Abstract P1-11-08: Practice patterns and uptake of adjuvant abemaciclib in high risk localized hormone receptor positive, HER2-negative breast cancer

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Abstract Introduction: In MonarchE, two years of adjuvant abemaciclib combined with endocrine therapy (ET) improved invasive disease-free survival and distant relapse free survival, with recent data confirming continued benefit beyond the two-year treatment period. The FDA approved abemaciclib in October 2021 in patients (pts) with HR+, HER2- early breast cancer (EBC) with node positive and Ki-67 ≥20%, based on an unplanned MonarchE analysis. The approval was amended in March 2023 to revert back to the intention to treat (ITT) protocol, including ≥4 axillary lymph nodes (ALN) or 1-3 ALN with size >50 mm or grade 3. There is a paucity of real-world data surrounding abemaciclib adoption in the eligible patient (pt) population. In this study we aimed to define practice patterns at Mayo Clinic, a large academic enterprise, to understand adjuvant abemaciclib Electronic Medical Record (EMR) documentation, physician recommendations and pt preferences in abemaciclib utilization. Methods: As part of an IRB exempt quality improvement project, we retrospectively analyzed a registry database of pts meeting MonarchE eligibility criteria at Mayo Clinic. We analyzed if pts met criteria for adjuvant abemaciclib based on the October 2021 approval and the amended March 2023 approval along with diagnostic and staging information. EMR notes were reviewed for documented abemaciclib discussion, discussion outcome with pts, oncologist prescriptions and timing of drug start. Time dependent analysis related to FDA label indication were based on abemaciclib start within 6 months of adjuvant ET initiation. Results: 400 pts met MonarchE criteria and initial analysis included 123 consecutive pts in Rochester, MN who started ET between April 2021 and October 2023. The median age at diagnosis was 56 years. Race/ethnicity included 104 (85%) White, 11 (9%) Asian, 7 (6%) Black, and 2 (1.6%) Hispanic. A total of 65 (53%) pts received neoadjuvant systemic therapy including 14 (11%) with neoadjuvant ET. 85/123 (69%) pts had EMR indicated abemaciclib discussion. Of these, 53 met both early and late FDA criteria, 25 pts were eligible only for the original FDA-label criteria and 45 were eligible only based on the March 2023 indication. The proportion of pts meeting each specific criteria included N2/N3 disease (60/123) or N1 with ≥5 cm (32/123), G3 (28/123) or elevated Ki-67 (58/123). Adjusting for time dependence of the FDA approval, 64/87 (73%) pts had a documented adjuvant abemaciclib discussion in the EMR. Of the 36 pts that met the IIT population but prior to the recent FDA approval, 21 (58%) had a documented abemaciclib discussion. Of the 85 documented discussions, 73 pts were recommended adjuvant abemaciclib. Of the 12 pts that were not recommended abemaciclib, main reasons included adjuvant olaparib in gBRCA1/2 carriers (n=3), comorbidity concerns (n=2), and ET tolerance difficulties (n=2). Of the 73 pts recommended to take abemaciclib, 13 (18%) pts declined. The most common EMR documented reasons for declining included concerns for side effects (n=4), perceived benefit (n=1), cost (n=1) or unknown/other (n=7). 4 pts (3.3%) had a breast cancer recurrence, 3 of these pts had EMR abemaciclib documentation. Of these, all 3 pts developed distant recurrence, 1 was prior to abemaciclib start and 2 were 22-24 months after surgery with intermittent abemaciclib use due to side effects. Conclusions: In this retrospective study of high-risk HR-positive EBC, an adjuvant abemaciclib discussion was documented in the EMR 69% of the time. Most pts who were recommended abemaciclib did start it, though nearly 20% declined. With the possible approval of a second adjuvant CDK 4/6 inhibitor, prospective real-time capture of practice patterns from the EMR may inform pt management. Data for the full Mayo Clinic Enterprise will be available at the time of the meeting. Citation Format: Sarah K. Premji, Tanmayi S. Pai, Savannah S. Liddell, Nathaniel E. Wiest, Dhauna Karam Prasad, Whitney R. Harris, Lisa L. Ellsworth, Jenna E. Hoppenworth, Shikha Patel, Farah Raheem, Melissa Noyes, Lida A. Mina, Pooja Advani, Amye J. Tevaarwerk, Brenda J. Ernst, Matthew P. Goetz, Karthik V. Giridhar. Practice patterns and uptake of adjuvant abemaciclib in high risk localized hormone receptor positive, HER2-negative breast cancer [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P1-11-08.

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