Remission and Survival after Single Versus Double Induction with 7+3 for Newly Diagnosed Acute Myeloid Leukemia: Results from the Planned Interim Analysis of Randomized Controlled SAL-Daunodouble Trial

• Published in: Blood 2020-11, Vol.136 (Supplement 1), p.1-3
• Main Authors: Röllig, Christoph, Steffen, Björn, Alakel, Nael, Herbst, Regina, Noppeney, Richard, Hanoun, Maher, Racil, Zdenek, Schäfer-Eckart, Kerstin, Krämer, Alwin, Neubauer, Andreas, Baldus, Claudia D, Schliemann, Christoph, Kaufmann, Martin, Mertova, Jolana, Jost, Edgar, Niemann, Dirk, Novak, Jan, Krause, Stefan W, Scholl, Sebastian, Held, Gerhard, Parmentier, Stefani B., Szotkowski, Tomáš, Zak, Pavel, Rank, Andreas, Wass, Maxi, Buske, Sebastian, Kramer, Michael, Fiebig, Frank, Haake, Annett, Schetelig, Johannes, Platzbecker, Uwe, Thiede, Christian, Müller-Tidow, Carsten, Berdel, Wolfgang E., Serve, Hubert, Ehninger, Gerhard, Mayer, Jiri, Bornhäuser, Martin
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2020-140246

Background Double induction using two subsequent 7+3 regimens of cytarabine plus anthracycline is commonly performed in AML patients with an adequate performance status in order to maximize dose intensity upfront. However, for patients with a good early response at day 15 of first induction, there is no prospective randomized evidence on the necessity or value of a second induction cycle. Aims In order to answer the question if good responders of the first 7+3 induction could be spared a second induction cycle, we set up randomized-controlled SAL DaunoDouble trial. The study prospectively assesses the outcome of patients with a good early response with respect to the number of induction cycles (single versus double). We assumed non-inferiority of single induction in terms of complete remission (CR/CRi) rate, based on a margin of 7.5%. Here, we present the results of the planned interim analysis. Methods Patients (pts) 18-65 years with newly diagnosed AML, normal cardiac and organ function received a first induction cycle with seven days of cytarabine plus three days of daunorubicin (“7+3”). Response assessment in bone marrow was done on day 15 after the initiation of chemotherapy and confirmed by central review. A blast count