292P - Real-world evidence on risk of recurrence (ROR) in patients (pts) with node-negative (N0) and node-positive HR+/HER2– early breast cancer (EBC) from US electronic health records (EHR)

Background

While a CDK4/6 inhibitor is approved for high-risk node-positive HR+/HER2− EBC, its use is not approved for N0 disease. Pts with N0 disease and high-risk features may particularly be at risk for disease recurrence, but contemporary information on ROR and mortality is limited. Here, real-world data was used to estimate risk for pts with HR+/HER2− EBC.

Methods

Pts aged ≥18 years with AJCC stage I-III HR+/HER2− EBC in the US Flatiron Health EBC de-identified EHR-derived database (2011-2023) were included. ROR and all-cause mortality from time of diagnosis were assessed descriptively across nodal status, including a subgroup of pts with N0 disease with high-risk characteristics (N0 high-risk) as defined by NATALEE eligibility criteria: T4N0, T3N0, or T2N0 with additional criteria (grade [G]2 with Ki-67≥20% or high genomic risk, or G3).

Results

Of 15,017 pts, 7564 met study criteria: 5557 (73.5%) N0 disease [679 (12.2%) N0 high-risk], 1560 (20.6%) N1, and 447 (5.9%) N2-3. Overall median follow-up was 79.1 (45.7, 113.6) mo. Median age was 65, 62, 61, and 61 y in N0, N0 high-risk, N1, and N2-3 groups, respectively. In total, 94.7%, 86.9%, 90.8%, and 85.0% received (neo)adjuvant endocrine therapy; 15.8%, 47.4%, 45.0%, and 68.9% received (neo)adjuvant chemotherapy. Most pts were postmenopausal (76.2%, 68.6%, 67.1%, and 69.1%). ROR and mortality were positively associated with nodal status (P

Conclusions

This contemporary real-world analysis revealed considerable ROR across pts with positive nodal status and pts with N0 high-risk disease. N0 high-risk had 3.2× risk of distant recurrence and 1.5× risk of mortality at 7 y vs N0. Treatments to improve outcomes are needed, including for pts with N0 high-risk disease.

Clinical trial identification

Editorial acknowledgement

Editorial assistance in the writing of the abstract was provided by Safiyya Ali, MSc, CMPP of Nucleus Global.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

K. Jhaveri: Financial Interests, Personal and Institutional, Advisory Board: Novartis, Astrazeneca, Pfizer, Genentech/Roche, Lilly Pharmaceuticals/Loxo Oncology, Gilead; Financial Interests, Personal and Institutional, Other, Consultant: Novartis, Astrazeneca, Pfizer, Genentech/Roche, Lilly Pharmaceuticals/Loxo Oncology, Gilead; Financial Interests, Personal and Institutional, Funding: Novartis, Astrazeneca, Pfizer, Genentech/Roche, Lilly Pharmaceuticals/Loxo Oncology, Gilead; Financial Interests, Personal, Advisory Board: BMS, Jounce Therapeutics, Taiho Oncology, AbbVie, Eisai, Blueprint Medicines, Seattle Genetics, Daiichi Sankyo, Olema Pharmaceuticals, Sun Pharma Advanced Research Company Ltd, Menarini/Stemline; Financial Interests, Personal, Other, Consultant: BMS, Jounce Therapeutics, Taiho Oncology, AbbVie, Eisai, Blueprint Medicines, Seattle Genetics, Daiichi Sankyo, Olema Pharmaceuticals, Sun Pharma Advanced Research Company Ltd, Menarini/Stemline; Financial Interests, Institutional, Funding: Debio Pharmaceuticals, Zymeworks, PUMA Biotechnology, Merck Pharmaceuticals, Context Therapeutics. G. Curigliano: Financial Interests, Personal, Advisory Board: Roche, Novartis, Lilly, Pfizer, AstraZeneca, Daichii Sankyo, Ellipsis, Veracyte, Exact Science, Celcuity, Merck, BMS, Gilead, Sanofi. L.M. Spring: Financial Interests, Personal, Other: Novartis, Merck, Phillips. J. Gligorov: Financial Interests, Personal and Institutional, Other, Clinical Trials: Roche-Genentech, Novartis, Eisai, Exact Science, Pfizer, Lilly; Financial Interests, Personal and Institutional, Other, Travel support: Roche-Genentech, Novartis, Eisai, Exact Science, Pfizer, Mylan, Lilly, Pierre Fabre; Financial Interests, Personal and Institutional, Advisory Board: Roche-Genentech, Novartis, Eisai, Exact Science, Pfizer, Mylan, Lilly, Pierre Fabre; Financial Interests, Personal and Institutional, Speaker’s Bureau: Roche-Genentech, Novartis, Eisai, Exact Science, Pfizer, Mylan, Lilly, Pierre Fabre; Financial Interests, Personal, Other, Clinical Trials: Daiichi Sankyo, MSD; Financial Interests, Personal, Advisory Board: Daiichi Sankyo, MSD, Astrazeneca; Financial Interests, Personal, Speaker’s Bureau: Astrazeneca. N. Harbeck: Financial Interests, Personal, Other, Consulting: Novartis, Pfizer, Roche, Sandoz/Hexal, Gilead, Seagen, Sanofi; Financial Interests, Personal, Invited Speaker: Novartis, Lilly, Pfizer, AstraZeneca, Daiichi Sankyo, MSD, Pierre-Fabre, Roche, Gilead, Seagen, Sanofi, Viatris, Medscape, Onkowissen, Zuelligpharma, Aptitude Health, Art Tempi; Financial Interests, Institutional, Funding: Novartis, Lilly, AstraZeneca, Daiichi Sankyo, MSD, Pierre-Fabre, Roche, West German Study Group, Seagen, Palleos, TRIO, BMS; Financial Interests, Personal, Advisory Board: Pfizer, Sandoz/Hexal, Gilead, Seagen, Sanofi; Financial Interests, Personal, Leadership Role, Co director WST: West German Study Group; Non-Financial Interests, Member: AGO Breast Committee; Non-Financial Interests, Member, Breast Cancer Educational Programs: ESO/ESCO; Non-Financial Interests, Leadership Role, Founding Editor: BreastCare Journal. D. Juric: Financial Interests, Institutional, Funding: Pfizer, Amgen, InventisBio, Arvinas, Takeda, Blueprint, Astrazeneca, Ribon Therapeutics, Infinity. H. Owusu: Financial Interests, Personal, Full or part-time Employment: Novartis. M. Akdere: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Stocks or ownership: Novartis. J. Kim: Financial Interests, Institutional, Other, Employee of Genesis Research, whom Novartis has paid fees for consulting: Novartis. F. Cardoso: Financial Interests, Personal, Advisory Board, Consulting: Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, EISAI, GE Oncology, Genentech, GSK, Macrogenics, Medscape, Merck-Sharp, Merus, Mylan, Mundipharma, Novartis, Pfizer, Pierre Fabre, Prime Oncology, Roche, Sanofi, Samsung Bioepis, Teva, Seagen, Debiopharm, Gilead, Iqvia, Touchime. All other authors have declared no conflicts of interest.