Erythropoietin reduces anemia and transfusions - A randomized trial with or without erythropoietin during chemotherapy

BACKGROUND. Anemia has been reported to develop during preoperative chemoth erapy with paclitaxel and carboplatin. The use of recombinant human erythro poietin (EPO) has been shown to reduce anemia and subsequent packed red blo od cell transfusions. The current study is a report of a Phase III, prospec tive, randomized trial with or without EPO that confirms the original obser vations of less anemia and fewer transfusions in those patients randomized to receive EPO concurrently with paclitaxel and carboplatin. METHODS. Thirty patients with advanced head and neck or lung carcinoma were treated with 2 courses Of paclitaxel, 230 mg/m(2), and carboplatin, 7.5 mg /mL/minute, repeated every 21 days. The treatment group was comprised of 15 patients randomized to receive concurrent EPO, 150 U/kg, 3 times per week; in patients deemed nonresponsive the dose was increased Co 300 U/kg and 45 0 U/kg in subsequent courses. The control group was comprised of 15 patient s randomized not to receive EPO. RESULTS. Twenty-seven patients were evaluable. After 2 courses of chemother apy the mean hemoglobin decrease was 1.2 g/dL in the EPO group versus 2.8 g /dL in the control group (P = 0.037). There was a highly significant decrea se in hemoglobin over time in patients who did not receive EPO (P = 0.008). After 4 courses of chemotherapy, fewer patients were transfused in the EPO arm: 2 of 13 (15%) in the EPO treatment group versus 5 of 14 (36%) in the control group. CONCLUSIONS. There was significantly less anemia and transfusions were redu ced by 50% in patients randomized to receive EPO during chemotherapy with p aclitaxel and carboplatin. Cancer 1999;86:1362-7. (C) 1999 American Cancer Society.