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.

Autor: Jackisch C; Department of Gynecology and Obstetrics, Sana Klinikum Offenbach GmbH, Offenbach, Germany. c.jackisch@kem-med.com.; OncoNet Rhein Main e. v., Frankfurt, Germany. c.jackisch@kem-med.com.; KEM, Evang. Kliniken Essen-Mitte gGmbH, Henricistr. 92, 45136, Essen, Germany. c.jackisch@kem-med.com., Anastasiadou L; Department of Palliative Medicine, Agaplesion Markus Hospital, Frankfurt, Germany., Aulmann S; Optipath Frankfurt MVZ Pathology, Frankfurt, Germany., Argyriadis A; Department of Gynecology and Obstetrics, Sana Klinikum Offenbach GmbH, Offenbach, Germany., Möbus V; OncoNet Rhein Main e. v., Frankfurt, Germany.; Department of Gynecology and Obstetrics, Städtische Kliniken Frankfurt Hoechst, Frankfurt, Germany., Solbach C; OncoNet Rhein Main e. v., Frankfurt, Germany.; Department of Gynecology and Obstetrics, Universitaetsklinikum Frankfurt, Frankfurt, Germany., Baier P; Department of Gynecology and Obstetrics, Ketteler Krankenhaus Offenbach, Offenbach, Germany., Giesecke D; Department of Gynecology and Obstetrics, Hochtaunus Kliniken, Bad Homburg, Germany., Ackermann S; Department of Gynecology and Obstetrics, Städtische Kliniken Darmstadt, Darmstadt, Germany., Schulmeyer E; Department of Gynecology and Obstetrics, Main Kinzig Kliniken, Gelnhausen, Germany., Gabriel B; Department of Gynecology and Obstetrics, St. Josefs Hospital, Wiesbaden, Germany., Mosch D; Department of Gynecology and Obstetrics, Varisano Kliniken Frankfurt-Main Taunus, Bad Soden I.T., Germany., Buchen S; OncoNet Rhein Main e. v., Frankfurt, Germany.; Department of Obsetrics and Gynecology, Agaplesion Kliniken Wiesbaden, Wiesbaden, Germany., Krapfl E; OncoNet Rhein Main e. v., Frankfurt, Germany.; Department of Obsterics and Gynecology, Agaplesion Klliniken Langen, Langen, Germany., Hurst U; Department of Gynecology and Obstetrics, Kreiskrankenhaus Bergstrasse, Heppenheim, Germany., Vescia M; Department of Obsetrics and Gynecology, GPR Klinikum Ruesselsheim, Rüsselsheim, Germany., Tesch H; OncoNet Rhein Main e. v., Frankfurt, Germany.; Center for Oncology and Hematology, Onkologie Bethanien, Frankfurt, Germany., Thill M; OncoNet Rhein Main e. v., Frankfurt, Germany.; Department of Gynecology and Gynecological Oncology, Agaplesion Markus Hospital, Frankfurt, Germany.
Jazyk: angličtina
Zdroj: Breast cancer research and treatment [Breast Cancer Res Treat] 2024 Sep; Vol. 207 (2), pp. 263-274. Date of Electronic Publication: 2024 Jun 14.
DOI: 10.1007/s10549-024-07390-y
Abstrakt: 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%- < 40%, determined locally) as a prognostic marker for intermediate/high risk in EBC, pN0-1 patients.
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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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