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中国HER2阳性不可切除或转移性乳腺癌患者的真实世界治疗模式与结局

Real-world treatment patterns and outcomes among patients with HER2-positive unresectable or metastatic breast cancer in China.

作者信息

Huang Jiajia, Chen Limin, Song Lihua, Tong Zhongsheng, Sun Tao, Wang Xiaojia, Liu Yi, Wang Shusen

机构信息

Department of Medical Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.

Department of Breast Medical Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.

出版信息

Front Oncol. 2025 May 14;15:1527990. doi: 10.3389/fonc.2025.1527990. eCollection 2025.

Abstract

BACKGROUND

Breast cancer is now the most commonly diagnosed cancer in the world and the leading cause of cancer mortality in women worldwide. In past few years, anti- human epidermal growth factor receptor-2 (HER2) therapy for metastatic breast cancer (mBC) has rapidly altered in China. This study aimed to describe treatment patterns and outcomes in patients with HER2-positive unresectable or metastatic breast cancer in the real-world setting.

METHODS

This multicenter, retrospective analysis evaluated the treatment patterns and the efficacy in newly diagnosed HER2+ mBC patients between Jan 1, 2020 and Aug 31, 2022. Electronic medical records from 5 cancer centers in China were used.

RESULTS

Among 865 patients, the most common first-line (1L) treatment regimen was dual anti-HER2 blockade monoclonal antibody-based therapy (Dual anti-HER2 mAB: 36.07%), followed by single anti-HER2 blockade mAB-based therapy (Single anti-HER2 mAB: 21.97%) and single Tyrosine Kinase Inhibitor-based therapy (Single TKI: 19.19%). In the second-line (2L), the primary treatment was single TKI regimen (35.45%), followed by TKI+anti-HER2 blockade mAB-based therapy (TKI+anti-HER2 mAB: 16.36%) and single anti-HER2 mAB (15.15%). mBC at initial diagnosis, recurrence post 6 months of (neo)adjuvant treatment, absence of brain metastasis, and younger age, were associated with the choice of dual anti-HER2 mAB regimen in 1L treatment. Conversely, patients receiving anti-HER2 therapy in (neo)adjuvant setting, having brain metastasis, and experiencing a recurrence within 6 months were more likely to receive TKI-based regimen. The median rwPFS of 1L and 2L treatment declined sequentially, with values of 11.04 [95% confidence interval (CI) 10.19-12.03] months and 7.59 (95% CI 6.21-9.20) months, respectively. Longer disease-free interval (DFI) and the choice of dual-anti HER2 regimen in 1L treatment were associated with longer rwPFS.

CONCLUSION

The results of this study provide valuable real-world insight into HER2 positive mBC treatment trends and clinical outcomes, informing subsequent patient management.

摘要

背景

乳腺癌目前是全球最常被诊断出的癌症,也是全球女性癌症死亡的主要原因。在过去几年中,中国转移性乳腺癌(mBC)的抗人表皮生长因子受体2(HER2)治疗迅速发生了变化。本研究旨在描述现实环境中HER2阳性不可切除或转移性乳腺癌患者的治疗模式和结局。

方法

这项多中心回顾性分析评估了2020年1月1日至2022年8月31日期间新诊断的HER2+mBC患者的治疗模式和疗效。使用了中国5家癌症中心的电子病历。

结果

在865例患者中,最常见的一线(1L)治疗方案是基于双重抗HER2阻断单克隆抗体的治疗(双重抗HER2单克隆抗体:36.07%),其次是基于单一抗HER2阻断单克隆抗体的治疗(单一抗HER2单克隆抗体:21.97%)和基于单一酪氨酸激酶抑制剂的治疗(单一酪氨酸激酶抑制剂:19.19%)。在二线(2L)治疗中,主要治疗方案是单一酪氨酸激酶抑制剂方案(35.45%),其次是基于酪氨酸激酶抑制剂+抗HER2阻断单克隆抗体的治疗(酪氨酸激酶抑制剂+抗HER2单克隆抗体:16.36%)和单一抗HER2单克隆抗体(15.15%)。初诊时的mBC、(新)辅助治疗6个月后复发、无脑转移以及较年轻,与1L治疗中双重抗HER2单克隆抗体方案的选择相关。相反,在(新)辅助治疗中接受抗HER2治疗、有脑转移以及在6个月内复发的患者更有可能接受基于酪氨酸激酶抑制剂的方案。1L和2L治疗的中位真实世界无进展生存期(rwPFS)依次下降,分别为11.04[95%置信区间(CI)10.19 - 12.03]个月和7.59(95%CI 6.21 - 9.20)个月。更长的无病间期(DFI)和1L治疗中双重抗HER2方案的选择与更长的rwPFS相关。

结论

本研究结果为HER2阳性mBC的治疗趋势和临床结局提供了有价值的真实世界见解,为后续患者管理提供了依据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/34de/12116439/513685c764f5/fonc-15-1527990-g001.jpg

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