目的:探讨抗体药物偶联物(antibody-drug conjugate,ADC)维迪西妥单抗治疗后肿瘤患者神经毒性发生情况及其影响因素,为实现个体化用药提供更多决策依据.方法:收集2020年1月—2023年6月我院接受维迪西妥单抗治疗的临床病例,记录患者临床信息,利用回顾性分析、单因素以及回归分析方法确定维迪西妥单抗致神经毒性的影响因素.结果:本研究共纳入137例接受维迪西妥单抗治疗的肿瘤患者,出现神经毒性37例,占比27.01％,其中手足麻木16例(11.7％),四肢关节痛和肌痛伴麻木和麻刺感23例(16.8％),肌力减退13例(9.5％),行走困难6例(4.4％).本研究中神经毒性出现时间范围在治疗后d3～d241,中位发生时间为治疗后d42,约50％患者在用药2周期后即出现了神经系统毒性.经单因素和多因素回归分析显示性别、年龄、体重指数(body mass index,BMI)、美国东部肿瘤协作组(Eastern Cooperative On-cology Group,ECOG)评分及既往是否合并疾病对神经毒性的影响差异有统计学意义(P＜0.05),而既往合并疾病[比值比(odds ratio,OR)=10.125,95％置信区间(95％confidence interval,95％CI):3.194～32.101,P＜0.001]及年龄(OR=2.802,95％CI:1.137～6.908,P=0.025)是维迪西妥单抗治疗后出现神经毒性的独立危险因素(OR＞1,P＜0.05).结论:既往合并疾病和年龄是维迪西妥单抗治疗后出现神经毒性的影响因素.因此,在使用抗体偶联药物维迪西妥单抗治疗时,对于既往合并高血压、糖尿病等基础疾病及年龄60岁以上患者需密切关注神经毒性的发生情况,积极采取预防性干预措施.
Analysis on the characteristics and influencing factors of peripheral neurotoxicity induced by antibody-drug conjugate disitamab vedotin
Objective:To investigate neurotoxicity's occurrence and influencing factors in tumor patients treated with antibody-drug conjugate(ADC)disitamab vedotin,providing evidence for individualized drug administration.Methods:The cases of patients treated with disitamab vedotin in our hospital from January 2020 to June 2023 were collected,and the clinical information of the patients was recorded.Retrospective analysis,univariate analysis and regression analysis were used to determine the influencing factors of neurotoxicity induced by disitamab vedotin.Results:A total of 137 patients who underwent the treatment of disitamab vedotin were included in this study.Among the patients,37 cases appeared neurotoxicity,accounting for 27.01％,in which insensitive hands and feet in 16 cases(11.7％),limbs arthralgia and myalgia with numbness and tingling in 23 cases(16.8％),decreased muscle strength in 13 cases(9.5％),walking difficult 6 cases(4.4％).In this study,the onset time of neurotoxicity ranged from 3 days to 241 days after treatment,and the median time was 42 days after treatment.About 50％of patients developed neurological toxicity after 2 cycles of treatment.Univariate and multivariate regression analysis showed that gender,age,BMI,ECOG score and history of comorbidities had statistically significant effects on neurotoxicity(P＜0.05),and history of comorbidities(OR=10.125,95％CI:3.194～32.101,P＜0.001)and age(OR=2.802,95％CI:1.137～6.908,P=0.025)were independent risk factors for neurotoxicity after disitamab vedotin treatment(OR＞1,P＜0.05).Conclusion:Previous disease and age are the factors influencing neurotoxicity after disitamab vedotin treatment.Therefore,when using the antibody-drug conjugate(ADC)disitamab vedotin,it is necessary to pay close attention to the occurrence of neurotoxicity and preventive intervention measures should be actively taken for patients over 60 years old with previous underlying diseases such as hypertension and diabetes.
peripheral neuropathyantibody-drug conjugatedisitamab vedotinanalysis of influencing factors
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