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Clinical Trial
. 2009 Nov 10;27(32):5397-403.
doi: 10.1200/JCO.2008.20.6490. Epub 2009 Oct 13.

Daunorubicin versus mitoxantrone versus idarubicin as induction and consolidation chemotherapy for adults with acute myeloid leukemia: the EORTC and GIMEMA Groups Study AML-10

Franco Mandelli  1 , Marco Vignetti, Stefan Suciu, Roberto Stasi, Maria-Concetta Petti, Giovanna Meloni, Petra Muus, Filippo Marmont, Jean-Pierre Marie, Boris Labar, Xavier Thomas, Francesco Di Raimondo, Roel Willemze, Vincenzo Liso, Felicetto Ferrara, Liliana Baila, Paola Fazi, Robert Zittoun, Sergio Amadori, Theo de Witte
Affiliations
Clinical Trial

Daunorubicin versus mitoxantrone versus idarubicin as induction and consolidation chemotherapy for adults with acute myeloid leukemia: the EORTC and GIMEMA Groups Study AML-10

Franco Mandelli et al. J Clin Oncol. .

Erratum in

  • J Clin Oncol. 2010 Mar 10;28(8):1438

Abstract

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 [corrected] 5-year overall survival rates were 31%, 34%, and 34%, [corrected] 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.

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Conflict of interest statement

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

Figures

Fig 1.
Fig 1.
CONSORT diagram: study design and patient disposition. (*) In each arm, percentage of autologous stem-cell transplantation (AutoSCT) is calculated on the total number of patients in complete remission (CR) without an HLA-identical sibling, and percentage of allogeneic stem-cell transplantation (AlloSCT) is calculated on the total number of patients in CR with an HLA-identical sibling. Trt, treatment.
Fig 2.
Fig 2.
Global population of patients: duration of overall survival from diagnosis, according to the treatment arm. DNR, daunorubicin; MXR, mitoxantrone; IDA, idarubicin; HR, hazard ratio; O, observed number of deaths.
Fig 3.
Fig 3.
Patients with an HLA sibling donor available. (A) Disease-free survival from complete remission according to treatment arm. (B) Survival from complete remission according to treatment arm. DNR, daunorubicin; MXR, mitoxantrone; IDA, idarubicin; HR, hazard ratio; O, observed number of events.
Fig 4.
Fig 4.
Patients without an HLA sibling donor available. (A) Disease-free survival from complete remission according to treatment arm. (B) Survival from complete remission according to treatment arm. DNR, daunorubicin; MXR, mitoxantrone; IDA, idarubicin; HR, hazard ratio; O, observed number of events.
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