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The REMAR (Rhein-Main-Registry) real-world study: prospective evaluation of the 21-gene breast recurrence score® assay in addition to Ki-67 for adjuvant treatment decisions in early-stage breast cancer

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Title: The REMAR (Rhein-Main-Registry) real-world study: prospective evaluation of the 21-gene breast recurrence score® assay in addition to Ki-67 for adjuvant treatment decisions in early-stage breast cancer
Authors: Christian Jackisch, Louiza Anastasiadou, Sebastian Aulmann, Athanasios Argyriadis, Volker Möbus, Christine Solbach, Peter Baier, Dagmar Giesecke, Sven Ackermann, Elke Schulmeyer, Boris Gabriel, Dietrich Mosch, Stephanie Buchen, Eckart Krapfl, Ursula Hurst, Mario Vescia, Hans Tesch, Marc Thill
Source: Breast Cancer Res Treat
Publisher Information: Springer Science and Business Media LLC, 2024.
Publication Year: 2024
Subject Terms: Adult, Aged, 80 and over, 0301 basic medicine, Gene Expression Profiling, Clinical Decision-Making, Breast Neoplasms, Middle Aged, Prognosis, Clinical Trial, Risk Assessment, Clinical Decision-Making [MeSH], Aged, 80 and over [MeSH], Aged [MeSH], Breast cancer, Neoplasm Recurrence, Local/pathology [MeSH], Breast Neoplasms/therapy [MeSH], Neoplasm Staging [MeSH], 21-gene assay, Adjuvant treatment, Neoplasm Recurrence, Local/genetics [MeSH], Ki-67 Antigen/metabolism [MeSH], Chemotherapy, Adjuvant/methods [MeSH], Biomarkers, Tumor [MeSH], Risk Assessment/methods [MeSH], Registry, Breast Neoplasms/pathology [MeSH], Female [MeSH], Recurrence Score, Adult [MeSH], Humans [MeSH], Prospective Studies [MeSH], Breast Neoplasms/genetics [MeSH], Breast Neoplasms/drug therapy [MeSH], Breast Neoplasms/metabolism [MeSH], Middle Aged [MeSH], Prognosis [MeSH], Gene Expression Profiling/methods [MeSH], Ki-67, Registries [MeSH], 03 medical and health sciences, Ki-67 Antigen, 0302 clinical medicine, Chemotherapy, Adjuvant, Biomarkers, Tumor, Humans, Female, Prospective Studies, Registries, Neoplasm Recurrence, Local, Aged, Neoplasm Staging
Description: Purpose Ki-67 is recommended by international/national guidelines for risk stratification in early breast cancer (EBC), particularly for defining “intermediate risk,” despite inter-laboratory/inter-observer variability and cutoff uncertainty. We investigated Ki-67 (> 10%– Methods This prospective, non-interventional, real-world study included females ≥ 18 years, with pN0/pN1mi/pN1, HR+ , HER2-negative EBC, and locally determined Ki-67 ranging 10%–40%. The primary outcome was changes in treatment recommendations after disclosing the Oncotype DX Breast Recurrence Score®(RS) assay result. Results The analysis included 567 patients (median age, 57 [range, 29–83] years; 70%/1%/29%/ with pN0/pN1mi/pN1 disease; 81% and 19% with RS results 0–25 and 26–100, respectively). The correlations between local and central Ki-67, local Ki-67, and the RS, and central Ki-67 and the RS results were weak (r = 0.35, r = 0.3, and r = 0.46, respectively), and discrepancies were noted in both directions (e.g., local Ki-67 was lower or higher than central Ki-67). After disclosing the RS, treatment recommendations changed for 190 patients (34%). Changes were observed in pN0 and pN1mi/pN1 patients and in patients with centrally determined Ki-67 ≤ 10% and > 10%. Treatment changes were aligned with RS results (adding chemotherapy for patients with higher RS results, omitting it for lower RS results), and their net result was 8% reduction in adjuvant chemotherapy use (from 32% pre-RS results to 24% post-RS results). Conclusion The Oncotype DX® assay is a tool for individualizing treatments that adds to classic treatment decision factors. The RS result and Ki-67 are not interchangeable, and Ki-67, as well as nodal status, should not be used as gatekeepers for testing eligibility, to avoid under and overtreatment.
Document Type: Article
Other literature type
Language: English
ISSN: 1573-7217
0167-6806
DOI: 10.1007/s10549-024-07390-y
Access URL: https://pubmed.ncbi.nlm.nih.gov/38874685
https://repository.publisso.de/resource/frl:6518260
Rights: CC BY
Accession Number: edsair.doi.dedup.....24d5b9b46e4d539affbeb019826130a1
Database: OpenAIRE
Description
Abstract:Purpose Ki-67 is recommended by international/national guidelines for risk stratification in early breast cancer (EBC), particularly for defining “intermediate risk,” despite inter-laboratory/inter-observer variability and cutoff uncertainty. We investigated Ki-67 (> 10%– Methods This prospective, non-interventional, real-world study included females ≥ 18 years, with pN0/pN1mi/pN1, HR+ , HER2-negative EBC, and locally determined Ki-67 ranging 10%–40%. The primary outcome was changes in treatment recommendations after disclosing the Oncotype DX Breast Recurrence Score®(RS) assay result. Results The analysis included 567 patients (median age, 57 [range, 29–83] years; 70%/1%/29%/ with pN0/pN1mi/pN1 disease; 81% and 19% with RS results 0–25 and 26–100, respectively). The correlations between local and central Ki-67, local Ki-67, and the RS, and central Ki-67 and the RS results were weak (r = 0.35, r = 0.3, and r = 0.46, respectively), and discrepancies were noted in both directions (e.g., local Ki-67 was lower or higher than central Ki-67). After disclosing the RS, treatment recommendations changed for 190 patients (34%). Changes were observed in pN0 and pN1mi/pN1 patients and in patients with centrally determined Ki-67 ≤ 10% and > 10%. Treatment changes were aligned with RS results (adding chemotherapy for patients with higher RS results, omitting it for lower RS results), and their net result was 8% reduction in adjuvant chemotherapy use (from 32% pre-RS results to 24% post-RS results). Conclusion The Oncotype DX® assay is a tool for individualizing treatments that adds to classic treatment decision factors. The RS result and Ki-67 are not interchangeable, and Ki-67, as well as nodal status, should not be used as gatekeepers for testing eligibility, to avoid under and overtreatment.
ISSN:15737217
01676806
DOI:10.1007/s10549-024-07390-y