Abstract 14P
Background
The effectiveness of the HER2DX pCR-score in predicting pCR to anti-HER2 neoadjuvant chemotherapy (NACT) in patients (pts) with HER2+ BC in real-world clinical setting has not been thoroughly evaluated. This study aims to assess the performance of the HER2DX pCR-score in a clinical environment at a single institution.
Methods
We analyzed standardized HER2DX pCR-scores from pts with stage I-III HER2+ BC receiving trastuzumab-based CT at the Hospital Clinic of Barcelona between Nov/21 - Jan/24. This cohort was not previously included in HER2DX validation datasets. The primary goal was to explore the association between HER2DX pCR-score groups and pCR, considering hormone receptor (HR) status, Ki67, TILs, grade, HER2 IHC (3+ vs. 2+), and the type of CT (single taxane vs. multi-agent). Logistic regression methods were employed for statistical analysis.
Results
We included 86 pts with a median age of 51.9 years. Median TILs were 15.0%, 62.8% were HR+, 48.0% had grade 3, 20.9%, 61.6% and 17.4% were diagnosed with stage I, II and III, respectively, and 67.4% were treated with multi-agent CT. The overall pCR rate was 64.0% (95% CI 53.9.-74.0). The distribution across HER2DX pCR-high, -medium, and -low groups was 46.5%, 20.9%, and 32.6%, respectively, and the distribution ofHER2DX risk high and low was 58.1% and 41.9%, respectively. Univariable analysis demonstrated a significant association between HER2DX pCR score and pCR (high vs. low, odds ratio = 5.4, p = 0.002). In the multivariable model, HER2DX pCR-score remained associated with pCR after adjustment by clinico-pathological variables and type of CT (high vs low, OR = 7.4, [95% CI 1.37-40.25]; p = 0.020). The pCR rates in the HER2DX pCR-low and pCR-high groups were 35.7% and 75.0%, respectively. The selection of multi-agent versus single-agent CT was strongly associated with the HER2DX risk group.
Conclusions
The HER2DX pCR-score is significantly associated with pCR in pts with early-stage HER2+ BC undergoing anti-HER2-based NACT in a real-world setting. A low HER2DX pCR-score is consistently correlated with a reduced likelihood of achieving pCR, independently of the use of multiagent CT and clinico-pathological factors.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
O. Martínez-Sáez: Financial Interests, Personal, Invited Speaker: Novartis, Eisai; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Other, Travel expenses: Roche; Financial Interests, Personal, Other, Medical advisory: Reveal Genomics. M. Marin: Financial Interests, Institutional, Full or part-time Employment, Product Manager: Reveal Genomics, S.L. L. Pare Brunet: Financial Interests, Institutional, Full or part-time Employment: Reveal Genomics S.L.; Financial Interests, Institutional, Other, Patent pending: In vitro method for the prognosis of patients suffering from HER2-positive breast cancer - 905333: SOLTI; Financial Interests, Institutional, Other, Patent filed: EP23382703: Reveal Genomics S.L.; Financial Interests, Institutional, Other, Patent filed: EP23383369: Reveal Genomics S.L. A. Vivancos: Financial Interests, Personal, Advisory Board: Roche, Bristol Myers Squibb, Guardant Health, Bayer, INCYTE; Financial Interests, Personal, Stocks/Shares: Reveal Genomics; Financial Interests, Institutional, Research Grant, Preclinical Research Grant: Bristol Myers Squibb, Roche, Incyte. M.J. Vidal Losada: Financial Interests, Personal, Advisory Board: Novartis/Pfizer, Roche, Pfizer, AstraZeneca/Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Novartis/Pfizer, Roche/Genentech, AstraZeneca/Daiichi Sankyo, Gilead Sciences, Veracyte, Guardanthealth; Financial Interests, Personal, Other, Travel, Accommodations, expenses: Pfizer; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Gilead Sciences. I. Garcia Fructuoso: Financial Interests, Personal, Invited Speaker, And travel expenses: Novartis; Financial Interests, Personal, Invited Speaker, And Travel expenses: Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Other, Travel expenses: Gilead, Lilly. T. Pascual: Financial Interests, Personal, Invited Speaker: Pfizer/ AstraZeneca / Veracyte / Novartis; Financial Interests, Personal, Advisory Board: Roche/Genentech, Novartis. F. Schettini: Financial Interests, Personal, Invited Speaker: Novartis, Gilead, Daiichi-Sankyo; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Other, Travel expenses: Novartis, Gilead, Daiichi-Sankyo. P. Villagrasa Gonzalez: Financial Interests, Personal, Full or part-time Employment, CEO and co-founder of the company: Reveal Genomics S.L.; Financial Interests, Personal, Ownership Interest: Reveal Genomics S.L.; Financial Interests, Personal, Royalties, PCT/EP2021/086493 - In Vitro Method for the Prognosis of Patients Suffering from HER2-Positive Breast Cancer: Reveal Genomics S.L. F. Brasó-Maristany: Financial Interests, Personal, Full or part-time Employment, part time employment: Reveal Genomics SL; Financial Interests, Personal, Other, Patents filed: EP23382703 and EP23383369: Reveal Genomics SL; Financial Interests, Personal, Other, Patents filed: PCT/EP2022/086493, PCT/EP2023/060810: Fundació de Recerca Clínic Barcelona-Institut d'Investigacions Biomèdiques August Pi i Sunyer. A. Prat: Financial Interests, Personal, Invited Speaker: Roche, 1TRIALSP, S.L.; Financial Interests, Personal, Invited Speaker, Lecture fees: Novartis, Daiichi Sankyo; Financial Interests, Personal, Advisory Board, Advisory role/consultancy: Novartis, Pfizer, Peptomyc; Financial Interests, Institutional, Invited Speaker, Clinical trials: Daiichi Sankyo; Financial Interests, Institutional, Other, Contracted research: Boehringer, Medica Scientia inno. Research; Financial Interests, Personal, Advisory Board: AstraZeneca, Reveal Genomics; Financial Interests, Personal, Member of Board of Directors, Leadership role: Reveal Genomics, SL.; Financial Interests, Personal, Stocks/Shares: Reveal Genomics; Financial Interests, Personal, Royalties: Reveal Genomics, International Oncology Bureau, S.L.,; Financial Interests, Institutional, Invited Speaker: Roche, AstraZeneca, Novartis; Financial Interests, Personal and Institutional, Invited Speaker: Daiichi Sankyo; Financial Interests, Institutional, Funding: Reveal Genomics; Non-Financial Interests, Institutional, Other, Leadership roles: Patronage committee: Actitud Frente al Cáncer Foundation; Non-Financial Interests, Personal, Other, Asociación Española de Investigación sobre el Cáncer: ASEICA; Non-Financial Interests, Personal, Other, Research Foundation that gives grants to researchers: FERO. M. Munoz: Financial Interests, Personal, Expert Testimony: Roche, Novartis; Financial Interests, Personal, Other, International conference travel grants: Roche, Pfizer, Lilly, Gilead; Financial Interests, Personal, Advisory Board: Pierre Fabre, Seagen, AstraZeneca. All other authors have declared no conflicts of interest.