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

J 2017

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

PLATZBECKER, U., A. SYMEONIDIS, E.N. OLIVA, J.S. GOEDE, M. DELFORGE et. al.

Basic information

Original name

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

Authors

PLATZBECKER, U. (276 Germany), A. SYMEONIDIS (300 Greece), E.N. OLIVA (380 Italy), J.S. GOEDE (756 Switzerland), M. DELFORGE (56 Belgium), Jiří MAYER (203 Czech Republic, guarantor, belonging to the institution), B. SLAMA (250 France), S. BADRE (840 United States of America), E. GASAL (840 United States of America), B. MEHTA (840 United States of America) and J. FRANKLIN (840 United States of America)

Edition

Leukemia, London, Nature Publishing Group, 2017, 0887-6924

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

Impact factor

Impact factor: 10.023

RIV identification code

RIV/00216224:14110/17:00098732

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1038/leu.2017.192

UT WoS

000409232000013

Keywords in English

darbepoetin alfa

Abstract

V originále

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 mu g 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).

Citovat

PLATZBECKER, U., A. SYMEONIDIS, E.N. OLIVA, J.S. GOEDE, M. DELFORGE, Jiří MAYER, B. SLAMA, S. BADRE, E. GASAL, B. MEHTA and J. FRANKLIN. A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes. Leukemia. London: Nature Publishing Group, 2017, vol. 31, No 9, p. 1944-1950. ISSN 0887-6924. Available from: https://dx.doi.org/10.1038/leu.2017.192.

@article{1398987,
   author = {Platzbecker, U. and Symeonidis, A. and Oliva, E.N. and Goede, J.S. and Delforge, M. and Mayer, Jiří and Slama, B. and Badre, S. and Gasal, E. and Mehta, B. and Franklin, J.},
   article_location = {London},
   article_number = {9},
   doi = {http://dx.doi.org/10.1038/leu.2017.192},
   keywords = {darbepoetin alfa},
   language = {eng},
   issn = {0887-6924},
   journal = {Leukemia},
   title = {A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes},
   volume = {31},
   year = {2017}
}

TY  - JOUR
ID  - 1398987
AU  - Platzbecker, U. - Symeonidis, A. - Oliva, E.N. - Goede, J.S. - Delforge, M. - Mayer, Jiří - Slama, B. - Badre, S. - Gasal, E. - Mehta, B. - Franklin, J.
PY  - 2017
TI  - A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes
JF  - Leukemia
VL  - 31
IS  - 9
SP  - 1944-1950
EP  - 1944-1950
PB  - Nature Publishing Group
SN  - 08876924
KW  - darbepoetin alfa
N2  - 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 mu g 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).
ER  -

PLATZBECKER, U., A. SYMEONIDIS, E.N. OLIVA, J.S. GOEDE, M. DELFORGE, Jiří MAYER, B. SLAMA, S. BADRE, E. GASAL, B. MEHTA and J. FRANKLIN. A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes. \textit{Leukemia}. London: Nature Publishing Group, 2017, vol.~31, No~9, p.~1944-1950. ISSN~0887-6924. Available from: https://dx.doi.org/10.1038/leu.2017.192.

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