Endocrine response assessment in HR-positive HER2-negative early breast cancer: concordance of local versus central Ki67 measurements in the WSG ADAPTcycle trial (n = 5292)
Year: 2025
Type: article
Abstract: BACKGROUND: ) as a marker for endocrine therapy response (ETR) has been shown to be a favorable prognostic factor in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC). So far, all studies have used centralized immunohistochemical measurements. In order to assess the robustness of this marker for clinical routine, we have now compared local and central Ki67 measurements in the WSG ADAPTcycle trial. PATIENTS AND METHODS: In the WSG ADAPTcycle trial (n = 5292 screened, 1684 randomized; 85 sites in Germany), patients with intermediate-risk EBC based on Oncotype DX and ETR were randomized to (neo)adjuvant chemotherapy followed by endocrine therapy (ET) versus ribociclib + aromatase inhibitor (AI) (premenopausal: + gonadotropin-releasing hormone). Concordance of local and central Ki67 [baseline (BL), post-ET] was evaluated in the whole trial cohort and in different subgroups. RESULTS: ≤10%) was observed in 1663 patients (64.2%) centrally versus 1571 (60.7%) locally with an OA of 80.5% (95% CI 79% to 82.1%). While overall, among local ET responders, 206 (13.1%) were central non-responders, >90% concordance was seen in AI-treated patients. CONCLUSIONS: When comparing central and local Ki67 assessments in the large multicenter randomized WSG ADAPTcycle trial, we observed similar rates of ET responders. The agreement between local and central Ki67 assessments at BL and post-endocrine treatment was high, but not yet optimal, with the highest concordance observed in AI-treated patients. Incorporating ETR into daily clinical practice together with multigene assays (as used in WSG ADAPT and ADAPTcycle) needs to be supported by clinicopathological markers for therapy decision making and accompanied by quality assurance programs for Ki67 determination.
Source: ESMO Open
Authors: M. Hamann, M. Christgen, O. Gluz, U. Nitz, S. Kuemmel, M. Braun, M. Thill, R. Wuerstlein, P. Wimberger, A. Hartkopf, C. Schem, M. Zaiss, V. Bjelic-Radisic, M. Just, K. Veselinovic, M. Vincent, M. Graeser, K. Krauss, O. Hoffmann, K. Lüdtke-Heckenkamp, R.E. Kates, C. zu Eulenburg, K. Jóźwiak, S. Burmeister, M. Hauptmann, F. Baehner, P. Schmid, H.-H. Kreipe, N. Harbeck
Institutions: Rotkreuzklinikum München, Medizinische Hochschule Hannover, Evangelisches Krankenhaus Bethesda Mönchengladbach, Women‘s Healthcare Group, University Hospital Cologne, Kliniken Essen-Mitte, Charité - Universitätsmedizin Berlin, Agaplesion Markus Hospital, LMU Klinikum, Ludwig-Maximilians-Universität München, University Hospital Carl Gustav Carus, Technische Universität Dresden, Universitäts Frauenklinik, Mammazentrum Hamburg, Krankenhaus Jerusalem, Witten/Herdecke University, Helios Universitätsklinikum Wuppertal, University Hospital Ulm, Krankenhaus Köln-Holweide, Essen University Hospital, Universität Hamburg, Medizinische Hochschule Brandenburg Theodor Fontane, Exact Sciences (United States), Queen Mary University of London, Barts Cancer Institute
Language: English
Subfield: Cancer Research
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $3,910
OpenAlex ID: W4413257566