索拉非尼治疗转移性肾癌的临床疗效与安全性

Clinical efficacy and safety of sorafenib in the treatment of metastatic renal cell carcinoma

目的观察索拉非尼治疗转移性肾癌患者的临床疗效与安全性。方法回顾性分析2012年8月至2014年9月西京医院泌尿外科38例索拉菲尼治疗转移性肾癌患者的临床资料。38例患者均采用索拉非尼400mg,2次/d给药方案,对无进展生存期、总体生存期、治疗反应及安全性进行评估。结果所有患者随访时间为12～158周,中位随访时间52周。患者无进展生存期的中位数为50.5周(95%CI:40.3～59.0),总体生存期的中位数为52.5周(95%CI:43.1～61.4)。38例患者中,没有出现完全缓解,最佳疗效是部分缓解。总体治疗反应为8例(21.1%)获得部分缓解,12例(31.6%)为疾病稳定,18例(47.4%)发生疾病进展,疾病控制率为52.7%。最常见的不良反应包括手足皮肤反应、高血压、恶心、厌食症、吞咽困难、疲劳、腹泻和口腔溃疡。最常见的3～4级不良事件为高血压(28.9%)、手足皮肤反应(13.2%)、吞咽困难(13.2%)、口腔溃疡(10.5%)和腹泻(7.9%)。8例(21.1%)患者由于出现手足皮肤反应、高血压和口腔溃疡而减少药量,上述不良反应可经对症治疗和减少剂量得到缓解。结论索拉非尼对转移性肾癌患者有效,尽管有些患者需要减量治疗,但总体耐受良好。

Objective To evaluate the clinical efficacy and safety of sorafenib in the treatment of metastatic renal cell carcinoma(RCC).Methods Medical records of 38 metastatic RCC cases treated with 400 mg sorafenib twice daily during Aug.2012 and Sep.2014 were retrospectively reviewed.The progression-free survival(PFS),overall survival(OS),therapeutic response and safety of all patients were assessed.Results The patients were followed up for 12-158 weeks(median 52 weeks).The median PFS was 50.5 weeks(95%CI:40.3-59.0),and the median OS was 52.5 weeks(95%CI:43.1-61.4).No patients demonstrated complete response,and the best was partial response.In detail,8 patients(21.1%) achieved a partial response,12(31.6%)stable disease,and 18(47.4%)progressive disease.The overall disease control rate was 52.7%.The most common adverse events associated with sorafenib included hand-foot skin reactions(HFSR),hypertension,nausea,anorexia,dysphagia,fatigue,diarrhea,and oral ulcer.The most common grade 3~4 adverse events were hypertension(28.9%),HFSR(13.2%),dysphagia(13.2%),oral ulcer(10.5%) and diarrhea(7.9%).For the 8 patients(21.1%) who had treatment-induced HFSR,hypertension and oral ulcer,the dose of sorafenib was reduced,and the adverse reactions were alleviated.Conclusions Sorafenib is effective for patients with metastatic RCC.The overall tolerance is good although some patients require dose reduction.