Nitz, Ulrike A., Gluz, Oleg, Kuemmel, Sherko ORCID: 0000-0001-9355-494X, Christgen, Matthias, Braun, Michael, Aktas, Bahriye ORCID: 0000-0002-5474-051X, Luedtke-Heckenkamp, Kerstin, Forstbauer, Helmut, Grischke, Eva-Maria, Schumacher, Claudia, Darsow, Maren, Krauss, Katja, Nuding, Benno, Thill, Marc, Potenberg, Jochem, Uleer, Christoph, Warm, Mathias, Fischer, Hans Holger, Malter, Wolfram, Hauptmann, Michael ORCID: 0000-0001-8539-0148, Kates, Ronald E., Graeser, Monika, Wuerstlein, Rachel, Shak, Steven, Baehner, Frederick, Kreipe, Hans H. and Harbeck, Nadia (2022). Endocrine Therapy Response and 21-Gene Expression Assay for Therapy Guidance in HR+/HP2-Early Breast Cancer. J. Clin. Oncol., 40 (23). S. 2557 - 2572. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1527-7755

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Abstract

PURPOSE To our knowledge, WSG-ADAPT-HR+/HER2- (ClinicalTrials.gov identifier: NCT01779206; n = 5,625 registered) is the first trial combining the 21-gene expression assay (recurrence score [RS]) and response to 3-week preoperative endocrine therapy (ET) to guide systemic therapy in early breast cancer. MATERIALS AND METHODS Baseline and postendocrine Ki67 (Ki67(post)) were evaluated centrally. In the en docrine trial, all patients received exclusively ET: patients with pathologic regional lymph node status (pN) 0-1 (ie, 0-3 involved lymph nodes) entered control arm if RS <= 11 and experimental arm if RS12-25 with ET response (Ki67(post) <= 10%). All other patients (including N0-1 RS12-25 without ET response) received dose-dense chemotherapy (CT) followed by ET in the CT trial. Primary end point of the endocrine trial was non-inferiority of 5-year invasive disease-free survival (5y-iDFS) in experimental (v control) arm; secondary end points included distant DFS, overall survival, and translational research. RESULTS Intention-to-treat population comprised 2,290 patients (n = 1,422 experimental v n = 868 control): 26.3% versus 34.6% premenopausal and 27.4% versus 24.0% pN1. One-sided 95% lower confidence limit of the 5y-iDFS difference was -3.3%, establishing prespecified noninferiority (P = .05). 5y-iDFS was 92.6% (95% CI, 90.8 to 94.0) in experimental versus 93.9% (95% CI, 91.8 to 95.4) in control arm; 5-year distant DFS was 95.6% versus 96.3%, and 5-year overall survival 97.3% versus 98.0%, respectively. Differences were similar in age and nodal subgroups. In N0-1 RS12-25, outcome of ET responders (ET alone) was comparable with that of ET nonresponders (CT) for age > 50 years and superior for age <= 50 years. ET response was more likely with aromatase inhibitors (mostly postmenopausal) than with tamoxifen (mostly premenopausal): 78.1% versus 41.1% (P< .001). ET response was 78.8% in RS0-11, 62.2% in RS12-25, and 32.7% in RS > 25 (n = 4,203, P < .001). CONCLUSION WSG-ADAPT-HR+/HER2- demonstrates that guiding systemic treatment by both RS and ET response is feasible in clinical routine and spares CT in pre- and postmenopausal patients with <= 3 involved lymph nodes. (C) 2022 by American Society of Clinical Oncology

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Nitz, Ulrike A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gluz, OlegUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuemmel, SherkoUNSPECIFIEDorcid.org/0000-0001-9355-494XUNSPECIFIED
Christgen, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Braun, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Aktas, BahriyeUNSPECIFIEDorcid.org/0000-0002-5474-051XUNSPECIFIED
Luedtke-Heckenkamp, KerstinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Forstbauer, HelmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grischke, Eva-MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schumacher, ClaudiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Darsow, MarenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krauss, KatjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nuding, BennoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thill, MarcUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Potenberg, JochemUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Uleer, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Warm, MathiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, Hans HolgerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Malter, WolframUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hauptmann, MichaelUNSPECIFIEDorcid.org/0000-0001-8539-0148UNSPECIFIED
Kates, Ronald E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Graeser, MonikaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wuerstlein, RachelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Shak, StevenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baehner, FrederickUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreipe, Hans H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Harbeck, NadiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-696580
DOI: 10.1200/JCO.21.02759
Journal or Publication Title: J. Clin. Oncol.
Volume: 40
Number: 23
Page Range: S. 2557 - 2572
Date: 2022
Publisher: LIPPINCOTT WILLIAMS & WILKINS
Place of Publication: PHILADELPHIA
ISSN: 1527-7755
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
KI67; INDEX; MULTICENTER; PREDICTION; DECISIONS; TAMOXIFEN; KI-67Multiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69658

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