比较阿昔替尼联合不同PD-1单抗治疗晚期肾癌疗效的回顾性分析

Retrospective Analysis for Comparing Efficacy of Axitinib Combined with Different PD-1 Monoclonal Antibody in Treatment of Advanced Renal Cell Carcinoma

目的比较阿昔替尼与不同PD-1单抗联用治疗晚期肾癌的疗效。方法收集晚期肾癌患者的临床资料,根据不同的用药方案设为阿昔替尼+特瑞普利单抗、阿昔替尼+替雷利珠单抗和阿昔替尼+信迪利单抗3个研究组。记录患者联合用药前后的影像学检查结果,按Recist 1.1评价疗效,以病情进展、患者死亡、停药、改变治疗方案为终点计算各组患者的无事件生存期(EFS),收集血常规和肝功、心功、肾功、炎症反应等生化检测指标,统计分析患者联合用药前后各项指标的变化,以P<0.05为差异具有统计学意义。结果经筛选,共纳入40例晚期肾癌患者的临床数据。3个研究组的客观缓解率(ORR)依次为阿昔替尼+特瑞普利单抗组71.43%、阿昔替尼+替雷利珠单抗组64.29%、阿昔替尼+信迪利单抗组25.00%,其中阿昔替尼+特瑞普利单抗组和阿昔替尼+替雷利珠单抗组的ORR显著均高于阿昔替尼+信迪利单抗组(P<0.05);疾病控制率(DCR)依次为阿昔替尼+特瑞普利单抗组82.86%、阿昔替尼+替雷利珠单抗组100.00%、阿昔替尼+信迪利单抗组91.67%,3组比较差异没有统计学意义。3个研究组的平均EFS依次为阿昔替尼+特瑞普利单抗组(14.6±4.9)个月、阿昔替尼+替雷利珠单抗组(10.1±3.6)个月、阿昔替尼+信迪利单抗组(9.5±3.2)个月,其中阿昔替尼+特瑞普利单抗组的平均EFS比另外两组较长且差异具有统计学意义(P<0.05);中位EFS依次为阿昔替尼+特瑞普利单抗组16.5个月、阿昔替尼+替雷利珠单抗组9.6个月、阿昔替尼+信迪利单抗组8.8个月。3个研究组的各项生化指标和血常规检测结果在联合用药前后变化并无显著性差异,且均在正常参考范围内。结论3种联合用药方案均可有效控制病情进展,其中阿昔替尼与特瑞普利单抗联用疗效最好,其次为阿昔替尼与替雷利珠单抗联用,阿昔替尼与信迪利单抗联用关键疗效指标均不如前两者。

OBJECTIVE To compare the efficacy of combined therapy using axitinib with different PD-1 monoclonal antibodies in the treatment of advanced renal cell carcinoma.METHODS Clinical data from patients diagnosed with advanced renal cell carcinoma were collected and divided into three groups according to different regimens:axitinib+toripalimab,axitinib+tislelizumab,and axitinib+sintilimab.Imaging results before and after combined therapy were recorded and evaluated according to RECIST 1.1 criteria.The event free survival(EFS)of each group of patients was calculated with endpoints including disease progression,patient death,discontinuation of medication,and changes in treatment method.Hematologic and biochemical examination including liver function,heart function,kidney function and inflammatory reaction were collected and statistically analyzed for changes before and after the therapy.Statistical significant was defined as P<0.05.RESULTS After screening,clinical data from 40 patients were collected.The objective response rates(ORR)were 71.43%in the axitinib+toripalimab group,64.29%in the axitinib+tislelizumab group,and 25.00%in the axitinib+sintilimab group.Among them,the ORR of the axitinib+toripalimab group and the axitinib+tislelizumab group was significantly higher than that of the axitinib+sintilimab group(P<0.05).The disease control rates(DCR)were 82.86%in the axitinib+toripalimab group,100.00%in the axitinib+tislelizumab group,and 91.67%in the axitinib+sintilimab group,with no statistically significant difference among the three groups.The average EFS of the three study groups was(14.6±4.9)months in the axitinib+toripalimab group,(10.1±3.6)months in the axitinib+tislelizumab group,and(9.5±3.2)months in the axitinib+sintilimab group,respectively.Among them,the average EFS of the axitinib+toripalimab group was longer than that of the other two groups,and the difference was statistically significant(P<0.05).The median EFS was 16.5 months in the axitinib+toripalimab group,9.6 months in the axitinib+tislelizumab group,and 8.8 months in the axitinib+sintilimab group.There were no significant differences in hematologic or biochemical examination results before and after combined therapy,and all results were within the normal reference range.CONCLUSION All three combined therapy regimens could effectively control the progression of advanced renal cell carcinoma.The combination of axitinib with toripalimab showed the best therapeutic effect,followed by axitinib with tislelizumab.The key efficacy results of the axitinib+sintilimab combination were less favorable compared to those of the other two combinations.