摘要
目的：评价索拉非尼治疗进展性肾癌的疗效,分析患者长期存活的因素。方法：选择晚期转移性肾癌患者19例,年龄39~73岁,中位年龄51岁。组织学分型以透明细胞癌或透明细胞癌为主16例（84.2%）,嫌色细胞癌1例,乳头状细胞癌2例。采用索拉非尼400mg,每天2次口服,直至肿瘤再次进展或出现不可耐受的不良反应时止。结果：治疗后的生存时间已超过5年者19例,可评价疗效,占同期患者的28.4%（19/67）。平均随访时间5.8年,按RECIST标准评价疗效：部分缓解（PR）8例,其中肺部病灶6例,肾脏病灶1例;完全缓解（CR）1例,为肺部病灶;疾病稳定（SD）7例,疾病进展（PD）3例;总缓解率为13.4%（9/67）,疾病控制率为23.8%（16/67）。发生频率较高的不良反应分别为手足皮肤反应16例（16/19,84.2%）,脱发15例（78.9%）,血压升高14例（73.7%）,疲乏14例（73.7%）,食欲下降13例（68.4%）,牙龈肿痛11例（57.8%）,腹泻10例（52.6%）,皮疹9例（47.4%）,口腔黏膜炎9例（47.4%）,贫血5例（26.3%）。转氨酶升高4例（21.1%）。索拉非尼完全失效后,采用舒尼替尼治疗1例,PD;采用依维莫司治疗1例,SD。中位无进展时间为31.4个月。结论：索拉非尼治疗转移性肾癌患者耐受性良好,疗效显著,不良反应多为轻中度,长期生存的患者相关预后因素仍需进一步观察。
Objective.. To explore long-term efficacy and safety data for these therapies of sorafenib for Chinese patients with metastatic renal cell carcinoma （RCC）. Method：Long-term survival data were collected retrospective- ly from 19 patients with metastatic RCC who received sorafenib, including 12 males and 7 females. The median age was 51 （range, 39-73） years old. All patients received a pathologic diagnosis of RCC, which consisted of 16 cases of clear cell carcinoma, 1 of chromophobe cell carcinoma and 2 of papillary cell carcinoma. These cases were treated with sorafenib oral therapy （800 mg/d） continuously until disease progression or unacceptable toxicities oc- curred. Overall response rate （ORR） and safety were evaluated. Result.. The five-year survival rate was 28.4%, with a median follow-up of 5.8 years. Eight cases were found partial remission （PR）, and one case was found complete remission （CR）. Moreover, seven cases had stable disease （SD）, and three cases had progressive disease （PD）. ORR was 13.4% （9/67）, and disease control rate （DCR） was 23.8% （16/67）. Frequent all-grade adverse events were hand-foot syndrome 16 cases （84.2 %）, alopecia 15 cases （78.9 %）, hypertension 14 cases （73.7 %）, loss of appetite 13 cases （68.4%）, swollen gums 11 cases （57.8~/00）, diarrhea 10 cases （52.6%）, fatigue 14 cases （73.7%）, rash 9 cases （47.4%）, oral mucositis 9 cases （47.4%）, and anemia 5 cases （26.3%）. Four out of 19 patients had abnormally elevated ALT/AST （21. 1%）. Sequential treatments after failure of sorafenib were sunitinib for one case （PD） and everolimus for one case （SD）. The median progression-free survival was 31.4 months. Conclusion ：Sorafenib improves response rate with manageable toxicity and provides an estimated five-year survival rate of 28.4% for RCC. Exploratory analyses showed numerically higher objective response rate and lon- ger overall survival （OS） and progression free survival （PFS） in p
出处
《临床泌尿外科杂志》
2015年第7期607-609,共3页
Journal of Clinical Urology
基金
国家自然科学基金项目(编号30772165)
关键词
肾细胞癌
索拉非尼
长期生存
临床试验
renal cell carcinoma
sorafenib
long-term survival
clinical trial
