The efficacy and safety of pyrotinib in treating HER2-positive metastatic breast cancer patients:A multi-center study

Abstract

Abstract Purpose: To investigate the efficacy and safety of pyrotinib in treating patients with HER2-positive metastatic breast cancers (MBC). Patients and Methods: We performed a multi-center retrospective study, and the HER2-positive MBC patients were recruited. The progression-free survival (PFS), and overall survival (OS) were considered in the assessment of treatment outcomes. Results: 275 female patients were enrolled. The objective response rate (ORR) and disease control rate (DCR) , were found in 154 of 275 (56%) and in 205 of 275 (75%), respectively. The median effective time was 45 days. The median follow-up time was 41 months.The median time for progression and OS were 16 and 35 months. The PFS of survival general population at 1-year, 2-year and 3-year was 72.7% , 40.4%, and 33.1%, respectively, whle the OS was 91.6% , 78.2%, and 63.2%, respectively. The PFS of brain metastases patients at 1-3-year was 67.3%, 25% and 13.5%, while, the OS was 84.6%, 63.5% and 46.2%. Conclusion: Pyrotinib mono-therapy showed equivalent local control rates, PFS and OS, compared with the combined therapy of pyrotinib and chemotherapy in both the general population and patients with brain metastases, with manageable toxicity, highlighting the significance of mono-therapy of pyrotinib in treating HER-2 positive MBC.