Serve, Hubert and Krug, Utz and Wagner, Ruth and Sauerland, M. Cristina and Heinecke, Achim and Brunnberg, Uta and Schaich, Markus and Ottmann, Oliver and Duyster, Justus and Wandt, Hannes and Fischer, Thomas and Giagounidis, Aristoteles and Neubauer, Andreas and Reichle, Albrecht and Aulitzky, Walter and Noppeney, Richard and Blau, Igor and Kunzmann, Volker and Stuhlmann, Reingard and Kraemer, Alwin and Kreuzer, Karl-Anton and Brandts, Christian and Steffen, Bjoern and Thiede, Christian and Mueller-Tidow, Carsten and Ehninger, Gerhard and Berdel, Wolfgang E. (2013) Sorafenib in Combination With Intensive Chemotherapy in Elderly Patients With Acute Myeloid Leukemia: Results From a Randomized, Placebo-Controlled Trial. JOURNAL OF CLINICAL ONCOLOGY, 31 (25). 3110-+. ISSN 0732-183X, 1527-7755
Full text not available from this repository. (Request a copy)Abstract
Purpose The prognosis of elderly patients with acute myeloid leukemia (AML) is still dismal even with intensive chemotherapy. In this trial, we compared the antileukemic activity of standard induction and consolidation therapy with or without the addition of the kinase inhibitor sorafenib in elderly patients with AML. Patients and Methods All patients received standard cytarabine and daunorubicin induction (7 + 3 regimen) and up to two cycles of intermediate-dose cytarabine consolidation. Two hundred one patients were equally randomly assigned to receive either sorafenib or placebo between the chemotherapy cycles and subsequently for up to 1 year after the beginning of therapy. The primary objective was to test for an improvement in event-free survival (EFS). Overall survival (OS), complete remission (CR) rate, tolerability, and several predefined subgroup analyses were among the secondary objectives. Results Age, sex, CR and early death (ED) probability, and prognostic factors were balanced between both study arms. Treatment in the sorafenib arm did not result in significant improvement in EFS or OS. This was also true for subgroup analyses, including the subgroup positive for FLT3 internal tandem duplications. Results of induction therapy were worse in the sorafenib arm, with higher treatment-related mortality and lower CR rates. More adverse effects occurred during induction therapy in the sorafenib arm, and patients in this arm received less consolidation chemotherapy as a result of higher induction toxicity. Conclusion In conclusion, combination of standard induction and consolidation therapy with sorafenib in the schedule investigated in our trial is not beneficial for elderly patients with AML. (C) 2013 by American Society of Clinical Oncology
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | HIGH-DOSE CYTARABINE; TYROSINE KINASE INHIBITORS; ACUTE MYELOGENOUS LEUKEMIA; STEM-CELL TRANSPLANTATION; AML-COOPERATIVE-GROUP; MYELODYSPLASTIC SYNDROME; PHASE-I; PROLONGED MAINTENANCE; OLDER PATIENTS; FLT3 LIGAND; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 31 Mar 2020 14:10 |
| Last Modified: | 31 Mar 2020 14:10 |
| URI: | https://pred.uni-regensburg.de/id/eprint/16076 |
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