Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial

Summary Background Anaemia is associated with poor cancer control, particularly in patients undergoing radiotherapy. We investigated whether anaemia correction with epoetin β could improve outcome of curative radiotherapy among patients with head and neck cancer. Methods We did a multicentre, double-blind, randomised, placebo-controlled trial in 351 patients (haemoglobin Findings 148 (82%) patients given epoetin β achieved haemoglobin concentrations higher than 140 g/L (women) or 150 g/L (men) compared with 26 (15%) given placebo. However, locoregional progression-free survival was poorer with epoetin β than with placebo (adjusted relative risk 1·62 [95% Cl 1·22–2·14]; p=0·0008). For locoregional progression the relative risk was 1·69 (1·16-2·47, p=0·007) and for survival was 1·39 (1·05-1·84, p=0·02). Interpretation Epoetin β corrects anaemia but does not improve cancer control or survival. Disease control might even be impaired. Patients receiving curative cancer treatment and given erythropoietin should be studied in carefully controlled trials.