The Lancet Regional Health: Western Pacific最新文献

{"title":"Using machine learning algorithms to predict colorectal cancer","authors":"Xingjian Xiao , Bo Hong , Kubra Maqsood , Xiaohan Yi , Guoqun Xie , Hailei Zhao , Bo Sun , Jianying Mao , Shiyou Liu , Xianglong Xu","doi":"10.1016/j.lanwpc.2024.101355","DOIUrl":"10.1016/j.lanwpc.2024.101355","url":null,"abstract":"<div><h3>Background</h3><div>Colorectal cancer (CRC) is the second most common type of cancer in China, with middle-aged and elderly adults being at high risk. However, the colonoscopy examination rate among middle-aged and elderly adults is very low. As of 2020, the colonoscopy examination rate in China was 914.8 per 100,000 people, and the distribution across regions was extremely uneven. Given the high incidence and mortality rates of colorectal cancer and the low screening rate of colonoscopies in the initial screening positive population for colorectal cancer, further interventions will be needed. The objective of this study was to use machine learning and 0.2 million consultation data to predict colorectal cancer and identify important predictors.</div></div><div><h3>Methods</h3><div>Our study was based on a population-based cross-sectional survey. We used data from 5,664 cases with colonoscopy results out of 49,701 initial positive consultations in the colorectal cancer screening project in Baoshan District, Shanghai, from 2013 to 2021. Multiple machine learning models including adaptive boosting classifier and gradient boosting machine were established to predict colorectal cancer. In the setting of outcome indicators, patients diagnosed with colorectal cancer through clinical colonoscopy results are considered to have colorectal cancer. An area under the curve (AUC) of each established model exceeding 0.7 was considered acceptable for predicting colorectal cancer. The optimal model was used to identify predictors of colorectal cancer.</div></div><div><h3>Findings</h3><div>The incidence of colorectal cancer and the colonoscopy rate is 3.58% (203/5664) and 11.4% (5664/49,701). Non-invasive predictors such as sociodemographic information, behavioural history, and medical history were used to predict the current occurrence of colorectal cancer. In our study, the accuracy of Gradient Boosting Machine, Support Vector Machine, and Light Gradient Boosting Machine reached 0.86, while the accuracy of eXtreme Gradient Boosting reached 0.84 in predicting the occurrence of colorectal cancer. Among the variables predicting colorectal cancer, age, occupation, education, history of bowel cancer in first-degree relatives, history of cholecystitis are important predictors.</div></div><div><h3>Interpretation</h3><div>Using machine learning methods and non-invasive predictors can accurately predict colorectal cancer in individuals with positive initial screening results for colorectal cancer. Our machine learning predictive models can provide further risk for colorectal cancer, which may help increase the colonoscopy examination rate among individuals with positive initial screening results. In individuals with positive colorectal cancer screenings, colonoscopy rates are low. Our machine learning models can enhance screening rates, aiding in disease prevention.</div></div><div><h3>Funding</h3><div>This study was supported by Health Promotion and Education o","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101355"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427544","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":"Baseline T2-based all-in-one automated deep learning management system for neoadjuvant therapy efficacy and prognosis in locally advanced rectal cancer","authors":"Kui Sun,&nbsp;Siyi Lu,&nbsp;Hao Wang,&nbsp;Wei Fu","doi":"10.1016/j.lanwpc.2024.101398","DOIUrl":"10.1016/j.lanwpc.2024.101398","url":null,"abstract":"<div><h3>Background</h3><div>Current methods for assessing the efficacy of neoadjuvant therapy and predicting patient survival and recurrence risk in locally advanced rectal cancer prior to treatment are limited. This study aimed to develop a multi-module automated deep learning system to evaluate the pathological complete response (pCR) and prognosis of neoadjuvant therapy in patients at baseline.</div></div><div><h3>Methods</h3><div>This multicenter study retrospectively included T2-weighted images from a total of 354 patients with pathologically confirmed locally advanced rectal cancer who received neoadjuvant therapy from 2018 to 2022. The long-term prognosis of patients was also recorded, including overall survival (OS) and disease-free survival (DFS). Center I contained 227 patients as the development cohort, and centers II and III contained 72 and 55 patients as the external test cohorts, respectively. Lesion delineation was performed manually by a radiologist with ten years of experience. Image preprocessing, including N4 bias field correction, resampling, and image normalization, was performed prior to analysis. The study consisted of four main modules; first, an advanced 3D-SwinUNETR segmentation module was constructed and trained using a development cohort. After 15000 iterations, the best model is saved and the corresponding prediction mask is generated. Second, based on the generated prediction masks, three different analysis modules are used. First, a 3D-ResNet-152 model is constructed and trained with the development cohort to predict pCR for patients. Second, based on the 3D-ResNet-152 model framework, quantitative deep features (QDLs) were extracted, and a prediction model was constructed to evaluate pCR through a feature screening method. Third, radiomics features (RFs) are extracted, and a predictive model is constructed to evaluate pCR through feature screening methods. Finally, a fusion model was constructed based on the three modules to assess neoadjuvant therapy efficacy, OS, and DFS. Dice similarity coefficients (DSC) was used to evaluate the segmentation model, Area under the receiver operating characteristic curve (AUC) was used to assess the predictive performance of neoadjuvant efficacy, Kaplan Meier was used for DFS and OS analysis, and Log-rank was used to test for statistical differences.</div></div><div><h3>Findings</h3><div>In the segmentation module, the DSC for the two external cohorts was 0.703±0.020 and 0.698±0.025, respectively. The fusion model demonstrated the best efficacy for assessing pCR, achieving AUCs of 0.756 and 0.751. Log-rank analysis indicated the fusion model's effectiveness in risk-stratifying OS, with p-values of 0.033 and 0.023, and suggested potential stratification for DFS, with p-values of 0.068 and 0.044.</div></div><div><h3>Interpretation</h3><div>This deep learning-based approach can effectively assess the neoadjuvant therapy efficacy and long-term prognosis at baseline.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101398"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427817","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":"National Thalassemia Registry: a 30 year journey of implementing carrier screening in Singapore","authors":"Stella Zhang ,&nbsp;Guek Peng Tan ,&nbsp;Soh Lan Peh ,&nbsp;Swee Lim Ang ,&nbsp;Sylvia Kam ,&nbsp;Weng Khong Lim ,&nbsp;Teck Wah Ting ,&nbsp;Angeline Lai ,&nbsp;Ee Shien Tan ,&nbsp;Saumya Shekhar Jamuar ,&nbsp;Hai Yang Law ,&nbsp;Ivy Ng","doi":"10.1016/j.lanwpc.2025.101471","DOIUrl":"10.1016/j.lanwpc.2025.101471","url":null,"abstract":"","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101471"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143178035","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":"Middle-age cerebral small vessel disease and cognitive function in later life: a population-based prospective cohort study","authors":"Ali Tanweer Siddiquee ,&nbsp;Yoon Ho Hwang ,&nbsp;Soriul Kim ,&nbsp;Sung Jin Shin ,&nbsp;Ji Soo Lee ,&nbsp;June Christoph Kang ,&nbsp;Min-Hee Lee ,&nbsp;Hyeon Jin Kim ,&nbsp;Seung Ku Lee ,&nbsp;Chol Shin","doi":"10.1016/j.lanwpc.2024.101284","DOIUrl":"10.1016/j.lanwpc.2024.101284","url":null,"abstract":"<div><h3>Background</h3><div>Cerebral small vessel disease (cSVD) is a major pathologic substrate of vascular contribution to cognitive impairment. However, population based long-term longitudinal cognitive function data in relation to cSVD are rare. We investigated the relationship between cSVD and cognitive decline over time in middle-aged through elderly population.</div></div><div><h3>Methods</h3><div>This prospective cohort study was conducted in a community-based adult population (avg. age 58.5 ± 6.4) who underwent both magnetic resonance imaging (MRI) and comprehensive neuropsychological tests at baseline (2011–2014). The participants were followed-up with the same neuropsychological test battery 4-yearly in two more cycles (in 2015–2018 and 2019–2022). A total of 2454 participants who were free of dementia and cerebrovascular disease at baseline with cognitive function testing at least 2 time points over the time were analyzed. Data analysis was performed from May 1, 2023 to January 31, 2024. SVD was defined by the presence of any of the visible MRI markers (age-related white matter change, lacunes and cerebral microbleeds) at baseline. The main outcomes were multivariable adjusted mean differences of cognitive test performances by cSVD groups over time. The neuropsychological assessment battery included verbal and visual memory, verbal fluency, Digit Symbol–coding, Trail Making Test–A, and Stroop Test. To examine the relationship between cSVD and cognitive function, we used linear mixed model for repeated measurements to compare the means (95% CIs) by cSVD groups.</div></div><div><h3>Findings</h3><div>Of the total, 908 (37.0%) participants had cSVD on MRI reading at baseline. By location, cSVD were mostly found in the frontal lobe followed by basal ganglia area of the brain. None of the cognitive test scores, except Trail Making Test–A, were significantly different between the cSVD groups at baseline. At 8-year follow-up, participants without cSVD performed significantly better than participants with cSVD in Stroop–color reading [Mean difference 1.19 (95% CI: 0.02–2.36), p = 0.0451] and visual reproduction-recognition [Mean difference 0.11 (95% CI: 0.01–0.21), p = 0.0221]. While no other cognitive tests showed any differential changes by cSVD groups, logical memory (Story Recall Tests) increased and Stroop-word reading decreased over time in both cSVD groups almost identically.</div></div><div><h3>Interpretation</h3><div>Silent cSVD was independently associated with decline in executive functioning over 8-year follow-up period in this Korean middle-aged through elderly general population. Future studies considering wider spectrum of cSVD and longer follow-up durations may help predict further cognitive outcomes.</div></div><div><h3>Funding</h3><div>This study was funded by the <span>Korea Centers for Disease Control and Prevention</span>.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101284"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11787597/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081101","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":"Closing the gap in dementia research by community-based cohort studies in the Chinese population","authors":"Xiaowen Zhou ,&nbsp;Zhenxu Xiao ,&nbsp;Wanqing Wu ,&nbsp;Yuntao Chen ,&nbsp;Changzheng Yuan ,&nbsp;Yue Leng ,&nbsp;Yao Yao ,&nbsp;Qianhua Zhao ,&nbsp;Albert Hofman ,&nbsp;Eric Brunner ,&nbsp;Ding Ding","doi":"10.1016/j.lanwpc.2025.101465","DOIUrl":"10.1016/j.lanwpc.2025.101465","url":null,"abstract":"<div><div>China accounts for 1/5 of the global population and China faces a particularly heavy dementia burden due to its rapidly ageing population. Unique historical events, genetic background, sociocultural factors, lifestyle, and the COVID-19 pandemic further influence cognitive outcomes in the Chinese population. We searched PubMed, Web of Science, and Embase for community-based cohort studies related to dementia in the Chinese population, and summarized the characteristics, methodologies, and major findings published over the last 25 years from 39 cohorts. We identified critical research gaps and propose future directions, including enhancing sample representativeness, investigating China-specific risk factors, expanding exposure measurements to the whole life-span, collecting objective data, conducting administer-friendly domain-specific cognitive assessments, adopting pathological diagnostic criteria, standardizing biobank construction, verifying multi-modal biomarkers, examining social and genetic-environmental aspects, and monitoring post-COVID cognitive health, to approach high quality of dementia studies that can provide solid evidence to policy making and promote global brain health research.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101465"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788756/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123676","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":"Highlights of the ESMO Asia Congress 2024","authors":"Jiefang Huang","doi":"10.1016/j.lanwpc.2025.101482","DOIUrl":"10.1016/j.lanwpc.2025.101482","url":null,"abstract":"","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101482"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143178030","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":"Regulatory flexibilities balancing unmet needs, benefits and risks in the approvals of imported cancer drugs in China: a cohort study from 2012 to 2021","authors":"Xiangyun Mao ,&nbsp;Jiachen Xu ,&nbsp;Xiaozhen Liu ,&nbsp;Shu Kong ,&nbsp;Yi Li ,&nbsp;Xiaoyin Bai ,&nbsp;Jiaxuan Yang ,&nbsp;Aaron S. Kesselheim ,&nbsp;Guanqiao Li","doi":"10.1016/j.lanwpc.2025.101483","DOIUrl":"10.1016/j.lanwpc.2025.101483","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;China has historically relied on importing new drugs to fulfill domestic clinical needs. However, stringent requirements for local clinical trials for these imported drugs has often delayed their market approval, restricting timely access for patients. To address this issue, China has implemented regulatory flexibility in certain contexts, allowing for expedited approval processes when appropriate. This study aimed to evaluate the characteristics of novel cancer drugs qualifying for flexible approval in China from 2012 to 2021, focusing on pivotal trials features, clinical benefits, safety profiles, and unmet medical needs.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;This cohort study identified all newly imported cancer drugs and their indications approved by the China’s National Medical Products Administration (NMPA) from 2012 to 2021. Indications meeting standard requirements were categorized as regular approvals, while those supported by limited clinical data from Chinese patients were classified as flexible approvals. Development strategies, pivotal trials characteristics, and clinical outcomes were extracted from publicly available review documents and drug labels. Unmet medical needs were assessed based on two dimensions: the availability of standard-of-care treatments and the novelty of medicines. We compared the pivotal trial characteristics, efficacy end points, safety (serious adverse events) and the extent of unmet clinical needs, between flexible and regular approvals using Chi-square tests. A random-effects meta-regression was conducted to examine the association between flexible status and hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Findings&lt;/h3&gt;&lt;div&gt;Among 59 novel cancer drugs approved for importation to China between 2012 and 2021, 56 products with 92 indications were included in this analysis, based on the availability of their review documents. Of these, 48 indications (52%) qualified for flexible approvals, while 44 indications (48%) received regular approvals. The median number of Chinese patients involved in the datasets for flexible approvals was significantly lower than for regular approvals (27 [IQR, 0–62] vs. 165 [IQR, 99–245], p &lt; 0.001). Flexible approvals were more frequently supported by early-phase (18/61 vs. 1/60, p &lt; 0.001) and single-arm (22/61 vs. 1/60, p &lt; 0.001) pivotal trials, with response rates frequently used as the primary endpoint (24/61 vs. 1/60, p &lt; 0.001). Meta-regression analysis revealed that flexible approvals were associated with improved OS (HR 0.61 vs. 0.72, p &lt; 0.01), and a weaker association for PFS (HR 0.39 vs. 0.51, p = 0.03). The rate of serious adverse events was slightly higher, but not significantly, in the flexible approval group than the regular approval group (43% vs. 35%, p = 0.06). Flexible approvals were more likely to be indicated for diseases with no available existing drugs (31/48 vs.","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101483"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143178056","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":"Sentinel lymph node biopsy using dye alone in patients with initially cN1 breast cancer and ycN0 status after neoadjuvant therapy: a multicenter diagnostic trial","authors":"Ang Zheng ,&nbsp;Lei Zhang ,&nbsp;Yu Cao ,&nbsp;Dian-Long Zhang ,&nbsp;Fei Ma ,&nbsp;Jian-Yi Li ,&nbsp;Fan Yao ,&nbsp;Li Ma ,&nbsp;Pei-Fen Fu ,&nbsp;Jia Wang ,&nbsp;Jian-Yun Nie ,&nbsp;Ying-Ying Xu ,&nbsp;Bao-Liang Guo ,&nbsp;Feng Jin ,&nbsp;Bo Chen","doi":"10.1016/j.lanwpc.2024.101315","DOIUrl":"10.1016/j.lanwpc.2024.101315","url":null,"abstract":"<div><h3>Background</h3><div>Given the known complications associated with axillary lymph node dissection (ALND) and the limited application of radiolabeled colloid tracking in China, dye-only sentinel lymph node biopsy (SLNB) is proposed as a feasible and alternative surgical treatment strategy for patients with initially clinically node-positive (cN1) breast cancer to a clinically node-negative (ycN0) status after neoadjuvant therapy (NAT). However, the clinical diagnostic performance of dye-only SLNB needs further verification.</div></div><div><h3>Methods</h3><div>We conducted a multicenter diagnostic clinical trial from July 2019 to September 2023 by recruiting 230 patients from 12 participating centers across six provinces in China. Adult women with clinical stage T1-4N1M0 breast cancer and ycN0 status after NAT were eligible. SLNB and ALND were performed sequentially for patients, while a single dye was used to guide sentinel lymph nodes during the operation. The primary endpoint was the false-negative rate (FNR) of SLNB after NAT in women with ycN0 disease. Furthermore, subgroup analyses were conducted by age, body mass index (BMI), the number of SLNs removed and tumor subtype. The trial is registered on <span><span>www.chictr.org.cn</span><svg><path></path></svg></span> (identifier: ChiCTR1900026929) and <span><span>www.isrctn.com</span><svg><path></path></svg></span> (identifier: ISRCTN31364289).</div></div><div><h3>Findings</h3><div>The detection rate of single-dye was 95.22% (219/230). Pathological examinations showed positive lymph node findings in 117 of 230 patients. SLNB was successful in 212 out of the 219 patients (96.80%). The FNR of dye-alone SLNB was 5.98% (7/117; 95% CI, 2.44%-11.94%). Furthermore, the FNR was lower in women under 60 years of age (2.33% vs. 16.13% older than 60 years, <em>P</em>=0.0139), with body mass index under 25 kg/m² (2.60% vs. 12.5%, <em>P</em>=0.0452), and with four or more SLNs (2.53% vs. 13.16% with fewer than four SLNs, <em>P</em>=0.0358). For HR negative/HER-2 positive cases, the FNR was 0%.</div></div><div><h3>Interpretation</h3><div>SLNB with dye alone in patients with initially cN1 breast cancer and ycN0 after neoadjuvant therapy resulted in clinically acceptable rate of FNR. When four or more SLNs are detected, patients with age ≤ 60 years, BMI&lt;25km/m² and Her2-positive would derive additional benefit from dye-alone SLNB.</div></div><div><h3>Funding</h3><div>This trial was funded by Tackling Key Problems and Serving Local Projects of Liaoning Province (ZF20190006, to BC), <span>National Natural Science Foundation of China</span> (82073282 and 82203873, to AZ) and Joint Fund Project of the Science and Technology Program of Liaoning Province (2023012141-JH3/4600, to AZ).</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101315"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427796","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":"Sorafenib combined with transarterial chemoembolization compared with sorafenib alone in advanced hepatocellular carcinoma (SELECT): a multicenter, phase 3, randomized, controlled trial","authors":"Yan Zhao ,&nbsp;Wei Bai ,&nbsp;Rong Ding ,&nbsp;Nan You ,&nbsp;Lin Zheng ,&nbsp;Lei Li ,&nbsp;Jianbin Wu ,&nbsp;Peng Zhang ,&nbsp;Wukui Huang ,&nbsp;Hui Zhang ,&nbsp;Yongjin Zhang ,&nbsp;Diwen Zhu ,&nbsp;Haiping Li ,&nbsp;Jie Yuan ,&nbsp;Daiming Fan ,&nbsp;Yong Lv ,&nbsp;Guohong Han","doi":"10.1016/j.lanwpc.2024.101300","DOIUrl":"10.1016/j.lanwpc.2024.101300","url":null,"abstract":"<div><h3>Background</h3><div>Patients with advanced hepatocellular carcinoma have poor prognosis. We aimed to investigate the efficacy of sorafenib combined with transarterial chemoembolization in patients with advanced hepatocellular carcinoma.</div></div><div><h3>Method</h3><div>SELECT was a randomized, multi-centre, controlled, phase 3 trial done at twelve centres in China. Eligible patients were aged 18 years or older and had advanced-stage hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage C diseases, Child-Pugh class A liver disease, Eastern Cooperative Oncology Group (ECOG) performance statuses of 0 or 1. Participants were randomly assigned (1:1) with a computer-generated random sequence to sorafenib combined with transarterial chemoembolization or sorafenib alone. The primary endpoint was overall survival. Secondary endpoints were time to progression, tumor response rate, disease control rate and safety. Efficacy was analyzed in the intention-to-treat, per-protocol and as-treated populations. Safety outcomes were analyzed in the safety population. This trial is registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, number NCT01906216.</div></div><div><h3>Findings</h3><div>Between September 7, 2013, and Dec 4, 2019, 199 patients were randomly assigned, 99 to the combination group and 100 to the sorafenib alone group. Protocol adherence was 86% (85 of 99 patients) in the combination group and 56% (56 of 100 patients) in the sorafenib alone group. The most common reason for discontinuation was disease progression (68 [69%] in the combination group and 80 [80%] in the sorafenib alone group). The median age was 55 years (IQR 46-63). 164 (82.4%) of 199 were male and 35 (17.6%) were female. At a median follow-up of 13.6 months (IQR 6.8-28.2), in the intention-to-treat population, median overall survival was 14.9 months (95%CI 10.5-19.3 months) in the combination group versus 11.9 months (95%CI 9.0-14.8 months) in the sorafenib alone group (HR 0.862 [95%CI 0.645-1.150]; P=0.312). Median time to progression survival was significantly longer in the combination group than the sorafenib alone group (10.0 months [95%CI 6.4-13.6 months] vs 5.9 months [95%CI 3.1-8.7 months]; HR 0.686 [95%CI 0.515-0.954]; P=0.016). In the per-protocol and as-treated analyses, both median overall survival and time to progression was significantly improved in the combination group compared with sorafenib alone group.</div></div><div><h3>Interpretation</h3><div>In SELECT trial, sorafenib combined with TACE did not show overall survival benefit over sorafenib alone in intention-to-treat analysis; however, significantly longer overall survival benefit and improved time to progression was observed in both per-protocol and as-treated analyses.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101300"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427888","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":"Framing effects in decision aid-based lung cancer screening: a randomized clinical pilot trial in primary care","authors":"Xiujing Lin,&nbsp;Feifei Huang","doi":"10.1016/j.lanwpc.2024.101307","DOIUrl":"10.1016/j.lanwpc.2024.101307","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;The balance of risks and benefits associated with low-dose CT (LDCT) screening necessitates that high-risk individuals make informed decisions about lung cancer screening (LCS) based on their preferences. Patient decision aids (PDAs) can align these choices with patient values, and research indicates that message framing (gain vs. loss) significantly impacts decision-making. Despite extensive public health research on framing effects, there is limited understanding of how these messages can enhance LCS uptake. To address this gap, our research team developed the first LCS PDA in China, the LCS Loss-Gain Balance (LCS-LG-B), which integrates both gain-framed (emphasizing the benefits of healthy behaviors) and loss-framed (highlighting the costs of inaction) approaches. This study aims to investigate the effects of this PDA-based program on LCS behaviors among high-risk Chinese individuals.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;An intervention was designed around the LCS-LG-B to increase LDCT screening rates among high-risk individuals. This intervention included lung cancer risk assessments, education on lung cancer and LCS, shared decision-making exercises, and support for screening behaviors (e.g., smoking cessation resources, LCS information, and patient-doctor communication groups). A randomized clinical pilot trial was conducted with 72 high-risk lung cancer individuals in southeastern China from May 10, 2023, to February 10, 2024, with follow-up until October 10, 2024. Participants were randomly assigned to either the loss-framed or gain-framed version of the LCS-LG-B. Outcomes assessed at baseline (T0), immediately after the intervention (T1), and at one (T2), three (T3), and six months (T4) included LCS knowledge, health beliefs, decision conflict, self-efficacy, preparation, regret, and LDCT rates. Data were analyzed using a generalized linear mixed model and Chi-square tests, and the study is registered at the Chinese Clinical Trial Registry (ChiCTR2300071171).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Findings&lt;/h3&gt;&lt;div&gt;Sixty participants (30 from each group) completed all outcome measurements. Significant improvements were noted in decision conflict (F = 50.177, P &lt; 0.001), self-efficacy (F = 57.505, P &lt; 0.001), preparation (F = 45.599, P &lt; 0.001), regret (F = 8.886, P &lt; 0.001), LCS knowledge (F = 70.981, P &lt; 0.001), health beliefs (F = 21.149, P &lt; 0.001), perceived barriers (F = 20.020, P &lt; 0.001), and perceived benefits (F = 3.098, P = 0.016). The mean perceived risk score was significantly higher in the loss-framed group at T2 (D = 1.533, P = 0.004), T3 (D = 1.900, P &lt; 0.001), and T4 (D = 1.267, P = 0.017). However, there were no significant differences between groups in decision conflict, self-efficacy, preparation, regret, and LCS knowledge at T1, T2, T3, and T4 (P &gt; 0.050). After the intervention, 12 participants (40.00%) in the loss-framed group underwent LDCT compared to 8 (26.67%) in the gain-fra","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101307"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427891","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}