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

Qiongwen Zhang; Ping He; Tinglun Tian; Xi Yan; Juan Huang; Zhang Zhang; Hong Zheng; Xiaorong Zhong; Ting Luo

doi:10.3389/fphar.2023.1100556

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

Front Pharmacol. 2023 Mar 21:14:1100556. doi: 10.3389/fphar.2023.1100556. eCollection 2023.

Authors

Qiongwen Zhang¹, Ping He², Tinglun Tian², Xi Yan², Juan Huang³, Zhang Zhang⁴, Hong Zheng^{2

5}, Xiaorong Zhong^{2

5}, Ting Luo^{2

5}

Affiliations

¹ Department of Head and Neck Oncology, Department of Radiation Oncology, Cancer Center, and State Key Laboratory of Biotherapy, West China Hospital of Sichuan University, Chengdu, China.
² Breast Disease Center, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
³ Department of Radiology, West China Hospital, Sichuan University, Chengdu, China.
⁴ Department of Pathology, West China Hospital, Sichuan University, Chengdu, China.
⁵ Multi-omics Laboratory of Breast Diseases, State Key Laboratory of Biotherapy, National Collaborative, Innovation Center for Biotherapy, West China Hospital, Sichuan University, Chengdu, China.

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.

Keywords: HER2-positive breast cancer; brain metastase; pyrotinib; real-world studies; tyrosine kinase inhibitors.

Grants and funding

This work was supported by Sichuan Province Science and Technology Plan Project (2021YFS0235), Sichuan Provincial Department of Science and Technology, International Cooperation in Science and Technology Innovation with Hong Kong, Macao, and Taiwan (2023YFH0095), and 1.3.5 Project for Disciplines of Excellence, West China Hospital, Sichuan University (grant numbers: ZYGD18012 and ZYJC21035).