Eva Blondeaux, Wanling Xie, Luca Carmisciano, Silvia Mura, Valeria Sanna, Michelino De Laurentiis, Roberta Caputo, Anna Turletti, Antonio Durando, Sabino De Placido, Carmine De Angelis, Giancarlo Bisagni, Elisa Gasparini, Anita Rimanti, Fabio Puglisi, Mauro Mansutti, Elisabetta Landucci, Alessandra Fabi, Luca Arecco, Marta Perachino, Marco Bruzzone, Luca Boni, Matteo Lambertini, Lucia Del Mastro, Meredith M Regan
BACKGROUND: Intermediate clinical endpoints (ICEs) are frequently used as primary endpoint in randomised trials (RCTs). We aim to assess whether changes in different ICEs can be used to predict changes in overall survival (OS) in adjuvant breast cancer trials. METHODS: Individual patient level data from adjuvant phase III RCTs conducted by the Gruppo Italiano Mammella (GIM) and Mammella Intergruppo (MIG) study groups were used. ICEs were computed according to STEEP criteria...
April 2024: EClinicalMedicine