Randomised phase III trial of FEC120 vs EC-docetaxel in patients with high-risk node-positive primary breast cancer

• Verfasst von: Janni, Wolfgang [VerfasserIn]
• Verfasst von: Wischnik, Arthur [VerfasserIn]
• Titel: Randomised phase III trial of FEC120 vs EC-docetaxel in patients with high-risk node-positive primary breast cancer
• Titelzusatz: final survival analysis of the ADEBAR study
• Verf.angabe: W. Janni, N. Harbeck, B. Rack, D. Augustin, J. Jueckstock, A. Wischnik, K. Annecke, C. Scholz, J. Huober, T. Zwingers, T.W.P. Friedl and M. Kiechle
• E-Jahr: 2016
• Jahr: 31 March 2016
• Umfang: 9 S.
• Fussnoten: Gesehen am 05.11.2019
• Titel Quelle: Enthalten in: British journal of cancer
• Ort Quelle: Edinburgh : Nature Publ. Group, 1999
• Jahr Quelle: 2016
• Band/Heft Quelle: 114(2016), 8, Seite 863-871
• ISSN Quelle: 1532-1827
• DOI: doi:10.1038/bjc.2016.82
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1681100401

Abstract

Background: Taxane-containing adjuvant chemotherapy has been established as standard treatment in node-positive breast cancer. This study compared efficacy and tolerability of epirubicin (E)/cyclophosphamide (C) followed by docetaxel (Doc) with a dose-dense 5-fluorouracil (F)+E+ C regimen. Methods: The ADEBAR study was a randomised phase III trial for women with primary invasive breast cancer and ≥4 metastatic axillary lymph nodes (n=1364). Treatment consisted of four 21-day cycles of E plus C, followed by four 21-day cycles of Doc (EC-Doc), or six 28-day cycles of E plus F plus C (FEC120). Results: Disease-free survival (DFS) was similar in the two treatment arms as shown by multivariate Cox regression adjusted for other prognostic factors (EC-Doc vs FEC120, hazard ratio (HR): 1.087; 95% confidence interval (CI): 0.878-1.346, P=0.444). In addition, there was no significant difference in overall survival (OS) between the two groups (HR: 0.974; 95% CI: 0.750-1.264, P=0.841). Haematologic toxicity was more common in FEC120 recipients; non-haematologic toxicities occurred more frequently in the EC-Doc arm. The serious adverse event rate was significantly higher in the FEC120 group (29.7% vs 22.5%). Conclusions: EC-Doc provides a feasible and effective alternative therapy option to FEC120 with a different safety profile in this high-risk breast cancer cohort.