| 张俊美,杜红娟,盛倩文,等.德曲妥珠单抗在HER2阳性晚期乳腺癌脑转移患者中的疗效及安全性[J].肿瘤学杂志,2024,30(7):570-576. |
| 德曲妥珠单抗在HER2阳性晚期乳腺癌脑转移患者中的疗效及安全性 |
| Efficacy and Safety of Trastuzumab Deruxtecan for HER2-Positive Breast Cancer with Brain Metastases |
| 投稿时间：2023-12-25 |
| DOI：10.11735/j.issn.1671-170X.2024.07.B007 |
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| 中文关键词: 乳腺癌 德曲妥珠单抗 脑转移 人表皮生长因子受体2 疗效 不良反应 |
| 英文关键词:reast cancer trastuzumab deruxtecan brain metastases human epidermal growth factor receptor 2 efficacy adverse reaction |
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| 中文摘要: |
| 摘 要：［目的］ 探讨德曲妥珠单抗（trastuzumab deruxtecan，T-DXd）在人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）阳性晚期乳腺癌脑转移患者中的疗效及安全性，并探索性分析T-DXd的疗效预测标志物。［方法］ 回顾性分析2021年8月至2023年8月在西安国际医学中心医院接受T-DXd治疗的HER2阳性乳腺癌脑转移患者15例临床病理数据，通过Kaplan-Meier和Cox多因素回归方法评估12个临床病理特征与T-DXd无进展生存期（progress-free survival，PFS）的相关性，包括年龄、激素受体表达、HER2表达、Ki-67水平、转移灶数目、活动性脑转移、东部肿瘤协作组体力评分、T-DXd治疗线数、晚期阶段周期蛋白依赖性激酶4/6抑制剂治疗、抗HER2治疗、抗体药物偶联物治疗及脑转移局部放疗情况。［结果］ T-DXd中位治疗线数为5线，中位PFS为6.0个月，颅内肿瘤客观缓解率（objective response rate，ORR）为80%。HER2表达情况与T-DXd PFS显著性相关，HER2过表达组中位PFS较HER2低表达组明显延长（7.0个月 vs 3.5个月，P=0.016）。Cox多因素回归分析表明，HER2过表达是T-DXd PFS获益的独立预后因素（HR=0.215，95%CI：0.054~0.857，P=0.029）。Fisher精确检验提示上述临床病理因素均与T-DXd 颅内肿瘤ORR无显著性相关。T-DXd主要不良反应有恶心、呕吐、白细胞降低、中性粒细胞降低、血小板降低、贫血、疲乏等，3级及以上不良反应发生率较低。［结论］ T-DXd在HER2阳性晚期乳腺癌脑转移患者中颅内肿瘤ORR高。HER2过表达可作为T-DXd的PFS获益预测标志物，但与T-DXd的颅内肿瘤ORR无显著性相关。T-DXd耐受性良好。 |
| 英文摘要: |
| Abstract：［Objective］ To explore the efficacy and safety of trastuzumab deruxtecan(T-DXd) for human epidermal growth factor receptor 2 (HER2)-positive breast cancer with brain metastasis. ［Methods］ The clinical and pathological data of 15 HER2-positive breast cancer patients with brain metastasis who received T-DXd treatment in Xi’an International Medical Center Hospital from August 2021 to August 2023 were retrospectively analyzed. The correlation of progress-free survival(PFS) with clinicopathological characteristics of patients was analyzed with Kaplan-Meier method and Cox regression. ［Results］ The median treatment line of T-DXd was 5， the median PFS was 6.0 months， and the objective response rate(ORR) of intracranial tumors was 80%. HER2 expression status was significantly correlated with PFS of patients receiving T-DXd therapy. The median PFS of the HER2 overexpression group was significantly longer than that of the HER2 low expression group(7.0 months vs 3.5 months， P=0.016). Multivariate analysis showed that HER2 overexpression was an independent prognostic factor for PFS(HR=0.215， 95%CI： 0.054~0.857， P=0.029). Fisher’s exact test indicated that none of the studied clinical and pathological factors were significantly associated with ORR of the intracranial tumors. The main adverse reactions of T-DXd in this study were nausea and vomiting， leukopenia， neutropenia， thrombocytopenia， anemia， fatigue， etc.， with a low incidence of grade 3 or above adverse reactions. ［Conclusion］ T-DXd can effectively improve the ORR in HER2-positive breast cancer patients with brain metastasis. HER2 overexpression can be used as a predictive marker of PFS benefits of T-DXd treatment， but it has no significant correlation with the ORR of intracranial tumors. T-DXd therapy has good a tolerance. |
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