Sorafenib in Combination With Intensive Chemotherapy in Elderly Patients With Acute Myeloid Leukemia: Results From a Randomized, Placebo-Controlled Trial

• DOI: 10.1200/jco.2012.46.4990
• Publication Date: 2013-07-30T04:12:23Z
• Authors: Hubert Serve; Utz Krug; Ruth Wagner; M. Cristina Sauer...; Achim Heinecke; Uta Brunnberg; Markus Schaich; Oliver Ottmann; Justus Duyster; Hannes Wandt; Thomas Fischer; Aristoteles Giago...; Andreas Neubauer; Albrecht Reichle; Walter Aulitzky; Richard Noppeney; Igor Blau; Volker Kunzmann; Reingard Stuhlmann; Alwin Krämer; Karl-Anton Kreuzer; Christian Brandts; Björn Steffen; Christian Thiede; Carsten Müller-Tidow; Gerhard Ehninger; Wolfgang E. Berdel
• Keywords: Tolerability; Induction chemotherapy; Regimen

The prognosis of elderly patients with acute myeloid leukemia (AML) is still dismal even intensive chemotherapy. In this trial, we compared the antileukemic activity standard induction and consolidation therapy or without addition kinase inhibitor sorafenib in AML.All received cytarabine daunorubicin (7+3 regimen) up to two cycles intermediate-dose consolidation. Two hundred one were equally randomly assigned receive either placebo between chemotherapy subsequently for 1 year after beginning therapy. primary objective was test an improvement event-free survival (EFS). Overall (OS), complete remission (CR) rate, tolerability, several predefined subgroup analyses among secondary objectives.Age, sex, CR early death (ED) probability, prognostic factors balanced both study arms. Treatment arm did not result significant EFS OS. This also true analyses, including positive FLT3 internal tandem duplications. Results worse arm, higher treatment-related mortality lower rates. More adverse effects occurred during less as a toxicity.In conclusion, combination schedule investigated our trial beneficial AML.