Using a patient registry and novel follow-up protocol to impact identification, treatment, and adherence rates in HR+, HER2- early breast cancer patients at UF Health.

Abstract

e23225 Background: High recurrence risk remains a challenge in HR+, HER2- early breast cancer (EBC). Outcomes have improved with intensified adjuvant endocrine therapy (ET) through the addition of a CDK4/6 inhibitor, now the standard of care for high-risk patients per expanded FDA approval (abemaciclib,ribociclib) and updated clinical guidelines. However, real-world adoption of this standard is inconsistent due to gaps in processes for capturing clinical, pathological, and biological data essential for risk assessment and treatment eligibility. Even when patients initiate oral therapy, adherence and persistence may be suboptimal due to adverse events (AEs) or lack of robust monitoring and engagement protocols. Methods: To address these gaps, the University of Florida Division of Hematology and Oncology launched a quality improvement (QI) project aimed at optimizing risk assessment, treatment identification, and adherence in HR+, HER2- EBC patients. A patient registry was developed to track key clinical and pathological data for identifying and treating high-risk patients. Additionally, a follow-up protocol was implemented, including a phone call one week post-treatment initiation. During these calls, care team members assessed AEs, provided education on the 24/7 reporting line, antidiarrheal use, dose adjustments, and other mitigation strategies, and arranged clinic visits when needed. Results: The registry and follow-up protocol launched in March 2024. In the first ten months, 226 breast cancer patients were added to the registry, with 17 identified as HR+/HER2- node-positive. Of these, 13 were eligible for abemaciclib, and 8 initiated therapy. All 8 were contacted by nursing staff within one week of Rx. Of these, 2 discontinued therapy (fatigue, stroke), and 6 refilled prescriptions more than once. Reasons for dose adjustments were also documented. Conclusions: The project confirmed UF's ability to identify appropriate candidates for abemaciclib and improved staging accuracy within patient records. It also enhanced tracking of adherence, dose adjustments, and treatment discontinuation reasons. With this improved infrastructure, UF plans to expand the initiative to address patients who fail to initiate therapy after their initial prescription.