245P - Characteristics of real-world (RW) NATALEE and monarchE eligible populations: A US electronic health records (EHR) database analysis

Background

The NATALEE and monarchE trials reported significant invasive disease–free survival benefit for pts with HR+/HER2− early breast cancer (EBC). NATALEE included a wider EBC patient (pt) population than monarchE. This RW database analysis examined the epidemiology of HR+/HER2− EBC in pts eligible for NATALEE vs monarchE.

Methods

Data from ConcertAI Patient360, a US EHR database (Jan 2015-Jan 2023) was used. Pts ≥18 y with BC diagnosis who had surgery, stage I-III HR+/HER2− EBC at initial diagnosis, and started adjuvant endocrine therapy (ET) were included. NATALEE eligibility was stage II/III disease (AJCC 8th ed) irrespective of lymph node (LN) status, with high recurrence risk criteria for stage IIA T2N0 disease (grade [G] 2 with Ki-67 ≥20% or high genomic risk; G3). monarchE eligibility was ≥4 +LNs (N2/N3) or 1-3 +LNs (N1) and G3 and/or tumor size ≥5 cm (cohort 1) and 1-3 +LNs and Ki-67 ≥20% (G<3 and tumor size <5 cm; cohort 2).

Results

In total, 7060 pts met selection criteria. N0 disease (5286 [74.9%]) was most common, followed by N1 (1388 [19.7%]) and N2/3 (386 [5.5%]). A greater proportion of pts with N0 and N1 disease were eligible for NATALEE than monarchE (Table). T2N0 G2 pts who were eligible for NATALEE were likely undercounted: of 490 T2N0 G2 pts requiring Ki-67/genomic tests to meet NATALEE criteria, only 248 (50.6%) had a reported result, of whom 112 met the increased-risk criteria. Overall, 30.6% pts were eligible for NATALEE vs 14.5% for monarchE. Median age was 60 vs 59 y, respectively; 21.5% vs 22.8% were premenopausal, 55.6% vs 67.5% had prior chemotherapy (CT). For pts with N0 disease eligible for NATALEE: median age, 60 y; premenopausal, 20.3%; prior CT, 48.9%. Table: 245P

^a Pts with N1 micrometastatic (N1_mi) disease (114/1388 [8.2%]) were not included in NATALEE.

Conclusions

This RW analysis indicates that NATALEE represents a much larger number of pts at increased risk of recurrence who may benefit from addition of a CDK4/6i to ET vs monarchE, including select pts with N0 and all pts with macroscopic N1 disease.

Clinical trial identification

Editorial acknowledgement

Editorial assistance in the writing of the abstract was provided by Shashank Tandon, PhD of Nucleus Global.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

P. Tarantino: Financial Interests, Personal, Invited Speaker: AstraZeneca, Roche; Financial Interests, Personal, Advisory Board: Daiichi Sankyo, AstraZeneca, Daiichi Sankyo, Genentech, Eli Lilly, Gilead; Financial Interests, Institutional, Funding: AstraZeneca. H.S. Rugo: Financial Interests, Personal, Other, Consultancy/advisory support: NAPO, Mylan/Viatris, Daiichi Sankyo, Eisai; Financial Interests, Institutional, Local PI: Novartis, Lilly, Pfizer, Daiichi, AstraZeneca, Gilead Sciences, Inc.; Financial Interests, Institutional, Coordinating PI: OBI Pharma, F. Hoffmann-La Roche AG/Genentech, Inc., Merck; Financial Interests, Institutional, Research Grant: Stemline Therapeutics, Ambryx; Non-Financial Interests, Advisory Role, I advise a number of companies without compensation: various. G. Curigliano: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, Daiichi Sankyo, Novartis, Pfizer; Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Daiichi Sankyo, Lilly, Pfizer, Veracyte, BMS, Merck, Exact Sciences, Celcuity; Financial Interests, Personal, Writing Engagement: Pfizer; Financial Interests, Personal, Advisory Board, Advisory Board: Menarini, Gilead; Financial Interests, Personal, Other, Advisory Board: Ellipsis; Financial Interests, Institutional, Research Grant, Investigator Initiated Trial: Merck; Financial Interests, Institutional, Funding, Phase I studies: BMS, Novartis, AstraZeneca, Daiichi Sankyo, Roche, Blueprint Medicine, Kymab, Astellas, Sanofi, Philogen; Financial Interests, Institutional, Coordinating PI, Phase I clinical basket trial: Relay Therapeutics; Non-Financial Interests, Officer, Italian National Health Council as Advisor for Ministry of Health: Consiglio Superiore di Sanità; Non-Financial Interests, Advisory Role, Member of the Scientific Council. Patient advocacy association: Europa Donna; Non-Financial Interests, Advisory Role, Cancer Research Foundation: Fondazione Beretta; Non-Financial Interests, Officer, Editor of Chief of ESMO Open: ESMO; Non-Financial Interests, Leadership Role, Until the end of 2024: EUSOMA. J. O'Shaughnessy: Financial Interests, Personal, Advisory Board: Abbvie, Agendia, Amgen, Aptitude Health, AstraZeneca, Eisai, G1 Therapeutics, Lilly, Merck, Novartis, Pfizer, Puma, Roche, Carrick Therapeutics, Daiichi Sankyo, Gilead Sciences, Ontada, Pierre Fabre Pharmaceuticals, Samsung Bioepis, Sanofi, BioNtech, Byondis, Dava Oncology, Fishawack Health, Genzyme, GSK, Genentech, Loxo Oncology, Seagen, Stemline Therapeutics, Taiho Oncology, Veru. W. 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