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An economic evaluation of lung cancer screening with low-dose computed tomography in a high-risk population of (ex-)smokers in Belgium 低剂量计算机断层扫描肺癌筛查在高危人群(前)吸烟者在比利时的经济评价
IF 4.4 2区 医学
Lung Cancer Pub Date : 2025-08-05 DOI: 10.1016/j.lungcan.2025.108697
Mattias Neyt, Janis Luyten, Fabian Desimpel, Cécile Camberlin, Célia Primus-de Jong, Leen Verleye
{"title":"An economic evaluation of lung cancer screening with low-dose computed tomography in a high-risk population of (ex-)smokers in Belgium","authors":"Mattias Neyt,&nbsp;Janis Luyten,&nbsp;Fabian Desimpel,&nbsp;Cécile Camberlin,&nbsp;Célia Primus-de Jong,&nbsp;Leen Verleye","doi":"10.1016/j.lungcan.2025.108697","DOIUrl":"10.1016/j.lungcan.2025.108697","url":null,"abstract":"<div><h3>Background</h3><div>Before implementing a screening programme, it is important to balance the benefits against the harms and assess its cost-effectiveness. To date, no such evaluation of lung cancer screening has been conducted in Belgium. The objective of this study was to examine the cost-effectiveness of lung cancer screening using low-dose CT (LDCT) in a Belgian population of (ex-)smokers.</div></div><div><h3>Methods</h3><div>This economic evaluation is based on the results of the NELSON trial and supplemented with Belgian stage- and histology-specific survival data, Belgian real-world diagnosis and treatment costs, and information from the literature (e.g. quality of life). Incremental costs and effects were modelled by combining a decision tree (invitation, screening and diagnosis) with a Markov model (cancers detected in the intervention and comparator group). The results are expressed as costs per quality-adjusted life years (QALYs). Benefits and harms are also presented on a 1000-person figure.</div></div><div><h3>Findings</h3><div>Based on the NELSON screening strategy, three rounds of LDCT screening for lung cancer (in years 0, 1 and 3) compared to no screening is associated with an incremental gain of 4.6 QALYs and an incremental cost of €78<!--> <!-->000 per 100 participants. This results in an incremental cost-effectiveness ratio of €18<!--> <!-->530 per QALY gained.</div></div><div><h3>Interpretation</h3><div>In the Belgian healthcare setting, LDCT screening of (ex-)smokers for lung cancer is likely to be cost-effective if policy makers are willing to pay more than €20<!--> <!-->000 per QALY gained. However, before implementing lung cancer screening, it is important to gain insight into the impact of incidental findings, available budgets, and capacity within the healthcare system. It is also important to evaluate the willingness to participate when individuals are fully informed about the benefits and harms of LDCT lung cancer screening.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"207 ","pages":"Article 108697"},"PeriodicalIF":4.4,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144852885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Global, regional, and national economic consequences of tracheal, bronchial, and lung cancer 气管、支气管和肺癌的全球、区域和国家经济后果
IF 4.4 2区 医学
Lung Cancer Pub Date : 2025-08-04 DOI: 10.1016/j.lungcan.2025.108685
Guangyong Liu , Yuanyuan Liu , Hui Jing , Tianen Chen , Hui Wang , Huige Qiu , Jinghao Zhang , Yanmin Wu
{"title":"Global, regional, and national economic consequences of tracheal, bronchial, and lung cancer","authors":"Guangyong Liu ,&nbsp;Yuanyuan Liu ,&nbsp;Hui Jing ,&nbsp;Tianen Chen ,&nbsp;Hui Wang ,&nbsp;Huige Qiu ,&nbsp;Jinghao Zhang ,&nbsp;Yanmin Wu","doi":"10.1016/j.lungcan.2025.108685","DOIUrl":"10.1016/j.lungcan.2025.108685","url":null,"abstract":"<div><h3>Background</h3><div>Quantifying the macroeconomic impact of tracheal, bronchial, and lung cancers (lung cancer) is crucial for guiding resource allocation, given rising global incidence, aging populations, and constraints in low- and middle-income countries (LMICs). This study evaluated the global, regional, and national macroeconomic burden of lung cancer in 2021.</div></div><div><h3>Methods</h3><div>Disability-adjusted life years (DALYs) data came from the Global Burden of Disease (GBD) 2021 study. Gross Domestic Product (GDP) data, adjusted for Purchasing Power Parity (PPP), were sourced from the World Bank. The macroeconomic burden was estimated using the Value of Lost Welfare (VLW) approach, integrating DALYs with the Value of Statistical Life (VSL) extrapolated from US data, assuming income elasticity (IE) of 1.0. Results are in 2021 international dollars (USD), PPP-adjusted.</div></div><div><h3>Results</h3><div>Globally, lung cancer caused a VLW of United States Dollars (USD) 167.36 billion (0.17% of global GDP). Males bore a higher burden (USD 107.85 billion, 0.11% GDP) than females (USD 59.52 billion, 0.06% GDP). The VLW/GDP ratio was highest in Southeast Asia, East Asia, and Oceania (USD 54.82 billion, 2.62% regional GDP). Tobacco was the leading risk factor, contributing 105.2 billion USD (63%) of global VLW, followed by air pollution (22.9 billion) and occupational risks (27.6 billion).</div></div><div><h3>Conclusion</h3><div>This quantitative analysis demonstrates that lung cancers impose a significant global macroeconomic burden, with pronounced disparities across sexes (disproportionately affecting males) and geographic regions. These findings underscore the imperative to prioritize evidence-based interventions—particularly tobacco control in high-burden areas—to optimize resource allocation and improve patient prognosis worldwide.Key limitations include reliance on model-based VSL estimates (extrapolated from U.S. data) and the assumption of constant income elasticity (IE = 1.0); generalizability may be constrained by cross-country variations in willingness-to-pay and data availability, particularly in LMICs.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"207 ","pages":"Article 108685"},"PeriodicalIF":4.4,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144766848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Immune checkpoint inhibitors for advanced non-small cell lung cancer with preexisting COPD and CT-defined emphysema: A systematic review and meta-analysis 免疫检查点抑制剂治疗晚期非小细胞肺癌合并COPD和ct定义的肺气肿:一项系统综述和荟萃分析
IF 4.4 2区 医学
Lung Cancer Pub Date : 2025-08-04 DOI: 10.1016/j.lungcan.2025.108700
Yixiao Zhang , Jin Zhao , Zhuo Ma , Jiawen Yi , Yuan Yuan , Lu Lang , Chen Zhang , Min Zhu , Yuhui Zhang
{"title":"Immune checkpoint inhibitors for advanced non-small cell lung cancer with preexisting COPD and CT-defined emphysema: A systematic review and meta-analysis","authors":"Yixiao Zhang ,&nbsp;Jin Zhao ,&nbsp;Zhuo Ma ,&nbsp;Jiawen Yi ,&nbsp;Yuan Yuan ,&nbsp;Lu Lang ,&nbsp;Chen Zhang ,&nbsp;Min Zhu ,&nbsp;Yuhui Zhang","doi":"10.1016/j.lungcan.2025.108700","DOIUrl":"10.1016/j.lungcan.2025.108700","url":null,"abstract":"<div><h3>Background</h3><div>Preexisting chronic obstructive pulmonary disease(COPD) and Computed Tomography(CT)-defined emphysema are associated with worse prognosis in patients with non-small cell lung cancer(NSCLC) receiving chemotherapy, but the impact of these comorbidities on patients undergoing immune checkpoint inhibitors(ICIs) remains largely unclear.</div></div><div><h3>Methods</h3><div>Studies on the safety and efficacy outcomes among advanced NSCLC with preexisting COPD and CT-defined emphysema receiving ICIs from various databases up to August 2024 were collected. The number of events, as well as pooled effect size [odds ratio(OR) and hazard ratio (HR)] and 95% confidence intervals (CIs) were obtained.</div></div><div><h3>Results</h3><div>A total of 21 studies (7 on efficacy, 11 on safety, and 3 on both) were included. Meta-analysis revealed the pooled overall response rate (ORR) and pooled disease control rate (DCR) were 38% and 62%, respectively. Compared to patients without preexisting COPD and CT-defined emphysema, the pooled OR for ORR and DCR was 1.88 (95% CI, 1.45–2.44) and 2.23 (95% CI, 1.67–2.98), without heterogeneity. COPD and CT-defined emphysema were also associated with better progression-free survival (HR, 0.63 [95% CI, 0.50–0.80]) and overall survival (HR, 0.59 [95% CI, 0.41–0.88]). The pooled incidences of any grade and grade 3 or higher checkpoint inhibitor-related pneumonitis (CIP) were 20% and 6% in patients with preexisting COPD and CT-defined emphysema, which was significantly higher than that in those without these comorbidities (OR, 1.97 [95% CI, 1.41–2.76]; OR, 2.52 [95% CI, 1.72–3.70]). Moreover, most cases of CIP (84.0%) improved with ICIs discontinuation and/or the administration of corticosteroids.</div></div><div><h3>Conclusion</h3><div>Preexisting COPD and CT-defined emphysema were associated with favorable clinical efficacy and increased risk of CIP in the immunotherapy era. Most cases of CIP are treatable and manageable.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"207 ","pages":"Article 108700"},"PeriodicalIF":4.4,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144772981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Transcriptome analysis reveals crucial oncogenic and tumor suppressor miRNAs in lung adenocarcinoma 转录组分析揭示了肺腺癌中至关重要的致癌和抑瘤mirna
IF 4.4 2区 医学
Lung Cancer Pub Date : 2025-08-01 DOI: 10.1016/j.lungcan.2025.108540
Aparna Chaturvedi, Anup Som
{"title":"Transcriptome analysis reveals crucial oncogenic and tumor suppressor miRNAs in lung adenocarcinoma","authors":"Aparna Chaturvedi,&nbsp;Anup Som","doi":"10.1016/j.lungcan.2025.108540","DOIUrl":"10.1016/j.lungcan.2025.108540","url":null,"abstract":"<div><h3>Background</h3><div>MicroRNAs (miRNAs) play essential roles in post-transcriptional gene regulation and are increasingly recognized as key regulators in various diseases. This study aimed to identify the key miRNA biomarkers and decodes their regulatory mechanism involved in human lung adenocarcinoma (LUAD) using network-based integrative multi-omics approaches.</div></div><div><h3>Methods</h3><div>We applied Weighted Gene Co-expression Network Analysis (WGCNA) method on miRNA-Seq data to detect key miRNA modules that correlated with the disease traits. Then we used differential expression profile, level of gene significance, module-trait relationship, target-identification, gene set enrichment analysis (GSEA), and survival analysis approaches to decipher LUAD critical miRNAs.</div></div><div><h3>Results</h3><div>Our analysis demonstrated a core set of LUAD critical miRNAs (called as LCmiRs) that comprises 33 oncogenic and 17 tumor suppressor miRNAs. These key miRNAs were then mapped to their target mRNAs through a<!--> <!-->target-identification approach, allowing for the construction of miRNA-mRNA interaction networks that revealed critical regulatory relationships. The GSEA results showed that upregulated mRNAs, those were targets of downregulated miRNAs (i.e., tumor suppressor miRNAs), were predominantly associated with pathways related to cell division, oocyte maturation/meiosis, TGF-beta signalling pathway, and metabolic processes, while downregulated mRNAs, those were targets of upregulated miRNAs (i.e., oncogenic miRNAs), were linked to angiogenesis, negative regulation of growth, and receptor-mediated signaling. Validation of the identified oncogenic/tumor-suppressor miRNAs reported five novel miRNAs. Among these, the oncogenic miRNAs are hsa-miR-18a-3p, hsa-miR-589-3p, hsa-miR-1229-3p, and hsa-miR-3651, and tumor suppressor one is hsa-miR-618.</div></div><div><h3>Conclusions</h3><div>This study provides a systematic <em>in silico</em> framework for identifying LUAD associated miRNAs. The discovery of five novel miRNAs highlights their potential as diagnostic biomarkers and therapeutic targets, offering valuable insights for experimental and clinical investigations in LUAD.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"206 ","pages":"Article 108540"},"PeriodicalIF":4.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144809875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Corrigendum to “Sex disparities in advanced non-small cell lung cancer survival: A Danish nationwide study” [Lung Cancer 202 (2025) 108485] “晚期非小细胞肺癌生存率的性别差异:丹麦全国研究”[肺癌202(2025)108485]的更正。
IF 4.4 2区 医学
Lung Cancer Pub Date : 2025-08-01 DOI: 10.1016/j.lungcan.2025.108658
Matilde Grupe Frost , Kristoffer Jarlov Jensen , Espen Jimenez-Solem , Camilla Qvortrup , Jon Alexander Lykkegaard Andersen , Tonny Studsgaard Petersen
{"title":"Corrigendum to “Sex disparities in advanced non-small cell lung cancer survival: A Danish nationwide study” [Lung Cancer 202 (2025) 108485]","authors":"Matilde Grupe Frost ,&nbsp;Kristoffer Jarlov Jensen ,&nbsp;Espen Jimenez-Solem ,&nbsp;Camilla Qvortrup ,&nbsp;Jon Alexander Lykkegaard Andersen ,&nbsp;Tonny Studsgaard Petersen","doi":"10.1016/j.lungcan.2025.108658","DOIUrl":"10.1016/j.lungcan.2025.108658","url":null,"abstract":"","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"206 ","pages":"Article 108658"},"PeriodicalIF":4.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144600932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Shared decision making for personalized lung cancer care 肺癌个性化治疗的共同决策。
IF 4.4 2区 医学
Lung Cancer Pub Date : 2025-08-01 DOI: 10.1016/j.lungcan.2025.108614
Arthi Sridhar , Alex Adjei , Victor M. Montori , Konstantinos Leventakos
{"title":"Shared decision making for personalized lung cancer care","authors":"Arthi Sridhar ,&nbsp;Alex Adjei ,&nbsp;Victor M. Montori ,&nbsp;Konstantinos Leventakos","doi":"10.1016/j.lungcan.2025.108614","DOIUrl":"10.1016/j.lungcan.2025.108614","url":null,"abstract":"","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"206 ","pages":"Article 108614"},"PeriodicalIF":4.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144275300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Unbridled Enthusiasm for Neoadjuvant Chemoimmunotherapy followed by Surgery for Locally Advanced Non-Small Cell Lung Cancer 对局部晚期非小细胞肺癌手术后新辅助化疗免疫治疗的狂热。
IF 4.4 2区 医学
Lung Cancer Pub Date : 2025-08-01 DOI: 10.1016/j.lungcan.2025.108628
Drew Moghanaki, Emily A. Cameron, Edward B. Garon
{"title":"Unbridled Enthusiasm for Neoadjuvant Chemoimmunotherapy followed by Surgery for Locally Advanced Non-Small Cell Lung Cancer","authors":"Drew Moghanaki,&nbsp;Emily A. Cameron,&nbsp;Edward B. Garon","doi":"10.1016/j.lungcan.2025.108628","DOIUrl":"10.1016/j.lungcan.2025.108628","url":null,"abstract":"","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"206 ","pages":"Article 108628"},"PeriodicalIF":4.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144497429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Corrigendum to “AGREE-II appraisal of lung cancer management clinical practice guidelines by the OPTIMA consortium”. [Lung Cancer 205 (2025) 108610] “OPTIMA联盟肺癌管理临床实践指南的AGREE-II评估”的勘误表。[肺癌205(2025)108610]。
IF 4.4 2区 医学
Lung Cancer Pub Date : 2025-08-01 DOI: 10.1016/j.lungcan.2025.108659
Sindhu Bhaarrati Naidu , Amyn Bhamani , Charlotte Murray , Katharina Beyer , Rebecca C. Rancourt , Thorben Witte , Wouter H. van Geffen , Ilona Tietzova , Armin Frille , Adrien Costantini , Monika Schäfer , Steven MacLennan , Hagen Krüger , Solveiga Žibaitė , James N’Dow , Sara Jane MacLennan , Monique J. Roobol , Sam M Janes , Neal Navani , Muhammad Imran Omar , Torsten Blum
{"title":"Corrigendum to “AGREE-II appraisal of lung cancer management clinical practice guidelines by the OPTIMA consortium”. [Lung Cancer 205 (2025) 108610]","authors":"Sindhu Bhaarrati Naidu ,&nbsp;Amyn Bhamani ,&nbsp;Charlotte Murray ,&nbsp;Katharina Beyer ,&nbsp;Rebecca C. Rancourt ,&nbsp;Thorben Witte ,&nbsp;Wouter H. van Geffen ,&nbsp;Ilona Tietzova ,&nbsp;Armin Frille ,&nbsp;Adrien Costantini ,&nbsp;Monika Schäfer ,&nbsp;Steven MacLennan ,&nbsp;Hagen Krüger ,&nbsp;Solveiga Žibaitė ,&nbsp;James N’Dow ,&nbsp;Sara Jane MacLennan ,&nbsp;Monique J. Roobol ,&nbsp;Sam M Janes ,&nbsp;Neal Navani ,&nbsp;Muhammad Imran Omar ,&nbsp;Torsten Blum","doi":"10.1016/j.lungcan.2025.108659","DOIUrl":"10.1016/j.lungcan.2025.108659","url":null,"abstract":"","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"206 ","pages":"Article 108659"},"PeriodicalIF":4.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144600931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Corrigendum to “84 Outcomes of Durvalumab after Chemoradiotherapy in Unresectable NonSmall-Cell Lung Cancer” [Lung Cancer 200 (Supplement 1) (February 2025) 108194] “Durvalumab在不可切除的非小细胞肺癌放化疗后的84个结果”的更正[肺癌200(增刊1)(2025年2月)108194]
IF 4.4 2区 医学
Lung Cancer Pub Date : 2025-08-01 DOI: 10.1016/j.lungcan.2025.108675
Ahmed Elhofy , Eleanor Aynsley , Alexander Burns , Clive Peedell , Ahmed Shaheen , K. Yogalingam , Sanjana Masinghe , Gaurav Kumar
{"title":"Corrigendum to “84 Outcomes of Durvalumab after Chemoradiotherapy in Unresectable NonSmall-Cell Lung Cancer” [Lung Cancer 200 (Supplement 1) (February 2025) 108194]","authors":"Ahmed Elhofy ,&nbsp;Eleanor Aynsley ,&nbsp;Alexander Burns ,&nbsp;Clive Peedell ,&nbsp;Ahmed Shaheen ,&nbsp;K. Yogalingam ,&nbsp;Sanjana Masinghe ,&nbsp;Gaurav Kumar","doi":"10.1016/j.lungcan.2025.108675","DOIUrl":"10.1016/j.lungcan.2025.108675","url":null,"abstract":"","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"206 ","pages":"Article 108675"},"PeriodicalIF":4.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144805821","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comprehensive first-in-human phase I/II study of FHND-9041 in patients with EGFR-mutated advanced non-small cell lung cancer FHND-9041在egfr突变晚期非小细胞肺癌患者中的临床I/II期综合研究
IF 4.4 2区 医学
Lung Cancer Pub Date : 2025-07-31 DOI: 10.1016/j.lungcan.2025.108684
Liang Zeng , Fan Tong , Xingxiang Xu , Lianxi Song , Shidong Xu , Jie Zou , Bo Qiu , Weidong Mao , Hailong Liu , Bing Zhang , Feng Rong , Jun Sun , Hua Xie , Yongqian Jiang , Wenjuan Jiang , Zhan Wang , Sheng Zhang , Ruiguang Zhang , Lingjuan Chen , Yongqiang Zhu , Yongchang Zhang
{"title":"Comprehensive first-in-human phase I/II study of FHND-9041 in patients with EGFR-mutated advanced non-small cell lung cancer","authors":"Liang Zeng ,&nbsp;Fan Tong ,&nbsp;Xingxiang Xu ,&nbsp;Lianxi Song ,&nbsp;Shidong Xu ,&nbsp;Jie Zou ,&nbsp;Bo Qiu ,&nbsp;Weidong Mao ,&nbsp;Hailong Liu ,&nbsp;Bing Zhang ,&nbsp;Feng Rong ,&nbsp;Jun Sun ,&nbsp;Hua Xie ,&nbsp;Yongqian Jiang ,&nbsp;Wenjuan Jiang ,&nbsp;Zhan Wang ,&nbsp;Sheng Zhang ,&nbsp;Ruiguang Zhang ,&nbsp;Lingjuan Chen ,&nbsp;Yongqiang Zhu ,&nbsp;Yongchang Zhang","doi":"10.1016/j.lungcan.2025.108684","DOIUrl":"10.1016/j.lungcan.2025.108684","url":null,"abstract":"<div><h3>Introduction</h3><div>FHND-9041 is a novel third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI). This first-in-human study is a single-arm, multi-center, open-label, non-randomized phase Ⅰ/II trial that aims to evaluate the tolerability, safety, pharmacokinetics, and anti-tumor activity of FHND-9041 in patients with <em>EGFR</em>-mutated non-small cell lung cancer (NSCLC).</div></div><div><h3>Methods</h3><div>The phase I study enrolled 87 patients with previously-treated <em>EGFR</em> T790M-positive NSCLC. The dose escalation study was conducted at doses of 40, 80, 120, and 180 mg/day, with an expansion of 36 and 39 patients in the 80 mg and 120 mg dose groups, respectively, to evaluate safety and pharmacokinetics. With 80 mg QD as the recommended phase II dose, the phase II study assessed the efficacy and safety of FHND-9041 as first-line treatment in 37 treatment-naive patients.</div></div><div><h3>Results</h3><div>No dose-limiting toxicity was observed, and the maximum tolerated dose was not identified within the 40 − 180 mg dose range. Pharmacokinetic data indicated dose-proportional exposure up to 120 mg, with a plateau at 120 mg. The phase II study revealed an objective response rate of 62.2 % (23/37 evaluable patients) with a median progression-free survival of 15.5 months (95 % CI, 12.9 − 18.1). The most common adverse events were decreased white blood cell count (22.6 %) and diarrhea (21.8 %). Treatment-related grade 3/4 adverse events included decreased white blood cell count (11.3 %) and liver impairment (4.8 %).</div></div><div><h3>Conclusions</h3><div>FHND-9041 exhibits favorable safety and efficacy profile, supporting its further clinical development for <em>EGFR</em>-mutated advanced NSCLC.</div></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"207 ","pages":"Article 108684"},"PeriodicalIF":4.4,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144757862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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