培唑帕尼治疗转移性肾癌的疗效分析

Efficacy and safety of pazopanib for metastatic renal cell carcinoma

目的探究培唑帕尼治疗转移性肾细胞癌的疗效及不良反应。方法回顾性分析2017年7月—2019年12月在复旦大学附属中山医院接受培唑帕尼靶向治疗(800 mg口服,1次/d)的52例转移性肾细胞癌患者的临床资料,其中男性37例,女性15例;透明细胞癌41例(78.8%),非透明细胞癌11例(21.2%)。服药期间每2周采用实体肿瘤疗效评价标准1.1版进行疗效评价、不良事件按常见不良事件评价标准5.0版进行分级并定期随访。Kaplan-Meier法分析患者总生存期(OS)和无进展生存期(PFS)。结果中位随访时间为13.6个月。完全缓解(CR)1例(1.9%)、部分缓解(PR)13例(25.0%)、疾病稳定(SD)33例(63.5%)、疾病进展(PD)5例(9.6%)、客观反应率(ORR)为26.9%。中位PFS为14.6个月(95%CI:11.5~17.7),中位OS为18.9个月(95%CI:12.8~25.0)。其中,非透明细胞肾癌用药后PR 3例(27.3%),SD 7例(63.6%),PD 1例(9.1%)。不同IMDC危险度评分患者PFS无显著差异(P=0.445)。不良事件多为I/II级,常见为乏力、肝功能损害及造血系统毒性等;III/IV级不良事件少见,不良事件经管理后可缓解。结论培唑帕尼治疗转移性肾癌疗效好,安全性较高,是良好的治疗选择之一。

Objective To evaluate the efficacy and adverse events of pazopanib in the treatment of metastatic renal cell car⁃cinoma(RCC).Methods Clinical data of 52 patients with metastatic RCC who received pazopanib therapy(800 mg po qd)during Jul.2017 and Dec.2019 were retrospectively analyzed,including 37 male and 15 female,41 clear cell RCC cases,and 11 non-clear cell RCC cases.During medication,efficacy was evaluated with RECIST 1.1 every 2 weeks,and adverse events were graded according to CTCAE v5.0.The overall survival(OS)and progression-free survival(PFS)were determined with Kaplan-Meier and Log-rank analysis.Results During the median follow-up of 13.6 months,1(1.9%)patient had complete response,13(25.0%)had partial response,33(63.5%)had stable disease,and 5(9.6%)had progressive disease.The objective response rate was 26.9%.The median PFS was 14.6 months(95%CI:11.5-17.7 months),and the median OS was 18.9 months(95%CI:12.8-25.0 months).In non-clear cell RCC cases,3(27.3%)had partial response,7(63.6%)had stable disease,and 1(9.1%)had progressive disease.IMDC risk was not associated with PFS(P=0.445).Most adverse events were grade I/II,such as fatigue,liver damage and hematopoietic toxicity,while grade III/IV adverse events were rare and could be alleviated by man⁃agement.Conclusion Prazopanil has good efficacy and safety in the treatment of metastatic RCC,and is one of the good treat⁃ment options.