特瑞普利单抗联合舒尼替尼治疗晚期肾细胞癌的初步疗效分析

Toripalimab combined with sunitinib in the treatment of advanced renal cell carcinoma:an analysis of preliminary effectiveness

目的评估特瑞普利单抗联合舒尼替尼治疗晚期肾细胞癌的疗效与安全性。方法收集2020年1月至2022年3月于海军军医大学(第二军医大学)第二附属医院接受特瑞普利单抗联合舒尼替尼治疗的25例晚期肾细胞癌患者的临床资料。治疗方案为特瑞普利单抗240 mg静脉注射(每3周1次)和舒尼替尼50 mg口服(每日1次),根据患者耐受性调整剂量。对治疗效果进行影像学评估,按实体瘤疗效评价标准1.1版判断疗效,并按不良事件通用术语标准5.0版记录不良反应。采用Kaplan-Meier法进行生存分析。结果25例患者中男21例、女4例,中位年龄为59(95%CI 33~80)岁。病理类型包括23例肾透明细胞癌和2例转录因子E3(TFE3)基因融合相关性肾细胞癌,其中1例肾透明细胞癌伴部分肉瘤样变。所有患者均有局部进展或远处转移。中位随访时间11.0(95%CI2.5~24.0)个月。25例患者均完成疗效评价,部分缓解9例,疾病稳定12例,疾病进展4例;总体客观缓解率为36.0%(9/25),疾病控制率为84.0%(21/25);中位无进展生存期为12.7(95%CI 10.7~14.7)个月,中位总生存期尚未达到。治疗总体不良反应发生率为88.0%(22/25),常见不良反应包括皮疹、腹泻、手足皮肤反应等,90.0%(45/50)的不良反应为1~2级。结论特瑞普利单抗联合舒尼替尼对晚期肾细胞癌的初步疗效可观,安全性总体可控。

Objective To evaluate the efficacy and safety of toripalimab combined with sunitinib in the treatment of advanced renal cell carcinoma(RCC).Methods The clinical data of 25 patients with advanced RCC treated with toripalimab 240 mg by intravenous infusion every 3 weeks and sunitinib 50 mg orally once daily(with dose modifications according to patient tolerance)at The Second Affiliated Hospital of Naval Medical University(Second Military Medical University)from Jan.2020 to Mar.2022 were collected.The treatment effect was evaluated by imaging results,the efficacy was judged according to Response Evaluation Criteria in Solid Tumors(RECIST version 1.1),and adverse events were recorded according to Common Terminology Criteria for Adverse Events(CTCAE version 5.0).Survival analysis was performed by Kaplan-Merier method.Results Of the 25 patients,21 were male and 4 were female,with a median age of 59(95% confidence interval[CI]33-80)years old.The pathological types included clear cell renal cell carcinoma(ccRCC)in 23 patients,transcription factor 3(TFE3)gene fusion–associated RCC in 2 patients,and ccRCC with partial sarcomatoid degeneration in 1 patient.All patients had local progression or distant metastasis,with a median follow-up of 11.0(95%CI 2.5-24.0)months.All 25 patients were evaluable for efficacy,including partial response in 9 cases,stable disease in 12 cases,and progressive disease in 4 cases.The objective response rate was 36.0%(9/25),the disease control rate was 84.0%(21/25),the median progression-free survival was 12.7(95%CI 10.7-14.7)months,and the median overall survival has not been reached yet.The overall incidence of adverse events was 88.0%(22/25).Common adverse events included rash,diarrhea,hand-foot skin reaction and hypertension,with 90.0%(45/50)of them being grade 1-2.Conclusion Toripalimab combined with sunitinib is efficient in the treatment of advanced RCC,and the safety events are generally manageable.