IDARUBICIN MAYBE BETTER FOR AML

J Clin Oncol. 2009 Oct 13. [Epub ahead of print]

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Daunorubicin Versus Mitoxantrone Versus Idarubicin as Induction and Consolidation Chemotherapy for Adults With Acute Myeloid Leukemia: The EORTC and GIMEMA Groups Study AML-10.

Mandelli F, Vignetti M, Suciu S, Stasi R, Petti MC, Meloni G, Muus P, Marmont F, Marie JP, Labar B, Thomas X, Di Raimondo F, Willemze R, Liso V, Ferrara F, Baila L, Fazi P, Zittoun R, Amadori S, de Witte T.

Department of Cellular Biotechnologies and Hematology, "Sapienza" University; Department of Hematology, National Cancer Institute "Regina Elena"; Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) Data Center, GIMEMA Foundation; Department of Hematology, "Tor Vergata" University Hospital, Rome; Department of Medical Sciences, "Regina Apostolorum" Hospital, Albano Laziale; Department of Hematology "Le Molinette", "S.G. Battista" Hospital, Turin; Department of Hematology, "Ferrarotto" Hospital, Catania; Department of Hematology, University Hospital, Bari; Department of Hematology, "A. Cardarelli" Hospital, Napoli, Italy; European Organisation for Research and Treatment of Cancer Data Center, Brussels, Belgium; Department of Hematology, Radboud University Medical Center, Nijmegen; Department of Hematology, Leiden University Medical Center, Leiden, the Netherlands; Department of Hematology, Hotel-Dieu, Paris; Department of Hematology, "Edouard Herriot" Hospital, Lyon, France; and Institute of Hematology, University Hospital Centre Rebro, Zagreb, Croatia.

PURPOSE: To compare the antitumor efficacy of three different anthracyclines in combination with cytarabine and etoposide in adult patients with newly diagnosed acute myeloid leukemia (AML). PATIENTS AND METHODS: We randomly assigned 2,157 patients (age range, 15 to 60 years) to receive intensive induction-consolidation chemotherapy containing either daunorubicin, idarubicin, or mitoxantrone. After achieving complete remission (CR), patients were assigned to undergo either allogeneic or autologous stem-cell transplantation (SCT), depending on the availability of a sibling donor. RESULTS: The overall CR rate (69%) was similar in the three groups. Autologous SCT was performed in 37% of cases in the daunorubicin arm versus only 29% and 31% in mitoxantrone and idarubicin, respectively (P < .001). However, the disease-free survival (DFS) and survival from CR were significantly shorter in the daunorubicin arm: the 5-year DFS was 29% versus 37% and 37% in mitoxantrone and idarubicin, respectively. The proportion of patients who underwent allogeneic SCT (22%) was equivalent in the three treatment groups, and the outcome was similar as well: the 5-year overall survival rates were 34%, 34%, and 31%, respectively. CONCLUSION: In adult patients with AML who do not receive an allogeneic SCT, the use of mitoxantrone or idarubicin instead of daunorubicin enhances the long-term efficacy of chemotherapy.