舒尼替尼治疗肾转移癌疗效的影响因素分析

Influencing Factors of Sunitinih in the Treatment of Metastatic Renal Cell Carcinoma

目的探讨舒尼替尼治疗转移性肾细胞癌的个体化用药方案的安全性及有效性。方法选取转移性肾细胞癌的患者54例,均为肾透明细胞癌(36例)和乳头状肾细胞癌(18例)。单因素分析采用Kaplan—Meier法,多因素分析应用COX回归模型,分析舒尼替尼的疗效、不良反应及影响疗效的危险因素。结果治疗过程中,大部分患者的病情得到缓解或稳定,转移瘤的最大径缩小程度为24%~100%,平均为27.45%,疾病客观缓解率、控制率分别为37.04%、74.07%,中位PFS、OS分别为15.0个月、39.0个月。单因素生存分析,肿瘤病理类型及药物治疗方案不是影响舒尼替尼疗效的危险因素;多因素分析显示,肿瘤转移部位是影响转移性肾癌患者治疗效果的唯一预后相关因素。发生不良反应患者53例,占98.15%,发生率较高的是高血压、手足综合征、白细胞减少,标准剂量组和调整剂量组的减停药发生率分别为63.64%(14/22)、34.37%(11/32),差异具有统计学意义(χ2=4.490,P=0.034)。结论舒尼替尼对转移性肾透明细胞癌和乳头状肾细胞癌均有良好疗效,而调整剂量的舒尼替尼个体化治疗能够兼顾总体有效性和用药安全性。

Objective To study the efficacy and safety of the sunitinib in the treatment of metastatic renal cell carcinoma. Methods 54 cases of metastatic renal cell carcinoma were selected,36 cases were clear cell renal cell carcinoma and 18 cases were papillary renal cell carcinoma. Kaplan-Meier method and COX regression model were used to evaluate the efficacy,adverse events and risk factors. Results Majority of cases had remission or stable,the largest metastatic tumor size reduced 24%~ 100%,27. 45% in average. The objective response rate and disease control rate were 37. 04% and 74. 07%,the median PFS and OS were 15 and 39 months. Survival analysis showed that pathological types and therapeutic regimen were not risk factors of efficacy,multi-factor analysis showed that cancer metastatic sites was the only prognostic factors of efficacy. 53 cases had adverse reactions,accounted for 98. 15%,The adverse reactions mainly were leukopenia,hand-foot syndrome,and hypertension. Incidence in reduction of drug in standard dose group and dose adjustment group were 63. 64%( 14 /22) and 34. 37%( 11 /32),there had significant difference( χ2= 4. 490,P = 0. 034). Conclusion Sunitinib for metastatic renal clear cell carcinoma and papillary renal cell carcinoma is effective,and sunitinib in individualized treatment can take into account the effectiveness and safety in the overall.