[Multi-center real world study of the efficacy and safety of albumin-bound paclitaxel in the treatment of advanced breast cancer].

ABSTRACT

Objective: To observe the efficacy and safety of albumin-bound paclitaxel in the treatment of metastatic breast cancer. Methods: Multi-center data of patients who accepted single-drug albumin-bound paclitaxel or combination regimens from 2013 to 2019 were collected and the efficacy and safety were evaluated. Kaplan-Meier method was used for survival analysis, while Log-rank test was used to compare the survival rates. Results: A total of 203 advanced breast cancer cases were enrolled. The median progression-free survival time (PFS) lasted for 4 months, the median overall survival(OS)was 14 months, objective response rate (ORR) was 36.0% while the disease control rate (DCR) was 81.3%. The ORRs of Luminal, human epidermal growth factor receptor 2 (HER2) overexpression and triple-negative breast cancer patients underwent albumin-bound paclitaxel treatment were 37.3%, 45.5% and 31.0%, respectively, the DCRs were 85.5%, 68.2% and 78.9%, respectively. The OS of patients with relapse or metastasis who accepted less than two and more than two chemotherapy regimens were 22 months and 11 months (P<0.000 1), the ORRs were 44.9% vs 30.4%, DCRs were 87.2% vs 77.6% (P=0.018). The ORR and DCR of patients who accepted traditional paclitaxel treatment before the albumin-bound paclitaxel treatment were 35.8% and 82.1%, respectively. The common adverse reaction of these patients was numbness of limbs, which incidence rate was 64.5% (131/203), and 61.1% (124/203) were degree 1 to 2. Other adverse reactions including decreased white blood cells, which incidence rate was 56.1% (114/203); nausea and vomit, which incidence rate was 36.9% (75/203); anemia, which incidence rate was 21.2% (43/203); decreased platelet, which incidence rate was 18.7% (38/203); hepatic dysfunction, which incidence rate was 18.2% (37/203). Conclusions: Albumin-bound paclitaxel single or combination regimen is still significant efficient for various molecular subtypes of breast cancer patients or patients with traditional paclitaxel resistance or multi-line chemotherapy failure. Early usage has better prognosis, controllable adverse reaction and prominent clinical application value.