RECOMBINANT-HUMAN-ERYTHROPOIETIN IN THE PREVENTION OF CHEMOTHERAPY-INDUCED ANEMIA IN CHILDREN WITH MALIGNANT SOLID TUMORS

This prospective, randomised pilot study was designed to evaluate safe ty, feasibility and efficacy of recombinant human erythropoietin (rhEP O) in the prevention and treatment of chemotherapy-induced anaemia in children with solid tumours. 20 children (age 4-18 years) undergoing c yclic combination chemotherapy were randomised either to a control gro up or to receive rhEPO at a dose of 150 U/kg/dose subcutaneously three times/week for a minimum of 12 weeks or three chemotherapy cycles. Of 15 evaluable patients, 8 were randomised to the rhEPO group and 7 to the control group. RhEPO-treated patients showed an increase in the ha ematocrit over the first 8 weeks of therapy, with a significantly high er mean haematocrit at week 8 (33.2 +/- 2.1% versus 39.3 +/- 4.2% in t he control and rhEPO groups, respectively, P < 0.05). Similarly, signi ficantly higher haemoglobin concentrations could be demonstrated in th e rhEPO group by week 8 (11.06 +/- 1.35 g/dl versus 13.11 +/- 1.13 g/d l in the control and rhEPO groups, respectively, P < 0.05), with highe r precycle haemoglobin before chemotherapy cycles 3 and 4 and higher m idcycle haemoglobin between cycles 3 and 4. There was a trend towards a reduction of transfusion requirements during the 3rd month of therap y in rhEPO patients. The results of this pilot study indicate a signif icant benefit of rhEPO in children treated with intensive combination chemotherapy regimens. Further studies should target issues such as ap propriate dosing, timing and duration of rhEPO therapy in children wit h cancer. (C) 1998 Elsevier Science Ltd. All rights reserved.