Pyrotinib in combination with letrozole for hormone receptor-positive, human epidermal growth factor receptor 2-positive metastatic breast cancer (PLEHERM): a multicenter, single-arm, phase II trial

BMC Medicine

Research Article

Tao Sun¹  Min Yan²  Ting Luo³  Jincai Zhong⁴  Li Ran⁵  Huihua Xiong⁶  Xiaohong Yang⁷  Binliang Liu⁷  Quchang Ouyang⁷  Zhe-Yu Hu⁷  Liping Liu⁷  Huawu Xiao⁷  Ning Xie⁷  Jing Li⁷ 

[1] Cancer Hospital of Dalian University of Technology, Liaoning Cancer Hospital, Shenyang, China;Department of Breast Cancer, Henan Cancer Hospital, Zhengzhou, China;Department of Breast Surgery, West China Hospital, Sichuan University, Chengdu, China;Department of Medical Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China;Department of Oncology, The Affiliated Hospital of Guizhou Medical University, Guiyang, China;Department of Oncology, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China;Medical Department of Breast Cancer, Hunan Cancer Hospital, No. 283, Tongzipo Road, 410013, Changsha, China;Medical Department of Breast Cancer, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China;

关键词: Hormone receptor-positive;    HER2-positive;    Metastatic breast cancer;    Pyrotinib;    Letrozole;   

DOI  :  10.1186/s12916-023-02943-2

 received in 2022-12-08, accepted in 2023-06-14,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundHuman epidermal growth factor receptor 2 (HER2) targeted therapy combined with endocrine therapy has been recommended as an alternative treatment strategy for patients with hormone receptor (HR)-positive, HER2-positive metastatic breast cancer (MBC). This study aimed to evaluate the role of pyrotinib, an oral pan-HER irreversible tyrosine kinase inhibitor, in combination with letrozole for patients with HR-positive, HER2-positive MBC.MethodsIn this multi-center, phase II trial, HR-positive and HER2-positive MBC patients who were not previously treated for metastasis disease were enrolled. Patients received daily oral pyrotinib 400 mg and letrozole 2.5 mg until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was the clinical benefit rate (CBR) assessed by an investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1.ResultsFrom November 2019 to December 2021, 53 patients were enrolled and received pyrotinib plus letrozole. As of August 2022, the median follow-up duration was 11.6 months (95% confidence interval [CI], 8.7–14.0 months). The CBR was 71.7% (95% CI, 57.7–83.2%), and the objective response rate was 64.2% (95% CI, 49.8–76.9%). The median progression-free survival was 13.7 months (95% CI, 10.7–18.7 months). The most common treatment-related adverse event of grade 3 or higher was diarrhea (18.9%). No treatment-related deaths were reported, and one patient experienced treatment discontinuation due to adverse event.ConclusionsOur preliminary results suggested that pyrotinib plus letrozole is feasible for the first-line treatment of patients with HR-positive and HER2-positive MBC, with manageable toxicities.Trial registrationClinicalTrials.gov, NCT04407988.

【 授权许可】

CC BY   
© The Author(s) 2023

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