Impact of epoetin β on quality of life in patients with malignant disease

This open-label, prospective study was conducted to compare the impact of epoetin β 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]⩽11 g dl(−1)) were randomised to a 12-week treatment with s.c. epoetin β (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 ⩾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 β than with standard care (P<0.05); changes in FACT-An subscale score tended to be greater with epoetin β (P=0.076). Epoetin β 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 β therapy significantly improves QoL compared with standard care in anaemic patients with solid tumours and lymphoid malignancies.