REDUCED BLOOD-TRANSFUSIONS REQUIREMENTS AFTER ALLOGENEIC BONE-MARROW TRANSPLANTATION - RESULTS OF A RANDOMIZED, DOUBLE-BLIND-STUDY WITH HIGH-DOSE ERYTHROPOIETIN

Patients with haematological malignancies undergoing allogeneic BMT we re randomised to treatment with recombinant human erythropoietin (rHuE PO) (n = 25) or placebo (n = 25). rHuEPO was given at 200 U/kg daily f or 4 weeks and 200 U/kg twice weekly for a further 4 weeks. The groups were similar regarding several prognostic factors. There were no diff erences between the two groups regarding time to engraftment, fever, h ospitalisation, GVHD, infections, haemorrhages, transplant-related mor tality relapse and survival. However, more patients in the control gro up had a raised serum creatinine (43% vs 14%; p = 0.04). Red blood cel l (RBC) transfusion requirements for the first 2 months after BMT were significantly lower in the rHuEPO group compared with the control gro up (5 units vs 10; p = 0.04). Time to unsupported Hb > 70 g/l was less in patients treated with rHuEPO (14 days vs 24; p = 0.03). No effect was seen on platelet engraftment or the number of transfused platelet units. Two patients in the control group compared with none in the rHu EPO group became refractory to platelet transfusions. According to the protocol the study drug was reduced (Hb > 100) or discontinued (Hb > 120) for a mean of 3.6 weeks among 11 rHuEPO patients compared with 1. 9 weeks among 7 controls (p = 0.02). Seven of the treated patients com pared with none of the controls reached Hb > 120 during the study peri od (p = 0.004). Among the rHuEPO treated patients, EPO-levels were sig nificantly higher than in the controls. Mean EPO levels were 1265 mU/m l vs 193 (p < 0.001) during the first month and 254 mU/ml vs 87 (p < 0 .05) during the second month in the two groups, respectively. One week after rHuEPO was discontinued, EPO-levels were similar: 82 mU/ml in t he rHuEPO group vs 73 in the control group. Side-effects were rare; ho wever, three patients discontinued rHuEPO due to joint pain. The avera ge rHuEPO patient given 386000 units of the drug, received five fewer RBC transfusions and stayed 2 days less in hospital; costs approximate ly US$ 2000 more than the average control patient. We conclude that rH uEPO iv in high doses significantly raised Hb levels and reduced RBC t ransfusion requirements during the first 2 months after BMT.