We developed a drug-disease simulation model to predict antitumor response and overall survival in phase III studies from longitudinal tumor size data in phase II trials. We developed a longitudinal exposure-response tumor-growth inhibition (TGI) model of drug effect (and resistance) using phase II data of capecitabine (n = 34) and historical phase III data of fluorouracil (FU; n = 252) in colorectal cancer (CRC); and we developed a parametric survival model that related change in tumor size and patient characteristics to survival time using historical phase III data (n = 245).
September 1, 2009
Author(s): Laurent Claret, Pascal Girard, Paulo Hoff, Eric Van Cutsem, Klaas Zuideveld, Karin Jorga, Jan Fagerberg, Rene Bruno
Year: September 1, 2009