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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Friday, March 8, 2024
An article published in the Journal of Clinical Oncology presented 5-year estimates of invasive disease–free survival, distant relapse–free survival, and an updated evaluation of overall survival in patients with high-risk early breast cancer. Priya Rastogi, MD, of the UPMC Hillman Cancer Center, Pittsburgh, and colleagues examined patients who received 5 years of endocrine therapy with or without 2 years of the CDK4/6 inhibitor abemaciclib. Their findings revealed that patients who received abemaciclib showed significant improvement in invasive disease–free survival and distant relapse–free survival. They also found that after a median follow-up of 54 months, the benefit of abemaciclib was sustained.
“At the pivotal 5-year mark for adjuvant early breast cancer trials, adjuvant abemaciclib plus endocrine therapy continued to reduce the risk of developing invasive and distant disease recurrence well beyond the completion of treatment,” stated Dr. Rastogi and colleagues.
A total of 5,637 patients from the monarchE phase III global trial were included in this study. Patients were assigned to one of two cohorts, both of which were included in the intent-to-treat population. They were then randomly assigned (1:1) to receive at least 5 years of endocrine therapy with or without abemaciclib over a 2-year period. The primary study outcome included overall survival, which was planned to be tested for statistical significance per the gated strategy. Hazard ratios were estimated using the Cox proportional hazard model, and 5-year invasive disease–free survival, distant relapse–free survival, and overall survival rates were estimated using Kaplan-Meier methods.
After a median follow-up of 54 months, the benefit of abemaciclib was sustained, with hazard ratios of 0.680 (95% confidence interval [CI] = 0.599–0.772) for invasive disease–free survival and 0.675 (95% CI = 0.588–0.774) for distant relapse–free survival. There were also fewer deaths in the abemaciclib plus endocrine therapy arm compared with the endocrine therapy–alone arm, and no new safety signals were observed.
Disclosure: For full disclosures of the study authors, visit coi.ascopubs.org.
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