The Study Of Efficacy And Optimal Dose Of Recombinant Human Erythropoietin For Chinese Anemic Patients With Malignancies

Objective To study the efficacy and optimal dose of recombinant human erythropoietin for Chinese anemic patients with malignancies.Methods There were 131 adult patients with a confirmed diagnosis of malignancies scheduled to receive cisplatin-based chemotherapy. All patients had hemoglobin (Hb) level less than 11g/dL or decreased hemoglobin level more than 15g/L after one chemotherapy cycle, not less than 18 years, not received blood transfusion or erythropoietin before four weeks, and had a life expectancy of at least three months.All patients were randomly allocated to six groups including placebo group and five rhEPO groups with different doses which was 50u/kg, 100u/kg, 150u/kg, 200u/kg, 400u/kg respectively. rhEPO was injected subcutaneously thrice weekly. The doses were doubled after four weeks of therapy, if hemoglobin level did not increase by ≥10g/L. Treatment time was eight weeks. Blood transfusion and iron supplement was permitted. The end point was hemoglobin level, hematocrit level, transfusion rate, the proportion of responders (patients with an increase in hemoglobin ≥20g/L), change in Kamofsky performance status (KPS), and adverse events of rhEPO.Results 124 patients were enrolled.The mean Hb levels and hematocrit levels of all rhEPO teams increased gradually, and had statistical significance with those at baseline after four to six weeks of therapy. The significant difference in mean Hb and hematocrit level from baseline was initially found at four weeks after therapy in the 50u/kg group, and at six weeks after therapy in the other rhEPO groups. The mean KPS increased gradually after treatment of rhEPO, and had statistical significance with those at baseline after eight weeks of therapy. The transfusion rate and adverse events in rhEPO groups all showed statistical significance with those in placebo group.The efficancy of different rhEPO groups was not the same as each other. The efficancy of 50u/kg group was lessthan the other rhEPO groups, with effect rate of 9.1%( p>0.05) and 27.3% (p<0.05) after four and eight weeks respectively. The efficancy of the other rhEPO groups had not been different from each other, with higher effect rate of 28.6%~36.8%(p<0.05 or p< 0.01)and 57.1%~68.4%(p<0.01) after four and eight weeks than 50u/kg group. lOOu/kg group and other groups of rhEPO which dose was more than 1 OOu/kg had not statistical significance in such things as improvement of hemoglobin level, hematocrit level and KPS, dreased transfusion rate, adverse events and effect rate.Conclusion The efficancy of rhEPO is sure in treating anemic patients with malignancies and preventing chemotherapy-induced anemia in dose range from 50u/kg to 400u/kg thrice weekly. It can significantly increase the hemoglobin levels, hematocrit levels, and quality of life of anemic patients, showing a considerable safety during treatment. The efficancy of 50u/kg group is less than the other groups of rhEPO. 1 OOu/kg group of rhEPO has the same efficancy as the other groups which dose is more than 1 OOu/kg, showing safer and a effect-cost privilege. So we suggest that 1 OOu/kg more or less should be studied further for Chinese anemic patients with malignancies as optimal dose of rhEPO. Racial variations probably play a role on efficancy of rhEPO.