摘要
目的探讨索拉非尼治疗晚期肾癌的不良反应及其与疗效的相关性。方法晚期肾癌患者51例，有可测病灶，其中T1Nx，0.1M1 26例、T2Nx,0M1 12例、T3NxM1 8例、T4NxM1 5例，46例T1～T3患者原发灶已手术切除，5例T4NxM1患者原发灶未切除。51例患者均采用索拉非尼治疗，400mg每日2次口服，不间断治疗。每2个月复查CT评效，根据疗效及不良反应调整索拉非尼用量。2例患者由于不良反应减量为200mg每日2次，16例患者病情进展后予以增量治疗，其中12例患者增至600mg每日2次，4例增至800mg每日2次。详细记录患者治疗期间不良反应，并按照美国国立癌症研究所通用毒性标准3．0版进行分级，实体瘤评价标准进行疗效评价，观察客观反应率及无疾病进展生存期（PFS）。应用统计学软件分析不良反应的发生率及其与疗效的相关性。结果51例患者发生手足皮肤反应35例（68．6％），腹泻20例（39．2％），皮疹13例（25．5％），黏膜炎12例（23．5％），高血压9例（17．6％），骨髓抑制7例（13．7％）；发生3～4级不良反应患者的有效率33．3％（12／36），无3～4级不良反应患者12．0％（3／25）。患者手足皮肤反应发生率高于其他不良反应（P〈0．01），黏膜炎及皮疹发生与疗效具有相关性（P值分别为0．048及0．045），3～4级不良反应的发生与疗效具有相关性（P=0．008）。中位PFS为15．0个月（95％CI5．64～24．37个月），PFS与不良反应无相关性。结论晚期肾癌患者接受索拉非尼治疗后出现相关不良反应可作为疗效的预测因素。
Objective To identify the relationship between sorafenib＇s efficacy and its side effects in treatment of advanced renal cell carcinoma patients. Methods Fifty-one patients having measurable diseases were diagnosed with advanced renal cell carcinoma. Of whom, 26 patients were in stage T1Nx.0,1M1, 12 patients in stage T2Nx,0M1, 8 patients in stage T3NxM1, 5 patients in stage T4NxM1. These 46 patients of T1-T3 had their primary diseases removed, but the 5 T4 patients didn ＇t have their primary diseases removed. These 51 patients received oral sorafenib 400 mg Bid continually and they had CT scan every two months to evaluate the progression. The dosage of sorafenib was modified according to efficacy and toxicity. Two patients changed the dosage to 200 mg Bid due to se vere side effects. Sixteen patients increased the dosage to 600 mg Bid or 800 mg Bid. The response of Sorafenib and toxicities as well as their severity were recorded. The toxicity severity was graded according to National Cancer Institute Common Toxicity Criteria version 3.0. The efficacy was determined by RECIST criteria. The efficacy and progression free survival （PFS） were recorded. The statistics analysis was conducted between sorafenib＇s side effects and efficacy as well as their severity by multi-factor Logistic regression. Results The rates of adverse events in the patients receiving oral sorafenib were hand-foot skin reaction 68.6% （35/51）, diarrhea 39.2% （20/51）, rash 25.5% （13/ 51）, mucositis 23.5%（12/51）, hypertension 17.6% （9/51）, and myelosuppression 13.7% （7/51）. The response rate in the patients who had toxicity of grade 3-4 was 33.3%（12/36）, and that in the patients who had slight toxicity was 12.0% （3/25）. The rate of hand-foot skin reaction was higher than that of diarrhea, rash, mucositis, hypertension and bone marrow suppression （P〈0.01）. Sorafenib＇s efficacy was correlated to rash and mucositis （19= 0. 048, 0. 045 respectively）. More grade 3- 4 side effects occurred in the patie
出处
《中华泌尿外科杂志》
CAS
CSCD
北大核心
2009年第1期28-31,共4页
Chinese Journal of Urology
关键词
癌
肾细胞
疗效
不良反应
索拉非尼
Carcinoma,renal cell
Efficacy
Side effects
Sorafenib
