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  • Sorafenib or placebo in pat...
    Röllig, Christoph; Serve, Hubert; Noppeney, Richard; Hanoun, Maher; Krug, Utz; Baldus, Claudia D; Brandts, Christian H; Kunzmann, Volker; Einsele, Hermann; Krämer, Alwin; Müller-Tidow, Carsten; Schäfer-Eckart, Kerstin; Neubauer, Andreas; Burchert, Andreas; Giagounidis, Aristoteles; Krause, Stefan W; Mackensen, Andreas; Aulitzky, Walter; Herbst, Regina; Hänel, Mathias; Frickhofen, Norbert; Kullmer, Johannes; Kaiser, Ulrich; Kiani, Alexander; Link, Hartmut; Geer, Thomas; Reichle, Albrecht; Junghanß, Christian; Repp, Roland; Meinhardt, Achim; Dürk, Heinz; Klut, Ina-Maria; Bornhäuser, Martin; Schaich, Markus; Parmentier, Stefani; Görner, Martin; Thiede, Christian; von Bonin, Malte; Platzbecker, Uwe; Schetelig, Johannes; Kramer, Michael; Berdel, Wolfgang E; Ehninger, Gerhard

    Leukemia, 09/2021, Letnik: 35, Številka: 9
    Journal Article

    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.