首页 > 最新文献

ESMO Real World Data and Digital Oncology最新文献

英文 中文
Automated risk stratification in myelofibrosis 骨髓纤维化的自动风险分层
Pub Date : 2025-12-01 DOI: 10.1016/j.esmorw.2025.100654
D.T. Kristensen , T.C. El-Galaly , A.S. Roug
{"title":"Automated risk stratification in myelofibrosis","authors":"D.T. Kristensen , T.C. El-Galaly , A.S. Roug","doi":"10.1016/j.esmorw.2025.100654","DOIUrl":"10.1016/j.esmorw.2025.100654","url":null,"abstract":"","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"10 ","pages":"Article 100654"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145617882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Editoiral Board Editoiral董事会
Pub Date : 2025-12-01 DOI: 10.1016/S2949-8201(25)00561-2
{"title":"Editoiral Board","authors":"","doi":"10.1016/S2949-8201(25)00561-2","DOIUrl":"10.1016/S2949-8201(25)00561-2","url":null,"abstract":"","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"10 ","pages":"Article 100672"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145789920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Proof-of-concept: AI-assisted, natural-language-guided survival analysis achieves concordance with human-conducted results in glioblastoma 概念验证:人工智能辅助,自然语言引导的生存分析与人类进行的胶质母细胞瘤结果一致
Pub Date : 2025-12-01 DOI: 10.1016/j.esmorw.2025.100653
E. Omene , C. Marsters , J. Easaw , K. Young , C. Kolbeck , O. Abdelsalem , Y. Yuan

Background

The use of large language models with natural-language prompting may simplify survival analysis but requires validation against standard analyses carried out by trained analysts. We compared a human-conducted SPSS survival analysis to the Replit cloud development platform for conversational statistical analysis using a fully observed cohort of 1265 glioblastoma patients.

Patients and methods

Two statistical procedures—Kaplan–Meier estimation and Cox proportional hazards regression—were implemented. The reference analysis was carried out by an experienced clinical researcher using SPSS; the Replit-based analysis by an oncologist with no graduate level statistical or programming training employed the lifelines package through Claude language model integration via conversational chatbox interface. Statistical results were reviewed by a data science professor. Artificial intelligence- (AI) generated code was reviewed by a machine learning engineer. All patients had died at last follow-up, so no censoring occurred. Concordance was defined as exact matches in median survival times and hazard ratios (HR), reflecting the scientific principle that identical datasets processed with identical statistical methods must produce identical results.

Results

Initial comparison of median survival across 12 molecular/age subgroups found exact concordance in 7 of 12 subgroups (58.3%). The remaining discrepancies represented preprocessing differences rather than acceptable analytical variation. Natural-language troubleshooting through Replit’s conversational interface identified three sources of discrepancy: patient inclusion differences, age-group boundary definitions, and inconsistent molecular encoding. After harmonizing these factors, median survival times and HRs were identical across both analyses, achieving 100% concordance. The Replit-based approach required 1 h 40 min total time compared with 8.5 h for traditional analysis, representing a 80% time reduction while maintaining statistical rigor.

Conclusions

This proof-of-concept demonstrates that the Replit platform can achieve exact replication of standard Kaplan–Meier and Cox analyses carried out by an experienced analyst when subgroup definitions and data preprocessing are aligned. Although our findings are limited to a single dataset and workflow, they suggest conversational AI interfaces could reduce barriers to statistical analysis for clinical researchers. Broader validation across varied analytical scenarios is essential before widespread clinical implementation. Statistical expertise remains essential for data quality assessment and model validation.
使用带有自然语言提示的大型语言模型可以简化生存分析,但需要由训练有素的分析人员对标准分析进行验证。我们对1265名胶质母细胞瘤患者进行了全面观察,将人类进行的SPSS生存分析与用于会话统计分析的Replit云开发平台进行了比较。患者和方法采用kaplan - meier估计和Cox比例风险回归两种统计方法。参考分析由经验丰富的临床研究员使用SPSS进行;由没有研究生水平的统计学或编程训练的肿瘤学家进行的基于replit的分析使用了生命线包,通过对话式聊天盒界面通过Claude语言模型集成。数据科学教授对统计结果进行了审查。人工智能(AI)生成的代码由机器学习工程师进行审查。所有患者随访时均已死亡,故未进行复查。一致性被定义为中位生存时间和风险比(HR)的精确匹配,反映了用相同统计方法处理相同数据集必须产生相同结果的科学原理。结果初步比较12个分子/年龄亚组的中位生存期,发现12个亚组中有7个(58.3%)完全一致。剩余的差异代表了预处理差异,而不是可接受的分析差异。通过Replit的对话界面进行自然语言故障排除,确定了三个差异来源:患者纳入差异、年龄组边界定义和不一致的分子编码。在协调这些因素后,两种分析的中位生存时间和hr是相同的,达到100%的一致性。与传统分析的8.5小时相比,基于replit的方法需要1小时40分钟的总时间,在保持统计严谨性的同时减少了80%的时间。这个概念验证表明,当子组定义和数据预处理一致时,Replit平台可以实现由经验丰富的分析师进行的标准Kaplan-Meier和Cox分析的精确复制。尽管我们的研究结果仅限于单一数据集和工作流程,但它们表明对话式人工智能界面可以减少临床研究人员进行统计分析的障碍。在广泛的临床应用之前,必须对不同的分析方案进行更广泛的验证。统计专业知识对于数据质量评估和模型验证仍然至关重要。
{"title":"Proof-of-concept: AI-assisted, natural-language-guided survival analysis achieves concordance with human-conducted results in glioblastoma","authors":"E. Omene ,&nbsp;C. Marsters ,&nbsp;J. Easaw ,&nbsp;K. Young ,&nbsp;C. Kolbeck ,&nbsp;O. Abdelsalem ,&nbsp;Y. Yuan","doi":"10.1016/j.esmorw.2025.100653","DOIUrl":"10.1016/j.esmorw.2025.100653","url":null,"abstract":"<div><h3>Background</h3><div>The use of large language models with natural-language prompting may simplify survival analysis but requires validation against standard analyses carried out by trained analysts. We compared a human-conducted SPSS survival analysis to the Replit cloud development platform for conversational statistical analysis using a fully observed cohort of 1265 glioblastoma patients.</div></div><div><h3>Patients and methods</h3><div>Two statistical procedures—Kaplan–Meier estimation and Cox proportional hazards regression—were implemented. The reference analysis was carried out by an experienced clinical researcher using SPSS; the Replit-based analysis by an oncologist with no graduate level statistical or programming training employed the lifelines package through Claude language model integration via conversational chatbox interface. Statistical results were reviewed by a data science professor. Artificial intelligence- (AI) generated code was reviewed by a machine learning engineer. All patients had died at last follow-up, so no censoring occurred. Concordance was defined as exact matches in median survival times and hazard ratios (HR), reflecting the scientific principle that identical datasets processed with identical statistical methods must produce identical results.</div></div><div><h3>Results</h3><div>Initial comparison of median survival across 12 molecular/age subgroups found exact concordance in 7 of 12 subgroups (58.3%). The remaining discrepancies represented preprocessing differences rather than acceptable analytical variation. Natural-language troubleshooting through Replit’s conversational interface identified three sources of discrepancy: patient inclusion differences, age-group boundary definitions, and inconsistent molecular encoding. After harmonizing these factors, median survival times and HRs were identical across both analyses, achieving 100% concordance. The Replit-based approach required 1 h 40 min total time compared with 8.5 h for traditional analysis, representing a 80% time reduction while maintaining statistical rigor.</div></div><div><h3>Conclusions</h3><div>This proof-of-concept demonstrates that the Replit platform can achieve exact replication of standard Kaplan–Meier and Cox analyses carried out by an experienced analyst when subgroup definitions and data preprocessing are aligned. Although our findings are limited to a single dataset and workflow, they suggest conversational AI interfaces could reduce barriers to statistical analysis for clinical researchers. Broader validation across varied analytical scenarios is essential before widespread clinical implementation. Statistical expertise remains essential for data quality assessment and model validation.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"10 ","pages":"Article 100653"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145684415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Transportability of overall survival estimates from the USA to France in patients with metastatic triple-negative breast cancer 转移性三阴性乳腺癌患者的总生存估计从美国到法国的可移植性
Pub Date : 2025-11-21 DOI: 10.1016/j.esmorw.2025.100648
C. Esnault , L. Simomia , G. Machuron , M. Robain , B. Adamson , V. Machuron

Background

Metastatic triple-negative breast cancer (mTNBC) represents an aggressive breast cancer subtype with limited treatment options. The external validity of transportability for real-world evidence (RWE) applied across health care systems remains uncertain. This study evaluated the transportability of overall survival (OS) from the USA to France.

Patients and methods

We conducted a retrospective cohort study using de-identified or aggregated electronic health record-derived data from the USA and France. The study included adult female patients diagnosed with mTNBC initiating first-line systemic therapy before the widespread use of poly(ADP-ribose) polymerase (PARP) and programmed cell death (ligand) protein 1 (PD-(L)1) checkpoint inhibitors. To account for population differences, we reweighted the United States cohort to match the French population characteristics. OS was assessed from the start of first-line therapy using Kaplan–Meier curves.

Results

After adjustment, the United States (n = 812) and French (n = 2797) cohorts were well-balanced (standardized mean differences close to 0). Median OS was comparable between the unadjusted United States cohort [13.8 months, 95% confidence interval (CI) 12.6-15.0 months], the adjusted United States cohort (13.2 months, 95% CI 11.6-14.6 months) and the French cohort (13.8 months, 95% CI 13.2-14.6 months). OS rates at 1, 2, and 3 years in the French cohort were 55%, 30%, and 18%, respectively, and did not differ by >3% from those in the USA, regardless of adjustment.

Conclusions

This study shows evidence that OS estimates for mTNBC derived from United States RWE are transportable to the French setting. Findings support the use of international RWE in health technology assessment contexts, potentially facilitating more efficient and evidence-based decision making for novel therapies.
转移性三阴性乳腺癌(mTNBC)是一种侵袭性乳腺癌亚型,治疗选择有限。现实世界证据可运输性(RWE)在卫生保健系统中的外部有效性仍然不确定。本研究评估了总生存率(OS)从美国到法国的可移植性。患者和方法我们使用来自美国和法国的去识别或汇总电子健康记录数据进行了一项回顾性队列研究。该研究包括诊断为mTNBC的成年女性患者,在广泛使用聚(adp -核糖)聚合酶(PARP)和程序性细胞死亡(配体)蛋白1 (PD-(L)1)检查点抑制剂之前开始一线全身治疗。为了解释人口差异,我们重新调整了美国队列的权重,以匹配法国的人口特征。从一线治疗开始使用Kaplan-Meier曲线评估OS。结果调整后,美国(n = 812)和法国(n = 2797)队列平衡良好(标准化平均差异接近0)。未调整的美国队列(13.8个月,95%可信区间(CI) 12.6-15.0个月)、调整后的美国队列(13.2个月,95% CI 11.6-14.6个月)和法国队列(13.8个月,95% CI 13.2-14.6个月)的中位OS具有可比性。在法国队列中,1年、2年和3年的总生存率分别为55%、30%和18%,不考虑调整,与美国的总生存率相差不超过3%。结论:本研究表明,根据美国RWE得出的mTNBC的OS估计值也适用于法国。研究结果支持在卫生技术评估背景下使用国际RWE,可能促进对新疗法更有效和基于证据的决策。
{"title":"Transportability of overall survival estimates from the USA to France in patients with metastatic triple-negative breast cancer","authors":"C. Esnault ,&nbsp;L. Simomia ,&nbsp;G. Machuron ,&nbsp;M. Robain ,&nbsp;B. Adamson ,&nbsp;V. Machuron","doi":"10.1016/j.esmorw.2025.100648","DOIUrl":"10.1016/j.esmorw.2025.100648","url":null,"abstract":"<div><h3>Background</h3><div>Metastatic triple-negative breast cancer (mTNBC) represents an aggressive breast cancer subtype with limited treatment options. The external validity of transportability for real-world evidence (RWE) applied across health care systems remains uncertain. This study evaluated the transportability of overall survival (OS) from the USA to France.</div></div><div><h3>Patients and methods</h3><div>We conducted a retrospective cohort study using de-identified or aggregated electronic health record-derived data from the USA and France. The study included adult female patients diagnosed with mTNBC initiating first-line systemic therapy before the widespread use of poly(ADP-ribose) polymerase (PARP) and programmed cell death (ligand) protein 1 (PD-(L)1) checkpoint inhibitors. To account for population differences, we reweighted the United States cohort to match the French population characteristics. OS was assessed from the start of first-line therapy using Kaplan–Meier curves.</div></div><div><h3>Results</h3><div>After adjustment, the United States (<em>n</em> = 812) and French (<em>n</em> = 2797) cohorts were well-balanced (standardized mean differences close to 0). Median OS was comparable between the unadjusted United States cohort [13.8 months, 95% confidence interval (CI) 12.6-15.0 months], the adjusted United States cohort (13.2 months, 95% CI 11.6-14.6 months) and the French cohort (13.8 months, 95% CI 13.2-14.6 months). OS rates at 1, 2, and 3 years in the French cohort were 55%, 30%, and 18%, respectively, and did not differ by &gt;3% from those in the USA, regardless of adjustment.</div></div><div><h3>Conclusions</h3><div>This study shows evidence that OS estimates for mTNBC derived from United States RWE are transportable to the French setting. Findings support the use of international RWE in health technology assessment contexts, potentially facilitating more efficient and evidence-based decision making for novel therapies.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"10 ","pages":"Article 100648"},"PeriodicalIF":0.0,"publicationDate":"2025-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145571604","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prognostic role of Ki-67 in high-risk estrogen receptor-positive/HER2-negative early breast cancer: a population-based cohort study Ki-67在高危雌激素受体阳性/ her2阴性早期乳腺癌中的预后作用:一项基于人群的队列研究
Pub Date : 2025-11-21 DOI: 10.1016/j.esmorw.2025.100647
E. Tegnelius , J. Ahlgren , A. Valachis

Background and purpose

Abemaciclib is a CDK4/6-inhibitor approved for adjuvant use in estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer with high risk of relapse, defined as N2-N3 disease or high-risk N1 disease. The MonarchE study also included high Ki-67 in combination with N1 disease as a separate study cohort. We investigated the prognostic value of MonarchE risk group criteria, with or without the addition of Ki-67, when applied to a large set of real-world data (RWD).

Materials and methods

We carried out a retrospective cohort study using Breast Cancer Data Base Sweden (BCBaSe) 3.0, a research database including all Swedish breast cancer patients from 2008 to 2020. The cohort included 21 110 ER-positive/HER2-negative breast cancer patients, whereof 12 983 had available Ki-67 data.

Results

Risk groups were defined as N1 low risk, N1 high risk and N2-N3 very high risk, based on MonarchE criteria. Survival analyses showed an increasingly worse prognosis across the three groups for three outcomes including distant disease-free survival (DDFS), breast cancer-specific survival (BCSS), and overall survival (OS). Ki-67 ≥20% was associated with statistically significant worse DDFS, BCSS, and OS in the overall N1 group, but when comparing 5-year survival rates in the N1 group with and without Ki-67 stratification, no clinically meaningful absolute difference in OS was seen.

Conclusions

Our nationwide RWD results support the use of MonarchE's risk group criteria for selection of high-risk ER-positive/HER2-negative breast cancer patients who might derive benefit from adjuvant abemaciclib. The role of Ki-67 in risk stratification seems to be limited and without clear clinical significance.
背景和目的abemaciclib是一种cdk4 /6抑制剂,被批准用于雌激素受体(ER)阳性/人表皮生长因子受体2 (HER2)阴性、复发风险高的乳腺癌(定义为N2-N3疾病或高风险N1疾病)的辅助治疗。MonarchE研究还将合并N1疾病的高Ki-67患者作为单独的研究队列。当应用于大量真实数据(RWD)时,我们研究了有或没有添加Ki-67的MonarchE风险组标准的预后价值。材料和方法我们使用瑞典乳腺癌数据库(BCBaSe) 3.0进行了一项回顾性队列研究,该研究数据库包括2008年至2020年瑞典所有乳腺癌患者。该队列包括21 110例er阳性/ her2阴性乳腺癌患者,其中12 983例有Ki-67数据。结果根据MonarchE标准将危险分组分为N1低危、N1高危和N2-N3极高危。生存分析显示,三组患者的预后越来越差,包括远端无病生存期(DDFS)、乳腺癌特异性生存期(BCSS)和总生存期(OS)。总体N1组中Ki-67≥20%与DDFS、BCSS和OS差有统计学意义相关,但当比较有无Ki-67分层的N1组5年生存率时,OS无临床意义的绝对差异。结论:全国RWD结果支持使用MonarchE的风险组标准来选择可能从阿贝马昔lib中获益的高危er阳性/ her2阴性乳腺癌患者。Ki-67在危险分层中的作用似乎是有限的,没有明确的临床意义。
{"title":"Prognostic role of Ki-67 in high-risk estrogen receptor-positive/HER2-negative early breast cancer: a population-based cohort study","authors":"E. Tegnelius ,&nbsp;J. Ahlgren ,&nbsp;A. Valachis","doi":"10.1016/j.esmorw.2025.100647","DOIUrl":"10.1016/j.esmorw.2025.100647","url":null,"abstract":"<div><h3>Background and purpose</h3><div>Abemaciclib is a CDK4/6-inhibitor approved for adjuvant use in estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer with high risk of relapse, defined as N2-N3 disease or high-risk N1 disease. The MonarchE study also included high Ki-67 in combination with N1 disease as a separate study cohort. We investigated the prognostic value of MonarchE risk group criteria, with or without the addition of Ki-67, when applied to a large set of real-world data (RWD).</div></div><div><h3>Materials and methods</h3><div>We carried out a retrospective cohort study using Breast Cancer Data Base Sweden (BCBaSe) 3.0, a research database including all Swedish breast cancer patients from 2008 to 2020. The cohort included 21 110 ER-positive/HER2-negative breast cancer patients, whereof 12 983 had available Ki-67 data.</div></div><div><h3>Results</h3><div>Risk groups were defined as N1 low risk, N1 high risk and N2-N3 very high risk, based on MonarchE criteria. Survival analyses showed an increasingly worse prognosis across the three groups for three outcomes including distant disease-free survival (DDFS), breast cancer-specific survival (BCSS), and overall survival (OS). Ki-67 ≥20% was associated with statistically significant worse DDFS, BCSS, and OS in the overall N1 group, but when comparing 5-year survival rates in the N1 group with and without Ki-67 stratification, no clinically meaningful absolute difference in OS was seen.</div></div><div><h3>Conclusions</h3><div>Our nationwide RWD results support the use of MonarchE's risk group criteria for selection of high-risk ER-positive/HER2-negative breast cancer patients who might derive benefit from adjuvant abemaciclib. The role of Ki-67 in risk stratification seems to be limited and without clear clinical significance.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"10 ","pages":"Article 100647"},"PeriodicalIF":0.0,"publicationDate":"2025-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145571605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Recommendations and definitions for time-to-event endpoints using real-world data in oncology 肿瘤学中使用真实世界数据的时间到事件终点的建议和定义
Pub Date : 2025-11-20 DOI: 10.1016/j.esmorw.2025.100649
P.A.J. Vissers , M.A.G. Elferink , M.J. Bijlsma , L.G. van der Geest , M. Koopman , H.W.M. van Laarhoven , G.A.P. Nieuwenhuijzen , P.S.N. van Rossum , F.P.C. Sijtsma , G.R. Vink , J. de Vos-Geelen , H.W. Wilmink , J.H.W. de Wilt , R.H.A. Verhoeven , F.N. van Erning

Background

Real-world data is increasingly used to assess effectiveness of treatments in patients treated in everyday clinical practice. The aim of this study is to establish definitions for time-to-event endpoints based on real-world data, and to evaluate their applicability to cancer registry data.

Materials and methods

A multidisciplinary panel consisting of seven epidemiologists, one statistician and seven medical specialists with expertise in gastrointestinal oncology was composed to reach consensus on the definitions of time-to-event endpoints. After obtaining the final definitions, the time-to-event endpoints were applied to a population-based cohort of patients with different types of gastrointestinal cancer from the Netherlands Cancer Registry.

Results

For nine time-to-event endpoints, consensus on the definitions was reached: real-world data based (RW) recurrence-free survival, recurrence rate, local recurrence rate, locoregional recurrence rate, distant recurrence rate, progression-free survival, progression rate, treatment failure rate, and overall survival. For RW disease-free survival, no consensus was reached. All time-to-event endpoints appeared suitable for calculation with Netherlands Cancer Registry data for cohorts with follow-up data based on the established definitions, with the exception of RW-treatment failure rate due to the unavailability of cause of death.

Conclusions

This study offers clear definitions for time-to-event endpoints based on RW data which can be applied to cancer registry data. Uniform use of these definitions in future studies will enable better interpretation of results and aid in comparison between studies, but may require additional development when adapted to other countries, cancer types or data sources.
现实世界的数据越来越多地用于评估在日常临床实践中治疗的患者的治疗效果。本研究的目的是建立基于真实世界数据的时间到事件终点的定义,并评估其对癌症登记数据的适用性。材料和方法组成了一个多学科小组,由7名流行病学家、1名统计学家和7名具有胃肠道肿瘤学专业知识的医学专家组成,以就事件时间终点的定义达成共识。在获得最终定义后,将时间到事件终点应用于来自荷兰癌症登记处的不同类型胃肠道癌症患者的基于人群的队列。结果9个时间到事件终点的定义达成共识:基于真实世界数据(RW)的无复发生存、复发率、局部复发率、局部区域复发率、远处复发率、无进展生存、进展率、治疗失败率和总生存。对于RW无病生存,没有达成共识。除了由于无法获得死亡原因导致的rw治疗失败率外,所有到事件发生的时间终点似乎都适合用荷兰癌症登记处的数据计算,这些数据基于既定定义进行了随访。本研究提供了基于RW数据的时间到事件终点的明确定义,可应用于癌症登记数据。在未来的研究中统一使用这些定义将有助于更好地解释结果,并有助于研究之间的比较,但在适应其他国家、癌症类型或数据来源时可能需要进一步发展。
{"title":"Recommendations and definitions for time-to-event endpoints using real-world data in oncology","authors":"P.A.J. Vissers ,&nbsp;M.A.G. Elferink ,&nbsp;M.J. Bijlsma ,&nbsp;L.G. van der Geest ,&nbsp;M. Koopman ,&nbsp;H.W.M. van Laarhoven ,&nbsp;G.A.P. Nieuwenhuijzen ,&nbsp;P.S.N. van Rossum ,&nbsp;F.P.C. Sijtsma ,&nbsp;G.R. Vink ,&nbsp;J. de Vos-Geelen ,&nbsp;H.W. Wilmink ,&nbsp;J.H.W. de Wilt ,&nbsp;R.H.A. Verhoeven ,&nbsp;F.N. van Erning","doi":"10.1016/j.esmorw.2025.100649","DOIUrl":"10.1016/j.esmorw.2025.100649","url":null,"abstract":"<div><h3>Background</h3><div>Real-world data is increasingly used to assess effectiveness of treatments in patients treated in everyday clinical practice. The aim of this study is to establish definitions for time-to-event endpoints based on real-world data, and to evaluate their applicability to cancer registry data.</div></div><div><h3>Materials and methods</h3><div>A multidisciplinary panel consisting of seven epidemiologists, one statistician and seven medical specialists with expertise in gastrointestinal oncology was composed to reach consensus on the definitions of time-to-event endpoints. After obtaining the final definitions, the time-to-event endpoints were applied to a population-based cohort of patients with different types of gastrointestinal cancer from the Netherlands Cancer Registry.</div></div><div><h3>Results</h3><div>For nine time-to-event endpoints, consensus on the definitions was reached: real-world data based (RW) recurrence-free survival, recurrence rate, local recurrence rate, locoregional recurrence rate, distant recurrence rate, progression-free survival, progression rate, treatment failure rate, and overall survival. For RW disease-free survival, no consensus was reached. All time-to-event endpoints appeared suitable for calculation with Netherlands Cancer Registry data for cohorts with follow-up data based on the established definitions, with the exception of RW-treatment failure rate due to the unavailability of cause of death.</div></div><div><h3>Conclusions</h3><div>This study offers clear definitions for time-to-event endpoints based on RW data which can be applied to cancer registry data. Uniform use of these definitions in future studies will enable better interpretation of results and aid in comparison between studies, but may require additional development when adapted to other countries, cancer types or data sources.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"10 ","pages":"Article 100649"},"PeriodicalIF":0.0,"publicationDate":"2025-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145571606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Synthetic data for clinical research and innovation: opportunities, challenges and future directions 临床研究与创新的合成数据:机遇、挑战和未来方向
Pub Date : 2025-11-20 DOI: 10.1016/j.esmorw.2025.100651
Mattia Delleani
Data form the backbone of modern health care, driving improvements in patient care, enabling clinical research and supporting public health initiatives. The demand for high-quality individual-level data is growing, with electronic health records and clinical trial data offering critical opportunities for secondary analyses, hypothesis testing and methodological innovation. However, accessing and sharing this high-quality real-world data to enable personalized care and to respond to rapidly changing conditions is often limited by strict privacy requirements and complex regulations. This perspective highlights the promise of synthetic data in enabling research access, accelerating artificial intelligence development and supporting clinical trials while also discussing key barriers, including legal and ethical uncertainty, re-identification risk and the need for standardized validation frameworks. In this context, synthetic data present a promising path forward by enabling research while addressing privacy concerns, streamlining administrative processes and decreasing costs.
数据是现代卫生保健的支柱,推动患者护理的改善,使临床研究成为可能,并支持公共卫生举措。对高质量个人数据的需求正在增长,电子健康记录和临床试验数据为二次分析、假设检验和方法创新提供了重要机会。然而,访问和共享这些高质量的真实世界数据以实现个性化护理并对快速变化的情况做出反应,往往受到严格的隐私要求和复杂的法规的限制。这一观点强调了合成数据在促进研究获取、加速人工智能发展和支持临床试验方面的前景,同时也讨论了主要障碍,包括法律和伦理不确定性、重新识别风险和标准化验证框架的需求。在这种情况下,合成数据在解决隐私问题、简化管理流程和降低成本的同时,为研究提供了一条有前途的道路。
{"title":"Synthetic data for clinical research and innovation: opportunities, challenges and future directions","authors":"Mattia Delleani","doi":"10.1016/j.esmorw.2025.100651","DOIUrl":"10.1016/j.esmorw.2025.100651","url":null,"abstract":"<div><div>Data form the backbone of modern health care, driving improvements in patient care, enabling clinical research and supporting public health initiatives. The demand for high-quality individual-level data is growing, with electronic health records and clinical trial data offering critical opportunities for secondary analyses, hypothesis testing and methodological innovation. However, accessing and sharing this high-quality real-world data to enable personalized care and to respond to rapidly changing conditions is often limited by strict privacy requirements and complex regulations. This perspective highlights the promise of synthetic data in enabling research access, accelerating artificial intelligence development and supporting clinical trials while also discussing key barriers, including legal and ethical uncertainty, re-identification risk and the need for standardized validation frameworks. In this context, synthetic data present a promising path forward by enabling research while addressing privacy concerns, streamlining administrative processes and decreasing costs.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"10 ","pages":"Article 100651"},"PeriodicalIF":0.0,"publicationDate":"2025-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145571602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
JAVEMACS: a real-world study of avelumab maintenance therapy for advanced urothelial carcinoma in Japan JAVEMACS:日本晚期尿路上皮癌avelumab维持治疗的真实世界研究
Pub Date : 2025-11-20 DOI: 10.1016/j.esmorw.2025.100646
H. Kitamura , T. Kobayashi , Y. Endo , M. Ikeda , K. Yonemori , M. Nakayama , A. Fujihara , T. Abe , F. Shimizu , K. Fujimoto , T. Nakagawa , S. Hatakeyama , K. Murakami , K. Nishihara , D. Ikarashi , N. Masumori , S. Naito , K. Fujita , N. Hayakawa , T. Hara , E. Kikuchi

Background

Avelumab maintenance therapy was approved in Japan in February 2021 for patients with unresectable locally advanced or metastatic urothelial carcinoma (la/mUC) without disease progression after platinum-based chemotherapy (PBC). We report the primary analysis from the JAVEMACS chart review study of avelumab maintenance therapy in Japan.

Materials and methods

This multicenter, retrospective study collected data from medical charts of patients with la/mUC who received avelumab maintenance after first-line (1L) PBC.

Results

Between February 2021 and December 2023, 350 patients received avelumab maintenance; median age was 73 years and most were male (74.0%). Prior 1L PBC was cisplatin–gemcitabine in 56.0% and carboplatin–gemcitabine in 33.1%; 28.6% were cisplatin eligible and 52.9% were cisplatin ineligible/platinum eligible. At data cut-off (June 2024), 67 patients (19.1%) were still receiving avelumab. Among 283 patients who discontinued avelumab, 200 (70.7%) received second-line (2L) treatment. In the overall population, median overall survival (OS) from avelumab initiation was 31.8 months [95% confidence interval (CI) 24.6 months-not estimable (NE)]. In subgroups who received 2L enfortumab vedotin (EV) (n = 133), PBC (n = 41), or pembrolizumab (n = 17), median OS from the start of 2L treatment was 17.8 months (95% CI 11.9 months-NE), 15.1 months (95% CI 11.6 months-NE), and 15.6 months (95% CI 8.6-21.3 months), respectively. Limitations include the study’s retrospective nature.

Conclusions

Results from JAVEMACS confirm the effectiveness of avelumab maintenance in real-world clinical practice in Japan, supporting its recommendation for patients with la/mUC without disease progression following 1L PBC. This treatment sequence followed by 2L EV appeared to be associated with encouraging long-term outcomes in this real-world population.
davelumab维持治疗于2021年2月在日本被批准用于铂基化疗(PBC)后无疾病进展的不可切除的局部晚期或转移性尿路上皮癌(la/mUC)患者。我们报告了日本JAVEMACS图表回顾研究中avelumab维持治疗的主要分析。材料和方法这项多中心、回顾性研究收集了一线(1L) PBC后接受avelumab维持治疗的la/mUC患者的病历数据。在2021年2月至2023年12月期间,350名患者接受了avelumab维持治疗;中位年龄73岁,男性居多(74.0%)。既往1L PBC为顺铂-吉西他滨占56.0%,卡铂-吉西他滨占33.1%;28.6%的患者符合顺铂治疗条件,52.9%的患者不符合顺铂治疗条件。截至数据截止(2024年6月),67名患者(19.1%)仍在接受avelumab治疗。在283例停用avelumab的患者中,200例(70.7%)接受了二线(2L)治疗。在总体人群中,从avelumab开始的中位总生存期(OS)为31.8个月[95%置信区间(CI) 24.6个月-不可估计(NE)]。在接受2L enfortumab vedotin (EV) (n = 133), PBC (n = 41)或pembrolizumab (n = 17)的亚组中,从2L治疗开始的中位OS分别为17.8个月(95% CI 11.9个月- ne), 15.1个月(95% CI 11.6个月- ne)和15.6个月(95% CI 8.6-21.3个月)。局限性包括该研究的回顾性。JAVEMACS的研究结果证实了日本实际临床实践中avelumab维持治疗的有效性,支持其对1L PBC后无疾病进展的la/mUC患者的推荐。在现实世界人群中,这种治疗顺序加上2L EV似乎与令人鼓舞的长期结果相关。
{"title":"JAVEMACS: a real-world study of avelumab maintenance therapy for advanced urothelial carcinoma in Japan","authors":"H. Kitamura ,&nbsp;T. Kobayashi ,&nbsp;Y. Endo ,&nbsp;M. Ikeda ,&nbsp;K. Yonemori ,&nbsp;M. Nakayama ,&nbsp;A. Fujihara ,&nbsp;T. Abe ,&nbsp;F. Shimizu ,&nbsp;K. Fujimoto ,&nbsp;T. Nakagawa ,&nbsp;S. Hatakeyama ,&nbsp;K. Murakami ,&nbsp;K. Nishihara ,&nbsp;D. Ikarashi ,&nbsp;N. Masumori ,&nbsp;S. Naito ,&nbsp;K. Fujita ,&nbsp;N. Hayakawa ,&nbsp;T. Hara ,&nbsp;E. Kikuchi","doi":"10.1016/j.esmorw.2025.100646","DOIUrl":"10.1016/j.esmorw.2025.100646","url":null,"abstract":"<div><h3>Background</h3><div>Avelumab maintenance therapy was approved in Japan in February 2021 for patients with unresectable locally advanced or metastatic urothelial carcinoma (la/mUC) without disease progression after platinum-based chemotherapy (PBC). We report the primary analysis from the JAVEMACS chart review study of avelumab maintenance therapy in Japan.</div></div><div><h3>Materials and methods</h3><div>This multicenter, retrospective study collected data from medical charts of patients with la/mUC who received avelumab maintenance after first-line (1L) PBC.</div></div><div><h3>Results</h3><div>Between February 2021 and December 2023, 350 patients received avelumab maintenance; median age was 73 years and most were male (74.0%). Prior 1L PBC was cisplatin–gemcitabine in 56.0% and carboplatin–gemcitabine in 33.1%; 28.6% were cisplatin eligible and 52.9% were cisplatin ineligible/platinum eligible. At data cut-off (June 2024), 67 patients (19.1%) were still receiving avelumab. Among 283 patients who discontinued avelumab, 200 (70.7%) received second-line (2L) treatment. In the overall population, median overall survival (OS) from avelumab initiation was 31.8 months [95% confidence interval (CI) 24.6 months-not estimable (NE)]. In subgroups who received 2L enfortumab vedotin (EV) (<em>n</em> = 133), PBC (<em>n</em> = 41), or pembrolizumab (<em>n</em> = 17), median OS from the start of 2L treatment was 17.8 months (95% CI 11.9 months-NE), 15.1 months (95% CI 11.6 months-NE), and 15.6 months (95% CI 8.6-21.3 months), respectively. Limitations include the study’s retrospective nature.</div></div><div><h3>Conclusions</h3><div>Results from JAVEMACS confirm the effectiveness of avelumab maintenance in real-world clinical practice in Japan, supporting its recommendation for patients with la/mUC without disease progression following 1L PBC. This treatment sequence followed by 2L EV appeared to be associated with encouraging long-term outcomes in this real-world population.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"10 ","pages":"Article 100646"},"PeriodicalIF":0.0,"publicationDate":"2025-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145571603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
From Lindbergh’s cockpit to predictive, AI-driven health care: a roadmap for high-reliability medicine 从林德伯格的驾驶舱到预测性、人工智能驱动的医疗保健:高可靠性医疗的路线图
Pub Date : 2025-11-20 DOI: 10.1016/j.esmorw.2025.100650
B. Fuchs , P. Heesen
Modern health care remains largely intuition-driven, reactive, and fragmented, resulting in preventable errors and inefficiencies. In contrast, aviation has evolved into a highly structured, automated, and predictive safety system, achieving near-zero accident rates through standardization, automation, and artificial intelligence (AI)-assisted decision making. While medicine has incorporated certain aviation-inspired practices—such as checklists, crew resource management, and simulation training—it lacks the comprehensive data-driven framework and continuous oversight that underpins aviation’s safety culture. This perspective proposes a four-phase roadmap for integrating AI into health care, drawing on lessons from aviation’s transformation over the past century. Phase I emphasizes the standardization of clinical data and interoperability, mirroring aviation’s shift from handwritten logs to digital flight recorders. Phase II introduces AI-assisted decision support, paralleling the emergence of autopilot and early flight control systems. Phase III highlights real-time predictive monitoring, analogous to continuous flight data monitoring, while phase IV envisions autonomous health care systems, reflecting modern aircraft’s capacity for automated flight. However, aviation’s experience also reveals the perils of over-reliance on technology, including automation bias and deskilling, underscoring the need for regulatory adaptation, transparent error reporting, and robust human–AI collaboration. By integrating these safeguards, medicine can carefully integrate AI’s transformative potential to reduce errors, improve efficiency, and enhance patient outcomes, thereby shifting from an intuition-driven model to one of precision and reliability.
现代卫生保健在很大程度上仍然是直觉驱动的、被动的和分散的,导致可预防的错误和效率低下。相比之下,航空业已发展成为一个高度结构化、自动化和可预测的安全系统,通过标准化、自动化和人工智能(AI)辅助决策,实现了接近零的事故率。虽然医学已经纳入了一些受航空启发的实践,如检查清单、机组资源管理和模拟训练,但它缺乏支撑航空安全文化的全面数据驱动框架和持续监督。这一观点借鉴了过去一个世纪航空业转型的经验教训,提出了将人工智能融入医疗保健的四阶段路线图。第一阶段强调临床数据的标准化和互操作性,反映了航空业从手写日志到数字飞行记录器的转变。第二阶段引入人工智能辅助决策支持,同时出现自动驾驶仪和早期飞行控制系统。第三阶段强调实时预测监测,类似于连续飞行数据监测,而第四阶段设想自主医疗保健系统,反映现代飞机自动飞行的能力。然而,航空业的经验也揭示了过度依赖技术的危险,包括自动化偏见和去技能化,强调了适应监管、透明的错误报告和强大的人类与人工智能合作的必要性。通过整合这些保障措施,医学可以仔细整合人工智能的变革潜力,以减少错误,提高效率并改善患者的治疗效果,从而从直觉驱动的模型转变为精确和可靠的模型。
{"title":"From Lindbergh’s cockpit to predictive, AI-driven health care: a roadmap for high-reliability medicine","authors":"B. Fuchs ,&nbsp;P. Heesen","doi":"10.1016/j.esmorw.2025.100650","DOIUrl":"10.1016/j.esmorw.2025.100650","url":null,"abstract":"<div><div>Modern health care remains largely intuition-driven, reactive, and fragmented, resulting in preventable errors and inefficiencies. In contrast, aviation has evolved into a highly structured, automated, and predictive safety system, achieving near-zero accident rates through standardization, automation, and artificial intelligence (AI)-assisted decision making. While medicine has incorporated certain aviation-inspired practices—such as checklists, crew resource management, and simulation training—it lacks the comprehensive data-driven framework and continuous oversight that underpins aviation’s safety culture. This perspective proposes a four-phase roadmap for integrating AI into health care, drawing on lessons from aviation’s transformation over the past century. Phase I emphasizes the standardization of clinical data and interoperability, mirroring aviation’s shift from handwritten logs to digital flight recorders. Phase II introduces AI-assisted decision support, paralleling the emergence of autopilot and early flight control systems. Phase III highlights real-time predictive monitoring, analogous to continuous flight data monitoring, while phase IV envisions autonomous health care systems, reflecting modern aircraft’s capacity for automated flight. However, aviation’s experience also reveals the perils of over-reliance on technology, including automation bias and deskilling, underscoring the need for regulatory adaptation, transparent error reporting, and robust human–AI collaboration. By integrating these safeguards, medicine can carefully integrate AI’s transformative potential to reduce errors, improve efficiency, and enhance patient outcomes, thereby shifting from an intuition-driven model to one of precision and reliability.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"10 ","pages":"Article 100650"},"PeriodicalIF":0.0,"publicationDate":"2025-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145571523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Trends in smoking and obesity prevalence at breast cancer diagnosis: results from a 35-year real-world observational study 吸烟和肥胖在乳腺癌诊断中的流行趋势:一项35年真实世界观察性研究的结果
Pub Date : 2025-11-17 DOI: 10.1016/j.esmorw.2025.100632
R.D.S. Gbessemehlan , F. Nguyen Van Long , N.K.D. Adenyo , O. Haroun , A. Turgeon , A. Boubaker , C. Laflamme , J. Lemieux , H. Nabi

Background

Breast cancer (BC) is the most commonly diagnosed cancer among women. Understanding long-term trends in modifiable risk factors at the time of diagnosis is essential to inform and evaluate the effectiveness of BC prevention strategies. This study assessed 35-year trends in the prevalence of two modifiable risk factors—obesity and smoking—among BC women.

Methods

We conducted a retrospective cohort study including 14 595 women diagnosed with BC at the Centre des maladies du sein in Quebec City, Canada, between 1987 and 2021. Prevalence ratios (PRs) for obesity and smoking were estimated using multivariable log-binomial regression models adjusted for demographic and clinical characteristics.

Results

Over the 35-year period, obesity prevalence at diagnosis significantly increased [PR 1.19; 95% confidence interval (CI) 1.15-1.24; P < 0.0001], while smoking prevalence declined (PR 0.92; 95% CI 0.89-0.95; P < 0.0001). Stratified analyses showed more pronounced increase in obesity (PR 1.40; 95% CI 1.25-1.57; P < 0.0001) and decline in smoking (PR 0.82; 95% CI 0.78-0.86; P < 0.0001) among premenopausal women, compared with postmenopausal women (obesity: PR 1.16; 95% CI 1.11-1.21; P < 0.0001; smoking: PR 0.97; 95% CI 0.93-1.01; P = 0.1555).

Conclusions

The rising prevalence of obesity among BC patients at diagnosis underscores the need to strengthen public health efforts targeting obesity prevention. While anti-smoking measures appear to have been effective, additional strategies are warranted to address the growing burden of obesity and its potential impact on BC incidence in Canada and elsewhere.
乳腺癌(BC)是女性中最常见的癌症。在诊断时了解可改变的危险因素的长期趋势对于告知和评估BC预防策略的有效性至关重要。本研究评估了不列颠哥伦比亚省妇女中两种可改变的危险因素——肥胖和吸烟——35年来的流行趋势。方法:我们进行了一项回顾性队列研究,包括1987年至2021年间在加拿大魁北克市疾病中心诊断为BC的14595名妇女。使用多变量对数二项回归模型对人口统计学和临床特征进行调整,估计肥胖和吸烟的患病率。结果在35年的时间里,诊断时的肥胖患病率显著增加[PR = 1.19;95%置信区间(CI) 1.15-1.24;P < 0.0001],而吸烟率下降(PR = 0.92; 95% CI = 0.89-0.95; P < 0.0001)。分层分析显示,与绝经后妇女(肥胖:PR 1.16; 95% CI 1.11-1.21; P < 0.0001;吸烟:PR 0.97; 95% CI 0.93-1.01; P = 0.1555)相比,绝经前妇女的肥胖增加(PR 1.40; 95% CI 1.25-1.57; P < 0.0001)和吸烟减少(PR 0.82; 95% CI 0.78-0.86; P < 0.0001)更为明显。结论:诊断时BC患者肥胖患病率的上升,强调了加强针对肥胖预防的公共卫生努力的必要性。虽然反吸烟措施似乎是有效的,但在加拿大和其他地方,需要采取额外的策略来解决日益增长的肥胖负担及其对BC发病率的潜在影响。
{"title":"Trends in smoking and obesity prevalence at breast cancer diagnosis: results from a 35-year real-world observational study","authors":"R.D.S. Gbessemehlan ,&nbsp;F. Nguyen Van Long ,&nbsp;N.K.D. Adenyo ,&nbsp;O. Haroun ,&nbsp;A. Turgeon ,&nbsp;A. Boubaker ,&nbsp;C. Laflamme ,&nbsp;J. Lemieux ,&nbsp;H. Nabi","doi":"10.1016/j.esmorw.2025.100632","DOIUrl":"10.1016/j.esmorw.2025.100632","url":null,"abstract":"<div><h3>Background</h3><div>Breast cancer (BC) is the most commonly diagnosed cancer among women. Understanding long-term trends in modifiable risk factors at the time of diagnosis is essential to inform and evaluate the effectiveness of BC prevention strategies. This study assessed 35-year trends in the prevalence of two modifiable risk factors—obesity and smoking—among BC women.</div></div><div><h3>Methods</h3><div>We conducted a retrospective cohort study including 14 595 women diagnosed with BC at the Centre des maladies du sein in Quebec City, Canada, between 1987 and 2021. Prevalence ratios (PRs) for obesity and smoking were estimated using multivariable log-binomial regression models adjusted for demographic and clinical characteristics.</div></div><div><h3>Results</h3><div>Over the 35-year period, obesity prevalence at diagnosis significantly increased [PR 1.19; 95% confidence interval (CI) 1.15-1.24; <em>P</em> &lt; 0.0001], while smoking prevalence declined (PR 0.92; 95% CI 0.89-0.95; <em>P</em> &lt; 0.0001). Stratified analyses showed more pronounced increase in obesity (PR 1.40; 95% CI 1.25-1.57; <em>P</em> &lt; 0.0001) and decline in smoking (PR 0.82; 95% CI 0.78-0.86; <em>P</em> &lt; 0.0001) among premenopausal women, compared with postmenopausal women (obesity: PR 1.16; 95% CI 1.11-1.21; <em>P</em> &lt; 0.0001; smoking: PR 0.97; 95% CI 0.93-1.01; <em>P</em> = 0.1555).</div></div><div><h3>Conclusions</h3><div>The rising prevalence of obesity among BC patients at diagnosis underscores the need to strengthen public health efforts targeting obesity prevention. While anti-smoking measures appear to have been effective, additional strategies are warranted to address the growing burden of obesity and its potential impact on BC incidence in Canada and elsewhere.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"10 ","pages":"Article 100632"},"PeriodicalIF":0.0,"publicationDate":"2025-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145571522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
ESMO Real World Data and Digital Oncology
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1