Inclusion of Older Adults in Early-Phase Cancer Clinical Trials: Safety, Efficacy and a Way Forward.

IF 3.8 3区医学 Q2 GERIATRICS & GERONTOLOGY

Drugs & Aging Pub Date : 2025-10-23 DOI:10.1007/s40266-025-01260-y

Jessie Nguyen, Nicolò Matteo Luca Battisti, Danielle Ní Chróinín, Martin Hong, Udit Nindra, Jun Hee Hong, Walid Zwieky, Kate Wilkinson, Robert Yoon, Adam Cooper, Aflah Roohullah, Weng Ng, Wei Chua, Abhijit Pal

{"title":"Inclusion of Older Adults in Early-Phase Cancer Clinical Trials: Safety, Efficacy and a Way Forward.","authors":"Jessie Nguyen, Nicolò Matteo Luca Battisti, Danielle Ní Chróinín, Martin Hong, Udit Nindra, Jun Hee Hong, Walid Zwieky, Kate Wilkinson, Robert Yoon, Adam Cooper, Aflah Roohullah, Weng Ng, Wei Chua, Abhijit Pal","doi":"10.1007/s40266-025-01260-y","DOIUrl":null,"url":null,"abstract":"<p><p>Early-phase clinical trials (EPCTs) are critical for evaluating the safety, tolerability, efficacy and pharmacokinetics of novel oncology therapies. However, older adults are underrepresented in all phases of oncology clinical trials, including early-phase trials, creating a significant gap in evidence-based cancer management in this population, which translates into clinical practice. This is despite cancer incidence increasing with age, and a substantial proportion of cancer diagnoses occurring in individuals aged ≥ 65 years. Ageing is associated with physiological, physical and psychosocial changes which could underlie the hesitancy to include older adults in early-phase clinical trials, due to concerns of excessively compromising their safety and quality of life. However, the landscape of EPCTs has changed with higher safety and efficacy data. This review explores the current landscape of older adults in early-phase clinical trials, including the participation rate, the outcomes, and the multifaceted challenges contributing to the underrepresentation of older adults, and examines the potential strategies to enhance the inclusivity of older adults for treating older adults with cancer.</p>","PeriodicalId":11489,"journal":{"name":"Drugs & Aging","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drugs & Aging","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40266-025-01260-y","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GERIATRICS & GERONTOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Early-phase clinical trials (EPCTs) are critical for evaluating the safety, tolerability, efficacy and pharmacokinetics of novel oncology therapies. However, older adults are underrepresented in all phases of oncology clinical trials, including early-phase trials, creating a significant gap in evidence-based cancer management in this population, which translates into clinical practice. This is despite cancer incidence increasing with age, and a substantial proportion of cancer diagnoses occurring in individuals aged ≥ 65 years. Ageing is associated with physiological, physical and psychosocial changes which could underlie the hesitancy to include older adults in early-phase clinical trials, due to concerns of excessively compromising their safety and quality of life. However, the landscape of EPCTs has changed with higher safety and efficacy data. This review explores the current landscape of older adults in early-phase clinical trials, including the participation rate, the outcomes, and the multifaceted challenges contributing to the underrepresentation of older adults, and examines the potential strategies to enhance the inclusivity of older adults for treating older adults with cancer.

查看原文本刊更多论文

将老年人纳入早期癌症临床试验：安全性、有效性和前进的方向。

早期临床试验（epct）对于评估新型肿瘤疗法的安全性、耐受性、有效性和药代动力学至关重要。然而，在肿瘤临床试验的所有阶段，包括早期试验中，老年人的代表性不足，这在这一人群的循证癌症管理方面造成了重大差距，并转化为临床实践。尽管癌症发病率随着年龄的增长而增加，而且很大一部分癌症诊断发生在年龄≥65岁的个体中。衰老与生理、生理和社会心理变化有关，这可能是将老年人纳入早期临床试验犹豫不决的原因，因为担心过度损害他们的安全和生活质量。然而，随着安全性和有效性数据的提高，epct的前景发生了变化。本综述探讨了老年人早期临床试验的现状，包括参与率、结果和导致老年人代表性不足的多方面挑战，并探讨了提高老年人治疗老年人癌症的包容性的潜在策略。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Drugs & Aging 医学-老年医学

CiteScore

5.50

自引率

7.10%

发文量

审稿时长

6-12 weeks

期刊介绍： Drugs & Aging delivers essential information on the most important aspects of drug therapy to professionals involved in the care of the elderly. The journal addresses in a timely way the major issues relating to drug therapy in older adults including: the management of specific diseases, particularly those associated with aging, age-related physiological changes impacting drug therapy, drug utilization and prescribing in the elderly, polypharmacy and drug interactions.