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We investigated Ki-67 (&gt;\u200910%\u2013\u2009&lt;\u200940%, determined locally) as a prognostic marker for intermediate\/high risk in EBC, pN0-1 patients.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This prospective, non-interventional, real-world study included females\u2009\u2265\u200918\u00a0years, with pN0\/pN1mi\/pN1, HR+\u2009, HER2-negative EBC, and locally determined Ki-67 ranging 10%\u201340%. The primary outcome was changes in treatment recommendations after disclosing the Oncotype DX Breast Recurrence Score<jats:sup>\u00ae<\/jats:sup>(RS) assay result.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The analysis included 567 patients (median age, 57 [range, 29\u201383] years; 70%\/1%\/29%\/ with pN0\/pN1mi\/pN1 disease; 81% and 19% with RS results 0\u201325 and 26\u2013100, 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 (<jats:italic>r<\/jats:italic>\u2009=\u20090.35, <jats:italic>r<\/jats:italic>\u2009=\u20090.3, and <jats:italic>r<\/jats:italic>\u2009=\u20090.46, 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\u2009\u2264\u200910% and\u2009&gt;\u200910%. 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).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>The Oncotype DX<jats:sup>\u00ae<\/jats:sup> 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.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10549-024-07390-y","type":"journal-article","created":{"date-parts":[[2024,6,14]],"date-time":"2024-06-14T06:02:20Z","timestamp":1718344940000},"page":"263-274","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["The REMAR (Rhein-Main-Registry) real-world study: prospective evaluation of the 21-gene breast recurrence score\u00ae assay in addition to Ki-67 for adjuvant treatment decisions in early-stage breast cancer"],"prefix":"10.1007","volume":"207","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8537-3743","authenticated-orcid":false,"given":"Christian","family":"Jackisch","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louiza","family":"Anastasiadou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Aulmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Athanasios","family":"Argyriadis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Volker","family":"M\u00f6bus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Solbach","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Baier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dagmar","family":"Giesecke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sven","family":"Ackermann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elke","family":"Schulmeyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boris","family":"Gabriel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dietrich","family":"Mosch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Buchen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eckart","family":"Krapfl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ursula","family":"Hurst","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"Vescia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans","family":"Tesch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Thill","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,6,14]]},"reference":[{"issue":"1","key":"7390_CR1","doi-asserted-by":"publisher","first-page":"181","DOI":"10.1002\/1097-0142(19890101)63:1<181::AID-CNCR2820630129>3.0.CO;2-H","volume":"63","author":"CL Carter","year":"1989","unstructured":"Carter CL, Allen C, Henson DE (1989) Relation of tumor size, lymph node status, and survival in 24,740 breast cancer cases. 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Presented at the ESMO Congress 2022, 9-13 September 2022, Paris, France"}],"container-title":["Breast Cancer Research and Treatment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10549-024-07390-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10549-024-07390-y\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10549-024-07390-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,2]],"date-time":"2024-08-02T12:58:20Z","timestamp":1722603500000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10549-024-07390-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,14]]},"references-count":42,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,9]]}},"alternative-id":["7390"],"URL":"https:\/\/doi.org\/10.1007\/s10549-024-07390-y","relation":{},"ISSN":["0167-6806","1573-7217"],"issn-type":[{"value":"0167-6806","type":"print"},{"value":"1573-7217","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,14]]},"assertion":[{"value":"20 October 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 May 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 June 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Financial interests: C. Jackisch reports participating in advisory boards for Roche, AstraZeneca, Pfizer, Celgene, Lilly, and Exact Sciences; being a speaker and chairman for educational events for Roche, AstraZeneca, Pfizer, Celgene, Exact Sciences, Lilly, and Pierre-Fabr\u00e9; and receiving research funding from Novartis, Exact Sciences, and Roche. M. Thill reports participating in advisory boards for Agendia, Amgen, AstraZeneca, Aurikamed, Becton\/Dickinson, Biom \u2018Up, ClearCut, Clovis, Daiichi Sankyo, Eisai, Exact Sciences, Gilead Science, Gr\u00fcnenthal, GSK, Lilly, MSD, Norgine, Neodynamics, Novartis, Onkowissen, Organon, Pfizer, pfm Medical, Pierre-Fabre, Roche, RTI Surgical, Seagen, Sirius Pintuition, and Sysmex; receiving manuscript support from Amgen, ClearCut, Clovis, pfm medical, Roche, and Servier; receiving travel support from Amgen, Art Tempi, AstraZeneca, Clearcut, Clovis, Connect Medica, Daiichi Sankyo, Eisai, Exact Sciences, Hexal, I-Med-Institute, Lilly, MCI, Medtronic, MSD, Norgine, Novartis, Pfizer, pfm Medical, Roche, RTI Surgical, and Seagen; congress support from Amgen, AstraZeneca, Celgene, Daiichi Sanyko, Hexal, Neodynamics, Novartis, Pfizer, and Roche; lecture honoraria from Amgen, Art Tempi, AstraZeneca, Clovis, Connect Medica, Eisai, Exact Sciences, Gilead Science, Hexal, I-Med-Institute, J\u00f6rg Eickeler, Lilly, MCI, Medtronic, MSD, Novartis, Omniamed, Onkowissen, Pfizer, pfm Medical, Roche, RTI Surgical, Seagen, Sysmex, Vifor, and Viatris; and trial funding from Endomag, and Exact Sciences. The remaining authors declare no competing financial or non-financial interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study protocol was approved by the responsible Ethics Committee at the Board of Physicians in Hessen (study number FF48\/2015) and informed consent was obtained from all participating patients. The study has been carried out in accordance with the Declaration of Helsinki.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}