Department of Urology, Mayo Clinic, Rochester, MN, USA.
Cancer. 2012 Sep 15;118(18):4412-20. doi: 10.1002/cncr.26695. Epub 2012 Jan 3.
The objective of this study was to evaluate the accuracy of the pathologic inclusion criteria from all contemporary adjuvant trials in predicting disease progression (DP) for renal cell carcinoma (RCC).
A retrospective review was conducted on 1363 patients treated surgically for M0 RCC at the Mayo Clinic (Rochester, MN), from 1990 to 2001. Clinicopathologic features were reviewed to determine eligibility for the following trials: ARISER, ASSURE, EVEREST, PROTECT, SORCE, and S-TRAC. DP was defined as local recurrence or distant metastasis after surgery. The ability of each trial's inclusion criteria to accurately predict DP was evaluated by the c (concordance) index.
From the Mayo Clinic cohort, we determined that 41%, 45%, 45%, 33%, 47%, and 23% of the patients would have been eligible for the ARISER, ASSURE, EVEREST, PROTECT, SORCE, and S-TRAC clinical trials, respectively. Overall, 23% of all patients experienced DP (n = 317). Among eligible patients, 53%, 44%, 44%, 57%, 43%, and 59% developed DP during follow-up and 10%, 6%, 6%, 13%, 6%, and 18% went onto DP while not being eligible for the ARISER, ASSURE, EVEREST, PROTECT, SORCE, and S-TRAC trials, respectively. The c index of each trial to accurately predict DP from the pathologic inclusion criteria of ARISER, ASSURE, EVEREST, PROTECT, SORCE, and S-TRAC were 0.751, 0.751, 0.751, 0.742, 0.745, and 0.691, respectively.
Although the pathologic inclusion criteria of contemporary adjuvant trials have notable differences, all 6 adjuvant trials demonstrated high predictive accuracy of DP. Overall, 43% to 59% of patients included for the adjuvant trials would develop DP, whereas 6% to 18% of patients excluded from the trials would develop DP during follow-up.
本研究旨在评估所有当代辅助治疗试验的病理纳入标准预测肾细胞癌（RCC）疾病进展（DP）的准确性。
对 1990 年至 2001 年在梅奥诊所（明尼苏达州罗切斯特）接受手术治疗的 1363 例 M0 RCC 患者进行了回顾性分析。回顾临床病理特征，以确定以下试验的纳入标准：ARISER、ASSURE、EVEREST、PROTECT、SORCE 和 S-TRAC。DP 定义为手术后局部复发或远处转移。通过一致性（c）指数评估每个试验纳入标准准确预测 DP 的能力。
从梅奥诊所队列中，我们确定分别有 41%、45%、45%、33%、47%和 23%的患者将有资格参加 ARISER、ASSURE、EVEREST、PROTECT、SORCE 和 S-TRAC 临床试验。总体而言，23%的患者发生 DP（n=317）。在符合条件的患者中，53%、44%、44%、57%、43%和 59%在随访期间发生 DP，而 10%、6%、6%、13%、6%和 18%分别在不符合 ARISER、ASSURE、EVEREST、PROTECT、SORCE 和 S-TRAC 临床试验纳入标准的情况下发生 DP。从 ARISER、ASSURE、EVEREST、PROTECT、SORCE 和 S-TRAC 的病理纳入标准准确预测 DP 的每个试验的 c 指数分别为 0.751、0.751、0.751、0.742、0.745 和 0.691。
尽管当代辅助治疗试验的病理纳入标准存在显著差异，但所有 6 项辅助治疗试验均显示出 DP 预测的高准确性。总体而言，43%至 59%的纳入辅助试验的患者将发生 DP，而 6%至 18%的未纳入试验的患者在随访期间将发生 DP。
