舒尼替尼治疗晚期肾癌的临床观察

Clinical observation of Sunitinib treatment for patients with advanced renal cell carcinoma

目的观察舒尼替尼治疗晚期肾癌的疗效和安全性。方法2009年9月至2011年12月本院收治晚期肾癌患者16例，男10例，女6例。中位年龄57（38～74）岁。其中14例行原发肿瘤切除术，2例行肿瘤活检术。病理类型为透明细胞癌15例，乳头状细胞癌1例。口服方案：13例给予舒尼替尼50mg／d，连续给药4周，停药2周，6周为一个用药周期，3例给予37．5mg／d；有效或者病情稳定者继续口服舒尼替尼治疗。治疗时间6—27个月。结果16例可评价疗效患者中病情完全缓解（CR）1例（6．3％），病情部分缓解（PR）4例（25．0％），病情稳定（sD）9例（56．2％），疾病进展（PD）2例（12．5％），客观缓解率（ORR）31．3％，疾病控制率87．5％，中位无进展生存期（PFS）及总生存期（OS）因随访时间短无法评估。主要不良反应包括：手足皮肤反应3例（18．8％）、头发颜色改变5例（31．3％）、口腔溃疡6例（37．5％）、脱发2例（12．5％）、腹泻3例（18．8％）、造血系统副反应9例（56．3％）。结论舒尼替尼一线治疗晚期肾癌疗效好，不良反应多为轻中度，患者多可耐受，造血系统副反应应重视，长期疗效及安全性需进一步随访。

Objectives To observe the curative effect and safety of sunitiuib in the treatment of advanced renal cell carcinoma. Methods Sixteen patients with advanced renal cell carcinoma were enrolled from September 2009 to December 2011,10 male and 6 female patients, median age was 57years（ range from 38 to 74 years）. Fourteen patients had prior nephrectomy,and two patients were treated with cytokines previously. 15 cases of clear - cell RCC, 5 cases of papillary RCC. Thirteen patients were given sunitinib at a dosage of either 50mg daily（4weeks on/ 2weeks off）, three patients were given 37.5mg daily continuously. The treatment lasted from 6 to 27 months. Results Clinical efficacy could be evaluated in 16 patients. Of these, 1 achieved complete response （6.3%） ,4 achieved partial response（ 25.0% ）, 9 were stable （ 56.2% ） and 2 experienced disease progression （ 12.5% ）, the ORR was 31.3 % with the disease control rate of 87.5 %, However, the median PFS and OS were not yet available due to the short term follow up. During the treatment, the most common adverse events experienced by patients were hand - foot syndrome 3/16 （ 18.8% ） , changes in hair color 5/16 （ 31.3% ） , mucositis 6/16 （ 37.5% ） , alopecie 2/16 （ 12.5% ） ,diarrhea3/16（ 18.8% ） and adverse reaction of Hematnpnietic System 9/16 （56.3%）. Conclusions Sunitinib has a prominent effect in advanced renal cell carcinoma in a Chinese population with mostIy mild to moderate adverse reactions. More attention should be paid to adverse reaction of Hematopoietic System.