ArticleJournal of the National Cancer Institute2025
Prognostic implications of risk definitions from the monarchE and NATALEE trials.
Article in Journal of the National Cancer Institute, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.
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Who cites it
6 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- [Systemic treatment of breast cancer: professional guideline].Magyar onkologia · 2025Guideline
- Long-term efficacy of CDK4/6 inhibitors in early HR+, HER2- high-risk breast cancer: An updated systematic review and meta-analysis.Frontiers in pharmacology · 2025Pooled it
- Outcomes of Hormone receptor-positive/HER2-negative early breast cancer patients by risk of recurrence groups focusing on the intermediate-risk group: Retrospective analysis from GEICAM studies.Breast cancer research : BCR · 2026Trial
- Real-world clinical outcomes of intermediate-risk PAM50 (i-ROR) in HR+/HER2- early breast cancer and eligibility for adjuvant CDK4/6 inhibitors.Breast cancer research and treatment · 2026Article
- Prevalence and prognosis of patients with breast cancer eligible for adjuvant abemaciclib or ribociclib: a nationwide population-based study.The Lancet regional health. Europe · 2025Article
- Do all patients with early breast cancer meeting the NATALEE criteria benefit from adjuvant ribociclib?ESMO open · 2025Article
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20 authors.
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Abstract
backgroundThe monarchE and NATALEE trials employed different high-risk inclusion criteria. The main objective is to assess prognostic differences based on their inclusion criteria.
methodsPatients with hormone receptor-positive/HER2-negative early breast cancer enrolled in the phase III Mammella InterGruppo (MIG) 1, Gruppo Italiano Mammella (GIM) 2, 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 3 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).
resultsAmong 4795 patients, 1343 (28.0%) and 2689 (56.1%) were classified as HRC according to the monarchE and NATALEE, respectively. At a median follow-up of 7.0 years (y), 7-y DFS was 87% and 89% in the LRC and 69% and 76% in the HRC according to monarchE and NATALEE, respectively. The 7-y DFS was 89%, 84%, and 69% in concordant LRC, discordant cohort, and concordant HRC, respectively (discordant cohort vs concordant LRC: hazard ratio [HR] = 1.45, 95% CI = 1.22 to 1.73; concordant HRC vs concordant LRC: HR = 2.97, 95% CI = 2.53 to 3.48; P < .001). The 7-y OS was 96% in concordant LRC, 95% in discordant cohort, and 84% in concordant HRC (discordant cohort vs concordant LRC: HR = 1.52, 95% CI = 1.16 to 1.98; concordant HRC vs concordant LRC: HR = 3.38, 95% CI = 2.66 to 4.29; P < .001).
conclusionsPatients in the concordant HRC showed statistically and clinically significant poorer prognoses compared with patients in the discordant risk and concordant LRC.
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