单中心164例索拉非尼治疗晚期肾癌的临床预后分析  

Clinical prognosis analysis of 164 patients of advanced renal cell carcinoma treated with sorafenib from single center

作　　者：李永强[1] 邓建华[1] 郑克文[1] 李汉忠[1] 

机构地区：[1]中国医学科学院北京协和医院泌尿外科,100730

出　　处：《中华泌尿外科杂志》2015年第11期806-811,共6页Chinese Journal of Urology

摘　　要：目的 探讨索拉非尼治疗晚期肾癌的疗效和不良反应,并对影响患者预后的相关因素进行分析.方法 2007年6月至2014年3月共164例晚期肾癌患者接受索拉非尼治疗.男118例,女46例.年龄22～82岁,中位年龄60岁.122例（74.4％）的美国东部肿瘤协作组活动状态评分≤1分,145例（88.4％）为中、低危（MSKCC评分≤2分）患者.127例（77.4％）接受原发灶肾脏或肾肿瘤切除术.79例（47.9％）治疗前接受过免疫治疗.133例（81.1％）病理类型为透明细胞癌,其中Fuhrman分级Ⅰ级15例,Ⅱ级76例,Ⅲ级27例,Ⅳ级5例,未评价10例;分期TxN0M1 115例,TxN1M012例,T3N1M1 22例,T3b N1M1 15例.转移部位：肺（92/164,56.1％）、淋巴结（34/164,20.7％）和骨（34/164,20.7％）.164例均采用索拉非尼400 mg,2次/d方案治疗,治疗期间24例因不良反应较重,减量至200 mg,2次/d.分析164例的疗效及不良反应.采用Kaplan-Meier法计算无进展生存期（progression-free survival,PFS）和总生存期（overall survival,OS）.采用单因素和多因素Cox比例风险模型评估与PFS和OS相关的影响因素.结果 本组164例中,最常见的不良反应为手足综合征（154/164,93.9％）、腹泻（118/164,71.9％）、乏力（69/164,42.1％）和皮疹（62/164,37.8％）,最常见的3～4级不良反应为手足综合征（13/164,7.9％）和腹泻（8/164,4.9％）.疗效评价：完全缓解2例（1.2％）,部分缓解26例（15.9％）,疾病稳定105例（64.0％）,疾病进展31例（18.9％）,客观反应率为17.1％,疾病控制率为81.1％.中位PFS为11.5个月,中位OS为24.2个月.164例平均随访5.6年,5年生存率为15.9％ （95％ CI 12.9％ ～20.4％）.Cox比例风险模型结果显示影响患者PFS的独立风险因素为MSKCC评分≥3分、美国东部肿瘤协作组活动状态评分≥2分、有淋巴结转移和骨转移;影响患者OS的独立风险因素为MSKCC评分≥3分和淋巴结转移;药物相关性高血压是OS的有利因素.�Objective To evaluate the clinical efficacy and safety of sorafenib therapy and further to analyze the clinical prognostic factors of patients with advanced renal cell carcinoma （RCC）.Methods Data of 164 cases of patients with advanced RCC receiving sorafenib therapy from June 2007 to March 2014 were collected.Patients consisted of 118 males and 46 females, with median age of 60 years （ranged, 22-82）.ECOG score ≤ 1 was in 122 patients,while MSKCC score ≤2 in 145 cases.Nephrectomies were applied to 127 patients.133 of 164 patients were clear cell RCC, in which there were Fuhrman Ⅰ 15,Fuhrman Ⅱ76, Fuhrman Ⅲ27, Fuhrman Ⅳ 5, not evaluated 5.The clinical staging were TxN0M1 115,TxN1M0 12, T3N1M1 22, T3b N1M1 15, respetively.The commom metastatic sites were lung （92/164,56.1%）, lymph node（34/164,20.7%）and bone（34/164,20.7%）.All patients received sorafenib 400 mg bid at beginning.Adjustment of medication was allowed for 24 cases to ameliorate drug-related toxicities.Univariate and multivariate Cox proportional hazards models were used to assess the risk factors of Progression-free survival （PFS） and overall survival （OS）.Results PFS and OS were evaluated by using the Kaplan-Meier method.The most common drug-related toxicities were hand-foot syndrome （HFS） （154/164,93.9%） ,diarrhea （118/164,71.9%） ,fatigue （69/164,42.1%） and rash （62/164,37.8%）.The most common CTCAE grade 3-4 toxicities were HFS （13/164,7.9%） and diarrhea （8/164,4.9%）.RECIST evaluation with 2 cases （1.2%） of complete response,26 cases（15.9%） of partial response, 105 cases （64.0%） of stable disease,and 31 cases （18.9%） of progressive disease.The objective response rate was 17.1% and the disease control rate was 81.1%.The median PFS and OS were 11.5 months and 24.2 months.The 5-year survival rate was 15.9% （95% CI 12.9%-20.4%） ,with a median follow-up of 5.6 years.Multivariate Cox proportional hazards model showed four independent risk factors for PFS：MSKCC score ≥3

关 键 词：酪氨酸激酶抑制剂 索拉非尼 晚期肾癌 疗效 安全性 

分 类 号：R737.11[医药卫生—肿瘤]