Most younger patients had tumor size of 20 mm to less than 50 mm (48%), at least 4 positive lymph nodes (59%), G2 disease (49%), had received neoadjuvant chemotherapy (97%), and an ECOG performance status of 0 (86%). 2 Baseline factors relevant to this analysis included pathologic tumor size, number of positive lymph nodes, histopathological grade, prior neoadjuvant chemotherapy, and ECOG performance status. The baseline characteristics for the intention-to-treat population were well balanced with a median age of 51 years (range, 44-60). ![]() Patients who were than 75 years made up only 3% of the study population, which really precluded a detailed outcome analysis in this subgroup.” Efficacy, safety, and patient-reported outcome analyses were conducted in 2 age groups, those patients who were than 65 years and those that were 65 years or greater. All patients are off abemaciclib with a median follow up of 42 months. “All patients went on to receive 3 to 8 years of standard single-agent ET per patient and physician decision. “The objective of this analysis of monarchE was to explore the efficacy and safety of adjuvant abemaciclib and the subgroup of older patients were enrolled,” Hamilton said. MonarchE was a phase 3 trial that randomly assigned patients to receive 150 mg of adjuvant abemaciclib twice daily for 2 years in addition to standard-of-care ET or ET alone. In the intention-to-treat population 4-year DRFS rates was 88.4% with adjuvant abemaciclib and ET vs 82.5% with ET alone for a 34% reduction in the risk of developing a DRFS event (HR, 0.659 95% CI, 0.567-0.767). In older patients the 4-year DRFS rate was 86.1% with the addition of abemaciclib to ET vs 81.5% with ET alone (HR, 0.748 95% CI, 0.520-1.077). In terms of DRFS an absolute magnitude of benefit of 6.2% was observed in the younger patient population and 4.6% benefit was observed in the older population.1 Specifically, the 4-year iDFS rates in the younger patient population were 88.8% abemaciclib plus ET vs 82.6% with ET alone (HR, 0.647 95% CI, 0.548-0.764). “For patients with hormone receptor–positive, HER2-negative, high-risk, early breast cancer adjuvant abemaciclib plus ET showed consistent treatment benefit across age subgroups with clinically meaningful absolute risk reduction in both iDFS as well as DRFS rates observed in both younger and older patients.” Hamilton is the director of Breast and Gynecologic Cancer Research at Sarah Cannon Research Institute in Nashville, Tennessee. Hamilton, MD, said in a presentation of the data. “For our patients that were 65 years of age or greater, and consistent results were observed in cohort 1,” Erika P. The 48-month iDFS rates were 85.8% vs 79.4%, with and without abemaciclib, respectively. 1įindings from the landmark, 4-year analysis were previously presented at the 2022 San Antonio Breast Cancer Congress and published in Lancet Oncology.2 At a median follow-up of 42 months, a 34% reduction in the risk of developing an iDFS event was reported with adjuvant abemaciclib plus endocrine therapy (n = 2808) vs endocrine therapy alone (n = 2829 HR, 0.664 95% CI, 0.578-0.762 nominal P <. ![]() For patients who were younger than 65 years, the 4-year iDFS rates were 86.5% with abemaciclib and ET (n = 2371) vs 79.8% with ET alone (n = 2416) for an absolute magnitude of benefit of 6.7% (HR, 0.646 95% CI, 0.554-0.753). The 4-year iDFS rate for patients aged 65 years or older who received abemaciclib plus ET (n = 437) was 82.0% vs 76.8% for patients who received ET alone (n = 413) for an absolute magnitude of benefit of 5.2% (HR, 0.767 95% CI, 0.556-1.059). Findings from the age group analysis of the monarchE trial (NCT03155997) were presented during the 2023 ASCO Annual Meeting. A clinically meaningful absolute risk reduction in invasive disease-free survival (iDFS) and distant relapse-free survival (DRFS) with abemaciclib (Verzenio) plus endocrine therapy (ET) was maintained in patients with hormone receptor–positive, HER2-negative, high-risk early breast cancer regardless of age.
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