EClinicalMedicine最新文献

{"title":"Neoadjuvant sintilimab and chemotherapy followed by transoral surgery for HPV-positive resectable oropharyngeal cancer: a single-arm, two-centre, phase 2 trial.","authors":"Shida Yan, Xing Zhang, Fengjiao Li, Ankui Yang, Hui Li, Wanming Hu, Qiaohong Lin, Xiyuan Li, Mingyuan Du, Jingtao Chen, Guodong Man, Jianwei Zhang, Xuemei Fang, Li Ning, Shiting Zhang, Lili Han, Yanmei Ma, Jun Wang, Shuwei Chen, Ming Song","doi":"10.1016/j.eclinm.2025.103393","DOIUrl":"10.1016/j.eclinm.2025.103393","url":null,"abstract":"<p><strong>Background: </strong>Treatment deintensification, such as neoadjuvant immunochemotherapy and transoral surgery, has shown promise but remains under investigation in human papillomavirus-associated oropharyngeal squamous cell carcinoma (HPV⁺OPSCC). We aimed to explore the efficacy and safety of neoadjuvant immunochemotherapy and the feasibility of sequential transoral surgery in patients with resectable HPV⁺OPSCC.</p><p><strong>Methods: </strong>In this single-arm, two-centre, phase 2 trial, patients with resectable HPV⁺OPSCC (clinical stage T2-4N0-3M0) were recruited and received two cycles of neoadjuvant sintilimab, cisplatin, and nab-paclitaxel every three weeks, followed by transoral surgery, including transoral robotic surgery (TORS). The primary endpoint was major pathological response (MPR), defined as the residual viable tumor of less than or equal to 10% in the primary lesion. The study is registered with Chinese Clinical Trial Registry (ChiCTR2200058650) and is ongoing.</p><p><strong>Findings: </strong>Between April 13, 2022 and November 17, 2023, 27 patients were enrolled and all received two cycles of neoadjuvant immunochemotherapy, which all achieved partial responses. Among them, 25 patients received radical surgery (21 TORSs and 4 transoral surgeries). MPR was achieved in 24 patients (24/25, 96.0%), including 17 (17/25, 68.0%) with pathological complete response (pCR). Grade 1-2 treatment-related adverse events (TRAE) occurred in 24 of 27 patients (88.9%), including skin rash (12/27, 44.4%), alopecia (10/27, 37.0%), nausea (8/27, 29.6%), fatigue (8/27, 29.6%), and pain (8/27, 29.6%). Only one patient (1/27, 3.7%) experienced grade 3 TRAEs with no treatment-related death. For the per-protocol population, the 2-year DFS and OS were both 96.0% (95% CI: 88.6%-100.0%). Most patients experienced improved symptoms including pain and swallowing at 3 months post-surgery, and remained stable at 6 months and 1 year post-surgery. Circulating tumor HPV-DNA clearance had a trend to occur in patients with pCR.</p><p><strong>Interpretation: </strong>Neoadjuvant immunochemotherapy and sequential transoral surgery, including TORS, appears to be a feasible strategy that yields favorable oncologic and functional outcomes for patients with resectable HPV⁺OPSCC.</p><p><strong>Funding: </strong>Innovent Biologics.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"86 ","pages":"103393"},"PeriodicalIF":10.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12329559/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798499","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":"Exploring potential associations between GLP-1RAs and depressive disorders: a pharmacovigilance study based on FAERS and VigiBase data.","authors":"Min Wang, Xiaohong Chen, Zaiqiang Liu, Ziyi Li, Zhihong Zhu, Shao Liu, Sa Xiao","doi":"10.1016/j.eclinm.2025.103385","DOIUrl":"10.1016/j.eclinm.2025.103385","url":null,"abstract":"<p><strong>Background: </strong>GLP-1 receptor agonists (GLP-1RAs) are increasingly prescribed for diabetes and obesity management. Recent pharmacovigilance reports have raised concerns about potential neuropsychiatric adverse events, yet comprehensive safety assessments focusing on depressive disorders remain limited. This study investigated associations between specific GLP-1RAs and depressive disorders using real-world post-marketing surveillance data.</p><p><strong>Methods: </strong>We analyzed individual case safety reports (ICSRs) for liraglutide, semaglutide, and tirzepatide from the FDA Adverse Event Reporting System (FAERS) and WHO VigiBase databases through December 2024. Disproportionality analysis using reporting odds ratio (ROR) and information component (IC) identified signals of disproportionate reporting (SDRs) for depressive disorders. Time-to-onset analysis, stratified analyses, active comparator assessments, and co-medication evaluations were conducted to characterize these associations.</p><p><strong>Findings: </strong>Only semaglutide demonstrated statistically significant SDRs for depressive disorders in both databases (FAERS: ROR 1.26, 95% confidence interval (CI) 1.15-1.37; IC 0.33, 95% CI 0.20-0.45; VigiBase: ROR 1.38, 95% CI 1.27-1.49; IC 0.46, 95% CI 0.34-0.57), while liraglutide and tirzepatide showed no SDRs. Stratified analyses revealed increased disproportionality in females and healthcare professional reports. WSP analysis showed semaglutide-associated depression followed an early failure pattern, with no significant drug interactions identified with psychotropic medications.</p><p><strong>Interpretation: </strong>This pharmacovigilance investigation identified a semaglutide-specific SDR for depressive disorders across both databases, while liraglutide and tirzepatide showed no SDRs. Although inconsistent with reported protective effects in existing studies of GLP-1RAs, these findings suggest drug-specific rather than class-wide safety monitoring is warranted.</p><p><strong>Funding: </strong>This work was supported by grants from the Foshan \"Fourteen Five\" Key Medical Specialty Construction Project (grant number FSZD145035) and Natural Science Foundation of Hunan Province (grant number 2023JJ60520).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"86 ","pages":"103385"},"PeriodicalIF":10.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12329256/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798498","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":"Mapping diversity in gender identity and gender roles across sex and age in the Dutch general population: a large-scale cohort study.","authors":"Sarah M Burke, Daniëlle B A Kroeze, S Lucette Kiewiet, Aranka V Ballering","doi":"10.1016/j.eclinm.2025.103359","DOIUrl":"10.1016/j.eclinm.2025.103359","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Knowledge of diversity in gender identity and gender roles in the general population is limited. This study aimed to report the prevalence estimates of gender identity and gender roles among the adult general population, stratified by age and sex.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In the third general assessment of the prospective Dutch Lifelines Cohort Study, conducted between 2019 and 2023, sex and current gender identity were assessed using a self-reported categorical item, in which participants aged 18 years and older could indicate their sex assigned at birth (male or female) and current gender identity (man or woman), or select the option with a free-text field. Two separate dimensional measures assessed adherence to feminine and masculine gender roles. Using a cross-sectional study design, we describe the distribution of gender identities and adherence to gender roles, stratified by age and sex as registered by the municipality. Differences herein are assessed via independent t-tests and ANOVA.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;A total of 63,190 participants (mean age = 55.4 years [SD = 12.6]) were included in the study. Most participants identified as cisgender (36,835 [58.6%; 95% CI = 58.2-58.9] cisgender women; 25,893 [41.2%; 95% CI = 40.8-41.6] cisgender men). 66 (0.11%; 95% CI = 0.08%-0.13%) participants identified as non-cisgender. Among cisgender participants registered as males, masculine gender role scores increased across age groups, with younger individuals (18-30 years) scoring lower (M = 9.3, SD = 1.2) than older individuals (71-97 years; M = 9.7, SD = 1.0; &lt;i&gt;F&lt;/i&gt; &lt;sub&gt;(5,25925)&lt;/sub&gt; = 35.5; &lt;i&gt;p&lt;/i&gt; &lt; 0.0001; η&lt;sup&gt;2&lt;/sup&gt; = 0.008 [95% CI = 0.006-0.010]). A similar pattern was observed for adherence to feminine gender roles among cisgender participants registered as females, where younger individuals (M = 9.1, SD = 1.2) scored lower than older individuals (M = 9.7, SD = 1.0; &lt;i&gt;F&lt;/i&gt; &lt;sub&gt;(5,36900)&lt;/sub&gt; = 137.2; &lt;i&gt;p&lt;/i&gt; &lt; 0.0001, η&lt;sup&gt;2&lt;/sup&gt; = 0.018 [95% CI = 0.016-0.021]). Cisgender participants registered as male reported stronger adherence to masculine roles (M = 9.6, SD = 1.0), than their female counterparts to feminine roles (M = 9.3, SD = 1.2; t&lt;sub&gt;(60,459)=&lt;/sub&gt;27.7; &lt;i&gt;p&lt;/i&gt; &lt; 0.0001, Cohen's &lt;i&gt;d&lt;/i&gt; = 0.218 [95% CI = 0.202-0.234]).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;Although effect sizes are small, younger and female individuals indicate greater diversity in gender roles than older and male individuals, respectively. This shows that diversity in gender role adherence is common. A limitation of this study is the relatively older sample, which limits representation of younger individuals and may affect generalizability. These findings have implications for clinical practice and policy, as recognizing gender role diversity could help healthcare providers tailor interventions and assessments. Given the small but meaningful effect sizes, continued research on gender roles and the","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"86 ","pages":"103359"},"PeriodicalIF":10.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12399208/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946823","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":"Impact of mode of offer of self-sampling to people overdue cervical screening on screening participation: a randomised controlled trial.","authors":"Anita W W Lim, Rebecca Landy, Jane Rigney, Bernard North, Peter D Sasieni","doi":"10.1016/j.eclinm.2025.103357","DOIUrl":"10.1016/j.eclinm.2025.103357","url":null,"abstract":"<p><strong>Background: </strong>Offering self-sampling to non-attenders increases cervical screening uptake, but the optimal approach for offering kits remains unclear.</p><p><strong>Methods: </strong>Randomised controlled trial offering self-sampling. 13 GP (general practitioner) practices were randomised (1:1) to flagging women ≥6-months overdue cervical screening so that they could be offered a self-sampling kit if they attended their GP for any reason (N = 6080 women), or no opportunistic offer (N = 6577 women). Additionally, never screened women and those overdue screening by 15- or 27-months were individually randomised (2:1:1) to usual care (no systematic offer), a letter inviting them to order a kit (letter), or being sent a self-sampling kit (kit). The study ran from April 2019 to March 2020. The primary outcome was returning a self-sampling kit, and the secondary outcome was any cervical screening. The International Standard Randomised Controlled Trial Number (ISRCTN) is 23940319.</p><p><strong>Findings: </strong>In opportunistic offer practices, 342 (5.6%) returned a self-sample compared with 1.9% (123/6577) in practices not randomised to opportunistic offering (adjusted risk difference 4.4% (95% CI: 2.8%-6.0%)). Half (234/449) of women offered self-sampling opportunistically returned a sample. Among 6400 women individually randomised to no systematic offer vs letter vs kit, 1.7% (54/3197), 4.8% (76/1587; difference relative to no systematic offer 3.1% 95% CI: 2.0-4.2%) and 12.3% (198/1616; difference relative to no systematic offer 10.5%, 95% CI: 8.9-12.2%), returned a self-sample (the primary outcome), respectively. These observed differences were maintained in the secondary outcome, any cervical screening. No adverse effects were reported.</p><p><strong>Interpretation: </strong>In-person offers were most effective, but only a small proportion of non-attenders received such an offer. Postal invitations without a kit were less effective. The secondary outcome suggests those screened by self-sampling would not have been screened otherwise and contribute to increased screening coverage.</p><p><strong>Funding: </strong>Cancer Research UKC8162/A16892 to PS (consumables), C8162/A29083 to PS (JR, AL), C8162/A25356 to PS (BN); National Institute for Health Research Clinical Research Network (NIHR CRN) Central Portfolio Management System (CPMS) ID: 36156 (AL); Intramural Research Program, Division of Cancer Epidemiology and Genetics, National Cancer Institute (RL).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"86 ","pages":"103357"},"PeriodicalIF":10.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12399199/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946800","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":"Efficacy of an online mindfulness program (<i>MindOnLine</i>) to reduce fear of recurrence in people living with-and beyond-breast, prostate or colorectal cancer: a randomized controlled trial.","authors":"Patricia M Livingston, Natalie Winter, Lahiru Russell, Eric O, Allan Ben Smith, Helena Romaniuk, Michael Jefford, Anna Ugalde, Afaf Girgis, David W Austin, Cathrine Mihalopoulos, Richard Chambers, Jo Phipps-Nelson, Dishan Herath, Bodil Rasmussen, Kathryn Whitfield, Maria Ftanou, Kirsten Pilatti, Sally Sara, Annie Wootten, Mari Botti, Kate Gillan, Madhu Singh, David Campbell, Brindha Pillay, Philip Dundee, Michael O'Callaghan, Sue M Evans, Liliana Orellana, Victoria M White","doi":"10.1016/j.eclinm.2025.103373","DOIUrl":"10.1016/j.eclinm.2025.103373","url":null,"abstract":"<p><strong>Background: </strong>Fear of cancer recurrence (FCR) is a prevalent and debilitating condition that effects around 60% of people living with cancer. It is severe, persistent, and imposes a significant financial burden on the healthcare system. Given FCR's profound impact on mental health and quality of life, adopting targeted interventions to mitigate its effects is essential. This study reports on the efficacy of <i>MindOnLine</i>, an online mindfulness program, for people living with-and beyond-breast, prostate or colorectal cancer, in reducing FCR, anxiety and depression.</p><p><strong>Methods: </strong>Randomized controlled trial (1:1) comparing <i>MindOnline</i> with a waitlist group (ANZCTR: 12620000645954). Eligibility criteria: ≥18 years, living in Australia, completed active treatment/surveillance for stages 1-3 breast, prostate or CRC, within the last 5 years, had internet access, and a Fear of Cancer Recurrence Inventory (FCRI) severity score ≥13. <i>MindOnLine</i> was a self-directed, brief, online 9-week program, with a new module unlocked each week. The intervention incorporated education, mindfulness practices, and meditation, to promote awareness and emotion regulation. Data were captured at baseline, 9-weeks and 9-months post-randomization. Linear mixed models assessed <i>MindOnLine's</i> impact on the primary (FCRI total score) and secondary (anxiety (GAD-7), depression (PHQ-9)) outcomes.</p><p><strong>Findings: </strong>Between October 2020 and June 2023, 434 participants randomized, of which 58% had breast, 26% prostate and 16% colorectal cancer; 70% were female; 50% were aged ≥60 years; and 67.5% resided in metropolitan areas. At 9-weeks, <i>MindOnLine</i> decreased the FCRI total score (-5.61, 95% CI [-8.61, -2.61], p < 0.001); anxiety (-1.29 [-2.15, -0.43], p = 0.003) and depression (-1.47 [-2.34, -0.61], p < 0.001) scores, compared to the waitlist group. Intervention effects were sustained at 9-months (FCRI: -5.06 [-8.61, -1.52]; p = 0.005; anxiety: -1.22 [-2.21, -0.24], p = 0.015; depression: -1.09 [-2.03, -0.16], p = 0.022).</p><p><strong>Interpretation: </strong>Our findings demonstrate that a self-directed, brief, online mindfulness-based program mitigates moderate or severe fear of cancer recurrence. Further research is necessary to guide the development of future services, policies and practices by identifying how online mindfulness programs can be customized to effectively support diverse population groups, ensuring the programs are effective and accessible and impactful, regardless of their personal circumstances or geographical location.</p><p><strong>Funding: </strong>This study was funded by the National Health and Medical Research Council (NHMRC) Partnership Grant ID APP1179317, with partner cash contributions from the Department of Health, Victoria, Epworth HealthCare and Western Health.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"86 ","pages":"103373"},"PeriodicalIF":10.0,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12318308/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144774937","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":"Obinutuzumab induction and maintenance in patients with Waldenström macroglobulinaemia: an open-label, single-arm phase 2 study.","authors":"Tomasz Wróbel, Elżbieta Kalicińska, Jan Maciej Zaucha, Marta Morawska, Krzysztof Giannopoulos, Krzysztof Jamroziak, Ewa Lech-Marańda, Michał Taszner, Agnieszka Szeremet, Bartosz Małecki, Agnieszka Druzd-Sitek, Anna Łojko-Dankowska, Dominik Dytfeld","doi":"10.1016/j.eclinm.2025.103383","DOIUrl":"10.1016/j.eclinm.2025.103383","url":null,"abstract":"<p><strong>Background: </strong>Despite progress in the treatment of Waldenström macroglobulinaemia, this disease still remains a therapeutic challenge, especially in older patients with multiple comorbidities. This study aimed to assess obinutuzumab single-agent induction and maintenance activity and safety in patients with relapsed or refractory Waldenström macroglobulinaemia.</p><p><strong>Methods: </strong>This open-label, single-arm phase 2 study enrolled patients with relapsed or refractory Waldenström macroglobulinaemia with confirmed CD20 expression and measurable disease. Patients received an infusion of obinutuzumab 1000 mg on days 1, 8, and 15 during first cycle, followed by five more cycles with infusions on day 1. Patients with a response defined as stable disease or better at the end of the induction phase entered 2-year maintenance treatment with obinutuzumab 1000 mg every eight weeks, followed by the observation phase. The primary endpoint was best overall response. This trial is registered at ClinicalTrials.gov, NCT03679455, and EudraCT, 2016-005053-20.</p><p><strong>Findings: </strong>Between September 04, 2018 and March 25, 2021, we enrolled 23 patients (median age 66 years, range 52-86 years). The median duration of follow-up was 3.8 years (range 0.1-6.0).The best overall response rate (BOR) was 65.2% (15 of 23 [95% CI 42.7-83.6]). In patients with baseline IgM level ≥40 g/L, BOR was reported in 75.0% (9 of 12 [95% CI 42.8-90.5]).Overall response rate (ORR) at the end of induction was reported in 12 (51%) of 23 patients. At the end of the study, ORR was reported in 15 (65%) of 23 patients. After the end of the study, the percentage of patients who achieved a very good partial response (VGPR) and complete remission (CR) has increased significantly compared to proportion of patients who achieved VGPR and CR after the 6-month induction phase (26% vs 4%, and 4% vs 0%, respectively). Progression-free survival was 65% (95% CI 43-84); overall survival was 74% (95% CI 52-90).Grade 3 or higher adverse events occurred in 15 (65.2%) patients, however, treatment-related grade 3 or higher adverse events occurred in 8 (34.8%) patients. One death that occurred during the induction phase was associated to disease progression, one death that occurred during maintenance phase was related to COVID-19, and one with disease progression. The remaining 3 deaths occurred during the follow-up phase, during subsequent lines of treatment.</p><p><strong>Interpretation: </strong>Obinutuzumab is active as single-agent induction and maintenance in patients with relapsed or refractory Waldenström macroglobulinaemia with manageable toxicity. Clinically significant is the fact that very good responses were deepened after the completion of the study with obinutuzumab.</p><p><strong>Funding: </strong>Roche Polska Ltd.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"86 ","pages":"103383"},"PeriodicalIF":10.0,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12318314/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144774938","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":"Evaluation of clinical and safety outcomes of cancer vaccines in patients with advanced non-small cell lung cancer after first-line therapy: a systematic review and meta-analysis.","authors":"Shaoyi Chen, Zewen Sun, Yun Li, Fan Yang, Peiyu Wang, Kezhong Chen, Jun Wang, Mantang Qiu","doi":"10.1016/j.eclinm.2025.103369","DOIUrl":"10.1016/j.eclinm.2025.103369","url":null,"abstract":"<p><strong>Background: </strong>Despite numerous randomized controlled trials (RCTs) on cancer vaccines, systematic evaluations of their efficacy and safety for patients with advanced non-small cell lung cancer (NSCLC) following first-line therapy remain lacking.</p><p><strong>Methods: </strong>In this systematic review and meta-analysis (PROSPERO, CRD42024568178), PubMed, Cochrane Library, and Embase databases were searched from inception up to December 27, 2024. Published phase II or III RCTs reporting survival outcomes in advanced or metastatic NSCLC patients who received vaccine therapy after first-line therapy were included. Data were independently extracted by two reviewers. The primary outcome was overall survival (OS), with progression-free survival (PFS) as secondary outcome. Treatment-related adverse events (TRAEs) was the major safety outcome. Random-effects model was employed in this meta-analysis. Risk of bias was evaluated with RoB 2.</p><p><strong>Findings: </strong>Eleven RCTs comprising 3228 patients (67% male, n = 2162) were included, without high risk of bias. The included studies involved employing cancer vaccines as first-line maintenance therapy, second-line therapy, or third-line therapy. In general, Cancer vaccines associated with improved OS (HR = 0.85, 95% CI, 0.78-0.92, <i>P</i> < 0.001) but did not significantly improve PFS (HR = 0.91, 95% CI, 0.79-1.05, <i>P</i> = 0.195). Subgroup analyses indicated better OS for patients with ECOG = 1, first-line chemotherapy, squamous cell carcinoma, stable disease after first-line therapy, stage IV, and smoking history. Squamous cell carcinoma (HR = 0.74, 95% CI, 0.61-0.90, <i>P</i> = 0.003) responded better to vaccine therapy than adenocarcinoma (HR = 0.83, 95% CI, 0.55-1.26, <i>P</i> = 0.377). The pooled OR for TRAEs was 1.5 (95% CI, 0.63-3.61, <i>P</i> = 0.361). Exploratory analysis indicated that immune response to cancer vaccines may serve as a predictive biomarker for vaccines effect. Besides, consistent efficacy and safety results were obtained when the meta-analysis was specific to first-line maintenance therapy based on seven trials.</p><p><strong>Interpretation: </strong>This meta-analysis demonstrated the clinical efficacy and safety of cancer vaccines in advanced NSCLC patients after first-line therapy, especially in those with squamous cell carcinoma. Immune response was identified as a predictive biomarker for vaccines effect. This study provides the state-of-the-art evidence for the clinical application of cancer vaccines in advanced NSCLC patients after first-line therapy.</p><p><strong>Funding: </strong>20240484580, 20230484314, 2023YFF0723500, 2021RU002, 82173386, RZ2022-04.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"86 ","pages":"103369"},"PeriodicalIF":10.0,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12309020/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144752692","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":"Intimate partner violence during pregnancy against 601,534 women aged 15 to 49 years in 57 LMICs: prevalence, disparities, trends and associated factors using Demographic and Health Survey data.","authors":"David Jean Simon, Vénunyé Claude Kondo Tokpovi, Adama Ouedraogo, Kassoum Dianou, Ann Kiragu, Comfort Z Olorunsaiye, Bénédique Paul","doi":"10.1016/j.eclinm.2025.103382","DOIUrl":"10.1016/j.eclinm.2025.103382","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Pregnant women are at increased risk of intimate partner violence (IPV), with harmful outcomes for both mother and unborn baby. As this public health issue remained poorly documented in low- and middle-income countries (LMICs), this comprehensive study aimed to investigate prevalence and disparities of intimate partner violence during pregnancy (IPVDP) in 57 LMICs, grouped into WHO Regions and World Bank 2022 Income Classification. We also examined changes in IPVDP in LMICs and associated factors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Data for this study were extracted from Demographic and Health Surveys conducted in 57 LMICs from 2000 to 2024. Countries without domestic violence data were excluded from the study. We estimated overall, regional, sub-regional, and national-weighted prevalence of IPVDP among women aged 15-49 years. Trends in IPVDP were calculated at the national level using the average annual rate of change (AARC) in a subset of 31 countries with at least two survey rounds. A Poisson regression model was fitted for identifying factors associated with IPVDP.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;The study included a total weighted sample of 601,534 women. The pooled prevalence of IPVDP was 6.3% (95% CI 6.2-6.4). The Eastern Mediterranean region recorded the highest prevalence of IPVDP (11.3% [95% CI 10.8-11.9]), while the South-East Asia region (3.3% [95% CI 3.0-3.5]) the lowest. Similarly, low-income countries (LICs) reported the highest prevalence of IPVDP (8.2% [95% CI 7.9-8.4]). Further, prevalence varied greatly across countries, ranging from 1.1% (95% CI 0.6-1.5) in South Africa to 17.6% (95% CI 15.3-20.0) in Papua New Guinea. Examining AARC, most countries (23/31) experienced a decreasing trend in IPVDP, however, seven countries showed increasing trends, with the largest of 8.3% (95% CI 6.8-9.9) in Gambia and the smallest of 0.6% (95% CI -0.7 to 1.8) in the Democratic Republic of Congo. Similarly, we found that women: aged 15-19 years, from poor households, with primary education and below, who had more than 5 children, married before 18, who had not participated in household decision-making, and whose partners exhibited controlling behaviour had higher likelihood of experiencing IPVDP.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;Despite the implementation of numerous development programs aimed at reducing violence against women in LMICs in recent decades, IPVDP remains high in some countries and has even increased in others. Our findings indicate that efforts to reduce IPVDP and the associated health burdens need to be improved in many LMICs. In alignment with the 5.2 Sustainable Development Goal target (i.e., eliminate all forms of violence against women and girls), stakeholders such as NGOs and policymakers can use these findings to roll out interventions based on observed geographic and socio-demographic inequities to end IPVDP among vulnerable groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Funding: &lt;/strong&gt;The Fonds de Recherche","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"86 ","pages":"103382"},"PeriodicalIF":10.0,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12312060/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144759372","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":"Stigma measurement in health: a systematic review.","authors":"Sara Malone, Lara Counts, Luke Zabotka, Anneliese Williams, Nele Loecher, Kayla Wynja, Gemma Bryan, Robin Tanner, Ana Cáceres-Serrano, Gia Ferrara, Lucia Fuentes, Tharwa Bilbeisi, Marissa Maheu, Benjamin K Oelkers, Muna Ogwo, Lauren Yaeger, Asya Agulnik, Dylan Graetz","doi":"10.1016/j.eclinm.2025.103360","DOIUrl":"10.1016/j.eclinm.2025.103360","url":null,"abstract":"<p><strong>Background: </strong>Stigma experienced by individuals with disease is a barrier to health-seeking behaviors and outcomes. Our aim was to systematically review how stigma has been defined and measured and identify gaps in approaches to measurement and intervention.</p><p><strong>Methods: </strong>A systematic review was conducted following PRISMA guidelines. Databases were searched for stigma measurement in health through July 2024. 8123 citations were screened. Data on definitions, measurement, psychometrics, and interventions were extracted. PROSPERO: CRD42023433176.</p><p><strong>Findings: </strong>We identified 2267 studies (2605 tools) from 101 countries. 396 (15.2%) tools focused on development and 2369 (91.0%) applied tools. Most tools assessed adults (77.2%). Over 750 stigma tools were identified; many tools were adapted (n = 674) or shortened (n = 446). 117 studies reported effective interventions, primarily in adults. Key gaps included lack of consensus on definitions, limited pediatric-focused research, and insufficient attention to structural drivers of stigma.</p><p><strong>Interpretation: </strong>This review calls for standardized, context-sensitive stigma measurement and interventions applicable across conditions and settings. Addressing these gaps is crucial to reducing the global burden of stigma and enhancing health outcomes. Future research should focus on unified conceptual approaches and definitions to develop globally adaptable tools and scalable interventions that address both the experiences and structural drivers of stigma.</p><p><strong>Funding: </strong>Components for the programs involved in this work have been funded by St. Jude Children's Research Hospital, the National Cancer Institute (3POCA021765-44S2), the American Lebanese Syrian Associated Charities, and Siteman Cancer Center. The views in this paper are those of the authors and don't necessarily reflect the funding agencies. The funding agencies were not involved in the writing or submitting of this work.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"86 ","pages":"103360"},"PeriodicalIF":10.0,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12311962/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144759373","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 effectiveness and safety of atorvastatin versus rosuvastatin among patients with ischemic stroke or transient ischemic attack: a national registry-based observational study.","authors":"Jianhua Zhao, Xinya Li, Xue Xia, Xue Tian, Qin Xu, Xiaoli Zhang, Ruobing Tian, Xia Meng, Anxin Wang","doi":"10.1016/j.eclinm.2025.103381","DOIUrl":"10.1016/j.eclinm.2025.103381","url":null,"abstract":"<p><strong>Background: </strong>Atorvastatin and rosuvastatin are the most widely used statins in patients with ischemic stroke or transient ischemic attack (TIA). However, evidence on their effectiveness and safety during actual use is scarce. This study aims to compare the effectiveness and safety of initiating atorvastatin versus rosuvastatin among patients with ischemic stroke or TIA.</p><p><strong>Methods: </strong>This observational study was based on the Third China National Stroke Registry (CNSR-III), which recruited consecutive adult patients with ischemic stroke or TIA within 7 days from the onset of symptoms to enrollment from August 2015 to March 2018. This study identified 3322 adults aged ≥18 years who had a pre-stroke modified Rankin Scale (mRS) score of 0 and initiated atorvastatin or rosuvastatin on the day of onset. The primary outcome was the ideal outcome, as defined by a mRS score of 0, at 3 months. The secondary outcomes included the ideal outcome at discharge, at 6 months, and at 12 months, along with 12-month stroke recurrence, all-cause mortality, cardiovascular mortality, and major adverse cardiovascular events.</p><p><strong>Findings: </strong>A total of 3322 eligible patients were identified, with 2605 initiating atorvastatin and 717 initiating rosuvastatin. The proportion of patients achieving an ideal outcome, as defined by a modified Rankin Scale of 0, was 44.63% in rosuvastatin initiators, significantly higher than 41.46% in atorvastatin initiators, with a relative rate of 1.12 (95% confidence interval 1.03, 1.22). Also, a greater percentage of rosuvastatin initiators attained the ideal outcome at discharge and at 6 months, compared with atorvastatin initiators. Regarding other secondary outcomes, no statistically significant difference was observed.</p><p><strong>Interpretation: </strong>Compared with atorvastatin, rosuvastatin was associated with a potentially higher proportion of patients attaining a mRS score of 0 among patients with ischemic stroke or TIA who initiate atorvastatin or rosuvastatin, which was not yet sufficient to guide clinical practice. Further research is needed to validate these findings.</p><p><strong>Funding: </strong>This work was supported by National Key Research and Development Program of China (2022YFC2502400, 2022YFC2502404), Beijing Natural Science Foundation Haidian original innovation joint fund (L222123), and Youth Innovation Fund of Beijing Neurosurgical Institute (2025 Reform and Development-Youth 15).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"86 ","pages":"103381"},"PeriodicalIF":10.0,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12311946/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144759471","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}