索拉非尼治疗老年晚期肾癌疗效及不良反应观察

目的评价索拉非尼治疗老年晚期肾癌患者的长期疗效及安全性。方法回顾性分析应用索拉非尼治疗的老年晚期肾癌患者26例,观察肿瘤控制情况、长期存活情况、不良反应发生情况及其与疗效的关系。结果 26例患者中,获部分缓解4例（15.38%）,疾病稳定18例（69.23%）,疾病进展4例（15.38%）,无完全缓解患者,客观反应率15.38%,疾病控制率84.61%。中位随访23个月,中位总生存时间为17个月（95%置信区间：14.29~19.71个月）。索拉非尼相关的不良反应主要为手足综合征（13例,50%）、高血压（12例,46.15%）、腹泻（11例,42.31%）、疲乏（15例,57.69%）。不良反应多较轻微,老年患者耐受良好,3度不良反应仅3例,不良反应经对症治疗、药物减量、必要时停药均能缓解。主要不良反应对疗效预测无统计学意义（P〉0.05）。结论老年人应用索拉非尼治疗晚期肾癌近期及远期疗效良好,不良反应可以耐受,安全性良好。

Clinical observation on efficacy and safety of sorafenib therapy in elderly patients with advanced renal cell carcinoma

Objective To evaluate the long-term clinical efficacy and safety of sorafenib in elderly patients with advanced renal cell carcinoma. Methods The clinical datum of 26 elderly advanced renal cell carcinoma patients treated with sorafenib were reviewed retrospectively. The clinical outcome, survival status, adverse events and its relation with clinical outcome were investigated. Results Among the 26 patients, 4 patients got partial remission （PR 15.38%）, 18 patients had stable disease （SD 69.23%）, and 4 patients had progression of disease （PD 15.38%）. There was no complete remission （CR）. The objective response rate （ORR） was 15.38%, and the disease control rate （DCR） was 81.61%. The median time of follow-up was 23 months, and the median overall survival（OS） was 17 months（95% CI： 14.29-19.71）. The sorafenib-related adverse events mainly included hand-foot syndrome （13 patients, 50%）, high blood pressure（12 patients, 46.15%）, diarrhea （11 patients, 42.31%） and fatigue（15 patients, 57.69%）. Most patients had good tolerance to adverse events. Only 3 patients had III grade reaction. The adverse events could be relieved with symptomatic treatment, drug decrement or necessary treatment interruption. Univariate analysis revealed that main sorafenib-induced adverse events were not significant predictors for the response to sorafenib. Conclusion In elderly patients with advanced renal cell carcinoma, the long-term efficacy and safety of sorafenib were satisfying. The adverse events were tolerable.