Eastern Cooperative Oncology Group Statistical Office, Dana-Farber Cancer Institute, Boston, MA 02215, USA.
Clin Cancer Res. 2011 Aug 15;17(16):5443-50. doi: 10.1158/1078-0432.CCR-11-0553. Epub 2011 Aug 9.
To develop a single validated model for survival in metastatic renal cell carcinoma (mRCC) using a comprehensive international database.
A comprehensive database of 3,748 patients including previously reported clinical prognostic factors was established by pooling patient-level data from clinical trials. Following quality control and standardization, descriptive statistics were generated. Univariate analyses were conducted using proportional hazards models. Multivariable analysis using a log-logistic model stratified by center and multivariable fractional polynomials was conducted to identify independent predictors of survival. Missing data were handled using multiple imputation methods. Three risk groups were formed using the 25th and 75th percentiles of the resulting prognostic index. The model was validated using an independent data set of 645 patients treated with tyrosine kinase inhibitor (TKI) therapy.
Median survival in the favorable, intermediate and poor risk groups was 26.9 months, 11.5 months, and 4.2 months, respectively. Factors contributing to the prognostic index included treatment, performance status, number of metastatic sites, time from diagnosis to treatment, and pretreatment hemoglobin, white blood count, lactate dehydrogenase, alkaline phosphatase, and serum calcium. The model showed good concordance when tested among patients treated with TKI therapy (C statistic = 0.741, 95% CI: 0.714-0.768).
Nine clinical factors can be used to model survival in mRCC and form distinct prognostic groups. The model shows utility among patients treated in the TKI era.
利用综合国际数据库,为转移性肾细胞癌(mRCC)患者的生存开发一个单一的经验证的模型。
通过汇集临床试验的患者水平数据,建立了一个包含 3748 名患者的综合数据库,包括以前报告的临床预后因素。经过质量控制和标准化,生成描述性统计数据。使用比例风险模型进行单变量分析。使用中心分层的对数 - 逻辑模型和多变量分数多项式进行多变量分析,以确定生存的独立预测因子。使用多重插补方法处理缺失数据。使用所得预后指数的第 25 和第 75 百分位数形成三个风险组。使用接受酪氨酸激酶抑制剂(TKI)治疗的 645 名患者的独立数据集验证模型。
在有利、中间和差危组中,中位生存时间分别为 26.9 个月、11.5 个月和 4.2 个月。有助于预后指数的因素包括治疗、表现状态、转移部位数量、从诊断到治疗的时间以及治疗前的血红蛋白、白细胞计数、乳酸脱氢酶、碱性磷酸酶和血清钙。该模型在接受 TKI 治疗的患者中进行测试时显示出良好的一致性(C 统计量=0.741,95%CI:0.714-0.768)。
九个临床因素可用于对 mRCC 患者的生存进行建模,并形成不同的预后组。该模型在 TKI 时代接受治疗的患者中具有实用性。