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.

Základní údaje

Originální název

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

Autoři

PLATZBECKER, U.; A. SYMEONIDIS; E.N. OLIVA; J.S. GOEDE; M. DELFORGE; Jiří MAYER; B. SLAMA; S. BADRE; E. GASAL; B. MEHTA a J. FRANKLIN

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30205 Hematology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 10.023

Kód RIV

RIV/00216224:14110/17:00098732

Organizační jednotka

Lékařská fakulta

DOI

https://doi.org/10.1038/leu.2017.192

UT WoS

000409232000013

EID Scopus

2-s2.0-85028816042

Klíčová slova anglicky

darbepoetin alfa

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 15. 3. 2018 17:08, Soňa Böhmová

Anotace

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 a 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, roč. 31, č. 9, s. 1944-1950. ISSN 0887-6924. Dostupné z: https://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 = {https://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 a 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, roč.~31, č.~9, s.~1944-1950. ISSN~0887-6924. Dostupné z: https://doi.org/10.1038/leu.2017.192.

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