Epoetin delta: efficacy in the treatment of anaemia in cancer patients receiving chemotherapy.

To assess the effect of epoetin delta on anaemia in patients with cancer who were receiving chemotherapy.This report includes data from two 12-week studies of epoetin delta: a randomised, double-blind, placebo-controlled study of three times weekly epoetin delta (150 or 300IU/kg) and an open-label extension collecting further efficacy and safety information, in which patients initially received epoetin delta 150IU/kg. Co-primary end points for the double-blind study were an increase in haemoglobin levels and a reduction in the requirement for red blood cell transfusions compared with placebo.Double-blind study: 313 cancer patients were randomised to epoetin delta or placebo. Epoetin delta was associated with a significantly greater increase in haemoglobin levels from baseline compared with placebo (epoetin delta 150 and 300IU/kg vs placebo: 2.5 and 2.5g/dl vs 0.6g/dl; P<0.0001 for both comparisons), meeting one co-primary end point. However, there were no significant differences between groups in the proportion of patients requiring red blood cell transfusions (epoetin delta 150 and 300IU/kg vs placebo: 26.0 and 21.9% vs 26.9%), the second co-primary end point. Open-label study: 149 patients entered the extension study. During the extension, haemoglobin levels were maintained and a higher proportion of patients who previously received placebo required transfusions than those who had previously received epoetin delta (previous epoetin delta 150 and 300IU/kg: 7.1 and 11.4% vs previous placebo: 15.9%). Adverse events were as expected for this population in both studies.Epoetin delta shows potential as a treatment for anaemia in cancer patients receiving chemotherapy.