Final analysis of the prospective WSG-AGO EC-Doc versus FEC phase III trial in intermediate-risk (pN1) early breast cancer: efficacy and predictive value of Ki67 expression
In: Annals of oncology, Jg. 25 (2014), Heft 8, S. 1551-1557
Online
academicJournal
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Zugriff:
Background: Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. WSG-AGO epiribicine and cyclophosphamide (EC)-Doc is a large trial evaluating modern taxane-based chemotherapy in patients with 1―3 positive lymph nodes (LNs) only. Patients and methods: A total of 2011 BC patients (18-65 years, pN1) were entered into a randomized phase III trial comparing 4 × E90C600 q3w followed by 4 × docetaxel100 q3w (n = 1008) with the current standard: 6 × F500E100C500 q3w (n = 828) or C600M40F600 d1, 8x q4w (n = 175). Primary end point was event-free survival (EFS); secondary end points were overall survival (OS), toxicity, translational research, and quality of life. Central tumor bank samples were evaluable in a representative collective (n = 772; 40%). Ki-67 was assessed centrally in hormone receptor-positive disease as a surrogate marker for the distinction of luminal A/B-like tumors. Results: Baseline characteristics were well balanced between study arms in both main study and central tumor bank subset. At 59-month median follow-up, superior efficacy of EC-Doc [versus FEC (a combination of 5-fluorouracil, epirubicin, and cyclophosphamide)] was seen in EFS and OS: 5-year EFS: 89.8% versus 87.3% (P = 0.038); 5-year OS: 94.5% versus 92.8% (P = 0.034); both tests one-tailed. EC-Doc caused more toxicity. In hormone receptor-positive (HR)+ disease, only high-Ki-67 tumors (≥20%) derived significant benefit from taxane-based therapy: hazard ratio = 0.39 (95% Cl 0.18―0.82) for EC-Doc versus FEC (test for interaction; P = 0.01). Conclusion: EC-Doc significantly improved EFS and OS versus FEC in intermediate-risk BC (1-3 LNs) within all subgroups as defined by local pathology. In HR+ disease, patients with luminal A-like tumors may be potentially over-treated by taxane-based chemotherapy.
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Final analysis of the prospective WSG-AGO EC-Doc versus FEC phase III trial in intermediate-risk (pN1) early breast cancer: efficacy and predictive value of Ki67 expression
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Autor/in / Beteiligte Person: | NITZ, U ; GLUZ, O ; MÖBUS, V ; AUGUSTIN, D ; HOFFMANN, G ; WEISS, E ; BOHMER, S ; KREIENBERG, R ; DU BOIS, A ; SATTLER, D ; THOMSSEN, C ; KIECHLE, M ; HUOBER, J ; JÄNICKE, F ; WALLWIENER, D ; HARBECK, N ; KUHN, W ; KREIPE, H. H ; KATES, R. E ; HARTMANN, A ; ERBER, R ; SCHOLZ, M ; LISBOA, B ; MOHRMANN, S |
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Zeitschrift: | Annals of oncology, Jg. 25 (2014), Heft 8, S. 1551-1557 |
Veröffentlichung: | Oxford: Oxford University Press, 2014 |
Medientyp: | academicJournal |
Umfang: | print, 21 ref |
ISSN: | 0923-7534 (print) |
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