Assessment of the efficacy of two dosages and schedules of human recombinant erythropoietin in the prevention and correction of cisplatin-induced anemia in cancer patients

Despite the numerous studies demonstrating the effectiveness of epoetin alp ha (human recombinant erythropoietin) versus placebo in cisplatin-induced a nemia of cancer patients, data are lacking on the most effective doses and schedules of administration of epoetin alpha in this setting. The aim of th e present study was to assess the best dose and schedule of administration of epoetin alpha in cancer patients with cisplatin-induced anemia. This was an open, randomized, single-institution phase II study comparing the abili ty of two doses and schedules of epoetin alpha of preventing and/or correct ing anemia, measured as the increase in hemoglobin level and decrease in tr ansfusion requirements, in 20 chemotherapy-naive patients with advanced sta ge head and neck, esophageal, and lung cancer, treated with cisplatin at do ses greater than or equal to 80 mg/m(2). The secondary endpoint of the stud y was to assess the serum levels of certain cytokines involved in cancer an orexia/cachexia syndrome. The eligible patients were randomly assigned to t reatment with either: a) subcutaneous epoetin alpha 150 U/kg three times a week for up to 12 consecutive weeks (Group A); b) subcutaneous epoetin cc 5 0 U/kg daily for up to 12 consecutive weeks (Group B). The following labora tory parameters were assessed before the study entry and during the study: hemoglobin (weekly); serum iron, transferrin and ferritin (before entry). T he following immunological parameters were assessed before and after study end: Interleukin (IL)-1 alpha, IL-1 beta, IL-6 and Tumor Necrosis Factor (T NF) alpha. Twenty patients were enrolled, data were available for 17. Nine patients were assigned to Group A and 8 to Group B. No statistically signif icant difference of hemoglobin level was found between the 2 groups at base line, at month 1, 2 and 3, neither in the comparison of the change from bas eline between the two groups. In Group A fewer transfusions were administer ed per patient per month after the first month of epoetin alpha therapy, co mpared to Group B. No significant difference was found as for transfusion r equirements at month 1, 2 and 3 between Group A and B. The epoetin a dose a dministered was slightly higher than that projected. Epoetin alpha was well -tolerated. There was no statistically significant correlation between chan ge in hemoglobin level and tumor response for either group, neither between change in hemoglobin level and change in ECOG score from baseline to final was observed. The changes from baseline of IL-1 alpha and IL-1 beta, IL-6 and TNF alpha were not remarkable nor univocal in either group, there was n ot correlation between hemoglobin change and serum cytokine changes from ba seline, except for IL-6 in Group A.