Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: a randomized, double-blind, placebo-controlled study.
This phase 3, randomized, double-blind, placebo-controlled study was designed to evaluate the efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies. Patients (n = 344) with lymphoma or myeloma received darbepoetin alfa 2.25 microg/kg or placebo s.c., once weekly for 12 weeks. The percentage of patients achieving a haemoglobin response was significantly higher in the darbepoetin alfa group (60%) than in the placebo group (18%) (P < 0.001), regardless of baseline endogenous erythropoietin level. However, increased responsiveness was observed in patients with lower baseline erythropoietin levels. Darbepoetin alfa also resulted in higher mean changes in haemoglobin than placebo from baseline to the last value during the treatment phase (1.80 g/dl vs 0.19 g/dl) and after 12 weeks of treatment (2.66 g/dl vs 0.69 g/dl). A significantly lower percentage of patients in the darbepoetin alfa group received red blood cell transfusions than in the placebo group (P < 0.001). The efficacy of darbepoetin alfa was consistent for patients with lymphoma or myeloma. Improvements in quality of life were also observed with darbepoetin alfa. The overall safety profile of darbepoetin alfa was consistent with that expected for this patient population. Darbepoetin alfa significantly increased haemoglobin and reduced red blood cell transfusions in patients with lymphoproliferative malignancies receiving chemotherapy.
Hedenus
Michael
M
Department of Internal Medicine, Sundsvall Hospital, Sundsvall, Sweden. Michael.Hedenus@lvn.se
Adriansson
Magnus
M
San Miguel
Jesus
J
Kramer
Mark H H
MH
Schipperus
Martin R
MR
Juvonen
Eeva
E
Taylor
Kerry
K
Belch
Andrew
A
Altés
Albert
A
Martinelli
Giovanni
G
Watson
David
D
Matcham
James
J
Rossi
Gregory
G
Littlewood
Timothy J
TJ
D000368:Aged; D000704:Analysis of Variance; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D001803:Blood Transfusion; D000068256:Darbepoetin alfa; D003967:Diarrhea / Q000188:drug therapy; D004311:Double-Blind Method; D004921:Erythropoietin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005221:Fatigue / Q000188:drug therapy; D005260:Female; D005334:Fever / Q000188:drug therapy; D005500:Follow-Up Studies; D006801:Humans; D016014:Linear Models; D008223:Lymphoma / Q000150:complications / Q000188:drug therapy; D008232:Lymphoproliferative Disorders / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000188:drug therapy; D009325:Nausea / Q000188:drug therapy; D011788:Quality of Life
D004921:Erythropoietin; D000068256:Darbepoetin alfa