Darbepoetin alfa: in patients with chemotherapy-related anaemia.
Darbepoetin alfa, novel erythropoiesis stimulating protein closely related to human erythropoietin, has been developed for the treatment of chemotherapy-related anaemia in patients with non-myeloid malignancies. In three 12-week, phase II studies in patients with cancer and chemotherapy-related anaemia, subcutaneous darbepoetin alfa, administered in once-weekly or 2-, 3- or 4-weekly regimens, dose-dependently increased the mean haemoglobin levels. In a randomised, double-blind, phase III study in 320 patients with lung cancer and chemotherapy-related anaemia, recipients of subcutaneous darbepoetin alfa 2.25 micro g/kg once weekly, received red blood cell (RBC) transfusion approximate, equals 2-fold less frequently than placebo recipients (p < 0.001). In the same study, patients receiving darbepoetin alfa also received fewer standard units of RBC for transfusion and had greater haematopoietic response rate than placebo recipients (both p < 0.001). Subcutaneous darbepoetin alfa 2.25 micro g/kg once weekly also reduced patient-reported fatigue (assessed by a quality-of-life questionnaire) [p = 0.019 vs placebo]. black triangle Darbepoetin alfa was generally well tolerated in clinical trials. The most frequent darbepoetin alfa-related adverse events were: body oedema, arthralgia and skin rash.
Adis International Limited, Mairangi Bay, Auckland, New Zealand. demail@adis.co.nz
Risto S
RS
Cvetkovic
Karen L
KL
Goa
D000740:Anemia / Q000139:chemically induced / Q000188:drug therapy*; D000818:Animals; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001682:Biological Availability; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D000068256:Darbepoetin alfa; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004920:Erythropoiesis / Q000187:drug effects; D004921:Erythropoietin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D017467:Receptors, Erythropoietin / Q000819:agonists*; D016896:Treatment Outcome
D017467:Receptors, Erythropoietin; D004921:Erythropoietin; D000068256:Darbepoetin alfa