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Once‐weekly epoetin beta therapy in patients with solid tumours and chemotherapy‐induced anaemia: a randomized, double‐blind, dose‐finding study
Author(s) -
HERAS P.,
KRITIKOS K.,
HATZOPOULOS A.,
MITSIBOUNAS D.
Publication year - 2008
Publication title -
european journal of cancer care
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.849
H-Index - 67
eISSN - 1365-2354
pISSN - 0961-5423
DOI - 10.1111/j.1365-2354.2007.00892.x
Subject(s) - medicine , epoetin alfa , randomized controlled trial , chemotherapy , quality of life (healthcare) , anemia , erythropoietin , gastroenterology , surgery , nursing
Anaemia is common in patients receiving chemotherapy, causing symptoms that have a major impact on quality of life (QoL). Epoetin beta rapidly increases haemoglobin (Hb) levels and improves QoL in anaemic patients with a variety of tumours. This was a randomized, double‐blind, parallel‐group, dose‐finding study assessing the efficacy and safety of once‐weekly epoetin beta in patients with solid tumours receiving chemotherapy. Adult patients with anaemia (Hb < 11 g/dL) were randomized to receive epoetin beta 30 000 IU or 20 000 IU once weekly for 12 weeks. All patients received oral iron supplementation. Haemoglobin levels, transfusion need and QoL [Functional Assesment of Cancer Therapy‐fatigue (FACT‐F) subscale score] were assessed at regular intervals. Fifty patients were randomized; 30 patients received epoetin beta 30 000 IU once weekly and 20 received 20 000 IU once weekly. Mean (± SD) increase in Hb from baseline to week 12 was 1.75 ± 2.15 g/dL in the 30 000 IU group ( P = 0.008 vs. baseline) and 1.04 ± 1.75 g/dL in the 20 000 IU group (non‐significant). Haemoglobin response (increase in Hb ≥2 g/dL from baseline) was observed in 78.3% of patients receiving epoetin beta 30 000 IU and 66.7% receiving epoetin beta 20 000 IU. Improvements in FACT‐F subscale score were significantly ( P < 0.001) correlated with increases in Hb level. Transfusion use was low during the study in both groups. Both epoetin beta regiments were well tolerated and there were no dose‐dependant adverse events. Epoetin beta 30 000 IU once weekly is an effective and well‐tolerated treatment of anaemia in patients with solid tumours.