Andreas Burchert, Gesine Bug, Lea V Fritz, Jürgen Finke, Matthias Stelljes, Christoph Röllig, Ellen Wollmer, Ralph Wäsch, Martin Bornhäuser, Tobias Berg, Fabian Lang, Gerhard Ehninger, Hubert Serve, Robert Zeiser, Eva-Maria Wagner, Nicolaus Kröger, Christine Wolschke, Michael Schleuning, Katharina S Götze, Christoph Schmid, Martina Crysandt, Eva Eßeling, Dominik Wolf, Ying Wang, Alexandra Böhm, Christian Thiede, Torsten Haferlach, Christian Michel, Wolfgang Bethge, Thomas Wündisch, Christian Brandts, Susanne Harnisch, Michael Wittenberg, Heinz-Gert Hoeffkes, Susanne Rospleszcz, Alexander Burchardt, Andreas Neubauer, Markus Brugger, Konstantin Strauch, Carmen Schade-Brittinger, Stephan K Metzelder
PURPOSE: Despite undergoing allogeneic hematopoietic stem cell transplantation (HCT), patients with acute myeloid leukemia (AML) with internal tandem duplication mutation in the FMS- like tyrosine kinase 3 gene ( FLT3- ITD) have a poor prognosis, frequently relapse, and die as a result of AML. It is currently unknown whether a maintenance therapy using FLT3 inhibitors, such as the multitargeted tyrosine kinase inhibitor sorafenib, improves outcome after HCT. PATIENTS AND METHODS: In a randomized, placebo-controlled, double-blind phase II trial (SORMAIN; German Clinical Trials Register: DRKS00000591), 83 adult patients with FLT3- ITD-positive AML in complete hematologic remission after HCT were randomly assigned to receive for 24 months either the multitargeted and FLT3-kinase inhibitor sorafenib (n = 43) or placebo (n = 40 placebo)...
September 10, 2020: Journal of Clinical Oncology