Abstract
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 μg/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.
| Original language | English |
|---|---|
| Pages (from-to) | 394-403 |
| Number of pages | 10 |
| Journal | British Journal of Haematology |
| Volume | 122 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Aug 2003 |
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Keywords
- Anaemia
- Cancer
- Erythropoietin
- Lymphoma
- Myeloma
ASJC Scopus subject areas
- Hematology
Cite this
Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies : A randomized, double-blind, placebo-controlled study. / Hedenus, Michael; Adriansson, Magnus; San Miguel, Jesus; Kramer, Mark H H; Schipperus, Martin R.; Juvonen, Eeva; Taylor, Kerry; Belch, Andrew; Altés, Albert; Martinelli, Giovanni; Watson, David; Matcham, James; Rossi, Gregory; Littlewood, Timothy J.
In: British Journal of Haematology, Vol. 122, No. 3, 08.2003, p. 394-403.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies
T2 - A randomized, double-blind, placebo-controlled study
AU - Hedenus, Michael
AU - Adriansson, Magnus
AU - San Miguel, Jesus
AU - Kramer, Mark H H
AU - Schipperus, Martin R.
AU - Juvonen, Eeva
AU - Taylor, Kerry
AU - Belch, Andrew
AU - Altés, Albert
AU - Martinelli, Giovanni
AU - Watson, David
AU - Matcham, James
AU - Rossi, Gregory
AU - Littlewood, Timothy J.
PY - 2003/8
Y1 - 2003/8
N2 - 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 μg/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.
AB - 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 μg/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.
KW - Anaemia
KW - Cancer
KW - Erythropoietin
KW - Lymphoma
KW - Myeloma
UR - http://www.scopus.com/inward/record.url?scp=0041627742&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0041627742&partnerID=8YFLogxK
U2 - 10.1046/j.1365-2141.2003.04448.x
DO - 10.1046/j.1365-2141.2003.04448.x
M3 - Article
VL - 122
SP - 394
EP - 403
JO - British Journal of Haematology
JF - British Journal of Haematology
SN - 0007-1048
IS - 3
ER -