| 张俊美,杜红娟,盛倩文,等.维迪西妥单抗在HER2有表达的转移性乳腺癌患者中的疗效及安全性观察[J].肿瘤学杂志,2025,31(5):427-434. |
| 维迪西妥单抗在HER2有表达的转移性乳腺癌患者中的疗效及安全性观察 |
| Efficacy and Safety of Disitamab Vedotin in Patients with HER2-Positive Metastatic Breast Cancer |
| 投稿时间：2024-03-24 |
| DOI：10.11735/j.issn.1671-170X.2025.05.B008 |
|
 |
| 中文关键词: 维迪西妥单抗 人表皮生长因子受体2 转移性乳腺癌 疗效 安全性 |
| 英文关键词:Disitamab Vedotin human epidermal growth factor receptor 2 metastatic breast cancer efficacy safety |
| 基金项目: |
|
| 摘要点击次数: 11 |
| 全文下载次数: 6 |
| 中文摘要: |
| 摘 要：［目的］ 回顾性分析维迪西妥单抗（RC48）在人表皮生长因子受体2（human epidermal growth factor receptor 2，HER2）有表达的转移性乳腺癌中的疗效及安全性。［方法］ 分析2021年12月至2023年12月在西安国际医学中心医院接受RC48治疗的HER2有表达的转移性乳腺癌患者15例临床病理数据，评估其疗效及安全性，并探索分析疗效影响因素。［结果］ HER2有表达的转移性乳腺癌患者15例，RC48平均治疗线数为6线，客观缓解率（objective response rate，ORR）为40.0%，中位无进展生存期（median progression-free survival，mPFS）达到5.5个月。激素受体（hormone receptor，HR）表达、HER2表达、RC48治疗线数、晚期阶段是否接受过细胞周期蛋白依赖性激酶4/6抑制剂（cyclin-dependent kinase 4/6 inhibitor，CDK4/6i）及抗体药物偶联物（antibody-durg conjugate，ADC）治疗与PFS显著性相关。HR阴性组患者较阳性组mPFS明显延长（6.0个月 vs 2.0个月，P=0.002）。HER2过表达组mPFS较HER2低表达组明显延长（7.0个月 vs 2.0个月，P=0.036）。RC48治疗线数为1~4线对比≥5线患者，mPFS显著性延长（6.5个月 vs 2.0个月，P=0.023）。晚期阶段未接受过CDK4/6i治疗对比接受过CDK4/6i治疗的患者，mPFS明显延长（6.0个月 vs 2.0个月，P=0.007）。晚期阶段未接受过ADC治疗对比接受过ADC治疗的患者，mPFS明显延长（6.0个月 vs 1.0个月，P=0.047）。Cox多变量分析显示，HR表达（HR=0.018，95%CI：0.001~0.677，P=0.030）、HER2表达水平（HR=34.373，95%CI：2.096~563.747，P=0.013）、RC48治疗线数（HR=0.032，95%CI：0.002~0.552，P=0.018）、晚期阶段是否接受ADC治疗（HR=0.067，95%CI：0.005~0.952，P=0.046）是影响PFS获益的独立预后因素。RC48常见不良反应包括感觉异常、天冬氨酸转氨酶/丙氨酸氨基转移酶升高、骨髓抑制、疲乏、恶心及脱发，严重不良反应发生率较低。［结论］ RC48在HER2有表达的转移性乳腺癌患者中ORR及PFS良好，HR阴性、HER2过表达、RC48前线使用、晚期阶段未接受ADC治疗可以作为PFS获益的预测标志物，但以上因素均不影响ORR。 |
| 英文摘要: |
| Abstract： ［Objective］ To analyze the efficacy and safety of Disitamab Vedotin (RC48) in treatment of patient with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. ［Methods］ The clinical data of 15 HER2-positive patients with metastatic breast cancer who received RC48 treatment in Xi’an International Medical Center Hospital from December 2021 to December 2023 were retrospectively analyzed， and the efficacy and safety of RC48 treatment were evaluated. ［Results］ The patients had an average of 6 lines of treatment. The objective response rate (ORR) was 40.0%， the median progression-free survival (mPFS) was 5.5 months. Kaplan-Meier curves showed that the expression of hormone receptor(HR)， HER2 expression， number of RC48 treatment lines， receiving cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) and antibody-drug conjugate (ADC) treatment in the advanced stage were significantly associated with PFS of patients receiving RC48 treatment. The mPFS of HR-negative patients was significantly longer than that of HR-positive patients (6.0 months vs 2.0 months， P=0.002). The mPFS of patients with HER2 overexpression was significantly longer than that of patients with HER2 low expression (7.0 months vs 2.0 months， P=0.036). The mPFS of patients treated with 1~4 lines of RC48 was significantly longer than that of patients treated with ≥5 lines (6.5 months vs 2.0 months， P=0.023). The mPFS of patients without CDK4/6i treatment in the advanced stage was significantly longer than that of patients with CDK4/6i treatment (6.0 months vs 2.0 months， P=0.007). The mPFS of patients without ADC treatment in the advanced stage was significantly longer than that of patients with ADC treatment (6.0 months vs 1.0 month， P=0.047). Multivariate Cox regression model showed that HR expression (HR=0.018， 95%CI： 0.001~0.677， P=0.030)， HER2 expression(HR=34.373， 95%CI： 2.096~563.747， P=0.013)， number of RC48 treatment lines (HR=0.032， 95%CI： 0.002~0.552， P=0.018)， and receiving ADC treatment in the advanced stage (HR=0.067， 95%CI： 0.005~0.952， P=0.046) were independent prognostic factors affecting PFS benefit. The common adverse reactions of RC48 treatment included sensory abnormality， elevated aspartate aminotransferase and alanine transaminase， bone marrow suppression， fatigue， nausea and hair loss， while the incidence of severe adverse reactions was low. ［Conclusion］ Disitamab Vedotin (RC48) has good efficacy and safety for patients with HER2-positve metastatic breast cancer. HR negative expression， HER2 overexpression， RC48 front-line use， and no ADC treatment in late stage can be used to predict PFS in patients with RC48 treatment， but not for ORR. |
|
在线阅读
查看全文 查看/发表评论 下载PDF阅读器 |