舒尼替尼一线治疗转移性肾细胞癌临床疗效分析

摘要

Objective:To evaluate the efficacy and safety of sunitinib for the first line treatment of metastatic renal cell carcinoma. Methods:All 31 Patients with metastatic renal cell carcinoma administered sunitinib as the first line treatment from APril 2010 to APril 2012. Sunitinib was administered rePeatedly in a dose of 50mg oral daily for four weeks followed by two weeks off. Patients were followed uP until August 2013,and adverse events were recorded and managed. Efficacy was evaluated every two cycles,and overall survival and Progression free survival was analyzed with KaPlan - Meier analysis. Results:The average follow uP time was 22. 3 months,ranged from 8 to 35 months. All cases could be evaluated. 9(29. 0% )Patients were Partial resPonse,14(45. 2% )cases demonstrated stable disease,and 8 (25. 8% )Patients develoPed Progressive disease. Disease control rate was 74. 2% ,and the objective resPonse rate was 29% . Median Progressive free survival was 12 months(95% confidence interval:9. 2 - 14. 8 months),and the o-verall survival achieved 21 months(95% confidence interval:17. 9 - 24. 1 months). Most of the adverse events were grade Ⅰ or Ⅱ,grade Ⅲ and Ⅳ adverse events were infrequent. The most common adverse events were diarrhea,fa-tigue,hyPertension and hematoPoietic toxicity. 41. 9% cases needed decreasing the dosage or stoPPing the theraPy temPorarily,and the adverse events could be controlled by this management and symPtomatic treatment. Conclusion:With higher efficacy and safety,sunitinib would be a good choice for treatment of metastatic renal cell carcinoma.%目的：观察舒尼替尼一线治疗转移性肾细胞癌疗效及安全性。方法：2010年4月-2012年4月我科收治转移性肾细胞癌患者31例，采用舒尼替尼行靶向治疗（50mg，Pd，4/2方案）。服药期间进行不良事件管理及随访，每间隔2周期行疗效评价，随访截止至2013年8月，KaPlan - Meier 分析总体生存期及无进展生存期。结果：随访8-35个月，平均22.3个月，可评价31例，PR 9例（29.0%），SD 14例（45.2%），PD 8例（25.8%），疾病控制率为74.2%，客观反应率为29%。中位无进展生存期12个月（95% CI：9.2-14.8个月），中位总生存期21个月（95% CI：17.9-24.1个月）。不良事件多为Ⅰ/Ⅱ级，Ⅲ/Ⅳ级少见，常见的为腹泻、乏力、高血压及造血系统毒性等。41.9%的患者需调整给药剂量或暂时停药，不良事件经管理后可缓解。结论：舒尼替尼治疗转移性肾细胞癌疗效好，安全性较高，是转移性肾细胞癌较好的治疗选择之一。