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Sorafenib combined with transarterial chemoembolization compared with sorafenib alone in advanced hepatocellular carcinoma (SELECT): a multicenter, phase 3, randomized, controlled trial
IF 7.6 1区 医学
The Lancet Regional Health: Western Pacific Pub Date : 2025-02-01 DOI: 10.1016/j.lanwpc.2024.101300
Yan Zhao , Wei Bai , Rong Ding , Nan You , Lin Zheng , Lei Li , Jianbin Wu , Peng Zhang , Wukui Huang , Hui Zhang , Yongjin Zhang , Diwen Zhu , Haiping Li , Jie Yuan , Daiming Fan , Yong Lv , Guohong Han
{"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}
引用次数: 0
Framing effects in decision aid-based lung cancer screening: a randomized clinical pilot trial in primary care
IF 7.6 1区 医学
The Lancet Regional Health: Western Pacific Pub Date : 2025-02-01 DOI: 10.1016/j.lanwpc.2024.101307
Xiujing Lin, Feifei Huang
{"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}
引用次数: 0
Acceptability and accuracy of artificial intelligence–assisted sponge cytology for screening of esophageal squamous cell carcinoma and adenocarcinoma of the esophagogastric junction: a multi-center cohort study
IF 7.6 1区 医学
The Lancet Regional Health: Western Pacific Pub Date : 2025-02-01 DOI: 10.1016/j.lanwpc.2024.101292
Zhiyuan Fan , Shanrui Ma , Ye Gao , Feifan He , Xinqing Li , Wenqiang Wei
{"title":"Acceptability and accuracy of artificial intelligence–assisted sponge cytology for screening of esophageal squamous cell carcinoma and adenocarcinoma of the esophagogastric junction: a multi-center cohort study","authors":"Zhiyuan Fan ,&nbsp;Shanrui Ma ,&nbsp;Ye Gao ,&nbsp;Feifan He ,&nbsp;Xinqing Li ,&nbsp;Wenqiang Wei","doi":"10.1016/j.lanwpc.2024.101292","DOIUrl":"10.1016/j.lanwpc.2024.101292","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;Esophageal squamous cell carcinoma (ESCC) and adenocarcinoma of the esophagogastric junction (AEJ) present significant health challenges in China, often diagnosed at advanced stages with poor prognoses. Screening is the pivotal strategy to relieve the burden of ESCC and AEJ in high-risk areas. Even though endoscopy has proven effective in the early detection of both cancers in high-prevalence regions, its invasiveness and resource-intensiveness make it impractical for large-scale screening. Therefore, developing a less invasive and readily accessible method with good diagnostic accuracy to identify high-risk individuals before endoscopy is urgently needed. We aim to evaluate the acceptability and accuracy of artificial intelligence (AI)-assisted sponge cytology tests using a novel cell collection device for ESCC and AEJ screening in Chinese high-risk regions.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;Participants aged 50 years or older were recruited in five high-risk regions of ESCC and AEJ. Cells from esophagus and esophagogastric junction were collected using a novel and minimally invasive capsule sponge, and cytology slides were scanned by a trained AI system. The qualitative outcomes (indicating the location of abnormal cells) and quantitative outcomes (counts of total scanned cells, potentially abnormal cells and 105 cytological features) were reported. Participants scored acceptability immediately following the procedure on a scale of 0 (least) to 10 (most acceptable). Endoscopy was performed subsequently with biopsy as needed. Feature selection was performed using Boruta algorithm. Lasso logistic regression model was developed to predict a composite outcome of high-grade lesions (ESCC, AEJ and high-grade intraepithelial neoplasia), with cytological features and epidemiological features as the predictive features. Model performance was primarily measured with the area under the receiver operating characteristic curve (AUC). Internal validation of the prediction models was performed using the 1000-bootstrap resample.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Findings&lt;/h3&gt;&lt;div&gt;A total of 1852 participants were enrolled and completed the study procedure. No serious adverse events were documented during the cell collection process, and acceptability scores were 10 (72.1%), 9 (19.8%), 8 (3.8%), 7 (1.5%) and 6 (0.9%). 30 (1.6%) participants were diagnosed with high-grade lesions confirmed by endoscopic biopsy. The lasso logistic model achieved an AUC of 0.902 (95%&lt;em&gt;CI&lt;/em&gt;: 0.851, 0.952) for detecting high-grade lesions, outperforming that of the cytological diagnosis and the sole use of abnormal cell counts. Internal validation of the model by bootstrap analysis was used, and the mean AUC of the model was 0.9 (95%&lt;em&gt;CI&lt;/em&gt;: 0.845, 0.944).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Interpretation&lt;/h3&gt;&lt;div&gt;We demonstrate the safety and acceptability of AI-assisted sponge cytology in high-risk regions, with high accuracy for detecting ESCC, AEJ and their precursor","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101292"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427600","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}
引用次数: 0
Tumescence and sharp versus electrocautery dissection in minimal access mastectomy: a real-world retrospective cohort study
IF 7.6 1区 医学
The Lancet Regional Health: Western Pacific Pub Date : 2025-02-01 DOI: 10.1016/j.lanwpc.2024.101342
Yiwen Lu, Xinyu Ou, Zhihan Liu, Shicheng Su
{"title":"Tumescence and sharp versus electrocautery dissection in minimal access mastectomy: a real-world retrospective cohort study","authors":"Yiwen Lu,&nbsp;Xinyu Ou,&nbsp;Zhihan Liu,&nbsp;Shicheng Su","doi":"10.1016/j.lanwpc.2024.101342","DOIUrl":"10.1016/j.lanwpc.2024.101342","url":null,"abstract":"<div><h3>Background</h3><div>Tumescence and sharp or electrocautery techniques have been employed during skin flap development in minimal access nipple-sparing mastectomy (NSM) with immediate prosthesis breast reconstruction. Our study evaluated the impact of techniques on complications after this surgery.</div></div><div><h3>Methods</h3><div>In this real-world retrospective cohort study, 5436 individuals undergoing NSM from 12 centers in China were identified. After exclusions and propensity score matching (PSM), a total of 1252 female breast cancer patients who underwent minimal access NSM with immediate prosthesis breast reconstruction between January 2016 and December 2022 were included. The effect of surgical techniques on the perioperative outcomes and postoperative complications was investigated using logistic regression analysis. The level of significance was set at P&lt; .05.</div></div><div><h3>Findings</h3><div>After PSM, we found that patients in the tumescence and sharp dissection group (n=313) experienced significantly lower rates of necrotic complications (5.8% vs 13.0%; P= .001), infection (2.6% vs 5.6%; P= .041), implant loss (0.3% vs 2.2%; P= .025), and had shorter mean operation time (median [IQR] min, 177.0 [132.0-219.0] min, and 201.0 [143.0-249.0] min; P&lt; .001), compared with those in the electrocautery dissection group (n=939).</div></div><div><h3>Interpretation</h3><div>Tumescence and sharp dissection might be a better option in skip flap development during minimal access NSM with immediate prosthesis breast reconstruction, in regard to operation time and surgical complications. A limitation is the variation in surgeons’ skills across multiple centers.</div></div><div><h3>Funding</h3><div><span>National Key Research and Development Program of China</span> (2023YFC3404500), the <span>Natural Science Foundation of China</span> (92057210, 82125017, 82173064, 92359302, 82322030), <span>Science and Technology Program of Guangzhou</span> (202103000070, 202201020479), and the <span>New Cornerstone Science Foundation</span> through the New Cornerstone Investigator Program and the XPLORER PRIZE.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101342"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427607","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}
引用次数: 0
Better control of cancer in China by helping people quit smoking
IF 7.6 1区 医学
The Lancet Regional Health: Western Pacific Pub Date : 2025-02-01 DOI: 10.1016/j.lanwpc.2024.101289
Ho Cheung William LI , Wei Xia , Lishan Li , Oi Kwan Chung
{"title":"Better control of cancer in China by helping people quit smoking","authors":"Ho Cheung William LI ,&nbsp;Wei Xia ,&nbsp;Lishan Li ,&nbsp;Oi Kwan Chung","doi":"10.1016/j.lanwpc.2024.101289","DOIUrl":"10.1016/j.lanwpc.2024.101289","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;Smoking causes multiple types of cancers and chronic respiratory diseases. Evidence also shows that exposure to second-hand smoke for non-smoking spouses of smokers increases their risk of developing lung cancer by 20-30%. To better prevent the growth of cancer, it is crucial to help people quit smoking. We evaluated the effectiveness of a brief self-determination theory-based smoking cessation for smokers at emergency departments (ED) in China Hong Kong in real-world settings.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;A multicentre, single-arm, open-label, nonrandomized trial was conducted at four EDs of public hospitals in China Hong Kong. Current smokers aged 18 years or older and triaged as semi-urgent or non-urgent were included. Participants received brief counselling using the AWARD (Ask, Warn, Advise, Refer and Do-it-again) model, and active referral provided by trained health care professionals (HCPs). Referred participants received proactive telephone calls offering cessation counselling from the referred smoking cessation service provider. The primary outcome was biochemically validated abstinence at 6 months. The trial was prospectively registered in &lt;span&gt;&lt;span&gt;ClinicalTrials.gov&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt; (Identifier &lt;span&gt;&lt;span&gt;NCT03818360&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt;).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Findings&lt;/h3&gt;&lt;div&gt;Between 30 August 2019 and 26 November 2021, 1601 eligible individuals were enrolled and included in the analyses. Most participants were males (1443/1601, 90%) and participants' mean age was 48 (standard deviation=15) years. By intention-to-treat analysis, biochemically validated abstinence in the referred group was significantly higher than that in the unreferred group at the 6- (5·3% vs. 3·6%; adjusted OR 1·88, 95% CI, 1·01–3·41; p=0·04) and 12-month follow-up (8·1% vs. 3·5%; adjusted OR 2·98, 95% CI, 1·70–5·19; p&lt;0·001).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Interpretation&lt;/h3&gt;&lt;div&gt;This trial demonstrated that brief advice and active referral for smokers attending the ED were effective and feasible in real-world settings. This innovative and cost-effective approach could motivate HCPs to assist more smokers with cessation in routine clinical settings and improve smoking abstinence levels. This research could have significant long-term implications for the healthcare industry, particularly in preventing the development of cancers caused by smoking. It will help reduce healthcare expenditure and socioeconomic burden by reducing the risk of morbidity and mortality. Importantly, in the long term, this will help improve the physical health and health-related quality of life of the Chinese public, especially vulnerable groups such as women and children, by avoiding exposure to second-hand smoke. This will ultimately save more lives, protect the environment and promote sustainable development.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Funding&lt;/h3&gt;&lt;div&gt;Health Care Promotion Scheme, &lt;span&gt;Food and Health Bureau&lt;/span&gt;, Hong Ko","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101289"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427660","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}
引用次数: 0
Evaluation of lung cancer risk prediction models to select lung cancer screening participants in China: a real-world analysis in regional healthcare big data, Yinzhou, China
IF 7.6 1区 医学
The Lancet Regional Health: Western Pacific Pub Date : 2025-02-01 DOI: 10.1016/j.lanwpc.2024.101354
Ziqing Ye , Yongyue Wei
{"title":"Evaluation of lung cancer risk prediction models to select lung cancer screening participants in China: a real-world analysis in regional healthcare big data, Yinzhou, China","authors":"Ziqing Ye ,&nbsp;Yongyue Wei","doi":"10.1016/j.lanwpc.2024.101354","DOIUrl":"10.1016/j.lanwpc.2024.101354","url":null,"abstract":"<div><h3>Background</h3><div>A number of lung cancer prediction models have been developed worldwide. However, few validation studies have been conducted on Chinese populations. The objective of this study is to evaluate the feasibility and efficacy of 17 global lung cancer risk prediction models when applied to Chinese healthcare big data.</div></div><div><h3>Methods</h3><div>The study included individuals with information recorded in the Yinzhou regional health care database from January 1, 2010 to December 31, 2021. Seventeen lung cancer risk prediction models (Bach, Spitz, Hoggart, PLCO<sub>m2012</sub>, Korean Men, PLCO<sub>all2014</sub>, Pittsburgh Predictor, LLPi, LCRAT, HUNT, JPHC, Reduced HUNT, LLPv3, LCRS, OWL, UCL-I, Shanghai-LCM) were evaluated for their performance in overall population and subgroups. The discrimination of the 17 models was assessed using the Harrell's C-index and time-dependent area under the curve (AUC) as metrics. The calibration of the models was evaluated using the expected-to-observed ratio (EOR) and calibration curves. Moreover, the models were recalibrated in the Yinzhou population, and the calibration of the recalibrated models was evaluated.</div></div><div><h3>Findings</h3><div>A total of 907,200 study participants were included in the analysis, comprising 69,263 smokers and 837,937 non-smokers. Of the 17 models initially considered, only 6 (Bach, Hoggart, Pittsburgh Predictor, JPHC, Reduced HUNT, UCL-I) were available in the Yinzhou regional health care database with complete predictor data. Models that predicted risk over a ten-year period (Bach, JPHC, LCRS, and Shanghai-LCM) exhibited C-indices and AUCs of 0.75 or greater in the ever smokers. The majority of models demonstrated an overestimation of incidence risk in the ever smokers and an underestimation in the never smokers. The JPHC and LCRS models exhibited the most optimal calibration curves and the best EOR, whereas the other prediction models had suboptimal calibration. After recalibration, all models showed improved calibration; meanwhile, the JPHC and LCRS models retained the highest level of calibration.</div></div><div><h3>Interpretation</h3><div>Only six models can be directly applied to the Yinzhou regional health care database. The JPHC model developed for the Japanese population and the LCRS model developed based on the China Kadoorie Biobank (CKB) performed better in the Chinese population than other models.</div></div><div><h3>Funding</h3><div>This work was supported by the <span>National Natural Science Foundation of China</span> (82473728 to Y.W.) and <span>Medical and Health Science and Technology Project of Zhejiang Province</span>, China.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101354"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427681","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}
引用次数: 0
Magnetically controlled capsule gastroscopy and serology for screening precancerous high-risk events of gastric cancer: a cross-sectional study (SIGES)
IF 7.6 1区 医学
The Lancet Regional Health: Western Pacific Pub Date : 2025-02-01 DOI: 10.1016/j.lanwpc.2024.101413
Yuan Yang , Mao-Yao Wen , Yan Huang , Xin-Zu Chen , SIGES Research Group
{"title":"Magnetically controlled capsule gastroscopy and serology for screening precancerous high-risk events of gastric cancer: a cross-sectional study (SIGES)","authors":"Yuan Yang ,&nbsp;Mao-Yao Wen ,&nbsp;Yan Huang ,&nbsp;Xin-Zu Chen ,&nbsp;SIGES Research Group","doi":"10.1016/j.lanwpc.2024.101413","DOIUrl":"10.1016/j.lanwpc.2024.101413","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;Gastric cancer is a common malignancy in China, while screening and early detection of its precancerous high-risk events might help surveillance of high-risk subpopulation and improve the population survival. Magnetically controlled capsule gastroscopy (MCCG) emerged as a novel, non-invasive, and better compliant diagnostic method for screening gastric cancer and precancerous high-risk conditions, such as atrophic gastritis, gastric ulcer, and gastric polyp. The effectiveness of MCCG and the feasibility of sequential serology-MCCG protocol need to be preliminarily assessed in the aspect of screening precancerous high-risk events of gastric cancer.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;This cross-sectional study collected health check-up observations (18-75 years old) at the Health Management Center, West China Hospital of Sichuan University between 2018 and 2020. Demographic data were retrieved including sex, age, ethnicity, education level, body mass index, smoking, alcohol drinking, and family history of cancers. Those observations had undergone MCCG and relevant serologic examinations including pepsinogen-I (PG-I), pepsinogen-II (PG-II), PG-I/-II ratio (PGR), gastrin-17 (G-17), carcinoembryonic antigen (CEA), and carbohydrate antigen 19-9 (CA19-9). Major findings from MCCG concerned tumor and high-risk precancerous events, i.e. chronic atrophic gastritis (CAG), gastric ulcer, and gastric polyp. The primary outcome measure was all high-risk events, while the second outcome measures were any of the above events. The detection rate of MCCG was estimated, and the predictive strengthen of serology on MCCG findings was analyzed.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Findings&lt;/h3&gt;&lt;div&gt;A total of 1,432 eligible healthy check-up persons were included. MCCG reported none tumor and 114 cases with any precancerous high-risk event. The overall detection rate was 79.6‰ (95% CI 66.7‰-94.8‰) for all high-risk events, while the specific detection rates were 15.4‰ (95% CI 10.1‰-23.2‰) for CAG, 14.7‰ (95% CI 9.6‰-22.4‰) for gastric ulcers, and 55.2‰ (44.5‰-68.3‰) for gastric polyp, respectively. Compared between MCCG-positive (all high-risk events) and MCCG-negative groups, the baselines were generally comparable, with the only exception of age. The elder persons appeared significantly higher rates of high-risk events (P&lt;0.001), particularly increased as ≥60 years old. All the levels of serologic examinations were not significantly different between MCCG-positive and MCCG-negative groups. However, regarding CAG outcome dataset, the levels PG-I (median 58.9 ug/L, IQR 44.3 ug/L-85.2 ug/L, P=0.016) and PGR (median 6.2, IQR 3.4-9.5, P=0.017) were significantly lower in the CAG group, as well as G-17 (P=0.009). The serology couldn’t well predict in all high-risk events dataset, but serologic CAG performed great predictive strength for MCCG CAG (adjusted diagnostic odds ratio [aDOR]=10.40, 95% CI 2.08-51.98; SPE=98.6%; LR+=8.85). Additionally, CA19-9 sero","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101413"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427694","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}
引用次数: 0
Real-world multicenter study of T-DXd treatment in Chinese patients with metastatic breast cancer
IF 7.6 1区 医学
The Lancet Regional Health: Western Pacific Pub Date : 2025-02-01 DOI: 10.1016/j.lanwpc.2024.101416
Biyun Wang , Yumeng Li , Yannan Zhao , Die Sang , Peng Yuan , Yanxia Zhao , Zheng Lv , Ning Xie , Nanling Li , Juanjuan Li , Fang Wang
{"title":"Real-world multicenter study of T-DXd treatment in Chinese patients with metastatic breast cancer","authors":"Biyun Wang ,&nbsp;Yumeng Li ,&nbsp;Yannan Zhao ,&nbsp;Die Sang ,&nbsp;Peng Yuan ,&nbsp;Yanxia Zhao ,&nbsp;Zheng Lv ,&nbsp;Ning Xie ,&nbsp;Nanling Li ,&nbsp;Juanjuan Li ,&nbsp;Fang Wang","doi":"10.1016/j.lanwpc.2024.101416","DOIUrl":"10.1016/j.lanwpc.2024.101416","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) approved in China for HER2-positive or HER2-low metastatic breast cancer (MBC) patients. Little real-world evidence is available in China. This study aimed to investigate the real-world effectiveness and safety of T-DXd in Chinese MBC patients.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;This study retrospectively enrolled 309 MBC patients treated with T-DXd across 9 institutions nationwide in China between December 2019 and March 2024. T-DXd was administered intravenously at a dose of 5.4 mg/kg on day 1 of a 21-day cycle. Real-world progression-free survival (rwPFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Real-world adverse events (AEs) were graded according to CTCAE 4.0. The study was registered at &lt;span&gt;&lt;span&gt;ClinicalTrials.gov&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt; (&lt;span&gt;&lt;span&gt;NCT05594082&lt;/span&gt;&lt;svg&gt;&lt;path&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt;).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Findings&lt;/h3&gt;&lt;div&gt;A total of 309 MBC patients were included, with 168 HER2-positive and 141 HER2-negative patients (133 of HER2-low and 8 of HER2 0). Among HER2-positive and HER2-negative patients, median age was 53.5 and 55.0 years, 14.3% and 17.7% ECOG scores of 2, 83.9% and 84.4% patients with visceral metastases, 32.7% and 23.4% patients with brain metastasis, respectively. The median number of lines of therapy (LOT) for MBC patients receiving T-DXd was 4 for both groups. At the cutoff date of 30 July 2024, in patients with HER2-positive MBC, median rwPFS and OS was 12.1 [95% confidence interval (CI): 8.5-14.7] and 22.7 months (95% CI: 16.6-28.8). The longer rwPFS, median 23.3 months, was observed in LOT 1-2, than 12.2 months in LOT 3-5 and 8.2 months in LOT≥6 (P=0.001). In patients with HER2-negative MBC, median rwPFS and OS was 7.7 (95% CI: 6.6-8.8) and 15.7 months (95% CI: 11.4-20.0). The median rwPFS for HR+ and HR- patients was 7.7 and 8.1 months, respectively (P=0.870). Longer rwPFS of 9.5 months was observed in LOT 1-4 compared to 6.4 months in LOT≥6 among HER2-negative patients (P=0.026). Patients with prior ADCs exposure showed significantly shorter rwPFS of T-DXd in both HER2-positive (P=0.032) and negative patients (P=0.039). Brain metastasis did not impact the effectiveness of T-DXd. Incidence of AEs of any grade was 69.3% and severe (grade 3 or above) AEs was 13.9%; no fatal AEs were observed. Interstitial lung disease (ILD) occurred in 23 patients (7.4%), with 15 (4.9%) of grade 1, 4 (1.3%) of grade 2, and 4 (1.3%) of grade 3. 80.7% of ILD patients, including all with grade 1 and one with grade 2, underwent a rechallenge with T-DXd after symptomatic treatments and careful evaluations.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Interpretation&lt;/h3&gt;&lt;div&gt;In this largest dataset of T-DXd for Chinese patients with MBC to date, encouraging rwPFS of T-DXd was seen in heavily pretreated HER2-positive and HER2-negative MBC patients. Longer rwPFS was observed in MBC patients with fewer LOT and no","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101416"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427697","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}
引用次数: 0
Sentinel lymph node biopsy using dye alone in patients with initially cN1 breast cancer and ycN0 status after neoadjuvant therapy: a multicenter diagnostic trial
IF 7.6 1区 医学
The Lancet Regional Health: Western Pacific Pub Date : 2025-02-01 DOI: 10.1016/j.lanwpc.2024.101315
Ang Zheng , Lei Zhang , Yu Cao , Dian-Long Zhang , Fei Ma , Jian-Yi Li , Fan Yao , Li Ma , Pei-Fen Fu , Jia Wang , Jian-Yun Nie , Ying-Ying Xu , Bao-Liang Guo , Feng Jin , Bo Chen
{"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/m<sup>2</sup> (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/m<sup>2</sup> 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}
引用次数: 0
Consolidative and salvage thoracic radiotherapy (TRT) in extensive-stage small-cell lung cancer (ES-SCLC) with first-line chemoimmunotherapy: a retrospective study from a single cancer center
IF 7.6 1区 医学
The Lancet Regional Health: Western Pacific Pub Date : 2025-02-01 DOI: 10.1016/j.lanwpc.2024.101373
Aihua Lan , Huiling Dong , Zhiqin Zheng , Xiao Chu , Zhengfei Zhu
{"title":"Consolidative and salvage thoracic radiotherapy (TRT) in extensive-stage small-cell lung cancer (ES-SCLC) with first-line chemoimmunotherapy: a retrospective study from a single cancer center","authors":"Aihua Lan ,&nbsp;Huiling Dong ,&nbsp;Zhiqin Zheng ,&nbsp;Xiao Chu ,&nbsp;Zhengfei Zhu","doi":"10.1016/j.lanwpc.2024.101373","DOIUrl":"10.1016/j.lanwpc.2024.101373","url":null,"abstract":"<div><div>Extensive-stage small-cell lung cancer (ES-SCLC) continues to have poor outcome despite the survival improvements achieved by chemoimmunotherapy. Controversy exists regarding the survival effectiveness of consolidative thoracic radiotherapy (cTRT), and the role of salvage thoracic radiotherapy (sTRT) remains unexplored in the immunotherapy era. To address these issues, we conducted this retrospective study to investigate the impacts of cTRT and sTRT in ES-SCLC, and to compare the survival benefits of the two treatment regimes. ES-SCLC patients without baseline brain metastases receiving standard first-line chemoimmunotherapy were included in our study, cohorts were divided by treatment with cTRT, sTRT and no TRT. Kaplan-Meier survival curve and log-rank test were performed for comparison of survival between different groups. Univariable and multivariate analyses were carried out for further estimating the survival effectiveness of TRT. A total of 100 ES-SCLC patients without baseline brain metastases were included in our study, with 24 (24.0%) were allocated to the cTRT group, 18 (18.0%) were allocated to the sTRT group, and 58 (58.0%) to the No TRT group. cTRT dramatically decreased the rate of intrathoracic failure compared to sTRT and No TRT (29.4% vs. 60.0%). Moreover, patients who received cTRT had better overall survival (OS) compared to those who did not receive cTRT (median OS, not reached vs. 14.1 months; HR=0.40, 95% CI: 0.22-0.70, P=0.01). However, cTRT did not show significantly superior OS compared to sTRT alone (median OS, not reached vs. 21.0 months; HR=0.67, 95% CI: 0.27-1.66, P=0.39). In contrast, patients with only thoracic oligo-progression receiving sTRT (N=13) harbored better OS compared to patients with the same progression pattern in No TRT group (N=20) (median OS, 28.6 vs. 13.8 months; HR=0.44, 95% CI: 0.20-0.98, P=0.04). In conclusion, our study demonstrated in the chemoimmunotherapy era that cTRT greatly reduced the rate of initial intrathoracic failure and significantly improved the OS of ES-SCLC. Additionally, sTRT showed similar OS benefits with cTRT, and exhibits better OS compared to No TRT.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101373"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427988","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}
引用次数: 0
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