PREVENTION OF CHEMOTHERAPY-INDUCED ANEMIA BY THE USE OF ERYTHROPOIETIN IN PATIENTS WITH PRIMARY MALIGNANT BONE-TUMORS (A DOUBLE-BLIND, RANDOMIZED, PHASE-III STUDY)

Background: Patients undergoing chemotherapy for treatment of malignan cy frequently experience clinically significant anemia. Myelosuppressi ve chemotherapy impairs erythropoiesis, which may not fully recover be tween treatment cycles. Recombinant human erythropoietin (rHuEPO) has been effectively introduced in anemic patients suffering from chronic renal failure. The present study was designed to assess, first, whethe r rHuEPO treatment decreases transfusion requirements in chemotherapy- induced anemia and, second, whether high-dose rHuEPO application is sa fe. Study Design and Methods: Thirty consecutive anemic patients (hemo globin <11 g/dL) receiving combination chemotherapy for primary malign ant bone tumors were studied in a prospective, double-blind, randomize d, Phase III trial. Patients received chemotherapy according to one of two German protocols, depending on histologic diagnosis. All subjects enrolled were randomly assigned either to receive 600 IU of rHuEPO pe r kg of body weight intravenously twice a week or to receive a placebo during chemotherapy. To obtain comparable data, an observation period of 20 weeks was chosen. Twenty-nine patients fulfilled the criteria a nd were eligible for statistical evaluation. Results: Transfusion requ irements were significantly decreased from Week 8 of therapy (p<0.05) in the treatment group. Therapeutic benefits were even more evident wi th continuation of therapy (Week 12, p = 0.03; Week 16, p = 0.016; Wee k 20, p = 0.002). The blood required was 2.1 units of red cells in the treatment group and 8.4 units of red cells in the placebo group. All patients tolerated rHuEPO with no serious side effects. Conclusion: Th ese findings suggest that rHuEPO is an effective and well-tolerated th erapeutic option for decreasing the transfusion requirements in chemot herapy-induced anemia.