MedicalResearch.com Interview with:
Dr. Christoph Röllig
Medizinische Klinik und Poliklinik I
Universitätsklinikum der Technischen Universitä
Medical Research: What is the background for this study? What are the main findings?
Dr. Röllig: When this trial began in 2009, standard treatment for Acute Myelogenous Leukemia (AML) consisted of a combination of cytarabine plus anthracyclin/anthracendion and the need for improvement was obvious in the light of only around 50% long-term survivors even amongst younger patients. Although a promising approach, the use of kinase inhibitors in AML had not been shown to be beneficial and was not widely used. Sorafenib had been shown to be tolerable as single agent and in combination with commonly used chemotherapeutic agents. The results of the trial show that the addition of sorafenib to standard chemotherapy for newly diagnosed AML patients up to the age of 60 years is associated with significant prolongation of event-free survival and relapse-free survival compared to placebo plus standard chemotherapy. That means that patient who took sorafenib had less AML relapses.
To our knowledge, this is the first randomized-controlled showing that integrating a kinase inhibitor into standard intensive chemotherapy of younger patients with AML is associated with significant improvement of relapse-free survival, with no increase in treatment-related mortality. After a decade of evaluating the potential of kinase inhibitors in AML, their use in combination with standard treatment is becoming an important option for newly diagnosed younger patients.
Medical Research: What should clinicians and patients take away from your report?
Dr. Röllig: For patients who tolerate sorafenib treatment, its addition to standard chemotherapy lowers the risk for relapse, as a result the need for relapse treatment and allogeneic stem cell transplantation.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Röllig: Longer follow-up of this trial and results of other ongoing studies are needed to establish whether the benefit in relapse-free survival translates into improved overall survival.
Addition of sorafenib versus placebo to standard therapy in patients aged 60 years or younger with newly diagnosed acute myeloid leukaemia (SORAML): a multicentre, phase 2, randomised controlled trial
Dr. Christoph Röllig (2015). AML: Kinase Inhibitor Plus Standard Chemotherapy Reduces Relapse Risk