Lancet Healthy Longevity最新文献

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Rethinking causal effects across the lifespan 重新思考整个生命周期的因果效应
IF 13.1
Lancet Healthy Longevity Pub Date : 2024-03-01 DOI: 10.1016/S2666-7568(24)00026-6
Takeshi Nakagawa , Sala Giovanni
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引用次数: 0
Cancer survivorship and bone health 癌症幸存者与骨骼健康
IF 13.1
Lancet Healthy Longevity Pub Date : 2024-03-01 DOI: 10.1016/S2666-7568(24)00022-9
Peter KK Wong , Weiwen Chen
{"title":"Cancer survivorship and bone health","authors":"Peter KK Wong , Weiwen Chen","doi":"10.1016/S2666-7568(24)00022-9","DOIUrl":"10.1016/S2666-7568(24)00022-9","url":null,"abstract":"","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.1,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666756824000229/pdfft?md5=67e11c00a7453540c9b81dfc09e68e5e&pid=1-s2.0-S2666756824000229-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139713182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Risk of fractures in half a million survivors of 20 cancers: a population-based matched cohort study using linked English electronic health records 50 万 20 种癌症幸存者的骨折风险:一项基于人群的匹配队列研究,使用的是链接的英国电子健康记录。
IF 13.1
Lancet Healthy Longevity Pub Date : 2024-03-01 DOI: 10.1016/S2666-7568(23)00285-4
Eva Buzasi MSc , Helena Carreira PhD , Garth Funston PhD , Kathryn E Mansfield PhD , Harriet Forbes PhD , Helen Strongman PhD , Prof Krishnan Bhaskaran PhD
{"title":"Risk of fractures in half a million survivors of 20 cancers: a population-based matched cohort study using linked English electronic health records","authors":"Eva Buzasi MSc ,&nbsp;Helena Carreira PhD ,&nbsp;Garth Funston PhD ,&nbsp;Kathryn E Mansfield PhD ,&nbsp;Harriet Forbes PhD ,&nbsp;Helen Strongman PhD ,&nbsp;Prof Krishnan Bhaskaran PhD","doi":"10.1016/S2666-7568(23)00285-4","DOIUrl":"10.1016/S2666-7568(23)00285-4","url":null,"abstract":"<div><h3>Background</h3><p>A history of multiple myeloma, prostate cancer, and breast cancer has been associated with adverse bone health, but associations across a broader range of cancers are unclear. We aimed to compare the risk of any bone fracture and major osteoporotic fractures in survivors of a wide range of cancers versus cancer-free individuals.</p></div><div><h3>Methods</h3><p>In this population-based matched cohort study, we used electronic health records from the UK Clinical Practice Research Datalink linked to hospital data. We included adults (aged ≥18 years) eligible for linkage, and we restricted the study start to Jan 2, 1998, onwards and applied administrative censoring on Jan 31, 2020. The cancer survivor group included survivors of the 20 most common cancers. Each individual with cancer was matched (age, sex, and general practice) to up to five controls (1:5) who were cancer-free. The primary outcomes were any bone fracture and any major osteoporotic fracture (pelvic, hip, wrist, spine, or proximal humeral fractures) occurring more than 1 year after index date (ie, the diagnosis date of the matched individual with cancer). We used Cox regression models, adjusted for shared risk factors, to estimate associations between cancer survivorship and bone fractures.</p></div><div><h3>Findings</h3><p>578 160 adults with cancer diagnosed in 1998–2020 were matched to 3 226 404 cancer-free individuals. Crude incidence rates of fractures in cancer survivors ranged between 8·39 cases (95% CI 7·45–9·46) per 1000 person-years for thyroid cancer and 21·62 cases (20·18–23·18) per 1000 person-years for multiple myeloma. Compared with cancer-free individuals, the risk of any bone fracture was increased in 15 of 20 cancers, and of major osteoporotic fractures in 17 of 20 cancers. Effect sizes varied: adjusted hazard ratios (HRs) were largest for multiple myeloma (1·94, 95% CI 1·77–2·13) and prostate cancer (1·43, 1·39–1·47); HRs in the range 1·20–1·50 were seen for stomach, liver, pancreas, lung, breast, kidney, and CNS cancers; smaller associations (HR &lt;1·20) were observed for malignant melanoma, non-Hodgkin lymphoma, leukaemia, and oesophageal, colorectal, and cervical cancers. Increased risks of major osteoporotic fracture were noted most substantially in multiple myeloma (2·25, 1·96–2·58) and CNS (2·12, 1·56–2·87), liver (1·62, 1·01–2·61), prostate (1·60, 1·53–1·67), and lung cancers (1·60, 1·44–1·77). Effect sizes tended to reduce over time since diagnosis but remained elevated for more than 5 years in several cancers, such as multiple myeloma and stomach, lung, breast, prostate, and CNS cancers.</p></div><div><h3>Interpretation</h3><p>Survivors of most types of cancer were at increased risk of bone fracture for several years after cancer, with variation by cancer type. These findings can help to inform mitigation and prevention strategies.</p></div><div><h3>Funding</h3><p>Wellcome Trust.</p></div>","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.1,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666756823002854/pdfft?md5=6a950dff74083763add0b191a0e8c9ae&pid=1-s2.0-S2666756823002854-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139713183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The relationship between frailty and social vulnerability: a systematic review 虚弱与社会脆弱性之间的关系:系统性综述
IF 13.1
Lancet Healthy Longevity Pub Date : 2024-03-01 DOI: 10.1016/S2666-7568(23)00263-5
Peter Hanlon PhD , Heather Wightman BSc , Marina Politis BSc , Stella Kirkpatrick BSc , Caitlin Jones MBChB , Melissa K Andrew PhD , Davide L Vetrano PhD , Elsa Dent PhD , Emiel O Hoogendijk PhD
{"title":"The relationship between frailty and social vulnerability: a systematic review","authors":"Peter Hanlon PhD ,&nbsp;Heather Wightman BSc ,&nbsp;Marina Politis BSc ,&nbsp;Stella Kirkpatrick BSc ,&nbsp;Caitlin Jones MBChB ,&nbsp;Melissa K Andrew PhD ,&nbsp;Davide L Vetrano PhD ,&nbsp;Elsa Dent PhD ,&nbsp;Emiel O Hoogendijk PhD","doi":"10.1016/S2666-7568(23)00263-5","DOIUrl":"https://doi.org/10.1016/S2666-7568(23)00263-5","url":null,"abstract":"<div><p>Both frailty (reduced physiological reserve) and social vulnerability (scarcity of adequate social connections, support, or interaction) become more common as people age and are associated with adverse consequences. Analyses of the relationships between these constructs can be limited by the wide range of measures used to assess them. In this systematic review, we synthesised 130 observational studies assessing the association between frailty and social vulnerability, the bidirectional longitudinal relationships between constructs, and their joint associations with adverse health outcomes. Frailty, across assessment type, was associated with increased loneliness and social isolation, perceived inadequacy of social support, and reduced social participation. Each of these social vulnerability components was also associated with more rapid progression of frailty and lower odds of improvement compared with the absence of that social vulnerability component (eg, more rapid frailty progression in people with social isolation <em>vs</em> those who were not socially isolated). Combinations of frailty and social vulnerability were associated with increased mortality, decline in physical function, and cognitive impairment. Clinical and public health measures targeting frailty or social vulnerability should, therefore, account for both frailty and social vulnerability.</p></div>","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.1,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666756823002635/pdfft?md5=b12c0286decea331e46e55947087cd58&pid=1-s2.0-S2666756823002635-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139998893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy of decentralised home-based antihypertensive treatment in older adults with multimorbidity and polypharmacy (ATEMPT): an open-label randomised controlled pilot trial 针对多病多药老年人的分散式居家降压治疗(ATEMPT)的疗效:开放标签随机对照试验。
IF 13.1
Lancet Healthy Longevity Pub Date : 2024-03-01 DOI: 10.1016/S2666-7568(23)00259-3
Jeannette Majert MD , Milad Nazarzadeh DPhil , Rema Ramakrishnan PhD , Zeinab Bidel MSc , Deborah Hedgecott BSc , Abel Perez-Crespillo MBA , Wendy Turpie PhD , Naseem Akhtar BSc , Moira Allison BSc , Shishir Rao DPhil , Bernard Gudgin PhD , Melanie McAuley , Christine A'Court MRCP , Prof Laurent Billot MSc , Prof Dipak Kotecha PhD , Prof John Potter FRCP , Prof Kazem Rahimi FRCP
{"title":"Efficacy of decentralised home-based antihypertensive treatment in older adults with multimorbidity and polypharmacy (ATEMPT): an open-label randomised controlled pilot trial","authors":"Jeannette Majert MD ,&nbsp;Milad Nazarzadeh DPhil ,&nbsp;Rema Ramakrishnan PhD ,&nbsp;Zeinab Bidel MSc ,&nbsp;Deborah Hedgecott BSc ,&nbsp;Abel Perez-Crespillo MBA ,&nbsp;Wendy Turpie PhD ,&nbsp;Naseem Akhtar BSc ,&nbsp;Moira Allison BSc ,&nbsp;Shishir Rao DPhil ,&nbsp;Bernard Gudgin PhD ,&nbsp;Melanie McAuley ,&nbsp;Christine A'Court MRCP ,&nbsp;Prof Laurent Billot MSc ,&nbsp;Prof Dipak Kotecha PhD ,&nbsp;Prof John Potter FRCP ,&nbsp;Prof Kazem Rahimi FRCP","doi":"10.1016/S2666-7568(23)00259-3","DOIUrl":"10.1016/S2666-7568(23)00259-3","url":null,"abstract":"<div><h3>Background</h3><p>Older patients with multimorbidity and polypharmacy have been under-represented in clinical trials. We aimed to assess the effect of different intensities of antihypertensive treatment on changes in blood pressure, major safety outcomes, and patient-reported outcomes in this population.</p></div><div><h3>Methods</h3><p>ATEMPT was a decentralised, two-armed, parallel-group, open-label randomised controlled pilot trial conducted in the Thames Valley area, South East England. Individuals aged 65 years or older with multimorbidity (three or more chronic conditions) or polypharmacy (five or more types of medications) and a systolic blood pressure of 115–165 mm Hg were eligible for inclusion. Participants were identified through a search of national hospital discharge databases, identification of patients registered with an online pharmacy, and via targeted advertising on social media platforms. Participants were randomly assigned to receive up to two more classes versus up to two fewer classes of antihypertensive medications. Apart from routine home visits for conducting the baseline assessment, all communication, monitoring, and management of participants by the trial team was conducted remotely. The primary outcome was change in home-measured blood pressure.</p></div><div><h3>Findings</h3><p>Between Dec 15, 2020, and Aug 31, 2022, 230 participants were randomly assigned (n=126 to more <em>vs</em> n=104 to fewer antihypertensive medications). The frequency of serious adverse events was similar across both groups; no cardiovascular events occurred in the more antihypertensive drugs group, compared with six in the fewer antihypertensive drugs group, of which two were fatal. Over a 13-month follow-up period, the mean systolic blood pressure in the group allocated to receive more antihypertensive medications decreased from 134·5 mm Hg (SD 10·7) at baseline to 122·1 mm Hg (10·5). By contrast, in the group allocated to receive fewer antihypertensive medications, it remained relatively unchanged, moving from 134·8 mm Hg (SD 11·2) at baseline to 132·9 mm Hg (15·3); this corresponded to a mean difference of –10·7 mm Hg (95% CI –17·5 to –4·0).</p></div><div><h3>Interpretation</h3><p>Remotely delivered antihypertensive treatment substantially reduced systolic blood pressure in older adults who are often less represented in trials, with no increase in the risk of serious adverse events. The results of this trial will inform a larger clinical trial focusing on assessing major cardiovascular events, safety, physical functioning, and cognitive function that is currently in the planning stages. These results also underscore the efficiency of decentralised trial designs, which might be of broader interest in other settings.</p></div><div><h3>Funding</h3><p>National Institute for Health Research Oxford Biomedical Research Centre and the Oxford Martin School.</p></div>","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.1,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666756823002593/pdfft?md5=2990d5dcefbec103356b2a574d1778c5&pid=1-s2.0-S2666756823002593-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139717945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Restoring cancer care for our ageing populations 恢复对老龄人口的癌症护理
IF 13.1
Lancet Healthy Longevity Pub Date : 2024-03-01 DOI: 10.1016/S2666-7568(24)00031-X
The Lancet Healthy Longevity
{"title":"Restoring cancer care for our ageing populations","authors":"The Lancet Healthy Longevity","doi":"10.1016/S2666-7568(24)00031-X","DOIUrl":"https://doi.org/10.1016/S2666-7568(24)00031-X","url":null,"abstract":"","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.1,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S266675682400031X/pdfft?md5=6b68d95e9bebdf7aac6e6c0a0e0e1d14&pid=1-s2.0-S266675682400031X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139999442","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Performance of models for predicting 1-year to 3-year mortality in older adults: a systematic review of externally validated models 预测老年人 1 年至 3 年死亡率模型的性能:外部验证模型的系统回顾。
IF 13.1
Lancet Healthy Longevity Pub Date : 2024-03-01 DOI: 10.1016/S2666-7568(23)00264-7
Leonard Ho PhD , Carys Pugh PhD , Sohan Seth PhD , Stella Arakelyan PhD , Nazir I Lone PhD , Marcus J Lyall PhD , Atul Anand PhD , Prof Jacques D Fleuriot PhD , Paola Galdi PhD , Prof Bruce Guthrie PhD
{"title":"Performance of models for predicting 1-year to 3-year mortality in older adults: a systematic review of externally validated models","authors":"Leonard Ho PhD ,&nbsp;Carys Pugh PhD ,&nbsp;Sohan Seth PhD ,&nbsp;Stella Arakelyan PhD ,&nbsp;Nazir I Lone PhD ,&nbsp;Marcus J Lyall PhD ,&nbsp;Atul Anand PhD ,&nbsp;Prof Jacques D Fleuriot PhD ,&nbsp;Paola Galdi PhD ,&nbsp;Prof Bruce Guthrie PhD","doi":"10.1016/S2666-7568(23)00264-7","DOIUrl":"10.1016/S2666-7568(23)00264-7","url":null,"abstract":"<div><p>Mortality prediction models support identifying older adults with short life expectancy for whom clinical care might need modifications. We systematically reviewed external validations of mortality prediction models in older adults (ie, aged 65 years and older) with up to 3 years of follow-up. In March, 2023, we conducted a literature search resulting in 36 studies reporting 74 validations of 64 unique models. Model applicability was fair but validation risk of bias was mostly high, with 50 (68%) of 74 validations not reporting calibration. Morbidities (most commonly cardiovascular diseases) were used as predictors by 45 (70%) of 64 of models. For 1-year prediction, 31 (67%) of 46 models had acceptable discrimination, but only one had excellent performance. Models with more than 20 predictors were more likely to have acceptable discrimination (risk ratio [RR] <em>vs</em> &lt;10 predictors 1·68, 95% CI 1·06–2·66), as were models including sex (RR 1·75, 95% CI 1·12–2·73) or predicting risk during comprehensive geriatric assessment (RR 1·86, 95% CI 1·12–3·07). Development and validation of better-performing mortality prediction models in older people are needed.</p></div>","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.1,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666756823002647/pdfft?md5=9760cd5b6ae5544df0ba50f7b55ff511&pid=1-s2.0-S2666756823002647-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139708073","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Vitamin D at the crossroad of prediabetes, sarcopenia, and risk of falls 处于糖尿病前期、肌肉疏松症和跌倒风险十字路口的维生素 D。
IF 13.1
Lancet Healthy Longevity Pub Date : 2024-03-01 DOI: 10.1016/S2666-7568(24)00032-1
Andrea Giustina
{"title":"Vitamin D at the crossroad of prediabetes, sarcopenia, and risk of falls","authors":"Andrea Giustina","doi":"10.1016/S2666-7568(24)00032-1","DOIUrl":"10.1016/S2666-7568(24)00032-1","url":null,"abstract":"","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.1,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666756824000321/pdfft?md5=ddc2aa876d21425cfc5d747a56636d0a&pid=1-s2.0-S2666756824000321-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140029187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cetuximab versus methotrexate in first-line treatment of older, frail patients with inoperable recurrent or metastatic head and neck cancer (ELAN UNFIT): a randomised, open-label, phase 3 trial 西妥昔单抗与甲氨蝶呤对比用于无法手术的复发性或转移性头颈癌老年体弱患者的一线治疗(ELAN UNFIT):一项随机、开放标签的 3 期试验
IF 13.1
Lancet Healthy Longevity Pub Date : 2024-03-01 DOI: 10.1016/S2666-7568(23)00284-2
Prof Joël Guigay MD , Cécile Ortholan MD , Damien Vansteene MD , Didier Cupissol MD , Caroline Even MD , Marie-Christine Kaminsky MD , Christian Sire MD , Emmanuel Blot MD , Philippe Debourdeau MD , Laurence Bozec MD , Esma Saada-Bouzid MD , Jérôme Fayette MD , Pierre Dalloz MD , Yoann Pointreau MD , Hervé Le Caer MD , Claire Falandry MD , Laurence Digue MD , Antoine Braccini MD , Stéphane Lopez MD , Pierre Guillet MD , Anne Aupérin PhD
{"title":"Cetuximab versus methotrexate in first-line treatment of older, frail patients with inoperable recurrent or metastatic head and neck cancer (ELAN UNFIT): a randomised, open-label, phase 3 trial","authors":"Prof Joël Guigay MD ,&nbsp;Cécile Ortholan MD ,&nbsp;Damien Vansteene MD ,&nbsp;Didier Cupissol MD ,&nbsp;Caroline Even MD ,&nbsp;Marie-Christine Kaminsky MD ,&nbsp;Christian Sire MD ,&nbsp;Emmanuel Blot MD ,&nbsp;Philippe Debourdeau MD ,&nbsp;Laurence Bozec MD ,&nbsp;Esma Saada-Bouzid MD ,&nbsp;Jérôme Fayette MD ,&nbsp;Pierre Dalloz MD ,&nbsp;Yoann Pointreau MD ,&nbsp;Hervé Le Caer MD ,&nbsp;Claire Falandry MD ,&nbsp;Laurence Digue MD ,&nbsp;Antoine Braccini MD ,&nbsp;Stéphane Lopez MD ,&nbsp;Pierre Guillet MD ,&nbsp;Anne Aupérin PhD","doi":"10.1016/S2666-7568(23)00284-2","DOIUrl":"https://doi.org/10.1016/S2666-7568(23)00284-2","url":null,"abstract":"<div><h3>Background</h3><p>At present, there is no established standard treatment for frail older patients with recurrent or metastatic head and neck squamous cell carcinoma. We aimed to compare the efficacy and safety of cetuximab to those of methotrexate (the reference regimen) in this population.</p></div><div><h3>Methods</h3><p>This randomised, open-label, phase 3 trial was done at 20 hospitals in France. Patients aged 70 years or older, assessed as frail by the ELAN Geriatric Evaluation, with recurrent or metastatic head and neck squamous cell carcinoma in the first-line setting and with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2 were eligible for inclusion. Patients were randomly assigned (1:1) to receive cetuximab 500 mg/m<sup>2</sup> intravenously every 2 weeks or methotrexate 40 mg/m<sup>2</sup> intravenously every week, with minimisation by ECOG performance status, type of disease evolution, Charlson Comorbidity Index score, serum albumin concentration, and geriatrician consultation. To avoid deterministic minimisation and assure allocation concealment, patients were allocated with a probability of 0·80 to the treatment that most reduced the imbalance. Treatment was continued until disease progression or unacceptable toxicity, whichever occurred first. The primary endpoint was failure-free survival (defined as the time from randomisation to disease progression, death, discontinuation of treatment, or loss of 2 or more points on the Activities in Daily Living scale, whichever occurred first) and was analysed in the intention-to-treat population. 151 failures expected out of 164 patients were required to detect a hazard ratio (HR) of 0·625 with 0·05 alpha error, with 80% power. A futility interim analysis was planned when approximately 80 failures were observed, based on failure-free survival. Safety analyses included all patients who received at least one dose of the study drug. This study is registered on <span>ClinicalTrials.gov</span><svg><path></path></svg> (<span>NCT01884623</span><svg><path></path></svg>) and was stopped for futility after the interim analysis.</p></div><div><h3>Findings</h3><p>Between Nov 7, 2013, and April 23, 2018, 82 patients were enrolled (41 to the cetuximab group and 41 to the methotrexate group); 60 (73%) were male, 37 (45%) were aged 80 years or older, 35 (43%) had an ECOG performance status of 2, and 36 (44%) had metastatic disease. Enrolment was stopped for futility at the interim analysis. At the final analysis, median follow-up was 43·3 months (IQR 30·8–52·1). At data cutoff, all 82 patients had failure; failure-free survival did not differ significantly between the groups (median 1·4 months [95% CI 1·0–2·1] in the cetuximab group <em>vs</em> 1·9 months [1·1–2·6] in the methotrexate group; adjusted HR 1·03 [95% CI 0·66–1·61], p=0·89). The frequency of patients who had grade 3 or worse adverse events was 63% (26 of 41) in the cetuximab group and 73% (30 of 41) in the methotre","PeriodicalId":34394,"journal":{"name":"Lancet Healthy Longevity","volume":null,"pages":null},"PeriodicalIF":13.1,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666756823002842/pdfft?md5=d9483239644eb9f5b2012abb44d515e5&pid=1-s2.0-S2666756823002842-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139999440","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Thank you to The Lancet Healthy Longevity's clinical and statistical peer reviewers in 2023 感谢 2023 年《柳叶刀健康长寿》杂志的临床和统计同行评审员
IF 13.1
Lancet Healthy Longevity Pub Date : 2024-02-01 DOI: 10.1016/S2666-7568(24)00002-3
The Lancet Healthy Longevity Editors
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