Originally published as JCO Early Release 10.1200/JCO.2008.20.6490 on October 13 2009

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Google Scholar Articles by Mandelli, F. Articles by de Witte, T. PubMed PubMed Citation Articles by Mandelli, F. Articles by de Witte, T. Social Bookmarking                            What's this?

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

From the 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.

Corresponding author: Marco Vignetti, MD, "Sapienza" University, Via Benevento 6, 00161 Rome, Italy; e-mail: m.vignetti{at}gimema.it.

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.

Supported in part by Grants No. 2U10-CA11488-23 through 2U10-CA11488-36 from the National Cancer Institute, Bethesda, MD; and by grants from the Italian Cancer League and by the Italian Association Against Leukemias, Lymphoma, and Myeloma.

The contents of this study are solely the responsibility of the authors and do not represent the official views of the National Cancer Institute.

Presented in part at the 45th Annual Meeting of the American Society of Hematology, December 6-9, 2003, San Diego, CA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00002549 [ClinicalTrials.gov] .

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?