Short and long term effects of granulocyte colony-stimulating factor during induction therapy in acute myeloid leukemia patients younger than 65: Results of a randomized multicenter phase III trial

PubMedID: 20673585This prospective multicenter phase III clinical trial was designed to assess efficacy and safety of G-CSF as an adjunct to de novo AML remission induction therapy (www.clinicaltrials.gov. NCT00820976). Patients' characteristics were similar in both arms. G-CSF improved severity and duration of leukopenia. Three-year OS were similar (25.6 ± 5.1% vs. 31.8 ± 5.6%) in both arms except for patients with myeloblastic features. Significant factors for better survival were the use of G-CSF (p= 0.049), female sex (p= 0.05) and single induction cycle (p< 0.001) in multivariate analysis. Female patients performed better than male patients. Better survival obtained among female AML patients needs to be validated within the context of cytogenetic analysis. © 2010 Elsevier Ltd.The authors are indebted to the efforts of all the institutions who participated in the trial and their data management teams. Also the authors would like to thank to all physicians including Dr. Semra Dundar, who died in 2005, and their patients for this collaborative effort. Filgrastim was supplied by Roche, This study was partially supported by the Turkish Academy of Sciences. Monitoring and statistical analysis were performed by an independent clinical research organization (OMEGA, Ankara, Turkey). And a special thank you to the following hospitals and investigators that participated in this trial: Akdeniz University, Antalya, Turkey (L. Undar); Ankara University, Ankara, Turkey (M.B., M.O., O. l., G.G., A.U., H.A., E.A.); Cukurova University, Adana, Turkey (S.P.); Dokuz Eylul University, Izmir, Turkey (B. Undar); Ege University, Izmir, Turkey (S. Cagirgan); Erciyes University, Kayseri, Turkey (A. Unal, M. Cetin); Gulhane Military University, Ankara, Turkey (A. U. Ural, C. Beyan); Hacettepe University, Ankara, Turkey (S. Dundar, O.O., Y.B.); Inonu University, Malatya, Turkey (I. Aydogdu); Istanbul University of Cerrahpasa, Istanbul, Turkey (B. Ferhanoglu); Istanbul University of Istanbul, Istanbul, Turkey (D. Sargin, Sevgi Kalayoglu-Besisik); Marmara University, Istanbul, Turkey (M.B.); Osmangazi University, Eskisehir, Turkey (Z. Gulbas); Uludag University, Bursa, Turkey (A.T., R.A., F.O., T.O.). Contributions : M.B. provided the conception and design of the study, or acquisition of data, or analysis and interpretation of data; drafting the article or revising it critically for important intellectual content and final approval of the version to be submitted; M.O., E.A.S. and A.T. provided the conception and design of the study, or acquisition of data, or analysis and interpretation of data and final approval of the version to be submitted; R.A. and T.O. provided the drafting the article or revising it critically for important intellectual content and final approval of the version to be submitted and O.O, M.B., S.P., Y.B., O.I., F.O., G.G., A.U. and H.A. provided the final approval of the version to be submitted