Roellig, Christoph and Serve, Hubert and Noppeney, Richard and Hanoun, Maher and Krug, Utz and Baldus, Claudia D. and Brandts, Christian H. and Kunzmann, Volker and Einsele, Hermann and Kraemer, Alwin and Mueller-Tidow, Carsten and Schaefer-Eckart, Kerstin and Neubauer, Andreas and Burchert, Andreas and Giagounidis, Aristoteles and Krause, Stefan W. and Mackensen, Andreas and Aulitzky, Walter and Herbst, Regina and Haenel, Mathias and Frickhofen, Norbert and Kullmer, Johannes and Kaiser, Ulrich and Kiani, Alexander and Link, Hartmut and Geer, Thomas and Reichle, Albrecht and Junghanss, Christian and Repp, Roland and Meinhardt, Achim and Duerk, Heinz and Klut, Ina-Maria and Bornhaeuser, Martin and Schaich, Markus and Parmentier, Stefani and Goerner, Martin and Thiede, Christian and von Bonin, Malte and Platzbecker, Uwe and Schetelig, Johannes and Kramer, Michael and Berdel, Wolfgang E. and Ehninger, Gerhard (2021) Sorafenib or placebo in patients with newly diagnosed acute myeloid leukaemia: long-term follow-up of the randomized controlled SORAML trial. LEUKEMIA, 35 (9). pp. 2517-2525. ISSN 0887-6924, 1476-5551
Full text not available from this repository. (Request a copy)Abstract
Early results of the randomized placebo-controlled SORAML trial showed that, in patients with newly diagnosed acute myeloid leukaemia (AML), sorafenib led to a significant improvement in event-free (EFS) and relapse-free survival (RFS). In order to describe second-line treatments and their implications on overall survival (OS), we performed a study after a median follow-up time of 78 months. Newly diagnosed fit AML patients aged <= 60 years received sorafenib (n = 134) or placebo (n = 133) in addition to standard chemotherapy and as maintenance treatment. The 5-year EFS was 41 versus 27% (HR 0.68; p = 0.011) and 5-year RFS was 53 versus 36% (HR 0.64; p = 0.035). Allogeneic stem cell transplantation (allo SCT) was performed in 88% of the relapsed patients. Four years after salvage allo SCT, the cumulative incidence of relapse was 54 versus 35%, and OS was 32 versus 50%. The 5-year OS from randomization in all study patients was 61 versus 53% (HR 0.82; p = 0.282). In conclusion, the addition of sorafenib to chemotherapy led to a significant prolongation of EFS and RFS. Although the OS benefit did not reach statistical significance, these results confirm the antileukaemic activity of sorafenib.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ; |
| 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: | 30 Sep 2022 14:04 |
| Last Modified: | 30 Sep 2022 14:04 |
| URI: | https://pred.uni-regensburg.de/id/eprint/48154 |
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