TY  - JOUR
A1  - Möbus, Volker
A1  - Jackisch, Christian
A1  - Schneeweiss, Andreas
A1  - Huober, Jens
A1  - Lueck, Hans-Joachim
A1  - Bois, Andreas du
A1  - Thomssen, Christoph
A1  - Kurbacher, Christian M.
A1  - Kuhn, Walther
A1  - Nitz, Ulrike
A1  - Runnebaum, Ingo B.
A1  - Hinke, Axel
A1  - Kreienberg, Rolf
A1  - Untch, Michael
T1  - Adding epoetin alfa to intense dose-dense adjuvant chemotherapy for breast cancer : randomized clinical trial
T2  - Journal of the National Cancer Institute : JNCI
N2  - BACKGROUND: The AGO-ETC trial compared 5-year relapse-free survival of intense dose-dense (IDD) sequential chemotherapy with epirubicin (E), paclitaxel (T), and cyclophosphamide (C) (IDD-ETC) every 2 weeks vs conventional scheduled epirubicin/cyclophosphamide followed by paclitaxel (EC→T) (every 3 weeks) as adjuvant treatment in high-risk breast cancer patients. The objective of this study was to evaluate the safety and efficacy of epoetin alfa in a second randomization of the intense dose-dense arm.
METHODS: One thousand two hundred eighty-four patients were enrolled; 658 patients were randomly assigned to the IDD-ETC treatment group. Within the IDD-ETC group, 324 patients were further randomly assigned to the epoetin alfa group, and 319 were randomly assigned to the non-erythropoiesis-stimulating agent (ESA) control group. Primary efficacy endpoints included change in hemoglobin level from baseline to Cycle 9 and the percentage of subjects requiring red blood cell transfusion. Relapse-free survival, overall survival, and intramammary relapse were secondary endpoints estimated with Kaplan-Meier and Cox regression methods. Except for the primary hypothesis, all statistical tests were two-sided.
RESULTS: Epoetin alfa avoided the decrease in hemoglobin level (no decrease in the epoetin alfa group vs -2.20g/dL change for the control group; P < .001) and statistically significantly reduced the percentage of subjects requiring red blood cell transfusion (12.8% vs 28.1%; P < .0001). The incidence of thrombotic events was 7% in the epoetin alfa arm vs 3% in the control arm. After a median follow-up of 62 months, epoetin alfa treatment did not affect overall survival, relapse-free survival, or intramammary relapse.
CONCLUSIONS: Epoetin alfa resulted in improved hemoglobin levels and decreased transfusions without an impact on relapse-free or overall survival. However, epoetin alfa had an adverse effect, resulting in increased thrombosis.
Y1  - 2013
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/31719
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-317196
SN  - 1460-2105
SN  - 0027-8874
N1  - © The Author 2013. Published by Oxford University Press. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
VL  - 105
IS  - 14
SP  - 1018
EP  - 1026
PB  - Oxford Univ. Press
CY  - Oxford
ER  -