Abstract 12P
Background
HER2DX is a genomic test that provides prognostic (HER2DX risk score) and predictive information (pCR score) in HER2+ early BC. Here, we report an update of the results of the first ongoing decision impact study of HER2DX at Hospital Clinic of Barcelona.
Methods
We conducted an observational, prospective, pilot, unicentric study, since Nov/21 (ongoing), to analyze the impact of HER2DX in clinical practice in early-stage HER2+ BC. Any medical oncologist of the Breast Unit could order the test. A survey was completed by the treating physician before and after receiving the result of HER2DX. The main objective was to assess the % of change in the therapeutic plan after obtaining the HER2DX report. We also assess the change in the physician´s confidence before and after the test. Due to the exploratory nature of the study, there was no sample size calculation. Descriptive statistics were used.
Results
We report the results after the inclusion of 128 pts (as of 27th of Jan/24). Median age was 54 (range 30-90) and 55% of pts were postmenopausal. Most pts had stage I (37%) or II (48%), grade 2 (51%) or 3 (42%), ductal histology (85%), hormone receptor positive (62%), median Ki67 of 35 (range 3-90) and median TILs of 12 (range 0-90). 77% of pts received neoadjuvant therapy and 23% upfront surgery. Any change in the treatment plan before and after the HER2DX result was observed in 71 of 128 (55%) of the cases. Among them, 34% (n=24) of pts escalated therapy (7/24 used more intense chemotherapy (CT), 8/24 added another antiHER2 and 9/24 escalated both CT and antiHER2). A de-escalation strategy was noted in 66% (n=47) of the pts who changed the therapy. Among them, 18/47 received less intense CT, 18/47 less anti-HER2 and 11/47 both less CT and antiHER2. In pts who de-escalated the antiHER2, 23/29 received less antiHER2 (i.e. avoidance of pertuzumab or neratinib) and 6/29 shortened the duration of trastuzumab. In a scale from 1 (very unconfident) to 5 (completely confident), the mean confidence of physicians improved after the test (3.8 vs 4.6, p=0.002).
Conclusions
In this first prospective study, HER2DX impacted clinical care in early-stage HER2+ BC and improved the level of confidence of physicians.
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. 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. 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. 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. 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. 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.