Phase I Trial Improvement: A Question of Patient Selection, Trial Design, or Both?
Cette étude évalue la performance d'un nomogramme, développé à partir des données de 127 essais incluant au total 3 104 patients atteints d'une tumeur solide, pour prédire le risque de toxicité sévère associée à un cycle de traitement médicamenteux dans le cadre d'essais cliniques de phase I
The over all intent of a cancer phase I trial design is to evaluate the safety of a new drug (or drug combination), determine an optimal dose or dose range, and identify adverse effects. These trials are typically small and enroll patients with advanced cancer for which no standard treatment exists, usually because approved treatments have failed to prevent disease progression. Phase I trial design is an active research area with the goal sof(1)determiningam ore precise estimate of the optimal drug dose or dose range, and (2) providing safe treatment of patients at doses close to the therapeutic dose. The latter is meant to minimize the number of patients treated at subtherapeutic dose levels. A less researched area is that of patient selection for phase I trials...
Journal of Clinical Oncology , éditorial en libre accès, 2014