title: Impact of epoetin beta on quality of life in patients with malignant disease.
abstract: This open-label, prospective study was conducted to compare the impact of epoetin beta vs standard care on quality of life (QoL) in anaemic patients with lymphoid or solid tumour malignancies. A total of 262 anaemic patients (haemoglobin [Hb]<or=11 g dl(-1)) were randomised to a 12-week treatment with s.c. epoetin beta (initial dose 150 IU kg(-1) three times weekly) or standard care. Transfusions were recommended for both groups at an Hb threshold of 8.5 g dl(-1). The primary efficacy variables were improvement in QoL as measured using the Short-Form-36 physical component summary (SF-36 PCS) score and the Functional Assessment of Cancer Therapy fatigue and anaemia subscales (FACT-F and FACT-An). A visual analogue scale (VAS) was also used as a global QoL measure. Clinical response was defined as a >or=2 g dl(-1) increase in Hb level without need of transfusion after the initial 4 weeks of treatment. Baseline to final visit changes in SF-36 PCS, FACT-F and VAS scores were significantly greater with epoetin beta than with standard care (P<0.05); changes in FACT-An subscale score tended to be greater with epoetin beta (P=0.076). Epoetin beta significantly increased Hb concentrations relative to standard care (responders: 47% vs 13%; P<0.001). Levels of endogenous erythropoietin <50 mIU ml(-1) were significantly predictive of response (OR 2.496, 95% CI: 1.21-5.13). Epoetin beta therapy significantly improves QoL compared with standard care in anaemic patients with solid tumours and lymphoid malignancies.
authors.affiliation: Labo Hematologie Transplant, U.Z. Gasthuisberg, Leuven, Belgium. Marc.Boogaerts@med.kuleuven.ac.be
authors.forename: M
authors.initials: M
authors.lastname: Boogaerts
authors.forename: B
authors.initials: B
authors.lastname: Coiffier
authors.forename: C
authors.initials: C
authors.lastname: Kainz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004921:Erythropoietin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000523:psychology; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins
chemical_list: D011994:Recombinant Proteins; C103998:epoetin beta; D004921:Erythropoietin