首页|PD-1/CTLA-4双抗治疗妇科恶性肿瘤的疗效和安全性观察

PD-1/CTLA-4双抗治疗妇科恶性肿瘤的疗效和安全性观察

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目的 分析妇科恶性肿瘤患者应用PD-1/CTLA-4双抗治疗后的血常规、影像学等相关数据,评价该药物在妇科恶性肿瘤患者治疗中的有效性及安全性。方法 选取22例妇科恶性肿瘤患者,均接受程序性细胞死亡蛋白1(PD-1)/靶向细胞毒性T淋巴细胞相关抗原4(CTLA-4)双抗治疗加或不加化疗或靶向治疗,观察近期疗效、不良反应发生率。结果 CR患者4例,占18。2%,PR 2例,占9。1%,SD 6例,占27。3%,总有效率27。3%(CR+PR),临床获益率54。5%(CR+PR+SD)。PD 10例,占45。5%。随访至2023年10月31日,存活患者14例,占63。6%,死亡患者8例,占36。4%。治疗相关不良事件(TRAEs)发生率95。5%(21/22),其中重度不良反应发生率为50。0%(11/22):血红蛋白降低发生率9。1%(2/22),白细胞减少发生率27。3%(6/22),中性粒细胞减少发生率13。6%(3/22),ALT及AST升高、血小板减低、过敏反应发生率均为4。5%(1/22)。与免疫治疗相关的重度不良反应发生率为:重度血红蛋白降低、重度血小板减低、重度肝功能损伤均为4。5%(1/22)。结论 应用PD-1/CTLA-4双抗治疗晚期/复发妇科恶性肿瘤患者临床获益率较高,不良反应发生率低,具有较高的推广价值。
Efficacy and safety of PD-1/CTLA-4 bispecific antibody in the treatment of gynecological malignant tumor
Objective To analyze the blood routine,imaging and other related data of gynecological malignant tumor patients treated with PD-1/CTLA-4 bispecific antibody,and evaluate the effectiveness and safety of the drug in the treatment of gynecological malignant tumor patients.Methods 22 patients with gynecological malignant tumors were selected,all of whom received bispecific antibodies against programmed cell death protein-1(PD-1)/targeted cytotoxic T lymphocyte associated antigen-4(CTLA-4)with or without chemotherapy or targeted therapy.The recent efficacy and incidence of adverse reactions were observed.Results There were 4 cases of CR,accounting for 18.2%,2 cases of PR,accounting for 9.1%,6 cases of SD,accounting for 27.3%.The total clinical effective rate was 27.3%(CR+PR),with a clinical benefit rate of 54.5%(CR+PR+SD).There were 10 cases of PD,accounting for 45.5%.Follow-up to October 2023 showed that 14 patients were alive,accounting for 63.6%,and 8 patients were dead,accounting for 36.4%.The incidence of treatment-related adverse events(TRAEs)was 95.5%(21/22).The incidence of severe adverse reactions was 50.0%(11/22).The incidence of hemoglobin decrease above grade 3 was 9.1%(2/22),the incidence of leukopenia decrease above grade 3 was 27.3%(6/22),the incidence of neutropenia decrease above grade 3 was 13.6%(3/22),and the incidence of ALT and AST increase above grade 3 was 4.5%(1/22).Among them,the severe adverse reactions related to immunotherapy were:the incidence of severe hemoglobin reduction was 4.5%(1/22),the incidence of severe platelet reduction was 4.5%(1/22),and the incidence of severe liver function impairment was 4.5%(1/22).Conclusion The application of PD-1/CTLA-4 bispecific antibody in the treatment of advanced/recurrent gynecological malignant tumor has a high clinical benefit rate and a low incidence of severe adverse reactions,which has a high promotion value.

Late/recurrent gynecological malignant tumorsPD-1/CTLA-4 bispecific antibodyClinical efficacySecurity

谭化明、韩修臣、刘文丽、盛修贵、祁淑英

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汕头大学医学院 妇科,广东 汕头 515041

中国医学科学院肿瘤医院深圳医院 妇科,广东 深圳 518116

深圳大学医学部 临床医学,广东 深圳 518060

深圳市龙岗中心医院 生殖医学科,广东 深圳 518116

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晚期/复发妇科恶性肿瘤 PD-1/CTLA-4双抗 临床疗效 安全性

2024

实用妇科内分泌电子杂志

实用妇科内分泌电子杂志

ISSN:
年,卷(期):2024.11(19)