RECOMBINANT-HUMAN-ERYTHROPOIETIN TREATMENT IN CISPLATIN-ASSOCIATED ANEMIA - A RANDOMIZED, DOUBLE-BLIND TRIAL WITH PLACEBO

Purpose: To evaluate the effect of exogenous recombinant human erythropoietin (rHuEPO) on the increase of hemoglobin levels and on the transfusion requirements in patients with cisplatin (CDDP)-induced anemia, we performed a double-blind randomized trial with placebo. Patients and Methods: One hundred patients with CDDP-associated anemia (hemoglobin level < 90 g/L) were randomized to receive either placebo (saline solution) or rHuEPO (100 U/kg body weight subcutaneously) three times per week. The end points of this study were the increase in hemoglobin levels to greater than 100 g/L after 3, 6, and 9 weeks and the effect on transfusion requirements. Results: Ninety- nine of 100 patients were assessable for response and toxicity. In the rHuEPO arm, mean hemoglobin levels were statistically significantly increased after the third, sixth, and ninth weeks of therapy (101.1 ± 9.0, 102.4 ± 6.6, and 105.1 ± 9.4 g/L, respectively) compared with the mean baseline value (86.3 ± 6.2 g/L). In the placebo arm, there were no increases in mean hemoglobin levels at the third, sixth, and ninth weeks (81.0 ± 5.2, 81.3 ± 9.2, and 81.2 ± 11 g/L, respectively) compared with the mean baseline value (87.3 ± 5.2 g/L). Furthermore only 20% of patients required blood transfusions in the rHuEPO arm versus 56% of patients in the placebo arm (P = .01), with a mean units of blood transfused per patient of 0.30 in the rHuEPO arm and 1.8 in the placebo arm (P = .01). Treatment was well tolerated, with no significant side effects. Conclusion: CDDP-induced anemia is corrected by rHuEPO, which results in reduced blood transfusion requirements.