Evaluation of FLANG versus mitoxantrone and etoposide for the treatment of refractory/relapsed acute leukemia

Abstract

Introduction: Failure to respond to the chemotherapy and relapse occurrence is considerably high in acute leukemia as one of the most common hematologic malignancies requiring emergent efficacious well-tolerated salvage therapy. However, varieties of regimens have been investigated, since the best approach with an optimal response is a question. Objectives: In our study, we aimed to compare the efficacy of FLANG (fludarabine, cytosine arabinoside, mitoxantrone and G-CSF) versus mitoxantrone and etoposide for the treatment of refractory/relapsed acute leukemia. Patients and Methods: In this retrospective cohort study, 45 patients with acute leukemia were randomly divided into two groups of salvage therapy with FLANG (n=23) and mitoxantrone and etoposide (n=22). The patients were followed for five years. Progression-free survival, response to the treatment, chemotherapy-induced toxicity based on Criteria for Adverse Effects version 4 (CTCAE-4), and mortality were compared between the groups. Besides, to estimate the survival Kaplan-Meier curve and Cox regression were used. Results: Comparison of the two regimens revealed insignificant differences in terms of response rate (P=0.87), chemotherapy-induced toxicity (P=0.22) and mortality rate (P=0.26) and etiology of mortality (P=0.98). The median progression-free survival following FALNG and the latter regimen was four months (95% CI: 3.183, 4.862) versus three months (95% CI: 1.777, 4.223; P=0.38 ), respectively. Conclusion: Based on this study, the two salvage regimens of mitoxantrone plus etoposide and FLANG were similar in terms of complete remission, progression-free survival, and toxicity for the cases with refractory/ relapsed acute leukemia. Trial Registration: This study has been registered in the Iranian Registry of Clinical Trials and obtained code IRCT20190618043939N1 (https://en.irct.ir/trial/40272, Ethical code# IR.MUI.MED.REC.1398.586).