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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来自monarchE和NATALEE试验的风险定义的预后意义

monarchE和NATALEE试验采用不同的高危纳入标准。主要目的是根据其纳入标准评估预后差异。方法根据monarchE和NATALEE试验的纳入标准，将纳入MIG1、GIM2和GIM3期临床试验的激素受体阳性/ her2阴性早期乳腺癌患者分为高危队列（HRC）和低危队列（LRC）。随后，他们被进一步分为三个不同的队列：一致性LRC（两项试验均为低风险）、不一致性风险队列（只有一项试验为高风险）和一致性HRC（两项试验均为高风险）。主要结局为无病生存期（DFS）和总生存期（OS）。结果纳入的4795例患者中，根据monarchE和NATALEE分别有1343例（28.0%）和2689例（56.1%）分为HRC。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Journal of the National Cancer Institute

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