国际转移性肾细胞癌数据库联盟预后模型的外部验证及与其他模型的比较：一项基于人群的研究。
External validation and comparison with other models of the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model: a population-based study.
机构信息
Tom Baker Cancer Center, University of Calgary, Calgary, AB, T2N 4N2, Canada.
出版信息
Lancet Oncol. 2013 Feb;14(2):141-8. doi: 10.1016/S1470-2045(12)70559-4. Epub 2013 Jan 9.
BACKGROUND
The International Metastatic Renal-Cell Carcinoma Database Consortium model offers prognostic information for patients with metastatic renal-cell carcinoma. We tested the accuracy of the model in an external population and compared it with other prognostic models.
METHODS
We included patients with metastatic renal-cell carcinoma who were treated with first-line VEGF-targeted treatment at 13 international cancer centres and who were registered in the Consortium's database but had not contributed to the initial development of the Consortium Database model. The primary endpoint was overall survival. We compared the Database Consortium model with the Cleveland Clinic Foundation (CCF) model, the International Kidney Cancer Working Group (IKCWG) model, the French model, and the Memorial Sloan-Kettering Cancer Center (MSKCC) model by concordance indices and other measures of model fit.
FINDINGS
Overall, 1028 patients were included in this study, of whom 849 had complete data to assess the Database Consortium model. Median overall survival was 18·8 months (95% 17·6-21·4). The predefined Database Consortium risk factors (anaemia, thrombocytosis, neutrophilia, hypercalcaemia, Karnofsky performance status <80%, and <1 year from diagnosis to treatment) were independent predictors of poor overall survival in the external validation set (hazard ratios ranged between 1·27 and 2·08, concordance index 0·71, 95% CI 0·68-0·73). When patients were segregated into three risk categories, median overall survival was 43·2 months (95% CI 31·4-50·1) in the favourable risk group (no risk factors; 157 patients), 22·5 months (18·7-25·1) in the intermediate risk group (one to two risk factors; 440 patients), and 7·8 months (6·5-9·7) in the poor risk group (three or more risk factors; 252 patients; p<0·0001; concordance index 0·664, 95% CI 0·639-0·689). 672 patients had complete data to test all five models. The concordance index of the CCF model was 0·662 (95% CI 0·636-0·687), of the French model 0·640 (0·614-0·665), of the IKCWG model 0·668 (0·645-0·692), and of the MSKCC model 0·657 (0·632-0·682). The reported versus predicted number of deaths at 2 years was most similar in the Database Consortium model compared with the other models.
INTERPRETATION
The Database Consortium model is now externally validated and can be applied to stratify patients by risk in clinical trials and to counsel patients about prognosis.
FUNDING
None.
背景
国际转移性肾细胞癌数据库联盟模型为转移性肾细胞癌患者提供预后信息。我们在一个外部人群中测试了该模型的准确性，并将其与其他预后模型进行了比较。
方法
我们纳入了在 13 家国际癌症中心接受一线 VEGF 靶向治疗且在数据库中登记但未参与数据库联盟模型最初开发的转移性肾细胞癌患者。主要终点是总生存期。我们通过一致性指数和其他模型拟合指标比较了数据库联盟模型与克利夫兰诊所基金会（CCF）模型、国际肾脏癌工作组（IKCWG）模型、法国模型和纪念斯隆-凯特琳癌症中心（MSKCC）模型。
结果
共有 1028 例患者纳入本研究，其中 849 例患者有完整的数据来评估数据库联盟模型。中位总生存期为 18.8 个月（95%CI 17.6-21.4）。预先设定的数据库联盟风险因素（贫血、血小板增多、嗜中性粒细胞增多、高钙血症、卡氏功能状态<80%和诊断至治疗<1 年）是外部验证集中总生存不良的独立预测因素（风险比范围为 1.27 至 2.08，一致性指数 0.71，95%CI 0.68-0.73）。当将患者分为三个风险类别时，在低危组（无风险因素；157 例）中位总生存期为 43.2 个月（95%CI 31.4-50.1），中危组（1-2 个风险因素；440 例）为 22.5 个月（18.7-25.1），高危组（3 个或更多风险因素；252 例）为 7.8 个月（6.5-9.7）（p<0.0001；一致性指数 0.664，95%CI 0.639-0.689）。672 例患者有完整的数据来测试所有五个模型。CCF 模型的一致性指数为 0.662（95%CI 0.636-0.687），法国模型为 0.640（0.614-0.665），IKCWG 模型为 0.668（0.645-0.692），MSKCC 模型为 0.657（0.632-0.682）。与其他模型相比，数据库联盟模型的 2 年报告死亡人数与预测死亡人数最为相似。
结论
数据库联盟模型现已在外部得到验证，可用于在临床试验中按风险分层患者，并为患者提供预后咨询。
资助
无。
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