Limiting systemic endocrine overtreatment in postmenopausal breast cancer patients with an ultralow classification of the 70-gene signature
Opdam, M; van der Noort, V; Kleijn, M; Glas, A; Mandjes, I; Kleiterp, S; Hilbers, F S; Kruger, D T; Bins, A D; de Jong, P C; Schiphorst, P P J B M; van Dalen, T; Flameling, B; Rietbroek, R C; Beeker, A; van den Heiligenberg, S M; Bakker, S D; Wymenga, A N M; Oving, I M; Bijlsma, R M; van Diest, P J; Vermorken, J B; van Tinteren, H; Linn, S C
(2022) Breast Cancer Research and Treatment, volume 194, issue 2, pp. 265 - 278
(Article)
Abstract
PURPOSE: Guidelines recommend endocrine treatment for estrogen receptor-positive (ER+) breast cancers for up to 10 years. Earlier data suggest that the 70-gene signature (MammaPrint) has potential to select patients that have an excellent survival without chemotherapy and limited or no tamoxifen treatment. The aim was to validate the 70-gene signature
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ultralow-risk classification for endocrine therapy decision making. METHODS: In the IKA trial, postmenopausal patients with non-metastatic breast cancer had been randomized between no or limited adjuvant tamoxifen treatment without receiving chemotherapy. For this secondary analysis, FFPE tumor material was obtained of ER+HER2- patients with 0-3 positive lymph nodes and tested for the 70-gene signature. Distant recurrence-free interval (DRFI) long-term follow-up data were collected. Kaplan-Meier curves were used to estimate DRFI, stratified by lymph node status, for the three predefined 70-gene signature risk groups. RESULTS: A reliable 70-gene signature could be obtained for 135 patients. Of the node-negative and node-positive patients, respectively, 20% and 13% had an ultralow-risk classification. No DRFI events were observed for node-negative patients with an ultralow-risk score in the first 10 years. The 10-year DRFI was 90% and 66% in the low-risk (but not ultralow) and high-risk classified node-negative patients, respectively. CONCLUSION: These survival analyses indicate that the postmenopausal node-negative ER+HER2- patients with an ultralow-risk 70-gene signature score have an excellent 10-year DRFI after surgery with a median of 1 year of endocrine treatment. This is in line with published results of the STO-3-randomized clinical trial and supports the concept that it is possible to reduce the duration of endocrine treatment in selected patients.
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Keywords: Antineoplastic Agents, Hormonal/therapeutic use, Breast Neoplasms/drug therapy, Chemotherapy, Adjuvant, Early breast cancer, Endocrine treatment, Female, Humans, MammaPrint 70-gene signature, Overtreatment, Postmenopausal, Postmenopause, Prognosis, Tamoxifen/therapeutic use, Oncology, Cancer Research, Randomized Controlled Trial, Journal Article
ISSN: 0167-6806
Publisher: Springer New York
Note: Funding Information: This work was supported by Grants from Agendia®, and A Sister’s Hope. A Sister’s Hope did not have any influence on study design; data collection; and/or project management; data analysis, interpretation; or manuscript preparation, review, or approval. Agendia® generated MammaPrint® results for all submitted tumor samples, blinded to clinical outcome data. Agendia® did not have any influence on study design, or data analysis. Two employees from Agendia® were involved in project management, data interpretation, manuscript review, and approval (MK, AG). Funding Information: We would like to acknowledge the Core Facility Molecular Pathology & Biobanking (CFMPB) of the Netherlands Cancer Institute for supplying tissue material and lab support. We would also like to thank all patients, participating hospitals and involved general practitioners. Publisher Copyright: © 2022, The Author(s).
(Peer reviewed)