Key Points
• Source: Therapeutic Advances in Clinical Oncology
• Conclusion: “Abemaciclib with ET demonstrated clinically meaningful treatment benefit for IDFS [invasive disease-free survival] and DRFS [distant relapse-free survival] versus ET alone regardless of menopausal status and first ET, with a numerically greater benefit in the premenopausal compared to the postmenopausal population. Safety data in premenopausal patients are consistent with the overall safety profile of abemaciclib.”
• Researchers assessed the efficacy and safety of abemaciclib plus endocrine therapy (ET) for the large subgroup of premenopausal patients with HR+, HER2− EBC in monarchE (n=2451).
• “Treatment benefit was consistent across menopausal status, with a numerically greater effect size in premenopausal patients,” the authors wrote.
• In premenopausal patients, abemaciclib with ET led to a 42.2% decrease in IDFS and a 40.3% reduction in the risk of DRFS events. The absolute improvement at 3 years was 5.7% for IDFS and 4.4% for DRFS rates, with no new safety signals.
• One limitation of the current study is that menopausal status was determined at the time of diagnosis rather than at the time of randomization. Another limitation is that the current exploratory analysis was not powered or alpha controlled for statistical testing.