ANDRE NEDER RAMIRES ABDO
Índice h a partir de 2011
8
Projetos de Pesquisa
Unidades Organizacionais
Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas, Faculdade de Medicina - Médico
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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.
article 20 Citação(ões) na Scopus Efficacy and Safety Results From ASCEMBL, a Multicenter, Open-Label, Phase 3 Study of Asciminib, a First-in-Class STAMP Inhibitor, vs Bosutinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Previously Treated With >= 2 Tyrosine Kinase Inhibitors(2021) HOCHHAUS, Andreas; BOQUIMPANI, Carla; REA, Delphine; MINAMI, Yosuke; LOMAIA, Elza; VOLOSHIN, Sergey; TURKINA, Anna G.; KIM, Dong-Wook; APPERLEY, Jane; CORTES, Jorge E.; ABDO, Andre; FOGLIATTO, Laura Maria; KIM, Dennis Dong Hwan; COUTRE, Philipp D. le; SAUSSELE, Susanne; ANNUNZIATA, Mario; HUGHES, Timothy P.; CHAUDHRI, Naeem A.; CHEE, Lynette C. Y.; GUTIERREZ, Valentin Garcia; SASAKI, Koji; AIMONE, Paola; ALLEPUZ, Alex; QUENET, Sarah; BEDOUCHA, Veronique; MAURO, Michael J.- Efficacy and Safety Results from Ascembl, a Multicenter, Open-Label, Phase 3 Study of Asciminib, a First -in -Class STAMP Inhibitor, Vs Bosutinib in Patients with Chronic Myeloid Leukemia in Chronic Phase after >= 2 Prior Tyrosine Kinase Inhibitors: Update after 48 Weeks(2021) MAURO, Michael J.; MINAMI, Yosuke; REA, Delphine; HOCHHAUS, Andreas; LOMAIA, Elza; VOLOSHIN, Sergey; TURKINA, Anna G.; KIM, Dong-Wook; APPERLEY, Jane F.; CORTES, Jorge E.; ABDO, Andre N. R.; FOGLIATTO, Laura; KIM, Dennis Dong Hwan; COUTRE, Philipp D. le; SAUSSELE, Susanne; ANNUNZIATA, Mario; HUGHES, Timothy P.; CHAUDHRI, Naeem A.; CHEE, Lynette C. Y.; GUTIERREZ, Valentin Garcia; SASAKI, Koji; KAPOOR, Shruti; ALLEPUZ, Alex; QUENET, Sarah; BEDOUCHA, Veronique; BOQUIMPANI, Carla
- A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs(2021) REA, Delphine; MAURO, Michael J.; BOQUIMPANI, Carla; MINAMI, Yosuke; LOMAIA, Elza; VOLOSHIN, Sergey; TURKINA, Anna; KIM, Dong-Wook; APPERLEY, Jane F.; ABDO, Andre; FOGLIATTO, Laura Maria; KIM, Dennis Dong Hwan; COUTRE, Philipp le; SAUSSELE, Susanne; ANNUNZIATA, Mario; HUGHES, Timothy P.; CHAUDHRI, Naeem; SASAKI, Koji; CHEE, Lynette; GARCIA-GUTIERREZ, Valentin; CORTES, Jorge E.; AIMONE, Paola; ALLEPUZ, Alex; QUENET, Sara; BEDOUCHA, Veronique; HOCHHAUS, AndreasPatients with chronic myeloid leukemia in chronic phase (CML-CP) resistant/intolerant to >= 2 tyrosine kinase inhibitors (TKIs) are at high risk of experiencing poor outcomes because of disease biology and inadequate efficacy and/or safety of current therapies. Asciminib, a first-in-class BCR-ABL1 inhibitor Specifically Targeting the ABL Myristoyl Pocket (STAMP), has the potential to overcome resistance/intolerance to approved TKIs. In this phase 3, open-label study, patients with CML-CP previously treated with >= 2 TKIs were randomized (2:1) to receive asciminib 40 mg twice daily vs bosutinib 500 mg once daily. Randomization was stratified by major cytogenetic response (MCyR) status at baseline. The primary objective was to compare the major molecular response (MMR) rate at week 24 for asciminib vs bosutinib. A total of 233 patients were randomized to asciminib (n = 157) or bosutinib (n = 76). Median follow-up was 14.9 months. The MMR rate at week 24 was 25.5% with asciminib and 13.2% with bosutinib. The difference in MMR rate between treatment arms, after adjusting for MCyR at baseline, was 12.2% (95% confidence interval, 2.19-22.30; 2-sided P = .029). Fewer grade >= 3 adverse events (50.6% vs 60.5%) and adverse events leading to treatment discontinuation (5.8% vs 21.1%) occurred with asciminib than with bosutinib. The study showed a superior efficacy of asciminib compared with that of bosutinib, together with a favorable safety profile. These results support the use of asciminib as a new therapy in patients with CML-CP who are resistant/intolerant to >= 2 prior TKIs.
- Recommendations for the management of cardiovascular risk in patients with chronic myeloid leukemia on tyrosine kinase inhibitors: risk assessment, stratification, treatment and monitoring(2021) SEGURO, Fernanda Salles; SILVA, Carolina Maria Pinto Domingues Carvalho; MOURA, Carla Maria Boquimpani de; CONCHON, Monika; FOGLIATTO, Laura; FUNKE, Vaneuza Araujo Moreira; ABDO, Andre; MACEDO, Ariane Vieira Scarlatelli; SANTOS, Marilia Harumi Higushi dos; SARAIVA, Jose Francisco KerrThis manuscript summarizes the results of the consensus meeting composed of hematol-ogists and cardiologists to establish recommendations for the prevention and follow-up of cardiovascular (CV) risk in patients with chronic myeloid leukemia (CML) treated with BCR-ABL tyrosine kinase inhibitors (TKIs) from the point of view of clinical practice and from the perspective of hematology consultation. In the first medical appointment, the CV risk factors should be identified to perform the baseline risk stratification, based on the Brazilian Guideline of Dyslipidemia and Atheroscle-rosis Prevention Update (risk levels: very high, high, intermediate and low). Once stratified, the treatment of the CV risk factors should be administered. If the patient presents risk factors, such as hypertension, diabetes, renal disease, smoking and hyperc- holesterolemia, the evaluation and initial treatment may be done by the hematologist, being an option the request for evaluation by a specialist. If the patient has a history of previous CV disease, we recommend referral to a specialist. As the CV risk score is dynamic and the control of risk factors can reduce the patient risk, this expert consensus recommends that the re-evaluation of the CV risk after the baseline should be performed at 3 months, 6 months and 12 months. After this period, it should be done annually and, for specific patients, at the clinician's discretion. The evaluation of the baseline CV risk and the safe administration of a TKI allow the patient to benefit from the maximum treatment, avoiding unwanted effects. (C) 2020 Associacao Brasileira de Hematologia, Hemoterapia e Terapia Celular.
- Efficacy and safety of oral panobinostat plus subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma (PANORAMA 3): an open-label, randomised, phase 2 study(2021) LAUBACH, Jacob P.; SCHJESVOLD, Fredrik; MARIZ, Mario; DIMOPOULOS, Meletios A.; LECH-MARANDA, Ewa; SPICKA, Ivan; HUNGRIA, Vania T. M.; SHELEKHOVA, Tatiana; ABDO, Andre; JACOBASCH, Lutz; POLPRASERT, Chantana; HAJEK, Roman; ILLES, Arpad; WROBEL, Tomasz; SUREDA, Anna; BEKSAC, Meral; GONCALVES, Iara Z.; BLADE, Joan; RAJKUMAR, S. Vincent; CHARI, Ajai; LONIAL, Sagar; SPENCER, Andrew; MAISON-BLANCHE, Pierre; MOREAU, Philippe; SAN-MIGUEL, Jesus F.; RICHARDSON, Paul G.Background Improved therapeutic options are needed for patients with relapsed or relapsed and refractory multiple myeloma. Subcutaneous bortezomib has replaced intravenous bortezomib as it is associated with a more favourable toxicity profile. We investigated the activity and safety of three different dosing regimens of oral panobinostat in combination with subcutaneous bortezomib and oral dexamethasone for this indication. Methods PANORAMA 3 is an open-label, randomised, phase 2 study being done at 71 sites (hospitals and medical centres) across 21 countries. Patients aged 18 years or older with relapsed or relapsed and refractory multiple myeloma (as per International Myeloma Working Group 2014 criteria), who had received one to four previous lines of therapy (including an immunomodulatory agent), and had an Eastern Cooperative Oncology Group performance status of 2 or lower, were randomly assigned (1:1:1) to receive oral panobinostat 20 mg three times weekly, 20 mg twice weekly, or 10 mg three times weekly, plus subcutaneous bortezomib and oral dexamethasone. All study drugs were administered in 21-day cycles. Randomisation was done by an interactive response technology provider, and stratified by number of previous treatment lines and age. The primary endpoint was overall response rate after up to eight treatment cycles (analysed in all randomly assigned patients by intention to treat). Safety analyses included all patients who received at least one dose of any study drug. No statistical comparisons between groups were planned. This trial is ongoing and registered with ClinicalTrials.gov, NCT02654990. Findings Between April 27,2016, and Jan 17,2019,248 patients were randomly assigned (82 to panobinostat 20 mg three times weekly, 83 to panobinostat 20 mg twice weekly, and 83 to 10 mg panobinostat three times weekly). Median duration of follow-up across all treatment groups was 14.7 months (IQR 7.8-24.1). The overall response rate after up to eight treatment cycles was 62.2% (95% CI 50.8-72.7; 51 of 82 patients) for the 20 mg three times weekly group, 65.1% (53.8-75.2; 54 of 83 patients) for the 20 mg twice weekly group, and 50.6% (39.4-61.8; 42 of 83 patients) for the 10 mg three times weekly group. Grade 3-4 adverse events occurred in 71 (91%) of 78 patients in the 20 mg three times weekly group, 69 (83%) of 83 patients in the 20 mg twice weekly group, and 60 (75%) of 80 patients in the 10 mg three times weekly group; the most common (>= 20% patients in any group) grade 3-4 adverse events were thrombocytopenia (33 142%1 of 78,26 [31%] of 83, and 19 [24%] of 83 patients) and neutropenia (18 [23%], 13 [16%], and six [8%]). Serious adverse events occurred in 42 (54%) of 78 patients in the 20 mg three times weekly group, 40 (48%) of 83 patients in the 20 mg twice weekly group, and 35 (44%) of 83 patients in the 10 mg three times weekly group; the most common serious adverse event (>= 10% patients in any group) was pneumonia (nine [12%[ of 78, ten [12%] of 83, and nine [11%] of 80 patients). There were 14 deaths during the study (five 16%1 of 78 patients in the 20 mg three times weekly group, three [4%] of 83 in the 20 mg twice weekly group, and six [8%] of 80 in the 10 mg three times weekly group); none of these deaths was deemed treatment related. Interpretation The safety profile of panobinostat 20 mg three times weekly was more favourable than in previous trials of this regimen with intravenous bortezomib, suggesting that subcutaneous bortezomib improves the tolerability of the panobinostat plus bortezomib plus dexamethasone regimen. The overall response rate was highest in the 20 mg three times weekly and 20 mg twice weekly groups, with 10 mg three times weekly best tolerated.
- Teaching Video NeuroImages: Multisystemic Erdheim-Chester Disease Presenting as a Cerebellar Ataxia(2021) BRITO, Marcelo Houat de; OLIVEIRA, Marcos Castello Barbosa de; CASAL, Yuri Reis; ABDO, Andre Neder Ramires; LUCATO, Leandro Tavares; SIMABUKURO, Mateus Mistieri