Sao Paulo Medical Journal最新文献

{"title":"Vitamin D supplementation and central adiposity in male shift workers: a randomized clinical trial on metabolic health.","authors":"Luiz Menezes-Júnior, Virgínia Capistrano Fajardo, Fernando Luiz Pereira de Oliveira, George Luiz Lins Machado Coelho, Fausto Aloisio Pedrosa Pimenta, Raimundo Marques do Nascimento Neto, Sílvia Nascimento de Freitas","doi":"10.1590/1516-3180.2025.2955.18032026","DOIUrl":"10.1590/1516-3180.2025.2955.18032026","url":null,"abstract":"<p><strong>Background: </strong>Vitamin D deficiency is common among individuals with obesity; however, the association between low 25-hydroxyvitamin D [25(OH)D] concentrations and adiposity remains unclear. Shift workers are at increased risk for both vitamin D deficiency and metabolic disorders, making this population particularly relevant for investigating this relationship.</p><p><strong>Objectives: </strong>This study aimed to evaluate the effect of cholecalciferol supplementation on central adiposity, assessed by waist circumference (WC) and waist-to-height ratio (WHtR), among male shift workers.</p><p><strong>Design and setting: </strong>Randomized, double-blind, placebo-controlled clinical trial involving 198 male shift workers employed by an iron ore extraction company in Minas Gerais, Brazil.</p><p><strong>Methods: </strong>Participants with 25(OH)D concentrations <30 ng/mL and at least one metabolic abnormality, including metabolic syndrome, impaired fasting glucose, dyslipidemia, elevated blood pressure, or increased WC, were randomly assigned to receive placebo, cholecalciferol 14,000 IU/week, or cholecalciferol 28,000 IU/week for 4 months. Plasma 25(OH)D concentrations, WC, and WHtR were evaluated at baseline and post-intervention.</p><p><strong>Results: </strong>After 4 months, no significant differences in WC or WHtR were observed between the vitamin D supplementation groups (14,000 IU/week and 28,000 IU/week) and the placebo group. Nevertheless, serum 25(OH)D concentrations increased significantly in the supplementation groups: +6.23 ng/mL (p25 = 0.58; p75 = 10.61) in the 14,000 IU/week group and +15.25 ng/mL (p25 = 10.57; p75 = 19.68) in the 28,000 IU/week group. In contrast, the placebo group showed a decrease of -0.50 ng/mL (p25 = -1.03; p75 = 2.71). Despite these increases, supplementation produced no significant effect on central adiposity outcomes (p > 0.05).</p><p><strong>Conclusion: </strong>Although vitamin D supplementation effectively increased serum 25(OH)D concentrations, it did not reduce central adiposity among male shift workers. These findings indicate that vitamin D supplementation alone is unlikely to improve obesity-related outcomes in this high-risk occupational population and underscore the need for comprehensive strategies targeting metabolic health in shift workers.</p><p><strong>Clinical trial or systematic review registration: </strong>This study was registered in the Brazilian Registry of Clinical Trials (ReBEC) under identifier RBR-6CS352 on October 25, 2017.</p>","PeriodicalId":49574,"journal":{"name":"Sao Paulo Medical Journal","volume":"144 4","pages":"e20252955"},"PeriodicalIF":1.2,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13506169/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148841249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of aminomix-1 solution as an in vitro scolicidal agent on the bile ducts and liver in rats: a controlled experimental animal study.","authors":"Recep Çağlar, Hüseyin Pülat, Emine Tekingündüz, Tiinçe Aksak","doi":"10.1590/1516-3180.2025.3467.13052026","DOIUrl":"10.1590/1516-3180.2025.3467.13052026","url":null,"abstract":"<p><strong>Background: </strong>Many scolicidal agents are used to treat hydatid cysts. However, most of these have been discontinued because of complications. Currently, no safe, effective, and useful scolicidal agent are available for the treatment of hydatid cysts in humans. Therefore, novel agents with greater efficacy, fewer side effects, and lower costs are required. In this study, we evaluated the effects of aminomix-1 solution on the liver and bile ducts of rats.</p><p><strong>Materials and methods: </strong>Twenty-two male Wistar-Albino rats were divided into two groups. A 0.5 mL solution of aminomix-1 was injected into the common bile duct with a 27-gauge syringe without pressure in the experimental group and normal saline (0.9% isotonic) in the control group. Blood samples for hepatic function tests and liver and bile duct tissues were examined histopathologically 4 weeks after the procedure. All statistical analyses were performed using IBM SPSS Statistics for Windows, version 21.0. Statistical significance was set at p < 0.05.</p><p><strong>Results: </strong>The aminomix-1 group showed significantly higher aspartate aminotransferase and alkaline phosphatase levels than the control group. No significant differences were observed in the alanine aminotransferase and amylase levels. Total and direct bilirubin and gamma-glutamyl transferase levels were below the detection limits. No fibrosis or confluent necrosis was observed in either group. The aminomix-1 group showed moderate necrosis in the spotty (focal) necrosis analysis, which was borderline significant (p ≈ 0.08).</p><p><strong>Conclusion: </strong>Although aminomix-1 caused mild biochemical and histopathological changes, it did not cause advanced or irreversible liver damage or sclerosing cholangitis.</p>","PeriodicalId":49574,"journal":{"name":"Sao Paulo Medical Journal","volume":"144 4","pages":"e20253467"},"PeriodicalIF":1.2,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13506168/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148841175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Academic Leagues and the Formation of Physicians in Brazil.","authors":"Alberto Jorge Monteiro Dela Vega, Paulo Manuel Pêgo-Fernandes","doi":"10.1590/1516-3180.2026.1444.02032026","DOIUrl":"10.1590/1516-3180.2026.1444.02032026","url":null,"abstract":"","PeriodicalId":49574,"journal":{"name":"Sao Paulo Medical Journal","volume":"144 4","pages":"e20261444"},"PeriodicalIF":1.2,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13505577/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148842052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"From diagnosis to refusal-causes and barriers to organ donation after brain death: a cross-sectional study.","authors":"João Paulo Victorino, Vagner Pires de Campos Junior, Victor Nei Vasconcelos Monteiro, Karina Dal Sasso Mendes, Emanuele Seicenti de Brito, Carla Arena Ventura","doi":"10.1590/1516-3180.2025.3503.27032026","DOIUrl":"10.1590/1516-3180.2025.3503.27032026","url":null,"abstract":"<p><strong>Background: </strong>Brain death is the essential condition for organ procurement, yet donation rates in Brazil remain insufficient to meet national transplant needs. Understanding both the clinical determinants of brain death and the social or institutional barriers to organ donation is crucial for improving donation outcomes and informing public health strategies.</p><p><strong>Objectives: </strong>To identify the main causes of brain death and analyze the factors associated with organ non-donation at a university hospital in São Paulo State.</p><p><strong>Design and setting: </strong>This cross-sectional study with a quantitative approach was conducted at a university hospital in São Paulo State, using data from the Organ Procurement Organization affiliated with the Universidade de São Paulo.</p><p><strong>Methods: </strong>The medical records of all patients diagnosed with brain death between 2001 and 2015 were reviewed. Sociodemographic variables, clinical causes of brain death, and factors related to donation outcomes were assessed using descriptive statistics and chi-square tests.</p><p><strong>Results: </strong>In total, the data of 1,688 cases were analyzed, including those of 574 donors (34%) and 1,114 non-donors. Traumatic brain injury and hemorrhagic stroke were the predominant neurological causes of brain death. No significant association was observed between sex or cause of brain death and donation outcome. Public initiatives such as the 2001 consent law and the 2014 \"Green September\" campaign showed limited short-term impact on donation rates.</p><p><strong>Conclusion: </strong>Although neurological causes account for most cases of brain death, donation outcomes are strongly influenced by social and institutional factors-particularly family refusal and trust in the healthcare system.</p>","PeriodicalId":49574,"journal":{"name":"Sao Paulo Medical Journal","volume":"144 4","pages":"e20253503"},"PeriodicalIF":1.2,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13506167/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148841225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of thyroid hormone profiles and derived ratios for predicting thyroid nodule malignancy using the Bethesda system: thyroid hormone ratios in malignancy risk stratification of thyroid nodules: a cross-sectional study.","authors":"İrem Şenoymak, Mustafa Can Şenoymak, Memet Taşkın Egici, İrem Kahveci, İsra Oğuz, Adnan Gökçel","doi":"10.1590/1516-3180.2025.3317.08062026","DOIUrl":"https://doi.org/10.1590/1516-3180.2025.3317.08062026","url":null,"abstract":"<p><strong>Background: </strong>Thyroid nodules are common, and although most are benign, a proportion may be malignant. Fine-needle aspiration biopsy (FNAB), interpreted using the Bethesda System, is the standard diagnostic method. However, in euthyroid patients, the predictive value of thyroid function tests and their derived ratios in relation to Bethesda categories remains unclear.</p><p><strong>Objectives: </strong>To evaluate thyroid function parameters and their association with Bethesda classification in euthyroid patients with thyroid nodules, and to identify potential predictors of malignancy.</p><p><strong>Design and setting: </strong>This retrospective cross-sectional study was conducted at the University of Health Sciences Haydarpaşa Numune Training and Research Hospital and included a convenience sample of eligible euthyroid patients who underwent FNAB between January 2020 and December 2023.</p><p><strong>Methods: </strong>A total of 828 euthyroid patients were included. Demographic data, pre-biopsy TSH, fT3, fT4, and derived ratios (TSH/T4, TSH/T3, and T3/T4) were analyzed for correlations with Bethesda categories and compared between the benign and malignant groups.</p><p><strong>Results: </strong>The mean age was 52.85 ± 12.53 years, and 80.8% of participants were female. Benign cytology was found in 54.6% of cases, and malignant cytology was found in 2.8%. Cases with malignant cytology were younger (p = 0.003) and more frequently male (p = 0.021). No significant differences were observed in hormone levels or ratios between the benign and malignant groups. However, TSH and the TSH/T4 ratio showed positive correlations with Bethesda category (p = 0.034 and p = 0.033, respectively).</p><p><strong>Conclusion: </strong>The TSH level and TSH/T4 ratio were correlated with Bethesda categories; however, thyroid function tests and derived ratios showed no diagnostic value for predicting malignancy in euthyroid nodules.</p>","PeriodicalId":49574,"journal":{"name":"Sao Paulo Medical Journal","volume":"144 4","pages":"e20253317"},"PeriodicalIF":1.2,"publicationDate":"2026-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13475864/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148800802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Potentially inappropriate medication use among older outpatients-prevalence and contributing factors: a retrospective study.","authors":"Meris Esra Bozkurt, Ercument Ozturk","doi":"10.1590/1516-3180.2026.3658.08062026","DOIUrl":"https://doi.org/10.1590/1516-3180.2026.3658.08062026","url":null,"abstract":"<p><strong>Background: </strong>Adverse outcomes associated with potentially inappropriate medication (PIM) use are prevalent among older adults.</p><p><strong>Objectives: </strong>This study aimed to determine the frequency of PIM use older outpatients and assess its association with chronic comorbidities and geriatric syndromes using the screening tool of older persons' prescriptions (STOPP) and screening tool to alert to right treatment (START) version 3 criteria.</p><p><strong>Design and setting: </strong>This retrospective study included patients aged 65 years or older who attended geriatric outpatient clinics between January and June 2024.</p><p><strong>Methods: </strong>PIM use was evaluated using the STOPP/START version 3 criteria. Polypharmacy was defined as the use of five or more medications.</p><p><strong>Results: </strong>Among the 107 patients (median age, 77 years; range, 65-91), 71% (n = 76) used PIM, with a median of two PIMs per patient (range, 0-6). PIM use was significantly more prevalent among patients with polypharmacy (odds ratio [OR] = 3.986; 95% CI: 1.493-10.639; p = 0.006). Analyses based on the STOPP criteria also revealed significant associations of PIM use with dementia (OR = 13.240; 95% CI: 1.504-116.529; p = 0.02), polypharmacy (OR = 4.352; 95% CI: 1.476-12.827; p = 0.008), and a history of falls (OR = 3.131; 95% CI: 1.017-9.634; p = 0.047).</p><p><strong>Conclusion: </strong>Polypharmacy was significantly associated with greater odds of PIM use among older adults. Based on the STOPP version 3 criteria, dementia and a history of falls were also associated with increased PIM use in this population.</p>","PeriodicalId":49574,"journal":{"name":"Sao Paulo Medical Journal","volume":"144 4","pages":"e20263658"},"PeriodicalIF":1.2,"publicationDate":"2026-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13475865/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148800777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What happens next: The lingering effects of child abuse in a Mexican cohort.","authors":"Efrén Romero Martínez, Mireya Robledo Aceves, Alejandro Barrón Balderas, América Aime Corona Gutiérrez, Eva Elizabet Camarena Pulido, Diego Magallón Picazo","doi":"10.1590/1516-3180.2024.0465.R1.21052026","DOIUrl":"10.1590/1516-3180.2024.0465.R1.21052026","url":null,"abstract":"<p><strong>Background: </strong>Understanding the lingering effects of child abuse may improve healthcare pathways with preventive and supportive strategies.</p><p><strong>Objective: </strong>To compare adverse outcomes between survivors of child abuse and non-exposed subjects.</p><p><strong>Design and setting: </strong>This is a cohort study conducted at the Pediatric Emergency Department of the Nuevo Hospital Civil de Guadalajara, Guadalajara, Mexico.</p><p><strong>Methods: </strong>This cohort study of Mexicans compared adverse outcomes between survivors of child abuse and non-exposed individuals from 2011 to 2018. Additionally, we contacted survivors in 2020 to collect additional data, including sociodemographic and study variable-related information.</p><p><strong>Results: </strong>This study included 300 survivors of child abuse, paired by age with 300 non-exposed subjects. Neglect and sexual abuse were the most frequent types of abuse. Among the survivors, there was a higher risk of hyperactivity with attention deficit [Relative Risk (RR) = 4.65(2.06-10.51); P = 0.0001], drug abuse [RR = 3.09(1.25-7.63); P = 0.0001], mood disorders [RR = 2.97(1.81-4.86); P = 0.0001], tobacco use [RR = 2.79(1.60-4.88); P = 0.0001], and engagement with substance abuse and sexual intercourse at a younger age. Non-exposed subjects had a higher level of education [RR = 0.65(0.49-0.87); P = 0.0001] and were more engaged in sports [RR = 0.31(0.18-0.52); P = 0.0001].</p><p><strong>Conclusion: </strong>Survivors of child abuse are at risk for psychological problems and substance abuse. Increasing sports engagement and school attendance may protect against adverse outcomes.</p>","PeriodicalId":49574,"journal":{"name":"Sao Paulo Medical Journal","volume":"144 4","pages":"e2024465"},"PeriodicalIF":1.2,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13450752/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148725866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serum irisin levels in women with polycystic ovary syndrome: a cross-sectional case-control study.","authors":"Atahan Toyran, Yagmur Minareci, Cavidan Gulerman","doi":"10.1590/1516-3180.2026.3566.08042026","DOIUrl":"10.1590/1516-3180.2026.3566.08042026","url":null,"abstract":"<p><strong>Background: </strong>Polycystic ovary syndrome (PCOS) is a common endocrine-metabolic disorder. Irisin is an exercise-related myokine involved in energy homeostasis; however, prior studies have reported inconsistent associations between irisin and PCOS.</p><p><strong>Objectives: </strong>To compare serum irisin levels between women with PCOS and non-PCOS controls and to assess the discriminatory performance of irisin for PCOS.</p><p><strong>Design and setting: </strong>Cross-sectional, case-control study conducted at a tertiary referral center.</p><p><strong>Methods: </strong>We enrolled 144 women, 72 with PCOS and 72 non-PCOS as controls. Serum irisin levels were measured using an enzyme-linked immunosorbent assay. Adjusted comparisons were performed using a general linear model, and the association between irisin and PCOS was further evaluated using multivariable binary logistic regression. Receiver operating characteristic (ROC) analysis was used to assess the diagnostic performance of irisin.</p><p><strong>Results: </strong>Serum irisin levels in the PCOS group were significantly lower than those in the control group (p = 0.006). In the age and body mass index (BMI) adjusted ANCOVA model, PCOS status remained significantly associated with lower log-transformed irisin (p = 0.002). In a multivariable logistic regression analysis adjusted for age and BMI, log-transformed irisin levels remained independently associated with PCOS (p = 0.006). In ROC analysis, the area under the ROC curve for irisin was 0.632; an irisin cut-off of ≤ 16.2 ng/mL resulted in 87.5% sensitivity and 38.89% specificity.</p><p><strong>Conclusions: </strong>Women with PCOS had lower circulating irisin levels than controls, and this association persisted after adjusting for age and BMI. Discriminatory performance was modest, and specificity was low at the selected cutoff. Larger studies are warranted to validate these findings.</p>","PeriodicalId":49574,"journal":{"name":"Sao Paulo Medical Journal","volume":"144 4","pages":"e20263566"},"PeriodicalIF":1.2,"publicationDate":"2026-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13450751/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148727467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predictive modeling with machine learning for low birth weight in the state of São Paulo: a retrospective population-based study.","authors":"Allbert Velleniche de Aquino Almeida, Adriana de Oliveira Ribeiro Dos Santos, Luiz Fernando Costa Nascimento","doi":"10.1590/1516-3180.2025.3373.04052026","DOIUrl":"10.1590/1516-3180.2025.3373.04052026","url":null,"abstract":"<p><strong>Background: </strong>Low birth weight (LBW) is a major public health concern associated with increased neonatal morbidity and mortality.</p><p><strong>Objective: </strong>This study was aimed to develop a predictive learning model using machine learning techniques to identify LBW from live birth data.</p><p><strong>Methods: </strong>A retrospective population-based study was conducted using data from the Brazilian Live Birth Information System (SINASC), which includes all live births registered in the state of São Paulo between 2019 and 2023. After data curation and exclusion of records with missing or unknown information, a total of 2,548,570 live births were analyzed. Predictors included maternal sociodemographic characteristics, obstetric history, prenatal care indicators, and newborn characteristics. Logistic regression and random forest models were trained using an 80/20 train-test split, with class imbalance addressed through class weighting. Model performance was evaluated using accuracy, precision, recall, F1-score, and area under the receiver operating characteristic curve (AUC-ROC).</p><p><strong>Results: </strong>The analysis showed that the balanced logistic regression model performed best in terms of sensitivity (0.688), F1-score (0.567), and AUC-ROC (0.850). A proportional analysis of the variables between the LBW and normal-weight groups revealed a higher prevalence of LBW among mothers with low education levels, without a partner, of Black or Brown ethnicity, aged ≤ 19 years or ≥ 35 years, with multiple pregnancies, with a reduced number of prenatal consultations, and with late initiation of prenatal care.</p><p><strong>Conclusions: </strong>The findings highlight the importance of large-scale data analysis supported by machine learning techniques to inform public policies aimed at preventing LBW and promoting maternal and child health.</p>","PeriodicalId":49574,"journal":{"name":"Sao Paulo Medical Journal","volume":"144 3","pages":"e20253373"},"PeriodicalIF":1.2,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13398868/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148622257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment patterns and clinical outcomes in chronic myeloid leukemia treated with second-line nilotinib-association of molecular milestones and prognostic scores with deep molecular response: a real-world retrospective cohort study.","authors":"Irena Ćojbašić, Ivan Tijanić, Žarko Ćojbašić","doi":"10.1590/1516-3180.2026.3647.06052026","DOIUrl":"10.1590/1516-3180.2026.3647.06052026","url":null,"abstract":"<p><strong>Background: </strong>Real-world data on the treatment patterns and clinical outcomes of second-line nilotinib use in chronic myeloid leukemia (CML) remain limited, particularly regarding predictors of deep molecular response (DMR).</p><p><strong>Objectives: </strong>To characterize treatment patterns and long-term clinical outcomes in patients with CML receiving second-line nilotinib and to evaluate whether early molecular milestones combined with baseline prognostic scores predict DMR.</p><p><strong>Design and setting: </strong>Retrospective, single-center real-world study conducted at a tertiary academic center between 2011 and 2025.</p><p><strong>Methods: </strong>The data of 45 patients with CML receiving second-line nilotinib because of imatinib resistance or intolerance were analyzed. Treatment patterns, including duration and reasons for switching therapy, were assessed. Baseline prognostic scores (Sokal, European Treatment and Outcome Study [EUTOS], EUTOS Long-Term Survival [ELTS], Hammersmith) were calculated, and molecular responses were assessed according to the European LeukemiaNet (ELN) criteria. Predictors of DMR were examined using univariate and multivariate logistic regression, and survival outcomes were estimated using Kaplan-Meier analysis.</p><p><strong>Results: </strong>The median duration of nilotinib administration was 67.3 months, with 60% of patients achieving a best response of DMR and 46.7% maintaining a sustained DMR. Univariate analysis showed that a favorable Hammersmith score (p = 0.001), low ELTS risk (p = 0.028), and attainment of ELN-defined milestones at 6 (p = 0.020) and 12 months (p = 0.006) were significantly associated with DMR. Multivariate analysis demonstrated that the 12-month ELN milestone (p = 0.008) and favorable Hammersmith score (p = 0.023) were independently associated with a DMR. Patients achieving a DMR showed a nonsignificant trend toward improved overall survival.</p><p><strong>Conclusion: </strong>In this real-world cohort, a DMR and favorable survival outcomes were achieved when nilotinib was administered as second-line treatment. Integrating baseline prognostic scores with molecular milestones enables individualized monitoring and supports a sustained DMR as a marker of durable disease control.</p>","PeriodicalId":49574,"journal":{"name":"Sao Paulo Medical Journal","volume":"144 3","pages":"e20263647"},"PeriodicalIF":1.2,"publicationDate":"2026-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13384408/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148551254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}