舒尼替尼一线治疗晚期肾癌的临床疗效初步评价  

Preliminary evaluation of sunitinib as first line therapy in treating patients with metastatic renal cell carcinoma

作　　者：袁建林[1] 王福利[1] 秦卫军[1] 秦军[1] 杨晓剑[1] 田春娟[1] 秦荣良[1] 邵晨[1] 杨力军[1] 刘飞[1] 张更[1] 孟平[1] 张龙龙[1] 郑昱[1] 武国军[1] 

机构地区：[1]第四军医大学附属西京医院泌尿外科,西安710032

出　　处：《中华泌尿外科杂志》2015年第10期742-745,共4页Chinese Journal of Urology

摘　　要：目的：初步探讨舒尼替尼一线治疗晚期肾癌的有效性及安全性。方法2009年1月至2014年6月收治转移性肾癌患者66例，男42例，女24例。年龄26～75岁，中位年龄52岁。AJCC分期T3期35例，T4期31例。所有患者均发生远处器官转移，单一脏器转移52例，多发脏器转移14例。手术切除原发肾脏病灶病理检查确诊61例，穿刺病理检查确诊5例。肾透明细胞癌62例，乳头状肾细胞癌4例。采用口服舒尼替尼标准4／2方案：50mg，1次／d，服药4周停药2周为1个周期，持续至患者疾病进展或出现不可耐受的不良反应；至少2个周期进行1次疗效评价。结果本组66例随访5～66个月，63例可评价疗效。完全缓解2例（3．2％），部分缓解12例（19．0％），疾病稳定45例（71．4％），疾病进展4例（6．3％）。疾病控制率（完全缓解＋部分缓解＋疾病稳定）为93．7％（59／63），客观反应率（完全缓解＋部分缓解）为22．2％（14／63），因疾病进展死亡2例（3．2％）。Ⅰ／Ⅱ级不良反应包括乏力36例（57．1％）、血小板减少36例（57．1％）、手足反应32例（50．8％）、高血压27例（42．9％）、中性粒细胞减少15例（23．8％）、甲状腺功能异常12例（19．0％）、腹泻6例（9．5％）、脱发4例（6．3％）等，经对症处理后均可缓解并继续接受治疗。Ⅲ／Ⅳ级不良反应包括手足皮肤反应4例（6．3％）、高血压2例（3．2％）、中性粒细胞减少5例（7．9％）、血小板减少5例（7．9％），患者停药后进行治疗至不良反应为Ⅱ级以下时恢复用药，改为37．5mg一次顿服连续用药，患者未再出现Ⅲ／Ⅳ级不良反应。结论舒尼替尼治疗晚期肾细胞癌疗效显著，轻度不良反应患者可耐受，严重不良反应需要医疗干预。[Abstact] Objective To investigate the efficacy and safety of sunitinib as first line therapy in treating those patients with metastatic renal cell carcinoma （ mRCC ） .Methods A total of 66 patients , including 42 male and 24 female cases ,with metastatic renal cell carcinoma were enrolled from January 2009 to June 2014.The median age was 52 years （range 26-75 years）.According to American Joint Committee On Cancer （AJCC） staging,there were 35 cases of T3 stage,31 cases of T4 stage.All patients had distant metastasis ,including single organ metastasis in 52 patients and multiple organ metastasis in 14 cases.Sixty-one patients received prior radical nephrectomy ,5 patients received biopsy .Sixty-two patients were diagnosed as renal clear cell carcinoma and 4 patients were diagnosed as renal papillary cell carcinoma .Sunitinib was administered in standard 4/2 regimens.Briefly, patient takes 50 mg once a day orally for 4 weeks.Then the sunitinib will be stopped for 2 weeks.Six weeks was defined as 1 cycle.It should be continued until disease progression or occurrence of intolerable adverse reactions .The efficacy of sunitinib should be evaluated within 2 cycles.Results The duration of following-up ranged from 5 to 66 months.The efficacy could be evaluated in 63 patients.Two patients （ 3.2%） achieved complete remission .Twelve patients （ 19.0%） achieved partial remission.Forty-five patients （71.4%） demonstrated stable disease and 4 patients （6.3%） 〈br〉 developed progressive disease .The disease control rate was 93.7%（59/63） and the objective response rate was 22.2%（14/63）.2 （3.2%） patients died due to the progression of disease .The most commonⅠ-Ⅱadverse events included fatigue in 36 cases （ 57.1%） , thrombocytopenia in 36 cases （ 57.1%） , hand-foot syndrome in 32 cases （50.8%）,hypertension in 27 cases （42.9%）,neutropenia in 15 cases （23.8%）, hypothyroidism in 12 cases （19.0%）, diarrhea in 6 cases （9.5%） and alopecia in 4 cases （6.3%）.Ⅲ-

关 键 词：癌 肾细胞 舒尼替尼 肿瘤转移 

分 类 号：R737.11[医药卫生—肿瘤]