Prognostic implications of risk definitions from the monarchE and NATALEE trials

Journal of the National Cancer Institute Pub Date : 2025-02-03 DOI:10.1093/jnci/djaf031

Luca Arecco, Eva Blondeaux, Marco Bruzzone, Grazia Arpino, Carmine De Angelis, Michelino De Laurentiis, Roberta Caputo, Alessandra Fabi, Valeria Sanna, Stefania Gori, Fabio Puglisi, Luca Boni, Simone Nardin, Irene Giannubilo, Marta Perachino, Roberto Borea, Elisa Agostinetto, Evandro de Azambuja, Matteo Lambertini, Lucia Del Mastro

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Abstract

Background The monarchE and NATALEE trials employed different high-risk inclusion criteria. Main objective is to assess prognostic differences based on their inclusion criteria. Methods Patients with hormone receptor-positive/HER2-negative early breast cancer enrolled in the phase III MIG1, GIM2, and GIM3 trials were categorized as high-risk cohort (HRC) and low-risk cohort (LRC) according to the inclusion criteria of monarchE and NATALEE trials. Subsequently, they were further classified in three different cohorts concordant LRC (low-risk for both trials), discordant risk cohort (high-risk for only one trial), and concordant HRC (high-risk for both trials). Main outcomes were disease-free survival (DFS) and overall survival (OS). Results Among 4,795 patients included, 1,343 (28.0%) and 2,689 (56.1%) were classified as HRC according to the monarchE and NATALEE, respectively.

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Journal of the National Cancer Institute

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