FERNANDA SALLES SEGURO
Projetos de Pesquisa
Unidades Organizacionais
Instituto Central, Hospital das Clínicas, Faculdade de Medicina - Médico
Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/31 - Laboratório de Genética e Hematologia Molecular, Hospital das Clínicas, Faculdade de Medicina
Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/31 - Laboratório de Genética e Hematologia Molecular, Hospital das Clínicas, Faculdade de Medicina
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- MR 4log and low levels of NK cells are associated with higher molecular relapse after imatinib discontinuation: Results of a prospective trial(2021) SEGURO, Fernanda S.; MACIEL, Felipe V. R.; SANTOS, Fernanda M.; ABDO, Andre N. R.; PEREIRA, Thales D. M.; NARDINELLI, Luciana; ROCHA, Vanderson; BENDIT, IsraelBackground: Treatment-free survival (TFS) in chronic myeloid leukemia (CML) is a new goal. This prospective study aims to evaluate imatinib discontinuation's feasibility and safety in patients with deep molecular response MR4 (BCR-ABL1 < 0.01 % IS). Methods: Study was approved by the ethical committee and registered at Clinicaltrials.gov (NCT03239886). Incluision criteria were: age >= 18y, chronic phase, first-line imatinib for 36 months, MR4 for 12 months, no previous transplant or resistance. Imatinib was resumed when two samples confirmed the loss of MMR. The primary endpoint was molecular recurrence-free survival (MRFS) at 24 months. Lymphocyte subpopulations were counted in peripheral blood before discontinuation. Results: 31 patients were included from Dec/2016 until Oct/2017. Median age was 54years, 58 % male, 58 % low Sokal, 65 % b3a2 transcripts, and 61 % were in MR4.5. Imatinib therapy's median time was 9.7y (3-14.9 y), median time of MR4 was 6.9y (1.6-10.3y). MRFS at 24 months was 55 % (95 % CI 39-75). Thirteen patients relapsed, 46 % after six months of discontinuation, and all patients recovered MMR. Median time to recover MMR was one month. MR4.5 was the only factor associated with MRFS. NK cells proportion at baseline was lower in patients with only MR4 who relapsed after discontinuation. Conclusion: With a median duration of sustained MR4 above five years, as recommended by most TKI discontinuation guidelines, the TFS was similar to previous studies. Only MR4.5 was associated with lower risk of relapse. Further studies are needed to evaluate whether patients with only MR4 and low NK cell levels are suitable for discontinuation.
- Brazilian chronic myeloid leukemia working group recommendations for discontinuation of tyrosine kinase inhibitors in chronic myeloid leukemia in clinical practice(2022) BOQUIMPANI, Carla; SEGURO, Fernanda Salles; MAGALHAES, Gustavo Henrique Romani; PINTO, Ingrid Luise Soares; BENDIT, Israel; BORTOLINI, Jaisson Andre Pagnoncelli; PAGNANO, Katia Borgia Barbosa; CENTRONE, Renato; FUNKE, VaneuzaIntroduction: Treatment-free remission (TFR) is a new goal of chronic myeloid leukemia (CML) therapy. TFR is feasible when the patient has achieved a deep and stable molecular response and met the criteria required to ensure its success. Treatment discontinuation should not be proposed to the CML patient if minimum conditions are not met. In Brazil, for example, molecular tests (BCR::ABL1) are not broadly available, making it difficult to monitor the patients adequately. Objective: In this sense, providing TFR recommendations for Brazilian physicians are therefore necessary. These recommendations include the main criteria checklist to start the TKIs treatment discontinuing process in patients diagnosed with CML and the populationeligible characteristics for treatment discontinuation. Method: Age, risk score at diagnosis, TKI treatment duration, BCR::ABL1 transcripts type, depth of the molecular response for treatment discontinuation, treatment adherence, patient monitoring and withdrawal syndrome are essential factors to consider in TFR. After TKI discontinuation, BCR::ABL1 transcripts monitoring should be more frequent. When a major molecular response loss is observed during the monitoring of a patient in TFR, the TKI treatment should be resumed. Conclusion: These recommendations should serve as a basis for medical professionals interested in proposing TKI discontinuation for CML patients in clinical practice. It is important to highlight that, despite the benefits of TFR for the patients and the health system, it should only be feasible following the minimum standards proposed in this recommendation. (C) 2022 Published by Elsevier Espana, S.L.U.
- Treatment-Free Response in Chronic Myeloid Leukemia Using Brazilian Imatinib Copies As First Line - Results from Two Prospective Clinical Trials(2022) CENTRONE, Renato Torrescasana; SEGURO, Fernanda S.; BELLESSO, Marcelo; NARDINELLI, Luciana; BENDIT, Israel; ROCHA, Vanderson; ALVES, Adelson
- Risk factors and incidence of thrombosis in a Brazilian cohort of patients with Philadelphia-negative myeloproliferative neoplasms(2020) SEGURO, Fernanda Salles; TEIXEIRA, Larissa Lane Cardoso; ROSA, Lidiane Ines da; SILVA, Wellington Fernandes da; NARDINELLI, Luciana; BENDIT, Israel; ROCHA, VandersonFew data are available regarding epidemiology and outcomes of Philadelphia-negative chronic myeloproliferative neoplasms (MPN) in Latin America. Therefore, current models for MPN treatment are based in large cohorts of patients from Europe and North America. In this paper, we conducted a retrospective study to evaluate thrombotic and bleeding events in a cohort of patients with MPN from a reference center in Brazil. A total of 334 patients were included, being essential thrombocythemia the most common diagnosis. Here, we found that 41% of the MPN patients had a thrombotic event prior to the diagnosis. Thrombosis was more frequent in patients under 60 years-old. In a multivariable model, only JAK2 V617F mutation (OR 2.57 95% CI 1.58-4.18, p < 0.001) and presence of two cardiovascular risk factors (OR 1.90 95% CI 1.21-2.98, p < 0.005) were significant for thrombosis. The risk of thrombosis was similar among all subtypes of MPN. Cumulative incidence of thromboembolic event at 5 years from diagnosis was 5.8% (95% CI 3.5-8.9), which is similar to previous studies. The high incidence of thromboembolic events in younger patients suggests that socioeconomic disparities might have a role in the outcomes of MPN
- Financial Impact of Imatinib Discontinuation in Brazil - a Pharmoeconomic Study(2019) CENTRONE, Renato Torrescasana; BONAFE, Isabel; MIRANDA, Eliana C.; SEGURO, Fernanda S.; MAGALHAES, Gustavo H. R.; CLEMENTINO, Nelma D.; MOELLMANN-COELHO, Arthur; LUISE, Ingrid; CONCHON, Monika; GONCALVES, Natalia N.; BORTOLINI, Jaisson; FOGLIATTO, Laura Maria; SOUZA, Carmino Antonio; PAGNANO, Katia B.; BENDIT, Israel
- COVID-19 in chronic myeloid leukemia patients in Latin America(2021) PAGNANO, Katia B.; PERALTA, Evelyn Herrera; NAVARRO, Juan Ramon; SALAS, Lourdes del Rosario David; DELGADO, Nancy; MOIRAGHI, Beatriz; TORELI, Ana Carolina M.; PEROBELLI, Leila M.; FECHIO, Leonardo; QUIXADA, Acy T. S.; FUNKE, Vaneuza; BENDIT, Israel; SEGURO, Fernanda S.; PILLEUX, Lilian; BORTOLINI, Jaisson; LOURENCO, Andre L. G.; SAPELLI, Jaqueline; NUCCI, Fabio M.; PAVLOVSKY, Carolina; OLIVEIRA, Luciene Da Cruz; MOURA, Muriel Silva; PALMA, Leonardo C.; GONCALVES, Natalia N.; CONCHON, Monika; HOKAMA, Paula O. M.; ALMEIDA, Leandro Lustri; ZULLI, Roberto; SOUZA, Carmino Antonio de; BOQUIMPANI, Carla M.This observational, multicenter study aimed to report the clinical evolution of COVID-19 in patients with chronic myeloid leukemia in Latin America. A total of 92 patients presented with COVID-19 between March and December 2020, 26% of whom were severe or critical. The median age at COVID-19 diagnosis was 48 years (22-79 years), 32% were 60 years or older, and 61% were male. Thirty-nine patients presented with at least one comorbidity (42.3%). Eighty-one patients recovered (88%), and 11 (11.9%) died from COVID-19. There was one case of reinfection. Patients with a major molecular response presented superior overall survival compared to patients with no major molecular response (91 vs. 61%, respectively; p = 0.004). Patients in treatment-free remission and receiving tyrosine kinase inhibitors showed higher survival rates than patients who underwent hematopoietic stem cell transplantation and those who did not receive tyrosine kinase inhibitors (100, 89, 50, and 33%, respectively; p < 0.001).
- Salvage treatment for refractory or relapsed acute myeloid leukemia: a 10-year single-center experience(2020) SILVA, Wellington Fernandes da; ROSA, Lidiane Ines da; SEGURO, Fernanda Salles; SILVEIRA, Douglas Rafaele Almeida; BENDIT, Israel; BUCCHERI, Valeria; VELLOSO, Elvira Deolinda Rodrigues Pereira; ROCHA, Vanderson; REGO, Eduardo M.OBJECTIVES: The outcomes of refractory and relapsed acute myeloid leukemia (AML) patients in developing countries are underreported, even though the similar classic regimens are widely used. METHODS: We conducted a retrospective comparison of ""MEC"" (mitoxantrone, etoposide, and cytarabine) and ""FLAG-IDA"" (fludarabine, cytarabine, idarubicin, and filgrastim) in adults with first relapse or refractory AML. RESULTS: In total, 60 patients were included, of which 28 patients received MEC and 32 received FLAG-IDA. A complete response (CR) rate of 48.3% was observed. Of the included patients, 16 (27%) died before undergoing bone marrow assessment. No statiscally significant difference in CR rate was found between the two protocols (p=0.447). The median survival in the total cohort was 4 months, with a 3-year overall survival (OS) rate of 9.7%. In a multivariable model including age, fms-like tyrosine kinase 3 (FLT3) status, and stem-cell transplantation (SCT), only the last two indicators remained significant: FLT3-ITD mutation (hazard ratio [HR] =4.6, p< 0.001) and SCT (HR=0.43, p=0.01). CONCLUSION: In our analysis, there were no significant differences between the chosen regimens. High rates of early toxicity were found, emphasizing the role of supportive care and judicious selection of patients who are eligible for intensive salvage therapy in this setting. The FLT3-ITD mutation and SCT remained significant factors for survival in our study, in line with the results of previous studies.
- Chronic Myeloid Leukemia: Comparison of Survival between Pregnant and Non-Pregnant Women(2020) GHELFOND, Giovanna Iantevi; SANTOS, Fernanda; SEGURO, Fernanda S.; ABDO, Andre; PEREIRA, Thales; MACIEL, Felipe V. R.; ALVES, Lucas B. O.; BENDIT, Israel; ROCHA, Vanderson; REGO, Eduardo M.
- Duration of Major Molecular Response and Discontinuation in Deep Molecular Response (MR4.5) Were Associated with Longer Treatment-Free Survival after Imatinib Discontinuation - Results from Two Prospective Brazilian Trials(2019) PAGNANO, Katia B.; SEGURO, Fernanda S.; MIRANDA, Eliana C.; LOPES, Ana Beatriz Pascoal; ABDO, Andre; DELAMAIN, Marcia Torresan; PEREIRA, Thales; DUARTE, Gislaine Borba; SANTOS, Fernanda Maria; VIANNA, Jessica C. N.; SILVA, Matheus Sebastian Da; NARDINELLI, Luciana; POVOA, Valquiria; PAVAN, Graziele; VERGILIO, Bruna R.; ROCHA, Vanderson; SOUZA, Carmino Antonio; PAULA, Erich V. De; BENDIT, Israel
- Real-world Imatinib Mesylate Treatment in Patients with Chronic Myeloid Leukemia: The Importance of Molecular Monitoring and the Early Molecular Response(2023) FERREIRA, Amanda Pifano Soares; SEGURO, Fernanda Salles; ABDO, Andre Ramires Neder; SANTOS, Fernanda Maria; MACIEL, Felipe Vieira Rodrigues; NARDINELLI, Luciana; GIORGI, Ricardo Rodrigues; RUIZ, Antonio Roberto Lancha; FERREIRA, Milton Pifano Soares; REGO, Eduardo Magalhaes; ROCHA, Vanderson; BENDIT, IsraelIntroduction Chronic myeloid leukemia (CML) is a clonal myeloproliferative disorder characterized by the Philadelphia (Ph) chromosome. After the introduction of imatinib mesylate (IM) in 2000, the natural history of the disease changed. Data on the treatment of CML with IM are from randomized clinical trials. Establishing whether these results can be reproduced or if caution is needed when extrapolating data to the general population with CML is essential. Objectives To evaluate the molecular response (MR) in patients with chronic-phase CML (CML-CP) not included in clinical studies and correlate them with the responses obtained in clinical trials. Methods Between January 2007 and January 2017, 227 patients newly diagnosed with CML-CP treated with IM as first-line treatment were included. This study is an observational, retrospective, and single-center study. Results At a median follow-up time of 7.3 years, 60.3% of the 227 patients who started IM were still on IM. Early molecular response (EMR) at 3 and 6 months was achieved by 74.2% and 65%, respectively. The median time to a MMR was nine months. The MR4.0 and MR4.5 were 67.2% and 51.1%, respectively. The overall survival (OS), progression-free survival (PFS), and event-free survival (EFS) of the patients who exclusively used IM were 91%, 91%, and 85.1%, respectively. Conclusion The results presented are similar to those described in prospective and randomized trials, demonstrating that the outcomes are reproducible in the real world. EMR at 3 and 6 months reflects better long-term responses, including higher rates of deeper molecular responses. Considering treatment costs, the absence of literature evidence of an impact on overall survival demonstrated by first-line second-generation tyrosine kinase inhibitors (TKIs), and the global OS of 85.8%, imatinib mesylate (IM) is still an excellent therapeutic option.