Back
Full-text
Journal article

A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes.

  • Platzbecker U University Hospital Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik I, Dresden, Germany.
  • Symeonidis A Division of Hematology, Department of Internal Medicine, University of Patras Medical School, Patras, Greece.
  • Oliva EN Division of Hematology, Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.
  • Goede JS Division of Hematology, University Hospital and University of Zürich, Zürich, Switzerland.
  • Delforge M Department of Hematology &Chairman Leuven Cancer Institute, University Hospital Leuven, Leuven, Belgium.
  • Mayer J Department of Internal Medicine-Hematology and Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic.
  • Slama B Oncologie Médicale-Hématologie Clinique, Centre Hospitalier Departemental, Avignon, France.
  • Badre S Amgen Inc., Thousand Oaks, CA, USA.
  • Gasal E Amgen Inc., Thousand Oaks, CA, USA.
  • Mehta B Amgen Inc., Thousand Oaks, CA, USA.
  • Franklin J Amgen Inc., Thousand Oaks, CA, USA.
Show more…
  • 2017-06-20
Published in:
  • Leukemia. - 2017
Aged
Aged, 80 and over
Anemia
Blood Transfusion
Darbepoetin alfa
Erythropoietin
Female
Hemoglobins
Humans
Male
Myelodysplastic Syndromes
Risk
English The use of darbepoetin alfa to treat anemia in patients with lower-risk myelodysplastic syndromes (MDS) was evaluated in a phase 3 trial. Eligible patients had low/intermediate-1 risk MDS, hemoglobin ⩽10 g/dl, low transfusion burden and serum erythropoietin (EPO) ⩽500 mU/ml. Patients were randomized 2:1 to receive 24 weeks of subcutaneous darbepoetin alfa 500 μg or placebo every 3 weeks (Q3W), followed by 48 weeks of open-label darbepoetin alfa. A total of 147 patients were randomized, with median hemoglobin of 9.3 (Q1:8.8, Q3:9.7) g/dl and median baseline serum EPO of 69 (Q1:36, Q3:158) mU/ml. Transfusion incidence from weeks 5-24 was significantly lower with darbepoetin alfa versus placebo (36.1% (35/97) versus 59.2% (29/49), P=0.008) and erythroid response rates increased significantly with darbepoetin alfa (14.7% (11/75 evaluable) versus 0% (0/35 evaluable), P=0.016). In the 48-week open-label period, dose frequency increased from Q3W to Q2W in 81% (102/126) of patients; this was associated with a higher hematologic improvement-erythroid response rate (34.7% (34/98)). Safety results were consistent with a previous darbepoetin alfa phase 2 MDS trial. In conclusion, 24 weeks of darbepoetin alfa Q3W significantly reduced transfusions and increased rates of erythroid response with no new safety signals in lower-risk MDS (registered as EudraCT#2009-016522-14 and NCT#01362140).
Language
  • English
Open access status
hybrid
Identifiers
Persistent URL
https://sonar.ch/global/documents/11716
Statistics
Document views: 32 File downloads:
  • Full-text: 0