Clinical Study

British Journal of Cancer (2006) 94, 947–954. doi:10.1038/sj.bjc.6603004 www.bjcancer.com
Published online 28 March 2006

Epoetin alfa in platinum-treated ovarian cancer patients: results of a multinational, multicentre, randomised trial

This study was supported by Ortho Biotech, a division of Janssen-Cilag.

P M Wilkinson1, M Antonopoulos2, M Lahousen3, M Lind4 and P Kosmidis5 for the EPO-INT-45 Study Group

  1. 1Christie Hospital, Wilmslow Road, Manchester M20 4BX, UK
  2. 2Athina Hospital, Athens, Greece
  3. 3University Klinik fur Gynakologie, Graz, Austria
  4. 4Hull Royal, Hull, UK
  5. 5Ygeia Hospital, Athens, Greece

Correspondence: Dr PM Wilkinson, E-mail: peter.wilkinson@christie-tr.nwest.nhs.uk

Received 1 July 2005; Revised 27 October 2005; Accepted 16 January 2006; Published online 28 March 2006.

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Abstract

This multicentre, open-label, controlled clinical trial assessed the effects of epoetin alfa treatment on haematologic and quality of life (QOL) parameters in 182 anaemic (Hbless than or equal to12 g dl-1) ovarian cancer patients receiving platinum chemotherapy. Patients were randomised 2 : 1 to receive epoetin alfa 10 000–20 000 IU three times weekly plus best standard treatment (BST) or BST only. Main study end points were changes from baseline in haemoglobin (Hb) level, transfusion requirements, and QOL. For the epoetin alfa group, mean Hb increased by 1.8 g dl-1 by weeks 4–6 and was significantly increased from baseline through study end (P<0.001). The mean change in Hb from baseline was significantly (P<0.001) greater for epoetin alfa than BST patients at all postbaseline evaluations. Significantly fewer epoetin alfa than BST patients required transfusion(s) after the first 4 weeks of treatment (7.9 vs 30.5%; P<0.001). Also, significant (Pless than or equal to0.04) differences favouring the epoetin alfa group over the BST group were found for all three median CLAS scores (Energy Level, Ability to Do Daily Activities, Overall QOL) and the median average CLAS score during chemotherapy. These findings support use of epoetin alfa to increase Hb levels, reduce transfusion use, and improve QOL in anaemic ovarian cancer patients receiving platinum chemotherapy.

Keywords:

anaemia, epoetin alfa, haemoglobin, ovarian, quality of life

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