristimerin and paclitaxel additively induces autophagy in human breast cancer cells via ERK1/2 regulation

“…It inhibits the growth of tumor cells. It is an important therapeutic drug in the treatment of a number of types of cancer, including breast cancer ( 29 ). It is known to stabilize microtubules during DNA synthesis, thereby suppressing mitosis of cancer cells.…”

Breast cancer brain metastases: biology and new clinical perspectives

“…In a recent preclinical mouse tumor model mimicking postsurgical adjuvant or metastatic therapy, a VEGF pathway-targeting antibody drug (bevacizumab) with chemotherapy (paclitaxel) resulted in antitumor activity in a metastatic setting [ 72 ]. Based on these data and those already mentioned, preliminary clinical studies are ongoing and have shown some efficacy in the therapeutic role of targeting VEGF in combination with chemotherapy or radiation therapy [ 32 , 73 , 74 ].…”

Prospective observational study of bevacizumab combined with paclitaxel as first- or second-line chemotherapy for locally advanced or metastatic breast cancer: the JBCRG-C05 (B-SHARE) study

“…Although several cohort studies have been carried out in other countries [8][9][10][11], clinical experience of bevacizumab plus paclitaxel combination therapy in Japan has been limited to the small number of patients in the JO19901 study, which enrolled 120 patients [7]. Therefore, we conducted a prospective multicenter observational study to investigate the effectiveness and safety of this combination as first-or second-line therapy for LA/mBC in daily clinical practice.…”