Clinical Utility of Metrics Based on Tumor Measurements in Phase II Trials to Predict Overall Survival Outcomes in Phase III Trials by Using Resampling Methods.

摘要: Purpose Phase II clinical trials inform go/no-go decisions for proceeding to phase III trials, and appropriate end points in are critical facilitating this decision. solid tumor have traditionally used such as response defined by Response Evaluation Criteria Solid Tumors (RECIST). We previously reported that absolute relative changes measurements demonstrated potential, but not convincing, improvement over RECIST predict overall survival (OS). evaluated the metrics using additional measures of utility data from trials. Methods Resampling methods were assess outcomes simulated In all, 2,000 four actual (two positive OS two negative OS). Cox models three landmarked at 12 weeks adjusted baseline burden fit each tri...