Assessment of the pathologic inclusion criteria from contemporary adjuvant clinical trials for predicting disease progression after nephrectomy for renal cell carcinoma.

Background: 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).

Methods: 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.

Results: 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.

Conclusions: 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.