Designing clinical trials for kidney cancer based on newly developed prognostic and predictive tools.

Several advances have been made in our understanding of the molecular aberrations in renal cell carcinoma that have led to the identification of novel prognostic and predictive biomarkers. At the same time, several novel agents targeting these molecular aberrations have shown promising efficacy in the therapy of advanced renal cancer. As these agents enter more advanced-stage clinical trials, efforts must be made to integrate exploration of these novel prognostic and predictive markers into clinical trial design. These elements then can be combined with more traditional prognostic features to form more robust prognostic models. Finally, predictive markers and prognostic models should be validated prospectively, either as part of clinical trials designed specifically for that purpose or as part of large phase-3 trials. Once validated, these features can be used to best inform prognosis and guide therapy based on individual patient characteristics.