帕博利珠单抗与特瑞普利单抗治疗晚期黑色素瘤有效性及安全性对比  

Comparison on the effectiveness and safety of pembrolizumab and toripalimab in the treatment advanced melanoma

作　　者：李虎进 杨松巍 陈飚 LI Hujin;YANG Songwei;CHEN Biao(Department of Bone and soft tissue Oncology,Affiliated Cancer Hospital of Chongqing University,Chongqing 400030,China)

机构地区：[1]重庆大学附属肿瘤医院骨与软组织肿瘤科,重庆400030

出　　处：《中国处方药》2025年第3期68-72,共5页Journal of China Prescription Drug

摘　　要：目的比较帕博利珠单抗与特瑞普利单抗治疗晚期黑色素瘤患者的有效性及安全性。方法选取2021年6月~2023年6月在医院诊治的100例晚期黑色素瘤患者,采用随机数表法将患者分为帕博利珠单抗组(n=50,采用帕博利珠单抗治疗)和特瑞普利单抗组(n=50,采用特瑞普利单抗治疗)。比较两组患者治疗前和治疗2个周期后肝功能指标[包括丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、总胆红素(TBil)和直接胆红素(DBil)水平]、肾功能指标[包括血肌酐(Scr)、血尿素氮(BUN)和尿白蛋白(ALB)水平]、血液学不良反应发生情况[白细胞减少、血红蛋白减少和血小板减少情况],并采用Kaplan-Meier进行生存分析,Logrank Test比较两组中位总生存时间和中位无进展生存时间。结果治疗前后两组患者的ALT、AST、TBil和DBil水平比较,差异无统计学意义(P>0.05)。治疗前后两组患者的Scr、BUN和尿ALB水平比较,差异无统计学意义(P>0.05)。两组患者均多发Ⅰ~Ⅱ级不良反应,Ⅲ级以上不良反应发生率为13.00%(13/100),其中主要为白细胞减少和血小板减少,两组均只有1例Ⅲ~Ⅳ级血红蛋白减少情况。所有患者随访12~48个月,中位随访时间为30个月。生存分析显示,截至2024年6月,帕博利珠单抗组总生存率为24.99%,中位总生存时间为19.9个月,特瑞普利单抗组为17.68%、17.5个月,两组生存率比较,差异无统计学意义(Log-rankχ^(2)=1.235,Logrank P=0.266>0.05)。帕博利珠单抗组无进展生存率为5.69%,中位无进展生存时间为14.9个月,特瑞普利单抗组为5.27%、12.9个月,两组无进展生存率比较,差异无统计学意义(Log-rankχ^(2)=0.740,Log-rank P=0.390>0.05)。结论帕博利珠单抗和特瑞普利单抗在晚期黑色素瘤治疗中的有效性和安全性差异不显著,提示两种药物在晚期黑色素瘤的治疗中具有相似的临床效果和安全性。Objective To compare the effectiveness and safety of pembrolizumab and toripalimab in the treatment of patients with advanced melanoma.Methods A total of 100 patients with advanced melanoma treated in the hospital were enrolled between June 2021 and June 2023.According to random number table method,they were divided into pembrolizumab group(n=50,pembrolizumab)and toripalimab group(n=50,toripalimab).The liver function indexes[alanine aminotransferase(ALT),aspartate aminotransferase(AST),total bilirubin(TBil),direct bilirubin(DBil)],renal function indexes[serum creatinine(Scr),blood urea nitrogen(BUN),urinary albumin(ALB)]and occurrence of hematological adverse reactions(leukopenia,hemoglobin decrease,thrombocytopenia)were compared between the two groups before and after 2 cycles of treatment.Kaplan-Meier survival analysis was performed,median overall survival and median progression-free survival in the two groups were compared by Logrank Test.Results There was no significant difference in ALT,AST,TBil or DBil between two groups before and after treatment(P>0.05).There was no significant difference in Scr,BUN or urinary ALB between the two groups before and after treatment(P>0.05).The grading of adverse reactions was mainly at gradeⅠ-Ⅱin both groups,and incidence of grade>Ⅲadverse reactions was 13.00%(13/100).The main adverse reactions were leukopenia and thrombocytopenia.There was only 1 case with gradeⅢ-Ⅳhemoglobin decrease in each group,respectively.All patients were followed up for 12-48 months,with median follow-up time of 30 months.Survival analysis showed that as of June 2024,overall survival rates and median overall survival in pembrolizumab group and toripalimab group were(24.99%,19.9 months)and(17.68%,17.5 months),there was no significant difference in survival rate between the two groups(Log-rankχ^(2)=1.235,Log-rank P=0.266>0.05).The progression-free survival rates and median progression-free survival in pembrolizumab group and toripalimab group were(5.69%,14.9 months)and(5.27%,12.9 months),th

关 键 词：晚期黑色素瘤 帕博利珠单抗 特瑞普利单抗 有效性 安全性 

分 类 号：R739.5[医药卫生—肿瘤]