TREATMENT OF THE ANEMIA OF APLASTIC-ANEMIA PATIENTS WITH RECOMBINANT-HUMAN-ERYTHROPOIETIN IN COMBINATION WITH GRANULOCYTE-COLONY-STIMULATING FACTOR - A MULTICENTER RANDOMIZED CONTROLLED-STUDY

Citation
M. Bessho et al., TREATMENT OF THE ANEMIA OF APLASTIC-ANEMIA PATIENTS WITH RECOMBINANT-HUMAN-ERYTHROPOIETIN IN COMBINATION WITH GRANULOCYTE-COLONY-STIMULATING FACTOR - A MULTICENTER RANDOMIZED CONTROLLED-STUDY, European journal of haematology, 58(4), 1997, pp. 265-272
Citations number
24
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Hematology
ISSN journal
0902-4441
Volume
58
Issue
4
Year of publication
1997
Pages
265 - 272
Database
ISI
SICI code
0902-4441(1997)58:4<265:TOTAOA>2.0.ZU;2-C
Abstract
A multicenter randomized controlled study was undertaken in order to d etermine whether epoetin beta (EPO) ameliorates the anemia in aplastic anemia (AA) patients treated with granulocyte colony-stimulating fact or (G-CSF). Enrolled patients were randomized into 3 groups: group C r eceiving G-CSF alone as the control; group L receiving G-CSF and 200 I U/kg of EPO; group H receiving G-CSF and 400 IU/kg of EPO. Throughout the study, the dose and the administration interval of G-CSF were adju sted to maintain neutrophil counts between 1000 and 5000 mu l. EPO was administered subcutaneously for 12 wk as the first step in treatment and when favorable effects were observed over this period, treatment w as continued for another 12 wk as the second step in treatment. Signif icant erythroid responses were defined as increases in untransfused he moglobin values >1.0 g/dl or >50% decreases in RBC transfusion require ments over the treatment period. Of 131 patients enrolled, 88 patients allocated to groups L and H were evaluated for toxicity to EPO and 11 0 were evaluated for erythroid responses. Four of the 31 patients (12. 9%) in group C, 6 of the 41 patients (14.6%) of group L, and 14 of the 38 patients (36.8%) of group H showed erythroid responses in the firs t step in treatment. The erythroid responses of group H were significa ntly higher than those of the other 2 groups (p<0.05). The significant effects of EPO were due to erythroid responses in non-severe AA. Resp onding patients were significantly different from non-responders with regard to disease severity, hemoglobin concentration, reticulocyte cou nt, serum endogenous erythropoietin levels and serum transferrin recep tors; non-severe AA patients were more likely to respond to EPO, and r esponding patients had lower serum EPO and higher hemoglobin concentra tion, reticulocyte count and serum transferrin receptors than non-resp onders. The response rate increased in the second step in treatment, s uggesting that long-term treatment improved the efficacy of EPO. No se rious side-effects were observed. From these results, we conclude that EPO given in combination with G-CSF is a safe and effective alternati ve for the treatment of anemia of a subset of AA patients.