Brain Radiotherapy With Pyrotinib and Capecitabine in Patients With ERBB2 -Positive Advanced Breast Cancer and Brain Metastases

作者：Zhaozhi Yang, Jin Meng, Xin Mei, Miao Mo, Qin Xiao, Xu Han, Li Zhang, Wei Shi, Xing‐Xing Chen, Jinli Ma, Joshua D. Palmer, Zhimin Shao, Zhen Zhang, Xiaoli Yu, Xiaomao Guo · 发表于：JAMA Oncology · 年份：2024 · DOI：10.1001/jamaoncol.2023.5791 · 被引用次数：30 · 研究领域：Brain Metastases and Treatment、Lung Cancer Research Studies、Lung Cancer Treatments and Mutations

Importance: The potential benefit of combining intracranial effective systemic therapy with radiotherapy for patients with breast cancer with brain metastases remains unclear. Objective: To assess the activity and safety of combining radiotherapy with pyrotinib and capecitabine in patients with ERBB2-positive breast cancer and brain metastases. Design, Setting, and Participants: This was a single-arm, single-center, phase 2 nonrandomized clinical trial with a safety run-in phase. Between January 2020 and August 2022, patients with ERBB2-positive breast cancer and brain metastases were enrolled. The data cutoff date was February 1, 2023. Interventions: Patients received either fractionated stereotactic radiotherapy or whole-brain radiotherapy. Treatment with pyrotinib (400 mg, once daily) and capecitabine (1000 mg/m2, twice daily, on days 1-14 of each 21-day cycle) was initiated from the first day of radiotherapy to the seventh day after the completion of radiotherapy and continued until disease progression or unacceptable toxic effects. Main Outcomes and Measures: The primary end point was 1-year central nervous system (CNS) progression-free survival (PFS) rate. Secondary end points included CNS objective response rate (ORR), PFS, overall survival (OS), safety, and changes in neurocognitive function. Results: A total of 40 female patients (median age, 50.5 years [IQR, 46-59 years]) were enrolled and received treatment, including 3 patients in safety run-in phase. With a media...