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ABSTRACT In this randomized phase III study of the EORTC Leukemia Cooperative Group, patients with myelodysplastic syndromes (MDS) with 10–30% bone marrow blasts and hematopoietic failure

were treated with low-dose cytosine arabinoside (LD-AraC) (2 × 10 mg/m2/day subcutaneously (s.c.) days 1–14) either alone or in combination with rhGM-CSF or interleukin-3 (IL-3) both given

s.c. at a dose of 150 _μ_g/day from day 8 to 21. A total of 180 evaluable patients with a median age of 65 years and refractory anemia with an excess of blasts (RAEB, _n_=107) or RAEB in

transformation (RAEBt, _n_=73) were randomized. There were no differences among the three treatment regimens with respect to numbers of courses applied or treatment delays. Hemorrhage

occurred in approximately 40% in all arms, whereas infection rates were higher in the granulocyte/macrophage colony stimulating factor (GM-CSF)- or IL3-containing arm. The overall response

rate was 38.6% with no statistically significant difference among the three arms. In summary, a substantial proportion of patients had achieved relatively durable responses in all the three

arms. No influence of either growth factor was detected on the grade of cytopenia. Thus, the combination of LD-AraC with GM-CSF or IL-3 cannot be recommended for routine use in a high-risk

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supported in part by an educational grant from Sandoz/Novartis and by grant numbers 5U10-CA11488-20 through 5U10-CA11488-35 from the National Cancer Institute. Its contents are solely the

responsibility of the authors and do not represent the official views of the National Cancer Institute (Bethesda, MD, USA). Additional members of the EORTC CLG who participated to this

study: Drs P Stryckmans/D Bron (Institut J Bordet, Brussels), Drs A Louwagie/D Selleslag (AZ St Jan, Brugge), Drs M Peetermans/Z Berneman (UZ Antwerpen), Dr B Coiffier (Centre Hospitalier

Lyon Sud), Dr A Thyss (Centre A Lacassagne, Nice), Dr J-H Bourhis (Institut G Roussy, Villejuif), Dr D Fière (Hopital Edouard Herriot, Lyon), Drs R Zittoun/JP Marie (Hotel-Dieu, Paris), Dr D

Maraninchi (Institut Paoli-Calmettes, Marseille), Dr E Baumelou (Centre Foch, Suresnes), Drs B Lowenberg/P Sonnenveld (Erasmus Medical Center, Rotterdam), Dr H Gerhartz (Klinikum

Grosshadern, Munich), Dr M Ribeiro (Hospital Escolar San Joao, Porto), Dr I Ben-Bassat (Chaim Sheba Medical Center, Tel-Hashomer), Dr B Labar (Hospital Rebro, Zagreb). Thanks to the former

EORTC data manager: M Dardenne. AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * University Hospital, Medical University Innsbruck, Innsbruck, Austria H Zwierzina & J Loeffler-Ragg * EORTC

Data Center, Brussels, Belgium S Suciu & G Solbu * Institute of Hematology and Blood Transfusion, Prague, Czech Republic R Neuwirtova & J Cermak * Avicenne Hospital, Paris XIII

University, Paris, France P Fenaux * Ibni Sina Hospital, Ankara, Turkey M Beksac * Hotel Dieu, Nantes, France J Harousseau * Klinikum Grosshadern, Munich, Germany V Nuessler * University

Medical Center, Leiden, The Netherlands R Willemze * St Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands T de Witte * University Tor Vergata, Rome, Italy S Amadori

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LEUKEMIA COOPERATIVE GROUP CORRESPONDING AUTHOR Correspondence to H Zwierzina. RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE Zwierzina, H., Suciu, S.,

Loeffler-Ragg, J. _et al._ Low-dose cytosine arabinoside (LD-AraC) _vs_ LD-AraC plus granulocyte/macrophage colony stimulating factor _vs_ LD-AraC plus Interleukin-3 for myelodysplastic

syndrome patients with a high risk of developing acute leukemia: final results of a randomized phase III study (06903) of the EORTC Leukemia Cooperative Group. _Leukemia_ 19, 1929–1933

(2005). https://doi.org/10.1038/sj.leu.2403934 Download citation * Received: 10 March 2005 * Accepted: 22 July 2005 * Published: 08 September 2005 * Issue Date: 01 November 2005 * DOI:

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currently available for this article. Copy to clipboard Provided by the Springer Nature SharedIt content-sharing initiative KEYWORDS * myelodysplastic syndrome * low-dose cytosine

arabinoside * GM-CSF * interleukin-3 * phase III trial