舒尼替尼治疗转移性肾癌的近期疗效及耐受性  

Clinical efficacy and tolerance of sunitinib in the treatment of advanced renal cell carcinoma

作　　者：施国海[1] 叶定伟[1] 姚旭东[1] 张世林[1] 戴波[1] 张海梁[1] 沈益君[1] 朱耀[1] 朱一平[1] 马春光[1] 肖文军[1] 杨立峰[1] 

机构地区：[1]复旦大学附属肿瘤医院泌尿外科 复旦大学上海医学院肿瘤学系,上海200032

出　　处：《中华泌尿外科杂志》2011年第6期423-426,共4页Chinese Journal of Urology

摘　　要：目的探讨舒尼替尼治疗转移性肾癌两种方案的疗效、不良反应特点及其相应处理方法。方法舒尼替尼治疗晚期转移性肾癌病例45例，男25例，女20例，年龄36～78岁，平均48岁。随机分为2组，第1组：25例，舒尼替尼50mg／d口服，用药4周、间歇2周为1个周期。第2组：20例，舒尼替尼口服，37．5mg／d，连续服刖。观察评估治疗中出现的不良反应及相应的处理方法。结果全组可评估疗效40例，完全缓解1例，部分缓解3例，稳定28例，进展8例（死亡4例）。全组疾病控制率为80％（32／40）。2级以上的不良反应发生率：2组高血压分别有32％（8／25）与10％（2／20），P＝0．02；肝功能损害分别为32％（8／25）与20％（4／20），P＝0．011；手足皮肤反应分别为68％（17／25）与60％（12／20），血液学毒性分别为68％（17／25）与50％（10／20），口腔黏膜、反流性食管炎及胃炎分别为56％（14／25）与50％（10／20），疲劳乏力分别为64％（16／25）与40％（8／20）。不良反庇出现时间不同，但大多在服药3个月内出现。结论舒尼替尼治疗转移性肾癌所产牛的绝大多数常见小良反应发生率与国外报道略有不同，但通过严格随访，积极预防及对症处理，服药后安全性良好。舒尼替尼37．5mg／d，连续服用在肝功能损伤、高血压等方面优于间歇服用的方案。Objective To evaluate the clinical efficacy and side effects of sunitinib in the treat ment of advanced renal cell carcinoma. Methods Forty-five patients with advanced renal cell carcinorna and an average age of 48. 6 yrs were treated with sunitinib. Among the study group, 25 were male and 20 were female. In group one, patients received sunitinib treatment in repeated six week cy cles consisting of four weeks of sunitinib 50 mg daily followed by two weeks off treatment （schedule 4/2）. In group two, a single daily dose of sunitinib 37.5 mg was administrated to 20 patients without off treatment. A CT scan was used to evaluate the treatment efficacy after each cycle and the side effects were recorded accordingly. Results Clinical efficacy could be evaluated in 40 patients. Of these, two achieved complete response, eight achieved partial response, 27 were stable and the remai ning eight experienced disease progression with four patients dying during the study period. The side effects of sunitinib in group one and in group two included hypertension 32%（8/25） and 10% （2/20）, P=0.02; liver function impairment 32% （8/25） and 20%（4/20）, P=0.011; hand-foot skin reaction 68%（17/25） and 60% （12/20）, respectively. The incidence of major side effects of sunitinib were different in Chinese patients than from what had been previously reported in studies conducted in US and Europe. Generally, most of the sunitinib side effects were easy to manage. Conclusions There were differences between the two groups of Chinese patients treated with different sunitinib protocols. The protocol of sunitinib 37.5mg daily without of-treatment was belier than the protocol of sunitinib 50rag daily （schedule 4/2） in regard to liver function impairment and hyperten sion.

关 键 词：肾肿瘤 癌 舒尼替尼 

分 类 号：R737.11[医药卫生—肿瘤]