High Dose (HD-AraC) Vs Standard Dose Cytosine Arabinoside (SDAraC) during Induction and Value of IL-2 during Maintenance in Acute Myelogenous Leukemia (AML): Impact of AraC Dose on Complete Remission Rate and Toxicity (Results on the first 1700 randomized patients of the AML-12 trial of EORTC and GIMEMA Leukemia Groups)

The AML-12 randomized phase III trial of EORTC-LG and GIMEMA assessed the efficacy and toxicity of HD-AraC (3 g/m2/12 hrs for 4 days) combined with daunorubicin (50 mg/sqm for 3 days) and etoposide (50 mg/sqm for 5 days) vs SD-AraC (100 mg/sqm for 10 days) with the same drugs. Patients (pts) in comp...

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Published in:Blood 2008-11, Vol.112 (11), p.134-134
Main Authors: Willemze, Roelof, Suciu, Stefan, Mandelli, Franco, Labar, Boris, Marie, Jean-Pierre, Mistrik, Martin, Liso, Vincenzo, Fabbiano, Francesco, Nobile, Francesco, Sborgia, Marco, Rotoli, Bruno, Selleslag, Dominik L.D., Lefrere, Francois, Peta, Antonio, Martelli, Massimo F, Leone, Giuseppe, Cantore, Nicola, Beksac, Meral, Berneman, Zwi, Thomas, Xavier, Greco, Michele Mario, Bron, Dominique, Fillet, Georges, Guimaraes, Jose E., Muus, Petra, Fazi, Paola, Baila, Liliana, Vignetti, Marco, Amadori, Sergio, Meloni, Giovanna
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Language:English
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Summary:The AML-12 randomized phase III trial of EORTC-LG and GIMEMA assessed the efficacy and toxicity of HD-AraC (3 g/m2/12 hrs for 4 days) combined with daunorubicin (50 mg/sqm for 3 days) and etoposide (50 mg/sqm for 5 days) vs SD-AraC (100 mg/sqm for 10 days) with the same drugs. Patients (pts) in complete remission (CR) received consolidation consisting of AraC (500 mg/sqm/12 hrs for 6 days) and daunorubicin. Subsequently an allogeneic (allo-SCT) or autologous stem cell transplantation (auto-SCT) was planned according to donor availability and age. A 2nd randomization was performed after CR in pts without a donor: auto-SCT followed or not by low dose IL-2. The trial was powered to detect an 8% difference in the 5-yr survival rate; secondary endpoints were response to induction, DFS, toxicity. Randomization was performed centrally; the 1st randomization was stratified for age, performance status, WBC and center. Intent-to-treat analysis was done. From 9/1999 till 1/2008, 2005 previously untreated AML pts (APL excluded), age
ISSN:0006-4971
1528-0020
DOI:10.1182/blood.V112.11.134.134