FIVE-YEAR REAL-WORLD DATA ON AML RETROSPECTIVE STUDY FROM PUBLIC HEALTH CENTER IN BRAZIL

Abstract

Introduction: Acute myeloid leukemia (AML) is a heterogeneous aggressive leukemia with poor prognosis. The standard remission induction regimen for medically eligible patients with AML consists of a backbone of cytarabine & an anthracycline (“7+3” therapy). Brazil is a large country with striking differences in in climate, ethnic heterogeneity and socioeconomic factors. Objectives: To assess effectiveness (Eligible to the Next Treatment-ENT CR and suficient performance status to the next treatment, PFS and OS) and security (Early Mortality) of cytarabine and anthracycline in a public health center in Salvador, Brazil. Subgroups analyzed were about FTL3 and NPM1 mutations, leukocytes (>10,000 or 20,000 or <20,000), and transplanted or non-transplanted. Methods: It was a retrospective analysis of all the cases of non-promyelocytic AML diagnosed between 2018 and 2022 in the University Hospital Professor Edgar Santos of Federal University of Bahia, after being approved by the Ethics Committee of the hospital. Kaplan-Meier methods were used to determine the median of the time to OS and PFS. Results: A total of 45 patients were analyzed. Median age at diagnosis was 43 years (range, 16-69 years) with 62% females. There were 21% and 11% patients with FLT3-ITD and NPM1 mutations, respectively. Only 14 patients had karyotype test (85% with normal karyotype). Regarding effectiveness, 52% of patients were eligible for the next therapy after complete remission (consolidation or stem cell transplantation). Refractory patients were 20%. Early (4 weeks) mortality was 28%. The median of PFS and OS were 3.6 and 8.2 months respectively. Patients with FLT3 mutation, platelet < 20.000 and leukocytes < 10.000 had poor outcomes. In AML patients after stem cell transplantation, PFS and OS were, respectively 20 and 43 months. Average waiting time for start induction therapy was 12 days. Discussion: Bone marrow transplantation is indicated as standard in consolidation for patients with intermediate or unfavorable cytogenetic risk. The performance of the BMT carried out by the Hospital das Clínicas de Salvador can be considered a differential service in the public context, since not all services perform this treatment. Effectiveness and safety results of this study, which evaluated induction with a 7+3 scheme in patients with AML in a public service in Salvador/Bahia, showed that 52% were eligible for the next treatment (complete remission and with performance), mediated survival progression-free time of 3.6 months, median overall survival of 8.2 months, and early mortality of 28% (61% due to septicemia). These results are consistent with other real-life studies in Brazil. Conclusion: The outcomes were consistent with the literature, adjusted for the population in question. Even with access to diagnostic tests (not common in Brazilian's health public centers), patients did not have access to targeted therapies, with the 7+3 regimen being the only treatment for fit patients. To achieve complete remission followed consolidation/transplantation is still the BEST scenarios in AML eligible patients, but the improvement of access to diagnostic and treatment is still an unmet need.