舒尼替尼与索拉非尼一线治疗晚期肾细胞癌的对比研究

目的 评价分子靶向药物舒尼替尼与索拉非尼一线治疗晚期肾细胞癌的疗效与安全性.方法 42例晚期肾细胞癌患者根据治疗方法分为舒尼替尼组20例(50 mg,1次/d,口服4周,停药2周,6周为1周期)和索拉非尼组22例(400 mg,2次/d,口服,直至疾病进展,6周为1周期).每2周期评价疗效.结果 42例患者均可评价疗效,舒尼替尼组、索拉非尼组疾病缓解率(RR)分别为30.0％(6/20)、22.7％ (5/22),疾病控制率(DCR)分别为90.0％ (18/20)、77.3％ (17/22),中位无进展生存期(PFS)分别为10.8、6.2个月,中位总生存时间(0S)分别为25.6、18.6个月.两组比较,近期疗效RR(x2=0.287,P=0.592)和DCR(x2=1.222,P=0.269)差异无统计学意义;远期疗效PFS(x2=6.041,P=0.014)及OS(x2=11.245,P=0.001)差异有统计学意义.舒尼替尼组常见的不良反应为腹泻、乏力、口腔黏膜炎、恶心、呕吐等,多见Ⅰ～Ⅱ度,可耐受.索拉非尼组手足综合征发生率(59.1％)明显高于舒尼替尼组(25.0％),差异有统计学意义(x2=4.972,P=0.026).结论 舒尼替尼治疗晚期肾细胞癌疗效较好,不良反应小于索拉非尼,值得临床进一步推广应用.

Study on the difference of sunitinib and sorafenib as first-line treatment in advanced renal carcinoma

Objective To evaluate the efficacy and safety of sunitinib versus sorafenib in the first-line treatment of advanced renal cell carcinoma.Methods Forty-two patients with advanced renal cell carcinoma were divided into two groups according to the therapeutic method.Twenty patients were treated with sunitinib (50 mg, oral administration, once a day, for 4 weeks, drug withdrawal of 2 weeks, 6 weeks was a cycle) and 22 patients were treated with sorafenib (400 mg, oral administration, twice a day, until the disease progression, 6 weeks was a cycle).The efficacy and toxicity were evaluated every 2-cycle treatment.Results All 42 patients could be evaluated.The disease remission rate (RR), disease control rate (DCR) of sunitinib group and sorafenib group were 30.0％ (6/20), 22.7％ (5/22), 90.0％ (18/20), 77.3％ (17/22) respectively,the median progression free survival (PFS) were 10.8, 6.2 months, the median overall survival (OS) were 25.6, 18.6 months respectively.There were no statistical differences in the RR (x2 =0.287, P =0.592) and DCR (x2 =1.222, P =0.269) between the two groups.There were statistical difference in the PFS (x2 =6.041, P =0.014) and OS (x2 =11.245, P =0.001) between the two groups.The most common toxicities of the sunitinib group were diarrhea, fatigue, oral mucositis, nausea, vomiting, all these toxicities were mainly Ⅰ-Ⅱ degree, and could be well tolerated.The hand-foot syndrome rate of the sorafenib group obviously exceeded the sunitinib group (59.1％ vs.25.0％ , x2 =4.972, P =0.026).Conclusion Sunitinib has good efficacy in the first-line treatment of advanced renal cell carcinoma with less toxicity than sorafenib, so it is worthy of popularization.