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Blood, 15 July 2004, Vol. 104, No. 2, pp. 321-327.
Prepublished online as a Blood First Edition Paper on March 30, 2004; DOI 10.1182/blood-2003-07-2252.
 Previous Article | Next Article 
Submitted July 7, 2003
Accepted March 7, 2004
Effects of erythropoietin (rHuEpo) plus granulocyte colony stimulating factor (rHuG-CSF) for the treatment of myelodysplastic syndromes (MDS) on anemia, costs and quality of life: a randomized controlled trial
Nicole Casadevall*, Pierre Durieux, Stephanie Dubois, Francois Hemery, Eric Lepage, Marie-Catherine Quarre, Gandhi Damaj, Stephane Giraudier, Agnes Guerci, Guy Laurent, Herve Dombret, Christine Chomienne, Vincent Ribrag, Aspasia Stamatoullas, Jean-Pierre Marie, Anne Vekhoff, Frederic Maloisel, Robert Navarro, Francois Dreyfus, and Pierre Fenaux
Hematology, Hotel Dieu Hospital, Paris, France
Sante Publique, Hopital Europeen Georges Pompidou, Paris, France
Unite d'Information Medicale, Henri Mondor Hospital, Creteil, France
Hematology, Cochin Hospital, Paris, France
Hematology, Necker Hospital, Paris, France
Hematology, Henri Mondor Hospital, Creteil, France
Hematology, Nancy University Hospital, Nancy, France
Hematology, Purpan Hospital, Toulouse, France
Hematology, Saint-Louis Hospital, Paris, France
Hematology, Gustave Roussy Institute, Villejuif, France
Hematology, Henri Becquerel Center, Rouen, France
Hematology, Hautepierre Hospital, Strasbourg, France
Hematology, Lapeyronie Hospital, Montpellier, France
Hematology, Lille University Hospital, Lille, France
* Corresponding author; email: nicole.casadevall{at}htd.ap-hop-paris.fr.
In myelodysplastic syndromes (MDS), anemia responds to erythropoietin (rHuEpo) alone and in combination with granulocyte colony-stimulating factor (rHuG-CSF) in 10-20% and 35-40% of cases respectively. We randomly divided 60 low-grade anemic MDS patients with serum Epo levels <500 mU/ml into two groups: rHuEpo plus rHuG-CSF (arm A) or supportive care (arm B). After 12 weeks, erythroid responders were given rHuEpo alone for 40 additional weeks. They were also given rHuG-CSF if they relapsed. Responses were considered to be major if the hemoglobin (Hb) level  11.5 g/dl or minor if Hb levels were 1.5 g/dl or the Hb level remained stable without transfusion. There were 10/24 responders in arm A and 0/26 in arm B (p=0.01). Eight patients in arm A continued rHuEpo alone and six relapsed. The response was always restored in when rHuG-CSF was reintroduced. Mean direct costs per patient were 26723 euros (arm A) and 8746 euros (arm B). Quality of life was assessed with a FACT-An scale. Similar percentages of patients from both arms showed a significant clinical improvement. rHu-Epo plus rHuG-CSF led to a response in 41.7 % of MDS patients.This treatment was expensive. No effect on quality of life was demonstrated.
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