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维迪西妥单抗在HER2有表达的转移性乳腺癌患者中疗效及安全性观察

Observation of the efficacy and safety of Disitamab Vedotin in patients with HER2 expressing metastatic breast cancer

投稿时间：2024-03-24 修订日期：2024-10-20

DOI：

中文关键词: 维迪西妥单抗/RC48 HER2有表达转移性乳腺癌疗效预测指标安全性分析

英文关键词:Disitamab Vedotin/RC48 HER2 expression Metastatic breast cancer Efficacy predictor Safety analysis

基金项目:

作者	单位	邮编
张俊美	西安国际医学中心医院	710100
杜红娟	重庆市人民医院肿瘤科
盛倩文	西安国际医学中心肿瘤科
石小霞	西安国际医学中心肿瘤科
薛妍^*	西安国际医学中心肿瘤科	710100

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中文摘要:

[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的疗效及安全性，及其疗效预测标志物。[方法] 搜集15例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、转移性乳腺癌患者临床病理数据，评估其疗效及安全性，并探索性分析RC48的疗效预测指标。[结果] 本研究中HER2有表达的转移性乳腺癌患者，RC48平均治疗线数为6线，客观缓解率（objective response rate，ORR）为40%，疾病控制率（disease control rate, DCR）为66.7%，中位无进展生存期（median progression-free survival，mPFS）达到5.5个月。通过Kaplan-Meier方法评估了不同临床病理特征与RC48 PFS的相关性，结果发现雌激素受体（hormone receptor ，HR）表达情况、HER2表达水平、RC48治疗线数、晚期阶段是否接受过周期蛋白依赖性激酶4/6抑制剂（cyclin-dependent kinase4/6 inhibitor，CDK4/6i）及抗体药物偶联物（antibody-durg conjugate，ADC）治疗与RC48 PFS有显著相关性。HR阴性组患者较阳性组mPFS明显延长（6.0月 vs. 2.0月，P=0.002）。HER2过表达组mPFS较HER2低表达组明显延长（7.0月 vs. 2.0月，P=0.036）。RC48治疗线数为1-4线对比≥5线患者，mPFS显著延长（6.5月 vs. 2.0月，P=0.023）。晚期阶段未接受过CDK4/6i治疗对比接受过该治疗的患者，mPFS明显延长（6.0月 vs. 2.0月，P=0.007）。晚期阶段未接受过ADC治疗对比接受过该治疗的患者，mPFS明显延长（6.0月 vs. 1.0月，P=0.047）。使用Cox模型进行多变量分析显示，HR表达情况（HR=0.018，95% CI：0.001-0.677，P=0.030）、HER2表达水平（HR =34.373，95% CI：2.096-563.74，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RC48 PFS获益的独立预后因素。Fisher精确检验提示本研究中分析的所有临床病理因素均与RC48治疗的ORR无明显相关性。本研究中RC48常见不良反应有：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疗效良好，HR阴性、HER2过表达、RC48前线使用、晚期阶段未曾接受ADC治疗可以作为RC48 PFS获益的预测标志物，但以上因素均不影响其客观缓解率。RC48耐受性良好，临床使用安全。

英文摘要:

[Objective] To retrospectively analyze the efficacy and safety of Disitamab Vedotin/RC48 in metastatic breast cancer with expression of human epidermal growth factor receptor 2 (HER2), as well as its therapeutic predictive markers. [Methods] The clinicopathological data of 15 patients with metastatic breast cancer with HER2 expression who received RC48 treatment in Xi'an International Medical Center Hospital from December 2021 to December 2023 were collected, and their efficacy and safety were evaluated. [Results] In this study, patients with metastatic breast cancer with HER2 expression who received RC48 treatment had an average of 6 lines of treatment. The objective response rate (ORR) was 40%, and the disease control rate (DCR) was 66.7%, the median progression-free survival (mPFS) reached 5.5 months. The Kaplan-Meier method was used to evaluate the correlation between different clinicopathological characteristics and RC48 PFS. The results showed that the expression of estrogen receptor (HR), HER2 expression level, number of RC48 treatment lines, whether or not to receive cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) and antibody-drug conjugate (ADC) treatment in the advanced stage were significantly associated with RC48 PFS. The mPFS of patients with HR-negative expression was significantly longer than that of patients with HR-positive expression (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 who did not receive CDK4/6i treatment in the advanced stage was significantly longer than that of patients who received the treatment (6.0 months vs. 2.0 months, P=0.007). The mPFS of patients who did not receive ADC treatment in the advanced stage was significantly longer than that of patients who received the treatment (6.0 months vs. 1.0 month, P=0.047). Multivariate analysis using the Cox model showed that the expression of HR (HR=0.018, 95% CI: 0.001-0.677, P=0.030), HER2 expression level (HR=34.373, 95% CI: 2.096-563.74, P=0.013), number of RC48 treatment lines (HR=0.032, 95% CI: 0.002-0.552, P=0.018), and whether or not to receive ADC treatment in the advanced stage (HR=0.067, 95% CI: 0.005-0.952, P=0.046) were independent prognostic factors affecting RC48 PFS benefit. Fisher's exact test suggested that all clinicopathological factors analyzed in this study were not significantly associated with the ORR of RC48 treatment. The common adverse reactions of RC48 in this study included sensory abnormality, elevated aspartate aminotransferase/alanine aminotransferase, bone marrow suppression, fatigue, nausea, and hair loss, and the incidence of severe adverse reactions was low. [Conclusion] RC48 has good ORR and PFS efficacy in metastatic breast cancer patients with HER2 expression. HR negative, HER2 overexpression, RC48 front-line use, and no ADC treatment in late stage can be used as predictive markers of RC48 PFS benefit, but the above factors do not affect the objective response rate. RC48 has good tolerance and is safe for clinical use.

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