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@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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