Universität zu Köln

Nitz, U., Gluz, O., Zuna, I., Oberhoff, C., Reimer, T., Schumacher, C., Hackmann, J., Warm, M., Uleer, C., Runde, V., Duennebacke, J., Belzl, N., Augustin, D., Kates, R. E. and Harbeck, N. (2014). Final results from the prospective phase III WSG-ARA trial: impact of adjuvant darbepoetin alfa on event-free survival in early breast cancer. Ann. Oncol., 25 (1). S. 75 - 82. OXFORD: OXFORD UNIV PRESS. ISSN 1569-8041

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Abstract

Background: WSG-ARA plus trial evaluated the effect of adjuvant darbepoetin alfa (DA) on outcome in node positive primary breast cancer (BC). Patients and methods: One thousand two hundred thirty-four patients were randomized to chemotherapy either with DA (DA+; n = 615) or without DA (DA-; n = 619). DA (500 mu g q3w) was started at hemoglobin (Hb) levels <13.0 g/dl (<12 g/dl after DA label amendment) and stopped at Hb levels >= 14.0 g/dl (12 g/dl after label amendment). Primary efficacy end point was event-free survival (EFS); secondary end points were toxicity, quality of life (QoL) and overall survival (OS). Results: Venous thrombosis (DA+: 3.0%, DA-: 1.0%; P = 0.013) was significantly higher for DA+, but not pulmonary embolism (0.3% in both arms). Median Hb levels were stable in DA+ (12.6 g/dl) and decreased in DA-(11.7 g/dl). Hb levels > 15 g/dl were reported in 0.8% of cycles. QoL parameters did not significantly differ between arms. At 39 months, DA had no significant impact on EFS (DA+: 89.3%, DA-: 87.5%; Plog-rank = 0.55) or OS (DA+: 95.5%, DA-: 95.4%; Plog-rank = 0.77). Conclusions: DA treatment did not impact EFS or OS in routine adjuvant BC treatment.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Nitz, U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gluz, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Zuna, I. UNSPECIFIED UNSPECIFIED UNSPECIFIED Oberhoff, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Reimer, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schumacher, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hackmann, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Warm, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Uleer, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Runde, V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Duennebacke, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Belzl, N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Augustin, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kates, R. E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Harbeck, N. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-450719
DOI:	10.1093/annonc/mdt505
Journal or Publication Title:	Ann. Oncol.
Volume:	25
Number:	1
Page Range:	S. 75 - 82
Date:	2014
Publisher:	OXFORD UNIV PRESS
Place of Publication:	OXFORD
ISSN:	1569-8041
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language QUALITY-OF-LIFE; ERYTHROPOIESIS-STIMULATING AGENTS; DOSE-INTENSIFIED CHEMOTHERAPY; PLACEBO-CONTROLLED TRIAL; EPOETIN-ALPHA; DOUBLE-BLIND; DISEASE PROGRESSION; COMMUNITY ONCOLOGY; RANDOMIZED-TRIAL; CLINICAL-TRIALS Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/45071