Prolonged administration of erythropoietin increases erythroid response rate in myelodysplastic syndromes: a phase II trial in 281 patients.
Treatment with recombinant human erythropoietin (rHuEpo) improves anaemia in approximately 20% of patients with myelodysplastic syndromes (MDS). We investigated the potential advantage of a prolonged administration of rHuEpo to achieve higher erythroid response rates (RR) in 281 MDS patients: 118 with refractory anaemia (RA), 77 with refractory anaemia and ringed sideroblasts (RARS), 59 with refractory anaemia with excess of blasts and blast count < 10% (RAEB-I), and 27 with RAEB and blast count between 11-20% (RAEB-II). rHuEpo was given subcutaneously at a dose of 150 U/kg thrice weekly, for a minimum of 26 weeks. Response to treatment was evaluated after 12 and 26 weeks of therapy. The overall RR was 45.1%; the RR for RA, RARS, RAEB-I and RAEB-II were 48.3%, 58.4%, 33.8% and 13% respectively. A significant increase in RR was observed at week 26 in RA, RARS and RAEB-I patients, as the response probability increased with treatment duration. The RR was higher in the good cytogenetic prognostic group and serum Epo level of > 150 U/l at baseline predicted for non-response. The median duration of response was 68 weeks and the overall risk of leukaemic transformation was 21.7%. These results suggest that prolonged administration of rHuEpo produces high and long-lasting erythroid RR in MDS patients with low blast counts, particularly in those with pretreatment serum Epo levels of < 150 U/l and good cytogenetic prognosis.
Terpos
Evangelos
E
Department of Haematology, Faculty of Medicine, Imperial College of Science, Technology and Medicine, Hammersmith Hospital, London, UK. eterpos@hotmail.com
Mougiou
Athina
A
Kouraklis
Alexandra
A
Chatzivassili
Aria
A
Michalis
Evridiki
E
Giannakoulas
Nicholas
N
Manioudaki
Eleni
E
Lazaridou
Anna
A
Bakaloudi
Vassiliki
V
Protopappa
Maria
M
Liapi
Dimitra
D
Grouzi
Elisavet
E
Parharidou
Agapi
A
Symeonidis
Argyris
A
Kokkini
Garoufalia
G
Laoutaris
Nikolaos P
NP
Vaipoulos
George
G
Anagnostopoulos
Nikolaos I
NI
Christakis
John I
JI
Meletis
John
J
Bourantas
Konstantinos L
KL
Zoumbos
Nicholas C
NC
Yataganas
Xenophon
X
Viniou
Nora-Athina
NA
D000368:Aged; D000369:Aged, 80 and over; D000753:Anemia, Refractory / Q000188:drug therapy; D000754:Anemia, Refractory, with Excess of Blasts / Q000188:drug therapy; D000756:Anemia, Sideroblastic / Q000188:drug therapy; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome
D004921:Erythropoietin