索拉非尼治疗晚期肾癌患者33例长期临床观察

目的评估索拉非尼治疗晚期肾癌的长期疗效和安全性。方法对33例晚期肾癌患者给予索拉非尼口眼治疗,观察其肿瘤控制及长期生存状况、不良反应的发生、分级及转归。结果 33例晚期肾癌患者口服索拉非尼治疗,中位随访时间56周(12～98周)。其中完全缓解(CR)1例(3.0%)、部分缓解(PR)5例(15.2%)、疾病稳定(SD)21例(63.6%)、疾病进展(PD)6例(18.2%)。评估客观反应率(ORR)为18.2%,疾病控制率(DCR)为81.8%,中位无进展生存(PFS)时间为15.0个月(95%CI 6.5～23.5),中位总生存(OS)时间为24.0个月(95%CI 7.6～40.4)。主要不良反应包括手足皮肤反应、腹泻、高血压、皮疹、脱发和疲乏,除手足皮肤反应外,其他多为1～2级,对症处理大多可以缓解。结论索拉非尼治疗晚期肾癌的近期及远期疗效良好,长期使用不良反应可以耐受,安全性较好。

Long-term clinical observation of 33 patients with advanced renal cell carcinoma treated by sorafenib

Objective To investigate the clinical outcome,adverse events and turnover of sorafenib in advanced renal cell carcinoma patients,and to evaluate the long-term efficacy and safety of sorafenib.Methods Documented the clinical outcome, survival status,adverse events and turnover in 33 advanced renal cell carcinoma patients treated with sorafenib.Results 33 advanced renal cell carcinoma patients received sorafenib treatment.The median time of follow-up was 56 weeks(12～98 weeks).Among the 33 patients,1 patient had complete remission(CR,3.0%),5 patients got partial remission(PR, 15.2%),21 patients had stable disease(SD,63.6%) and 6 patients had progression of disease(PD,18.2%).The objective response rate(ORR) was 18.2%,the disease control rate(DCR) was 81.8%,the median progression-free survival (PFS) was 15.0 months(95%CI 6.5 -23.5) and the median overall survival(OS) was 24.0 months(95%CI 7.6～40.4).The sorafenib-related adverse events mainly included hand-foot skin reaction(HFSR),diarrhea,hypertension,fatigue, rash and alopecia.Most of the adverse events were classified as grade 1 to grade 2,except for HFSR.After proper corresponding management,most of the adverse events alleviated.Conclusion In advanced renal cell carcinoma patients,the long-term efficacy and safety of sorafenib are satisfying.