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. (276 Německo), A. SYMEONIDIS (300 Řecko), E.N. OLIVA (380 Itálie), J.S. GOEDE (756 Švýcarsko), M. DELFORGE (56 Belgie), Jiří MAYER (203 Česká republika, garant, domácí), B. SLAMA (250 Francie), S. BADRE (840 Spojené státy), E. GASAL (840 Spojené státy), B. MEHTA (840 Spojené státy) a J. FRANKLIN (840 Spojené státy)

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

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

UT WoS

000409232000013

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

Podrobný výpis o publikaci