title: Prolonged administration of erythropoietin increases erythroid response rate in myelodysplastic syndromes: a phase II trial in 281 patients.
abstract: 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.
authors.affiliation: Department of Haematology, Faculty of Medicine, Imperial College of Science, Technology and Medicine, Hammersmith Hospital, London, UK. eterpos@hotmail.com
authors.forename: Evangelos
authors.initials: E
authors.lastname: Terpos
authors.forename: Athina
authors.initials: A
authors.lastname: Mougiou
authors.forename: Alexandra
authors.initials: A
authors.lastname: Kouraklis
authors.forename: Aria
authors.initials: A
authors.lastname: Chatzivassili
authors.forename: Evridiki
authors.initials: E
authors.lastname: Michalis
authors.forename: Nicholas
authors.initials: N
authors.lastname: Giannakoulas
authors.forename: Eleni
authors.initials: E
authors.lastname: Manioudaki
authors.forename: Anna
authors.initials: A
authors.lastname: Lazaridou
authors.forename: Vassiliki
authors.initials: V
authors.lastname: Bakaloudi
authors.forename: Maria
authors.initials: M
authors.lastname: Protopappa
authors.forename: Dimitra
authors.initials: D
authors.lastname: Liapi
authors.forename: Elisavet
authors.initials: E
authors.lastname: Grouzi
authors.forename: Agapi
authors.initials: A
authors.lastname: Parharidou
authors.forename: Argyris
authors.initials: A
authors.lastname: Symeonidis
authors.forename: Garoufalia
authors.initials: G
authors.lastname: Kokkini
authors.forename: Nikolaos P
authors.initials: NP
authors.lastname: Laoutaris
authors.forename: George
authors.initials: G
authors.lastname: Vaipoulos
authors.forename: Nikolaos I
authors.initials: NI
authors.lastname: Anagnostopoulos
authors.forename: John I
authors.initials: JI
authors.lastname: Christakis
authors.forename: John
authors.initials: J
authors.lastname: Meletis
authors.forename: Konstantinos L
authors.initials: KL
authors.lastname: Bourantas
authors.forename: Nicholas C
authors.initials: NC
authors.lastname: Zoumbos
authors.forename: Xenophon
authors.initials: X
authors.lastname: Yataganas
authors.forename: Nora-Athina
authors.initials: NA
authors.lastname: Viniou
mesh_terms: 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
chemical_list: D004921:Erythropoietin