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Clinical Trial
. 2003 Apr 7;88(7):988-95.
doi: 10.1038/sj.bjc.6600801.

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

M Boogaerts  1 , B Coiffier, C Kainz; Epoetin beta QOL Working Group
Affiliations
Clinical Trial

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

M Boogaerts et al. Br J Cancer. .

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.

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Figures

Figure 1
Figure 1
Change in quality of life (QoL) score from baseline at weeks 3–4, 6–8 and 12 during epoetin β therapy or blood transfusion as assessed by the SF-36 PCS, FACT-F, FACT-An and VAS instruments. Data are presented as mean (s.d.) for the patient population without last observation carried forward.
Figure 2
Figure 2
Percentage of patients showing a clinical response to therapy defined as an increase in haemoglobin ⩾2 g dl−1 without the need for transfusion after the initial 4 weeks of treatment.
Figure 3
Figure 3
Change in median haemoglobin levels in response to epoetin β (n=133) or standard care (n=129) during the study period.
Figure 4
Figure 4
Median increase in haemoglobin levels in response to epoetin β (n=133) or standard care (n=129) at the end of the study period.
See this image and copyright information in PMC

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