OBJECTIVES : Acute Myeloid Leukaemia (AML) is the most prevailing form of cancer affecting bone marrow. As per the key statistics by American Cancer Society about 19,520 new cases of AML are expected in 2018 and most of them will be in adults. Sorafenib, a kinase inhibitor drug is investigated in some trails for the treatment of AML

METHODS : Clinical trials which included Sorafenib as an intervention for patients with AML, were identified in databases such as, Cochrane, and MEDLINE (via PubMed). No language and publication year restrictions were applied. Two researchers independently reviewed studies using the Cochrane methodology for systematic reviews. Outcomes of interest included progression-free survival (PFS), overall survival (OS) and overall response rate (ORR)

RESULTS : In total, 52 potentially relevant studies were screened. Five clinical trials with 541 treated patients having AML were included. Two clinical trials were double blind randomized placebo controlled studies, whereas remaining three were single arm studies. Sorafenib has a high OS (31% at 12 month) in single arm study. The long duration of progression-free survival (92% at 12 month) was also observed with Sorafenib. The addition of Sorafenib to standard chemotherapy has shown increased anti-leukaemic efficacy. However, the frequency of grade 3-4 adverse events show a similar or lower toxicity than the other reported acute myeloid leukaemia cohorts

CONCLUSIONS : Sorafenib is a promising treatment for AML patients with good clinical activity. The clinical trials clearly revealed prolonged PFS and increased response rates with Sorafenib. However due to no active control trial available, the results need to be interpreted cautiously along with the strategies to reduce toxicity. The trials with OS withr long-term follow-up are needed to determine the future role of Sorafenib