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http://dx.doi.org/10.25673/103212
Titel: | Adjuvant docetaxel in node-negative breast cancer patients : a randomized trial of AGO-Breast Study Group, German Breast Group, and EORTC-Pathobiology Group |
Autor(en): | Thomssen, Christoph Vetter, Martina Kantelhardt, Eva Johanna Meisner, Christoph Schmidt, Marcus Martin, Pierre M. Clatot, Florian Augustin, Doris Hanf, Volker Paepke, Daniela Meinerz, Wolfgang Hoffmann, Gerald Wiest, Wolfgang Sweep, Fred C. G. J. Schmitt, Manfred Jänicke, Fritz Loibl, Sibylle Minckwitz, Gunter Harbeck, Nadia |
Erscheinungsdatum: | 2023 |
Art: | Artikel |
Sprache: | Englisch |
Zusammenfassung: | Background: In node-negative breast cancer (NNBC), a high risk of recurrence is determined by clinico-pathological or tumor-biological assessment. Taxanes may improve adjuvant chemotherapy. Methods: NNBC 3-Europe, the first randomized phase-3 trial in node-negative breast cancer (BC) with tumor-biological risk assessment, recruited 4146 node-negative breast cancer patients from 2002 to 2009 in 153 centers. Risk assessment was performed by clinico-pathological factors (43%) or biomarkers (uPA/PAI-1, urokinase-type plasminogen activator/its inhibitor PAI-1). High-risk patients received six courses 5-fluorouracil (500 mg/m2), epirubicin (100 mg/m2), cyclophosphamide (500 mg/m2) (FEC), or three courses FEC followed by three courses docetaxel 100 mg/m2 (FEC-Doc). Primary endpoint was disease-free survival (DFS). Results: In the intent-to-treat population, 1286 patients had received FEC-Doc, and 1255 received FEC. Median follow-up was 45 months. Tumor characteristics were equally distributed; 90.6% of tested tumors had high uPA/PAI-1-concentrations. Planned courses were given in 84.4% (FEC-Doc) and 91.5% (FEC). Five-year-DFS was 93.2% (95% C.I. 91.1–94.8) with FEC-Doc and 93.7% (91.7–95.3) with FEC. Five-year-overall survival was 97.0% (95.4–98.0) for FEC-Doc and 96.6% % (94.9–97.8) for FEC. Conclusions: With adequate adjuvant chemotherapy, even high-risk node-negative breast cancer patients have an excellent prognosis. Docetaxel did not further reduce the rate of early recurrences and led to significantly more treatment discontinuations. |
URI: | https://opendata.uni-halle.de//handle/1981185920/105164 http://dx.doi.org/10.25673/103212 |
Open-Access: | Open-Access-Publikation |
Nutzungslizenz: | (CC BY 4.0) Creative Commons Namensnennung 4.0 International |
Journal Titel: | Cancers |
Verlag: | MDPI |
Verlagsort: | Basel |
Band: | 15 |
Heft: | 5 |
Originalveröffentlichung: | 10.3390/cancers15051580 |
Enthalten in den Sammlungen: | Open Access Publikationen der MLU |
Dateien zu dieser Ressource:
Datei | Beschreibung | Größe | Format | |
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cancers-15-01580-v3.pdf | 1.44 MB | Adobe PDF | Öffnen/Anzeigen |