CAJ | 학술논문

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。
목적：탐토서니체니치료전이성신세포암적개체화용약방안적안전성급유효성。방법선취전이성신세포암적환자54례，균위신투명세포암（36례）화유두상신세포암（18례）。단인소분석채용Kaplan—Meier법，다인소분석응용COX회귀모형，분석서니체니적료효、불량반응급영향료효적위험인소。결과치료과정중，대부분환자적병정득도완해혹은정，전이류적최대경축소정도위24％～100％，평균위27．45％，질병객관완해솔、공제솔분별위37．04％、74．07％，중위PFS、OS분별위15．0개월、39．0개월。단인소생존분석，종류병리류형급약물치료방안불시영향서니체니료효적위험인소；다인소분석현시，종류전이부위시영향전이성신암환자치료효과적유일예후상관인소。발생불량반응환자53례，점98．15％，발생솔교고적시고혈압、수족종합정、백세포감소，표준제량조화조정제량조적감정약발생솔분별위63．64％（14／22）、34．37％（11／32），차이구유통계학의의（χ2＝4．490，P＝0．034）。결론서니체니대전이성신투명세포암화유두상신세포암균유량호료효，이조정제량적서니체니개체화치료능구겸고총체유효성화용약안전성。
Objective To study the efficacy and safety of the sunitinib in the treatment of metastatic renal cell carcino-ma.Methods 54 cases of metastatic renal cell carcinoma were selected, 36 cases were clear cell renal cell carcinoma and 18 ca-ses were papillary renal cell carcinoma.Kaplan-Meier method and COX regression model were used to evaluate the efficacy,ad-verse 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 re-nal cell carcinoma is effective,and sunitinib in individualized treatment can take into account the effectiveness and safety in the o-verall.