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目的评价索拉非尼治疗晚期肾癌患者的疗效及安全性。方法回顾性分析自2007年1月至2013年8月于北京大学第一医院泌尿外科诊治的74例接受索拉非尼治疗的晚期肾癌患者。男性53例,女性21例,中位年龄55.4岁。治疗方案:初始剂量400mg,每天2次,4周为1周期,出现疾病进展时剂量递增或停药,出现不可耐受的毒副反应时暂减量或停药。结果 74例患者中位随访时间22.5个月,Kaplan-Meier生存分析示这74例患者中位总生存期23.0个月(范围:3~88月)。中位无疾病进展生存期13.0个月(范围:0~88月)。74例患者可用于疗效分析,根据RECIST标准评价最佳疗效:完全缓解3例(4.1%),部分缓解13例(17.6%),疾病稳定48例(64.9%),疾病进展10例(13.1%)。不良反应多为1至2级。通过减药、暂停药或对症治疗,大多不良反应可控并耐受。结论索拉非尼治疗晚期肾癌患者可取得较长的总生存期和无进展生存期,一线及二线治疗晚期肾癌有较高疾病控制率,且不良反应多可耐受。
Objective To evaluate the efficacy and safety of sorafenib in patients with advanced renal cell carcinoma. Methods A retrospective analysis was performed on 74 patients with advanced renal cell carcinoma treated with sorafenib from January 2007 to August 2013 at the Department of Urology, Peking University First Hospital. 53 males and 21 females, with a median age of 55.4 years. Treatment options: The initial dose of 400mg, 2 times a day, 4 weeks for a cycle, the incidence of disease progression dose escalation or withdrawal, the emergence of intolerable side effects of temporary reduction or withdrawal. Results The median follow-up time of 74 patients was 22.5 months. Kaplan-Meier survival analysis showed a median overall survival of 23.0 months (range: 3-88 months) in 74 patients. The median progression-free disease progression was 13.0 months (range: 0-88 months). According to RECIST criteria, 74 patients were evaluated for optimal efficacy: complete remission in 3 patients (4.1%), partial remission in 13 patients (17.6%), stable disease in 48 patients (64.9%), progressive disease in 10 patients (13.1% ). Adverse reactions are mostly 1 to 2 levels. By reducing the drug, drug suspension or symptomatic treatment, most of the adverse reactions can be controlled and tolerated. Conclusion Sorafenib in patients with advanced renal cell carcinoma can achieve longer overall survival and progression-free survival, first-line and second-line treatment of advanced renal cell carcinoma have a higher rate of disease control, and more tolerable adverse reactions.