A new approach to integrate toxicity grade and repeated treatment cycles in the analysis and reporting of phase I dose-finding trials
Doussau, A × Thiébaut, R Geoerger, B Schöffski, Patrick Floquet, A Le Deley, M C Mathoulin-Pélissier, S Rizzo, E Fumoleau, P Le Tourneau, C Paoletti, X #
Kluwer Academic Publishers
Annals of Oncology vol:26 issue:2 pages:422-8
Safety assessment beyond the dose-limiting toxicity evaluation period provides relevant information to define the recommended phase II dose (RP2D) of a new treatment. We retrospectively analyzed three phase I trials to illustrate two indicators: per-cycle probability of graded toxicity and cumulative probability of severe toxicity over the treatment period.