舒尼替尼治疗肾透明细胞癌的临床研究  

The study of sunitinib in the treatment of renal clear cell carcinoma

作　　者：冼志勇[1] 陈庆科[1] 刘久敏[1] 冯自卫[1] 罗耀雄[1] 毕学成[1] 叶楚津[1] 陈汉忠[1] 郑祥光[1] 

机构地区：[1]广东省人民医院泌尿外科,广州510080

出　　处：《中华泌尿外科杂志》2012年第4期308-311,共4页Chinese Journal of Urology

摘　　要：目的探讨舒尼替尼治疗肾透明细胞癌的疗效和安全性。方法我院2008年4月至2009年10月采用舒尼替尼治疗的肾透明细胞癌患者15例，男11例，女4例。年龄26～74岁，平均55岁。T3～T4期13例，其中8例曾行肾癌根治术，5例行肾活检术，病理诊断均为肾透明细胞癌。另2例为孤立肾肾癌T1期合并肾功能不全，活检病理诊断为肾透明细胞癌。1例既往有高血压病史，单药控制血压〈140／90mmHg（1mmHg=0．133kPa）。肿瘤最大径（9．5±3．3）cm，可评估转移灶包括腹膜后淋巴结（6例）、纵隔淋巴结（3例）、脑（2例）、肺（6例）、骨（2例）及肝脏（2例）。采用舒尼替尼50mg，每天1次，用药4周、停药2周的方案。每个治疗周期开始前采用RECIST疗效评价标准对本组患者进行临床评估。观察并记录肿瘤变化情况、不良反应以及生存期等数据。结果本组用药时间1．5～15．0个月（中位时间6．0个月），最短为1个周期，最长10个周期。其中部分缓解7例，疾病稳定7例，疾病进展1例。治疗的客观反应率为46．7％（7／15），疾病控制率为93．3％（14／15）。6个月无进展生存率为93．3％（14／15），中位无进展生存时间12个月，治疗后肾肿瘤最大径（8．7±4．0）cm。1例既往有高血压病史者，第二周期血压〉160／105mmHg，降压药加量并调整为两联后血压控制良好；1例治疗前无高血压病史者，第三周期出现血压〉150／100mmHg，使用降压药后血压控制良好。此2例治疗后肿瘤最大径分别从4．2om和3．2cm减小至2．0cm和1．3cm。本组1／2级不良反应：皮肤发黄及黄色汗液12例（80％），乏力12例（80％），甲状腺功能低下4例（26．7％），胆红素升高和三酰甘油升高各有7例（46．7％）；3／4级不良反应4例，其中因突发血小板减少，出现消化道出血1例；严重乏力、恶心、呕吐合并严重手足皮肤Objective static renal clear cell carcinoma To summarize the safety and efficacy of Sunitinib in the treatment of metaMethods Fifteen patients with clear cell metastatic RCC were treated with Sunitinib, with 11 males and 4 females, aged from 26 to 74 years with median age of 55 years. Thirteen cases of 15 were T3 to T4 stage, and 8 cases underwent radical nephrectomy, while 5 other cases underwent renal biopsy with the pathological diagnosis of renal cancer. The other two cases （one man and one woman） with the solitary kidney renal cell carcinoma （ stage T1a ） and renal insufficiency, were diagnosed as metastatic renal cell carcinoma by biopsy. Sunitinib monotherapy was administered by the regimen of 6 weeks per cy cle with daily oral Sunitinib 4 weeks, followed by 2 weeks off （ from 1 - 10 cycles）. Response was evaluated by RECIST. Renal tumor was 9.52 ±3.3 cm in diameter at baseline, and the assessment of metastases included retroperitoneal lymph nodes （6 cases） , mediastinal lymph nodes （3 cases） , brain （2 cases） , lung （6 cases） , bone （2 cases） and liver （2 cases）. Karnofsky score, tumor changes, adverse events and the survival of each patient was assessed and recorded. Results The follow-up duration was from 1.5 - 15 months, with median follow-up of 6 months, and tumor response was evaluated by RECIST. Seven of 15 patients （46.7%） treated with Sunitinib achieved partial responses （PR）, 7 patients （46.7%） demonstrated stable disease （SD） , and patient （6.7%） developed progressive disease （PD） during the follow-up. Objective Response Rate （ORR） was 46.7% , PR ＋ SD was 93.3% , 6 months PFS was 93.3% , and median PFS was 12 months, respectively. Renal tumor was 8.7 ± 4.0 cm in diameter after therapy. Two PR patients with the obvious effectiveness had experienced progressed hypertension, and one cases with hypertension that could be controlled below 140/90 mm Hg （ 1 mm Hg = 0. 133 kPa） by a single drug before treatment, showed increased bl

关 键 词：癌 肾细胞 舒尼替尼 高血压 

分 类 号：R737.11[医药卫生—肿瘤]