Timing and Reporting of Secondary Overall Survival End Points for Phase III Trials in Advanced/Metastatic Disease
Cet article passe en revue les essais cliniques de phase III publiés récemment en cancérologie, examine les pratiques pour reporter la survie globale en tant que critère d'évaluation secondaire de traitements ciblant un cancer de stade avancé ou métastatique puis présente des recommandations pour concevoir des essais intégrant la survie globale en tant que critère d'évaluation secondaire
Recent therapeutic advances have led to improved patient survival in many cancer settings. Although prolongation of survival remains the ultimate goal of cancer treatment, the availability of effective salvage therapies could make definitive phase III trials with primary overall survival (OS) end points difficult to complete in a timely manner. Therefore, to accelerate development of new therapies, many phase III trials of new cancer therapies are now designed with intermediate primary end points (eg, progression-free survival in the metastatic setting) with OS designated as a secondary end point. We review recently published phase III trials and assess contemporary practices for designing and reporting OS as a secondary end point. We then provide design and reporting recommendations for trials with OS as a secondary end point to safeguard OS data integrity and optimize access to the OS data for patient, clinician, and public-health stakeholders.
Journal of Clinical Oncology , article en libre accès, 2022