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曲妥珠单抗德鲁昔单抗在基于吡咯替尼的治疗失败后的HER2阳性脑转移乳腺癌患者中的疗效和安全性。

Efficacy and safety of trastuzumab deruxtecan in HER2-positive breast cancer patients with brain metastases after failure of pyrotinib-based therapy.

作者信息

Zhou Jinmei, Xiao Jinyi, Wu Xuexue, Wang Xiaobo, Bian Li, Zhang Shaohua, Jiang Zefei, Wang Tao

机构信息

Department of Oncology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100071, China.

出版信息

Sci Rep. 2025 May 22;15(1):17731. doi: 10.1038/s41598-025-02550-6.

DOI:10.1038/s41598-025-02550-6
PMID:40404737
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12099003/
Abstract

Tyrosine kinase inhibitors (TKIs) and trastuzumab deruxtecan (T-DXd) have shown efficacy in HER2-positive patients with brain metastases (BMs). This paper analyzed the efficacy and safety of T-DXd in HER2-positive breast cancer patients with BMs who progressed after pyrotinib treatment. We conducted a single-center, retrospective cohort study. HER2-positive patients with BMs who received T-DXd treatment after disease progression following pyrotinib therapy were identified from electronic medical records. The primary endpoint of this study was central nervous system progression-free survival (CNS-PFS). From April 2021 to July 2023, 15 patients were included in the study. The median CNS-PFS was 7.4 months [95% confidence interval (CI) 6.1-8.8 months], the median PFS for patients with extracranial/total lesions was 6.4 months (95% CI 4.4-8.3 months), and the median OS was 9.8 months (95% CI 5.9-13.8 months). The ORRs for intracranial, extracranial, and overall lesions were 33.3%, 71.4%, and 73.3%, respectively. Adverse events of grade 3 or higher with an incidence rate ≥ 5% included leukopenia (20.0%), neutropenia (13.3%), thrombocytopenia (6.7%), and nausea (6.7%). Adverse events of specific interest, interstitial lung disease or pneumonitis, occurred in 2 patents (13.3%), and both were grade 1. The preliminary data in this study suggest that in clinical practice in China, T-DXd is an optional treatment for patients with active/stable BMs who have progressed on pyrotinib. However, further studies are needed to determine its efficacy and the best treatment sequence for these patients.

摘要

酪氨酸激酶抑制剂(TKIs)和曲妥珠单抗德鲁昔单抗(T-DXd)已在HER2阳性脑转移(BMs)患者中显示出疗效。本文分析了T-DXd在接受吡咯替尼治疗后病情进展的HER2阳性乳腺癌脑转移患者中的疗效和安全性。我们进行了一项单中心回顾性队列研究。从电子病历中识别出在吡咯替尼治疗疾病进展后接受T-DXd治疗的HER2阳性脑转移患者。本研究的主要终点是中枢神经系统无进展生存期(CNS-PFS)。2021年4月至2023年7月,15例患者纳入研究。中位CNS-PFS为7.4个月[95%置信区间(CI)6.1 - 8.8个月],颅外/全身病变患者的中位PFS为6.4个月(95% CI 4.4 - 8.3个月),中位总生存期(OS)为9.8个月(95% CI 5.9 - 13.8个月)。颅内、颅外和全身病变的客观缓解率(ORR)分别为33.3%、71.4%和73.3%。发生率≥5%的3级及以上不良事件包括白细胞减少(20.0%)、中性粒细胞减少(13.3%)、血小板减少(6.7%)和恶心(6.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2946/12099003/0eb577529edb/41598_2025_2550_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2946/12099003/581b219e9073/41598_2025_2550_Fig1_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2946/12099003/0eb577529edb/41598_2025_2550_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2946/12099003/581b219e9073/41598_2025_2550_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2946/12099003/f1d2e2aaa9ec/41598_2025_2550_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2946/12099003/3743bd266776/41598_2025_2550_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2946/12099003/beabf1840209/41598_2025_2550_Fig4_HTML.jpg
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本文引用的文献

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Publisher Correction: Trastuzumab deruxtecan in HER2-positive advanced breast cancer with or without brain metastases: a phase 3b/4 trial.出版商更正:曲妥珠单抗德鲁昔单抗用于伴或不伴脑转移的HER2阳性晚期乳腺癌:一项3b/4期试验。
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Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer.泛亚地区适应性 ESMO 临床实践指南:转移性乳腺癌患者的诊断、分期和治疗。
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Intracranial response of brain metastases in patients with HER2-amplified breast cancer treated with trastuzumab-deruxtecan after failure of tucatinib-based therapy.
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