Real-world efficacy and safety of pyrotinib in patients with HER2-positive metastatic breast cancer: A prospective real-world study

Abstract

Background: Pyrotinib, a novel irreversible EGFR/HER2 dual tyrosine kinase inhibitor, shows encouraging anticancer activity and acceptable tolerability in multiple phase II and phase III randomized clinical trials, but the real-world data of pyrotinib, especially the outcomes in HER2-positive metastatic breast cancer, have been rarely reported. Here, we evaluated the treatment outcomes of pyrotinib in real-world practice in patients with HER2-positive metastatic breast cancer (MBC).Methods: This was a prospective, real-world, observational cohort study. Through the Breast Cancer Information Management System, HER-2 positive MBC patients treated with pyrotinib between 2017/06 and 2020/09 were included. Provider-reported objective response rate, progression-free survival (PFS), and overall survival (OS) were considered in the assessment of treatment outcomes. Tumor responses to pyrotinib treatment were calculated using RECIST 1.1. Adverse events were evaluated using clinical records.Results: The trial involved 113 individuals who were receiving pyrotinib treatment, with an average age of 51 years. Complete response, partial response and stable disease were observed in 9 (8.0%), 66 (58.4%), and 17 (15.0%) patients, respectively, while progressive disease was recorded in 20 (17.7%) patients. After a median follow-up of 17.2 months, the median PFS was 14.1. The most common adverse events of any grade were diarrhea (87.6%), vomiting (31.9%), and palmar-plantar erythrodysesthesia (26.6%). Among the patients with brain metastases, the median PFS and OS were 15.2 and 19.8 months, respectively. In addition, pyrotinib has similar efficacy in various subtypes of HER2-positive MBC patients, as shown by the lack of a significant difference of PFS and OS among pyrotinib-treated patients with or without brain metastases, or patients using pyrotinib as first-line, second-line, third-line or beyond therapies.Conclusion: Our real-world results demonstrated equivalent clinical efficacy in HER-2 positive MBC patients compared to phase II and phase III clinical trials with pyrotinib, and promising outcomes in patients with brain metastases.

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

“…The study revealed that the ORR and DCR of our group were 56% and 75%, respectively. The median time for PFS and OS in our group was 16 months 35 months.And our treatment outcomes were consistent with another latest study, .In that prospective trial of 113 patients with HER-2 positive MBC, the median PFS was 14.1 months with an ORR of 66.4% [25].There was no statistical signi cance for the PFS and OS of patients received combined chemotherapy with pyrotinib and pyrotinib mono-therapy, which indicated the signi cant role of pyrotinib mono-therapy in the treatment of HER-2 positive MBC to reduce the nancial burden of those patients.…”

Real-world data of pyrotinib-based therapy for patients with brain metastases of HER2-positive advanced breast cancer: a single-center retrospective analysis and molecular portraits

“…Results from the phase 3 PHOEBE (36) and PHENIX (23) studies have shown the favorable effects of pyrotinib in patients with HER2-positive MBC after trastuzumab. The PERMEATE trial (24), subpopulation analysis of the PHENIX trail (23), and retrospective real-world studies (22,37) showed the activity with pyrotinib against BM. Our study investigated the real-world data of pyrotinib in patients with BM at baseline in complicated clinical practice and supplemented the findings of clinical trials.…”

Efficacy of first‐line dual oral pyrotinib plus capetabine therapy in HER2‐positive metastatic breast cancer: A real‐world retrospective study

“…Some retrospective studies, which enrolled patients partially receiving PyroC therapy, have shown improvement in survival with the use of Pyro‐based regimens as first‐line treatment for HER2‐positive mBC. 19 , 20 However, the evidence level is not convincing enough. For instance, Yin et al.…”

“…Some retrospective studies, which enrolled patients partially receiving PyroC therapy, have shown improvement in survival with the use of Pyro-based regimens as first-line treatment for HER2-positive mBC. 19,20 However, the evidence level is not convincing enough. For instance, Yin et al reported that mPFS was 20.9 months for patients receiving first-line Pyro treatment, which enrolled only 28 patients, partially treated by PyroC.…”