@article{4673dfcbcf0b4f0492f14e197d534662,
title = "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",
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 × 10mg/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 150μg/ 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 MDS population.",
keywords = "Arabinoside, GM-CSF, Interleukin-3, Low-dose cytosine, Myelodysplastic syndrome, Phase III trial",
author = "Heinz Zwierzina and S. Suciu and J. Loeffler-Ragg and R. Neuwirtova and P. Fenaux and M. Beksac and J. Harousseau and V. Nuessler and J. Cermak and G. Solbu and R. Willemze and {de Witte}, T. and S. Amadori and P. Stryckmans and D. Bron and A. Louwagie and D. Selleslag and M. Peetermans and Z. Berneman and B. Coiffier and A. Thyss and Bourhis, {J. H.} and D. Fi{\`e}re and R. Zittoun and Marie, {J. P.} and D. Maraninchi and E. Baumelou and B. Lowenberg and P. Sonnenveld and H. Gerhartz and M. Ribeiro and I. Ben-Bassat and B. Labar and M. Dardenne",
note = "Funding Information: This work was 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 Fi{\`e}re (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.",
year = "2005",
month = nov,
doi = "10.1038/sj.leu.2403934",
language = "אנגלית",
volume = "19",
pages = "1929--1933",
journal = "Leukemia",
issn = "0887-6924",
publisher = "Springer Nature",
number = "11",
}
