EClinicalMedicine最新文献

{"title":"Letter to the editor in response to a letter by Fuchs and Santosham regarding; assessing safety and efficacy of a novel glucose-free amino acid oral rehydration solution for watery diarrhea management in children: a randomized, controlled, phase III trial.","authors":"Pradip Bardhan, Neil Fawkes, Adam B Smith, Olivier Fontaine","doi":"10.1016/j.eclinm.2025.103111","DOIUrl":"10.1016/j.eclinm.2025.103111","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103111"},"PeriodicalIF":9.6,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11925559/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment of non-Hodgkin lymphoma with point-of-care manufactured CAR T cells: a dual institution, phase 1 trial.","authors":"Armin Ghobadi, Paolo F Caimi, Jane S Reese, Krishna Goparaju, Martina di Trani, Julie Ritchey, Zachary Jackson, Benjamin Tomlinson, Jennifer M Schiavone, Sarah Kleinsorge-Block, Kayla Zamborsky, Linda Eissenberg, Dina Schneider, Kirsten M Boughan, Emily C Zabor, Leland Metheny, Molly Gallogly, Winfried Kruger, Michael Kadan, Andrew Worden A S, Ashish Sharma, Brenda W Cooper, Folashade Otegbeye, Rafick P Sekaly, David N Wald, Carmelo Carlo-Stella, John DiPersio, Rimas Orentas, Boro Dropulic, Marcos de Lima","doi":"10.1016/j.eclinm.2025.103138","DOIUrl":"10.1016/j.eclinm.2025.103138","url":null,"abstract":"<p><strong>Background: </strong>Point-of-care manufacture of chimeric antigen receptor (CAR)-T cells can significantly reduce the time from apheresis to infusion. We conducted a dual-institution phase I trial aimed evaluating the safety and feasibility of this manufacturing model.</p><p><strong>Methods: </strong>CASE 2417 was a phase I clinical trial. Adults with relapsed or refractory CD19 positive non-Hodgkin lymphoma (R/R NHL) treated with ≥2 prior systemic therapies were eligible. MB-CART-19 is an anti-CD19 CAR T-cell product manufactured using the CliniMACS Prodigy device with 4-1BB and CD3ζ costimulatory domains. Lymphodepletion included fludarabine 25 mg/m<sup>2</sup> for 3 days and cyclophosphamide 60 mg/kg for 1 day. Prophylactic tocilizumab was allowed. Three dose levels (0.5, 1.0 and 2.0 × 10<sup>6</sup> cells/kg) were tested using a 3 + 3 dose-escalation schema. The primary outcome of this study was to determine the safety as defined by the dose limiting toxicities of MB-CART-19 in patients with relapsed and refractory NHL, co-primary outcome was determining the phase 2 dose of MB-CART-19. Secondary outcomes include defining the toxicity profile and to evaluate the initial efficacy of MB-CART-19 against relapsed or refractory NHL. This study was registered in ClinicalTrials.govNCT03434769.</p><p><strong>Findings: </strong>Thirty-one patients were enrolled between July 2018 and January 2021. Twenty-four (77%) had aggressive lymphoma, 7 (24%) had indolent lymphoma (follicular lymphoma and marginal zone lymphoma). The median number of previous therapies was 5 (range 2-13, interquartile range [IQR] 3-5). All enrolled patients received MB-CART-19. Median apheresis to infusion time was 13 days (range 9-20, IQR 9-13). One dose limiting toxicity (DLT) was observed in dose escalation (fatal cytokine release syndrome [CRS]), whereas one patient died in dose expansion secondary to hemophagocytic syndrome. Both deaths were considered treatment-related. Twenty (65%) patients had CRS, three (10%) grade ≥3. Ten patients (32%) experienced immune effector cell neurotoxicity syndrome (ICANS), four (13%) grade ≥3. Neutropenia (n = 28, 90%), thrombocytopenia (n = 15, 48%) and anaemia (n = 13, 42%) were the most frequent grade ≥3 adverse events. Twenty-five out of 29 (86%, 95% confidence interval [CI]: 68-96%) response-evaluable patients had disease response and 22 (76%, 95% CI: 56-90%) had complete response; the overall and complete response rates for response-evaluable aggressive lymphoma patients (n = 22) were 82% (n = 18, 95% CI: 60-95%) and 73% (n = 16, 95% CI: 50-89%). Median follow up was 24.5 (IQR 17-32) months, median progression free survival (PFS) was 26 months (95% CI: 19-not reached [NR]) and median PFS was not reached (95% CI: 25 months-NR). Two-year estimates of PFS and overall survival (OS) were 63% (95% CI: 47-83%) and 68% (95% CI: 52-88%), respectively. Median PFS was 26 months (95% CI: 7-NR) for aggressive lymphoma patients with 2-year ","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103138"},"PeriodicalIF":9.6,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11925540/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669434","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Do the effects of interventions aimed at the prevention of childhood obesity reduce inequities? A re-analysis of randomized trial data from two Cochrane reviews.","authors":"Jennifer C Palmer, Annabel L Davies, Francesca Spiga, Berit L Heitmann, Russell Jago, Carolyn D Summerbell, Julian P T Higgins","doi":"10.1016/j.eclinm.2025.103130","DOIUrl":"10.1016/j.eclinm.2025.103130","url":null,"abstract":"<p><strong>Background: </strong>Public health attempts to prevent obesity in children and young people should aim to minimize health inequalities. Two Cochrane reviews examining interventions aiming to prevent childhood obesity found that interventions promoting (only) physical activity have a small beneficial effect on BMI for people aged 5-18 years, as do interventions promoting physical activity alongside healthy eating for 5-11 year olds. We examined whether the effectiveness of the interventions included in these reviews differed according to eight factors associated with inequity: place, race/ethnicity, occupation, gender/sex, religion, education, socio-economic status, and social capital (the PROGRESS framework).</p><p><strong>Methods: </strong>We collected data on change in BMI (standardized or unstandardized), subgrouped by baseline measures of PROGRESS factors, for intervention and control groups, from trial authors. We calculated the intervention effect per subgroup (mean difference), then contrasted these to estimate interactions between intervention and the baseline factors. We combined interaction estimates for each factor across trials using meta-analyses.</p><p><strong>Findings: </strong>We collected subgrouped data from 81 trials that took place between 2001 and 2020, involving 84,713 participants. We found no substantial differences in effectiveness of interventions for PROGRESS subgroups in most scenarios. However, in the younger age group (5-11 years), the effect of interventions on standardized BMI appeared to be higher in boys (average difference in mean differences 0.03; 95% CI 0.01 to 0.06; 45 studies, n = 44,740), which was consistent in direction with the BMI effect (average difference in mean differences 0.06 kg/m2; 95% CI -0.02 to 0.13; 31 studies, n = 27,083).</p><p><strong>Interpretation: </strong>Our findings suggest that those responsible for public health can promote these beneficial interventions without major concerns about increasing inequalities but should be mindful that these interventions may work better in boys aged 5-11 years than girls. More data are needed, so we encourage future trialists to perform subgroup analyses on PROGRESS factors.</p><p><strong>Funding: </strong>National Institute for Health and Care Research (NIHR).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103130"},"PeriodicalIF":9.6,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11925530/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Global estimates of rotavirus vaccine efficacy and effectiveness: a rapid review and meta-regression analysis.","authors":"Ottavia Prunas, Ernest O Asare, Elizabeth Sajewski, Yueqi Li, Zeaan Pithawala, Daniel M Weinberger, Joshua L Warren, George E Armah, Nigel A Cunliffe, Miren Iturriza-Gómara, Benjamin A Lopman, Virginia E Pitzer","doi":"10.1016/j.eclinm.2025.103122","DOIUrl":"10.1016/j.eclinm.2025.103122","url":null,"abstract":"<p><strong>Background: </strong>Rotavirus is the leading cause of diarrhoea worldwide, particularly affecting young children. While national rotavirus immunization programs have reduced rotavirus morbidity and mortality, vaccine performance varies considerably between high-income and low-income settings.</p><p><strong>Methods: </strong>We updated a previous systematic review of studies reporting rotavirus vaccine efficacy and vaccine effectiveness against severe rotavirus-associated gastroenteritis (RVGE) by performing a rapid review from July 1, 2020 through October 16, 2024. We included randomized controlled trials reporting vaccine efficacy against severe RVGE and case-control and cohort studies reporting vaccine effectiveness against hospitalization with RVGE in children <5 years old for current internationally licensed vaccines. We developed a meta-regression model for vaccine efficacy and effectiveness using widely available country-specific predictors of rotavirus vaccine performance and simultaneously estimated the relationship between vaccine efficacy and effectiveness. We used the model to predict vaccine efficacy and effectiveness for all countries and assessed its predictive accuracy using a modified leave-one-country-out validation approach.</p><p><strong>Findings: </strong>Predicted vaccine efficacy ranged from 69.6% to 94.3% across countries in the Americas, European, and Western Pacific Regions, with a decreased efficacy ranging from 18.6% to 85.3% in the African, South-East Asian, and Eastern Mediterranean regions. Estimates of vaccine effectiveness were generally lower than vaccine efficacy when efficacy was greater than 60%, but effectiveness was predicted to be higher when vaccine efficacy was low. A strong correlation (<i>r</i> = 0.63) was found between the observed and predicted vaccine efficacy and effectiveness, with 98.2% of observed efficacy and effectiveness estimates falling within the 95% prediction intervals.</p><p><strong>Interpretation: </strong>Our approach enhances the understanding of global variation in rotavirus vaccine performance and can be used to inform predictions of the potential impact of rotavirus vaccines for countries that have yet to introduce them. Higher-quality data on predictor variables and broader regional representation in vaccine trials are required for more robust vaccine performance estimates.</p><p><strong>Funding: </strong>National Institutes of Health/National Institute of Allergy and Infectious Diseases (R01AI112970) and the Bill & Melinda Gates Foundation (INV-17940).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103122"},"PeriodicalIF":9.6,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11925534/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correspondence on \"Changes in memory and cognition during the SARS-CoV-2 human challenge study\".","authors":"Raffaella Ravinetto, François Hirsch, Yves Donazzolo, Lorenzo Montrasio, François Bompart","doi":"10.1016/j.eclinm.2025.103144","DOIUrl":"10.1016/j.eclinm.2025.103144","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103144"},"PeriodicalIF":9.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11915166/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to Antipsychotic use during pregnancy and risk of specific neurodevelopmental disorders and learning difficulties in children: a multinational cohort study [eClinicalMedicine 70 (2024) 102531/DOI: 10.1016/j.eclinm.2024.102531].","authors":"Claudia Bruno, Carolyn E Cesta, Vidar Hjellvik, Sinna Pilgaard Ulrichsen, Marte-Helene Bjørk, Buket Öztürk Esen, Malcolm B Gillies, Mika Gissler, Alys Havard, Øystein Karlstad, Maarit K Leinonen, Mette Nørgaard, Sallie-Anne Pearson, Johan Reutfors, Kari Furu, Jacqueline M Cohen, Helga Zoega","doi":"10.1016/j.eclinm.2025.103139","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103139","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1016/j.eclinm.2024.102531.].</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103139"},"PeriodicalIF":9.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11914749/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656507","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to comment about article 'changes in memory and cognition during the SARS-CoV-2 human challenge study'.","authors":"Christopher Chiu, Adam Hampshire","doi":"10.1016/j.eclinm.2025.103143","DOIUrl":"10.1016/j.eclinm.2025.103143","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103143"},"PeriodicalIF":9.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11914745/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative therapeutic efficacy and safety of first-line and second-line therapies for metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis.","authors":"Bohao Jiang, Benqiao Wang, Yiming Chen, Yaang Chen, Bohan Li, Jianbin Bi","doi":"10.1016/j.eclinm.2025.103129","DOIUrl":"10.1016/j.eclinm.2025.103129","url":null,"abstract":"<p><strong>Background: </strong>There is no cross-sectional comparison on therapeutic and adverse effects for treatments of metastatic castration-resistant prostate cancer (mCRPCa). We aimed to horizontally compare them for all common first-line and second-line therapies.</p><p><strong>Methods: </strong>We conducted a network meta-analysis with a systematic review in four databases (Pubmed, Web of Science, Embase, and Cochrane Library) up to January 5th, 2025. All randomized controlled trials (RCT) related to mCRPCa treatments with a clear description in study design were included. Endpoints included the radiographic progression-free survival (rPFS), overall survival (OS), time to PSA progression (TTPP), PSA progression rate (PSARR), and adverse events. All data was extracted by two researchers and analyzed with Gemtc package in R and Stata15. This NMA protocol was registered online (ID: CRD42025633178).</p><p><strong>Findings: </strong>After screening among 33,694 articles, 24 RCTs involving 13,059 cases were included. For first-line treatments, combination therapies with second-generation androgen receptor inhibitors (ARIs) showed superior efficacies in OS [HR of poly(ADP-ribose) polymerase inhibitors (PARPi) + ARI: 0.63 (0.32,1.25)], TTPP [HR of Lu177 + ARI: 0.07 (0.01,0.87)] and PSARR [RR of Lu177 + ARI: 33.02 (15.56,71.62)] with the highest SUCRA (Surface under the Cumulative Ranking Curve) (72%, 91% and 97% respectively). PARPi + ARI also performed best for rPFS (SUCRA: 85%, with an insignificant HR [0.12 (0.02,2.35)]. For post-docetaxel second-line treatments, ARI also emerged as the preferred option. Efficacies of post-ARI second-line treatments were not evaluated due to the lack of related RCTs. No obvious heterogeneity and publication bias was detected during the therapeutic comparison.</p><p><strong>Interpretation: </strong>This study provided comparative evidence for first-line and post-chemotherapy second-line mCRPCa treatment options. Second-generation ARIs exhibited good efficacy, particularly when combined with other treatments. However, the safety analysis necessitated balance between benefits and adverse events, especially for combination therapies. Stronger evidence is needed through direct comparisons in future clinical trials.</p><p><strong>Funding: </strong>The study was supported by The National Natural Science Foundation of China (No. 82172568).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103129"},"PeriodicalIF":9.6,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11914769/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Public health, war and cross-border challenges: the recent cVDPV2 polio outbreak in Gaza.","authors":"Itamar Grotto, Hazem Agha, Ahmad Abu Al-Halaweh, Nadav Davidovitch, Martin McKee, Dorit Nitzan","doi":"10.1016/j.eclinm.2025.103136","DOIUrl":"10.1016/j.eclinm.2025.103136","url":null,"abstract":"<p><p>The recent vaccine-derived poliovirus type 2 (cVDPV2) outbreak in Gaza, linked to strains circulating in Egypt, highlights the challenges of maintaining vaccination efforts in conflict zones. Amid prolonged hostilities and a deteriorating healthcare system, vaccination coverage has significantly declined, leaving many children vulnerable to poliovirus and other preventable diseases. This report analysed the outbreak's context, vaccination strategies, and outcomes by reviewing vaccination coverage data, environmental surveillance reports, and public health interventions. It focused on the novel oral polio vaccine type 2 (nOPV2) campaigns and their effectiveness in mitigating transmission. The outbreak, detected in June 2024, included six environmental samples and one confirmed case of poliomyelitis in a 10-month-old child. Despite operational challenges, a vaccination campaign immunised 560,000 children under 10 years by September 2024. However, ongoing violence delayed subsequent rounds of vaccination, particularly in northern Gaza. Contributing factors included vaccine hesitancy, logistical hurdles, and the safety risks healthcare workers face. Regional collaboration remains limited despite cross-border transmission risks. The Gaza outbreak illustrates the critical need for robust vaccination programs, enhanced surveillance, and international cooperation to prevent poliovirus resurgence. Addressing vaccine hesitancy and logistical challenges is vital. Sustained funding and innovative strategies, including nOPV2 use, are essential to combat outbreaks in fragile settings and advance global eradication efforts.</p><p><strong>Funding: </strong>No additional funding was used in the preparation of this report.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103136"},"PeriodicalIF":9.6,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11919384/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Deep learning-based model for prediction of early recurrence and therapy response on whole slide images in non-muscle-invasive bladder cancer: a retrospective, multicentre study.","authors":"Fan Jiang, Guibin Hong, Hong Zeng, Zhen Lin, Ye Liu, Abai Xu, Runnan Shen, Ye Xie, Yun Luo, Yun Wang, Mengyi Zhu, Hongkun Yang, Haoxuan Wang, Shuting Huang, Rui Chen, Tianxin Lin, Shaoxu Wu","doi":"10.1016/j.eclinm.2025.103125","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103125","url":null,"abstract":"<p><strong>Background: </strong>Accurate prediction of early recurrence is essential for disease management of patients with non-muscle-invasive bladder cancer (NMIBC). We aimed to develop and validate a deep learning-based early recurrence predictive model (ERPM) and a treatment response predictive model (TRPM) on whole slide images to assist clinical decision making.</p><p><strong>Methods: </strong>In this retrospective, multicentre study, we included consecutive patients with pathology-confirmed NMIBC who underwent transurethral resection of bladder tumour from five centres. Patients from one hospital (Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China) were assigned to training and internal validation cohorts, and patients from four other hospitals (the Third Affiliated Hospital of Sun Yat-sen University, and Zhujiang Hospital of Southern Medical University, Guangzhou, China; the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China; Shenshan Medical Centre, Shanwei, China) were assigned to four independent external validation cohorts. Based on multi-instance and ensemble learning, the ERPM was developed to make predictions on haematoxylin and eosin (H&E) staining and immunohistochemistry staining slides. Sharing the same architecture of the ERPM, the TRPM was trained and evaluated by cross validation on patients who received Bacillus Calmette-Guérin (BCG). The performance of the ERPM was mainly evaluated and compared with the clinical model, H&E-based model, and integrated model through the area under the curve. Survival analysis was performed to assess the prognostic capability of the ERPM.</p><p><strong>Findings: </strong>Between January 1, 2017, and September 30, 2023, 4395 whole slide images of 1275 patients were included to train and validate the models. The ERPM was superior to the clinical and H&E-based model in predicting early recurrence in both internal validation cohort (area under the curve: 0.837 vs 0.645 vs 0.737) and external validation cohorts (area under the curve: 0.761-0.802 vs 0.626-0.682 vs 0.694-0.723) and was on par with the integrated model. It also stratified recurrence-free survival significantly (p < 0.0001) with a hazard ratio of 4.50 (95% CI 3.10-6.53). The TRPM performed well in predicting BCG-unresponsive NMIBC (accuracy 84.1%).</p><p><strong>Interpretation: </strong>The ERPM showed promising performance in predicting early recurrence and recurrence-free survival of patients with NMIBC after surgery and with further validation and in combination with TRPM could be used to guide the management of NMIBC.</p><p><strong>Funding: </strong>National Natural Science Foundation of China, the Science and Technology Planning Project of Guangdong Province, the National Key Research and Development Programme of China, the Guangdong Provincial Clinical Research Centre for Urological Diseases, and the Science and Technology Projects in Guangzhou.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103125"},"PeriodicalIF":9.6,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11909458/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}