舒尼替尼治疗转移性肾脏透明细胞癌的临床研究

目的 评价舒尼替尼治疗转移性肾脏透明细胞癌的疗效和安全性.方法 2008年6月至2009年6月共有23例转移性肾透明细胞癌患者接受舒尼替尼治疗,男性16例,女性7例,中位年龄52岁.其中一线治疗20例,索拉非尼治疗进展后二线治疗3例.患者病理检查均为肾脏透明细胞癌.治疗方案:舒尼替尼50 mg,每天1次,4/2方案,治疗4周停2周为1周期.直至疾病进展或者出现不可耐受的不良反应.结果 中位随访时间7.5个月(5个周期).根据RECIST标准进行疗效评价显示部分缓解(PR)4例(17.4%);疾病稳定(SD)18例(78.3%),疾病进展(PD)1例(4.3%).17例患者治疗超过6个月(4个周期),6个月的生存率为100%,6个月的无进展生存率为88.2%(15/17).不良反应多为Ⅰ～Ⅱ级,Ⅲ级不良反应为手足反应3例(13.0%)、血小板降低2例(8.7%)、腹泻1例(4.3%)和乏力1例(4.3%),Ⅳ级不良反应1例(4.3%).通过对症支持和减量治疗,不良反应大多可以控制并耐受.结论 舒尼替尼一线及二线治疗晚期转移性肾脏透明细胞癌可取得较高的客观控制率,不良反应可控制,严重不良反应少见.

Clinical study of Sunitinib in the treatment of metastatic renal clear cell carcinoma: a single center 23 cases experience

Objective To evaluate the efficacy and safety of Sunitinib in the treatment of metastatic renal clear cell carcinoma in our institution. Methods A total of 23 patients with metastatic clear cell RCC were enrolled from June 2008 to June 2009, male 16, female 7, median age 52 years. Twenty cases were treated by using Sunitinib as first-line therapy and 3 cases as second-line therapy. All pathological diagnosis was clear cell carcinoma. Sunitinib monotherapy was administered in repeated 6-week cycles of daily oral for 4 weeks, followed by 2 weeks off, until disease progression or intolerable toxicities occurred. Overall response rate and safety were evaluated. Results The median follow-up were 7.5 months (5 cycles ). Four of 23 patients( 17.4% ) were treated with Sunitinib achieved partial responses(PR); 18 patients (78. 3% )demonstrated stable disease(SD); 1 patient (4. 3% )developed progressive disease(PD) during the study.Seventeen patients received treatment over 6 months (5 cycles ). The 6 months' overall survival rate was 100%, 6 months' progression-free survival rate was 88.2%. The most commonly reported grade 3 adverse events included hand-foot syndrome ( 13.0% ), thrombocytopenia ( 8.7% ), diarrhea (4. 3% ) and fatigue (4. 3% ). Most grade 3 adverse events were ameliorated by dose-adjustment or treatment interruption.Conclusion The results of this study demonstrate the efficacy and manageable adverse-event profile of Sunitinib as a single therapy in first-line or second-line therapy for patients with metastatic clear cell RCC.