舒尼替尼治疗晚期肾癌的预后因素分析及国际转移性肾细胞癌数据库联盟预后模型验证

Prognostic factors of survival and verification of the prognostic model of IMDC in patients with metastatic renal cell carcinoma treated with sunitinib

目的探索舒尼替尼治疗转移性肾癌的预后因素,并进一步验证国际转移性肾细胞癌数据库联盟(IMDC)预后模型的准确性。方法回顾性收集服用舒尼替尼的115例晚期肾癌患者的临床资料,通过Kaplan-Meier法绘制生存曲线,并采用Log-rank法进行显著性检验,应用Cox比例风险模型进行单因素和多因素预后分析,采用Harrell一致性指数法对国际转移性肾细胞癌数据库联盟预后模型进行验证。结果中位随访时间14.6(2~54)个月,中位无进展生存时间11.3(9.4~13.2)个月。单因素分析结果显示:美国东部肿瘤协作组体能状态(ECOG)评分、IMDC分层、转移部位个数、骨转移、肝转移、首月相对剂量密度(1M-RDI)<50%、服药后出现≥3级手足综合症(HFS)、中性粒细胞与淋巴细胞比值(NLR)、初诊时有症状为影响肾癌预后的因素。多因素回归分析显示:ECOG评分≥2分、IMDC高分级、转移器官个数≥3个、NLR≥2.7、初诊有症状为影响肾癌预后的独立危险因素。根据IMDC分级,低、中、高危患者中位无进展生存时间分别为14.0、11.3和5.6(P<0.01)。本研究Harrell一致性指数为0.663(95%CI:0.610~0.716),表明该肾癌预后模型有一定的预测功能。结论ECOG评分、IMDC高分级、转移器官个数、NLR、初诊有症状为影响肾癌预后的独立危险因素,IMDC预后模型对转移性肾癌靶向治疗预后有一定的预测功能。

Objective To explore the prognostic factors of metastatic renal cell carcinoma(mRCC)treated with sunitinib,and to verify the accuracy of the International Metastatic Renal-Cell Carcinoma Database Consortium(IMDC)prognostic model.Methods Clinical data of 115 patients with advanced mRCC treated with sunitinib were collected.The survival curve was plotted with Kaplan-Meier method.Significance was tested with Log-rank.Univariate and multivariate analyses were performed with Cox proportional hazards regression model.The predictive ability of the model was verified using Harrell concordance index.Results Median follow-up was 14.6(2-54)months,and median progression-free survival was 11.3(9.4-13.2)months.Univariate analysis showed that ECOG performance status,IMDC stratification,number of metastatic sites,bone metastasis,liver metastasis,relative dose intensity in the first month(1M-RDI)<50%,hand-foot syndrome(HFS)≥3,neutrophil-to-lymphocyte ratio(NLR),and clinical symptoms at initial diagnosis were prognostic factors of mRCC.Multivariate regression analysis showed that ECOG performance status≥2,IMDC high rating,number of metastatic sites≥3,NLR≥2.7,and clinical symptoms at initial diagnosis were independent risk factors for the prognosis of mRCC.According to the IMDC stratification,progression-free survival was 14.0,11.3,and 5.6 months for the low,intermediate,and high-risk groups,respectively(P<0.01).The Harrell concordance index was 0.663(95%CI:0.610-0.716),indicating that this prognosis model had prediction function.Conclusion ECOG performance status,IMDC high rating,number of metastatic sites,NLR,and clinical symptoms at initial diagnosis are independent risk factors for the prognosis of mRCC.The IMDC prognostic model has a certain predictive ability for mRCC.