PS1049 COMPARATIVE RANDOMIZED STUDY OF PROTOCOL HAM VERSUS PROTOCOL FLAG IN RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA

Abstract

Background:Acute myeloid leukemia (AML) is the commonest type of acute leukemias in adults resulting from clonal proliferation of bone marrow precursor cells with disruption of hemostasis. Patients initially respond to induction therapy but the majority of patients suffer relapse and refractoriness with very poor subsequent prognosis.Aims:To compare two widely used salvage regimens in treatment of relapsed/refractory AML, HAM (cytarabine, Mitoxantrone, Colony stimulating factor) versus FLAG (cytarabine, fludarabine, Colony stimulating factor) protocols.Methods:Prospective randomized study included 90 patient diagnosed as relapsed/refractory AML were selected from Oncology Center, Mansoura University, Egypt, from January 2014 to December 2017. Patients received salvage therapy either HAM or FLAG protocol, then outcomes regarding to efficacy, side effects and overall survival were assessed.Results:Ninety patients were included in our study, 43 patients received HAM protocol versus 47 received FLAG protocol. Complete remission (CR) was 42.6% in HAM group versus 48.8% in FLAG group (p = 0.5). On the other hand, hepatic impairment was 46.8% in HAM group versus 30.3% in FLAG group (p = 0.2). Also, renal impairment was 6.4% in HAM group versus 18.6% in FLAG group (p = 0.07). In addition, Event free survival (EFS) was higher in FLAG vs. HAM arms (9 versus 4 months, p = 0.2). Lastly, overall survival (OS) in HAM group was shorter than in FLAG group (3 vs. 5 months, P = 0.09)Summary/Conclusion:Both HAM and FLAG protocols are adequate salvage chemotherapy in relapsed/refractory AML, with different toxicity profile as HAM has more hepatotoxicity while FLAG is more nephrotoxic, CR was slightly higher with FLAG with more survival benefit compared with HAM protocol.