Breast cancer research and treatment · 2026
Real-world clinical outcomes of intermediate-risk PAM50 (i-ROR) in HR+/HER2- early breast cancer and eligibility for adjuvant CDK4/6 inhibitors.
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Terán Santiago, Illia María, Quevedo María Carla, Moreno Marina López, Bianchi Manuel Alva, Lema Laura, González Cristina, Tolosa Pablo, Madariaga Ainhoa, Manso Luis, Ruano Yolanda, Parrilla Lucía, Cobos María Ángeles, Ciruelos Eva, Sánchez-Bayona Rodrigo
Аннотация
INTRODUCTION: Risk-adapted strategies are central to early breast cancer (EBC) management, particularly in HR+/HER2 - disease. Prosigna/PAM50 combined with clinicopathologic factors refines prognosis, with clearer guidance at ROR extremes, while decisions in the intermediate-risk (i-ROR) group remain challenging. Although adjuvant iCDK4/6 therapy improves outcomes in high-risk patients, eligibility in i-ROR may be overlooked. This study outlines clinicopathologic features, recurrence-free survival, and iCDK4/6 eligibility in i-ROR EBC to support treatment decision-making.
METHODS: We performed a retrospective analysis of 554 EBC patients who underwent PAM50 testing at Hospital Universitario 12 de Octubre (2015-2024). Clinical, pathological, diagnostic, follow-up, and recurrence data were obtained from records. Kaplan-Meier analyses estimated RFS, while multivariate logistic regression identified predictors of chemotherapy use within i-ROR. Descriptive statistics assessed eligibility for adjuvant ribociclib (NATALEE) and abemaciclib (monarchE).
RESULTS: Among 212 i-ROR patients (38%), 71.7% were postmenopausal, 65.5% Luminal A and 34% Luminal B intrinsic subtypes, and 53.7% node-negative. 68.4% did not receive chemotherapy. There were 11 relapses, predominantly Luminal A (72.7%), node-negative (63.6%), and chemotherapy-naive (90.9%). RFS at 12, 36, and 60 months was 100%, 97.9%, and 96.9%. Chemotherapy use was associated with younger age (p = 0.006), node positivity (p = 0.021), and luminal B subtype (p = 0.001). CDK4/6 eligibility was 44.3% for NATALEE and 14.6% for monarchE, with 10.8% meeting both; chemotherapy use was higher in monarchE-eligible patients (41.9% vs. 31.9%).
CONCLUSIONS: This real-world cohort of PAM50 i-ROR HR+/HER2 - EBC patients showed excellent prognosis (5-year RFS > 96%), yet relapses still occurred, highlighting the need for improved risk stratification and consideration of adjuvant therapies, including iCDK4/6.
METHODS: We performed a retrospective analysis of 554 EBC patients who underwent PAM50 testing at Hospital Universitario 12 de Octubre (2015-2024). Clinical, pathological, diagnostic, follow-up, and recurrence data were obtained from records. Kaplan-Meier analyses estimated RFS, while multivariate logistic regression identified predictors of chemotherapy use within i-ROR. Descriptive statistics assessed eligibility for adjuvant ribociclib (NATALEE) and abemaciclib (monarchE).
RESULTS: Among 212 i-ROR patients (38%), 71.7% were postmenopausal, 65.5% Luminal A and 34% Luminal B intrinsic subtypes, and 53.7% node-negative. 68.4% did not receive chemotherapy. There were 11 relapses, predominantly Luminal A (72.7%), node-negative (63.6%), and chemotherapy-naive (90.9%). RFS at 12, 36, and 60 months was 100%, 97.9%, and 96.9%. Chemotherapy use was associated with younger age (p = 0.006), node positivity (p = 0.021), and luminal B subtype (p = 0.001). CDK4/6 eligibility was 44.3% for NATALEE and 14.6% for monarchE, with 10.8% meeting both; chemotherapy use was higher in monarchE-eligible patients (41.9% vs. 31.9%).
CONCLUSIONS: This real-world cohort of PAM50 i-ROR HR+/HER2 - EBC patients showed excellent prognosis (5-year RFS > 96%), yet relapses still occurred, highlighting the need for improved risk stratification and consideration of adjuvant therapies, including iCDK4/6.
Предметные рубрики MeSH
HumansFemaleBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesRetrospective StudiesCyclin-Dependent Kinase 4Chemotherapy, AdjuvantMiddle AgedCyclin-Dependent Kinase 6Receptors, ProgesteroneAminopyridinesPrognosisProtein Kinase InhibitorsReceptors, EstrogenAgedAdultBiomarkers, TumorNeoplasm Recurrence, LocalPurinesBenzimidazoles