ATRA and Arsenic Trioxide (ATO) Versus ATRA and Idarubicin (AIDA) for Newly Diagnosed, Non High-Risk Acute Promyelocytic Leukemia (APL): Results of the Phase III, Prospective, Randomized, Intergroup APL0406 Study by the Italian-German Cooperative Groups Gimema-SAL-AMLSG

• Published in: Blood 2012-11, Vol.120 (21), p.6-6
• Main Authors: Lo-Coco, Francesco, Avvisati, Giuseppe, Orlando, Sonia Maria, Ferrara, Felicetto, Vignetti, Marco, Fazi, Paola, Di Bona, Eros, Specchia, Giorgina, Sica, Simona, Divona, Mariadomenica, Levis, Alessandro, Fiedler, Walter, Cerqui, Elisa, Breccia, Massimo, Fioritoni, Giuseppe, Salih, Helmut R, Brandts, Christian H., Morra, Enrica, von Lilienfeld-Toal, Marie, Hertenstein, Bernd, Wattad, Mohammed, Lubbert, Michael, Hänel, Matthias, Schmitz, Norbert, Link, Hartmut, Kropp, Maria Grazia, Rambaldi, Alessandro, La Nasa, Giorgio, Luppi, Mario, Ciceri, Fabio, Sauer, Michaela, Dohner, Hartmut, Ganser, Arnold, Mandelli, Franco, Ehninger, Gerhard, Amadori, Sergio, Thiede, Christian, Schlenk, Richard F, Platzbecker, Uwe
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V120.21.6.6

Abstract 6 Simultaneous ATRA and chemotherapy (CHT) is the current gold standard for newly diagnosed APL resulting in ∼80% cure rates, while arsenic trioxide (ATO) is the treatment of choice for relapsed patients. ATO in variable combinations including ± ATRA ± CHT has also been tested as front-line therapy yielding encouraging results in several pilot studies as well as in two phase III studies conducted in China and the US. So far, no randomised studies have compared front-line CHT-free ATO+ATRA combination against the standard ATRA+CHT approach. The phase III, randomised, prospective APL0406 trial was started in October 2007 by the Italian GIMEMA group and joined in November 2008 by the German SAL and AMLSG multicenter groups. Eligible patients were adults aged 18-