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文献精选 > 近年高分"肿瘤微环境"研究（IF≥30，近5年）

Older adult participation in cancer clinical trials: A systematic review of barriers and interventions. ​

文献信息 ​

DOI10.3322/caac.21638
PMID33002206
期刊CA: a cancer journal for clinicians
影响因子232.4
JCR 分区Q1
发表年份2021
被引次数209
关键词临床试验，老年人，肿瘤学，患者参与，患者选择
文献类型Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Systematic Review
ISSN0007-9235
页码78-92
期号71(1)
作者Mina S Sedrak, Rachel A Freedman, Harvey J Cohen, Hyman B Muss, Aminah Jatoi, Heidi D Klepin, Tanya M Wildes, Jennifer G Le-Rademacher, Gretchen G Kimmick, William P Tew, Kevin George, Simran Padam, Jennifer Liu, Andrew R Wong, Andrea Lynch, Benjamin Djulbegovic, Supriya G Mohile, William Dale

一句话小结 ​

随着全球老龄化，老年癌症患者的比例日益增加，但他们在癌症治疗研究中的代表性严重不足。本文系统评估了影响老年人参与临床试验的障碍及干预措施，发现现有证据质量较低，并提出了针对老年患者需求的研究基础设施修改建议，以促进他们在癌症试验中的参与。

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临床试验 · 老年人 · 肿瘤学 · 患者参与 · 患者选择

摘要 ​

癌症是一种与年龄相关的疾病，随着全球人口老龄化，患有癌症的老年人数日益增加，并将在几乎所有国家的肿瘤学人群中占据越来越大的比例。尽管如此，老年患者在制定癌症治疗标准的研究中仍然严重缺乏代表性。因此，我们对癌症治疗的了解大多基于在年轻、健康的患者中进行的临床试验，而有效的策略以提高老年癌症患者参与临床试验的参与度依然稀少。为此，作者对已发表的关于老年人参与癌症试验障碍及改善参与的干预措施的研究进行了系统评估。现有证据的质量较低，尽管文献中描述了多种障碍，但仅有一项干预研究旨在增加老年人参与试验的招募。研究结果明显突显了针对这一代表性不足人群在癌症试验中改善参与的基于证据的有效策略的匮乏。在这些局限性中，作者提出了对当前癌症研究基础设施的修改意见，以满足老年患者的需求。提供了几种未被充分利用的解决方案，以扩大临床试验的范围，使老年癌症患者能够参与。然而，按照目前的构建方式，仅靠这些建议无法填补老年肿瘤学中的证据缺口，需要采取措施，通过扩展专为这一人群设计的临床试验和利用真实世界数据来满足老年及虚弱成年人的需求。

英文摘要 ​

Cancer is a disease of aging and, as the world's population ages, the number of older persons with cancer is increasing and will make up a growing share of the oncology population in virtually every country. Despite this, older patients remain vastly underrepresented in research that sets the standards for cancer treatments. Consequently, most of what we know about cancer therapeutics is based on clinical trials conducted in younger, healthier patients, and effective strategies to improve clinical trial participation of older adults with cancer remain sparse. For this systematic review, the authors evaluated published studies regarding barriers to participation and interventions to improve participation of older adults in cancer trials. The quality of the available evidence was low and, despite a literature describing multifaceted barriers, only one intervention study aimed to increase enrollment of older adults in trials. The findings starkly amplify the paucity of evidence-based, effective strategies to improve participation of this underrepresented population in cancer trials. Within these limitations, the authors provide their opinion on how the current cancer research infrastructure must be modified to accommodate the needs of older patients. Several underused solutions are offered to expand clinical trials to include older adults with cancer. However, as currently constructed, these recommendations alone will not solve the evidence gap in geriatric oncology, and efforts are needed to meet older and frail adults where they are by expanding clinical trials designed specifically for this population and leveraging real-world data.

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主要研究问题 ​

  1. 在提高老年患者参与癌症临床试验的过程中，哪些具体的干预措施被证明是有效的？
  2. 除了年龄和健康状况外，还有哪些社会或经济因素可能影响老年患者参与临床试验的意愿？
  3. 如何评估老年患者在癌症临床试验中的特殊需求，以便设计更具包容性的研究方案？
  4. 目前有哪些成功的案例可以作为改善老年患者参与癌症临床试验的参考？
  5. 未来的研究应该如何着重于填补老年肿瘤学领域的证据空白，以提高临床试验的参与率？

核心洞察 ​

研究背景和目的 ​

随着全球人口老龄化，癌症已成为一种主要的老年疾病，老年癌症患者的数量正在增加。然而，老年患者在设定癌症治疗标准的研究中仍然严重不足。因此，本研究旨在系统评估影响老年人参与癌症临床试验的障碍及改善参与度的干预措施。

主要方法/材料/实验设计 ​

本研究为系统评价，采用以下步骤：

Mermaid diagram
  • 文献检索：通过多个数据库系统性检索关于老年患者参与癌症临床试验的相关研究。
  • 筛选相关研究：依据特定标准筛选出符合条件的文献。
  • 评估研究质量：使用标准化工具评估纳入研究的质量。
  • 分析参与障碍：识别并总结影响老年患者参与的多重障碍。
  • 分析干预措施：评估已实施的干预措施的效果。
  • 总结障碍与干预效果：对障碍和干预措施进行总结，并提出改进建议。

关键结果和发现 ​

  • 研究表明，现有文献描述了多种影响老年患者参与癌症临床试验的障碍，如健康状况、社会支持不足、信息获取困难等。
  • 尽管文献中提及了多重障碍，但仅有一项干预研究专门针对提高老年患者的参与度。
  • 可用证据的质量普遍较低，显示出有效策略的缺乏。

主要结论/意义/创新性 ​

本研究强调了老年癌症患者在临床试验中参与的不足及其对癌症治疗研究的影响。尽管已有一些建议提出如何改进现有的癌症研究基础设施以适应老年患者的需求，但单靠这些建议无法弥补老年肿瘤学领域的证据缺口。未来需要设计专门针对老年患者的临床试验，并利用真实世界数据来提高参与度。

研究局限性和未来方向 ​

  • 局限性：现有研究的证据质量低，且干预措施数量有限，缺乏有效的、基于证据的策略。
  • 未来方向：
    • 需要开展更多专门针对老年癌症患者的临床试验。
    • 应考虑利用真实世界数据和患者的具体需求来设计研究。
    • 改善研究基础设施，增加老年患者的参与度，以确保他们在癌症治疗研究中的代表性。

参考文献 ​

  1. Survey of oncologists' perceptions of barriers to accrual of older patients with breast carcinoma to clinical trials. - Alice B Kornblith;Margaret Kemeny;Bercedis L Peterson;Judith Wheeler;Jeffrey Crawford;Nancy Bartlett;Gini Fleming;Stephen Graziano;Hyman Muss;Harvey Jay Cohen; - Cancer (2002)
  2. TELEHEALTH ALLOWS FOR CLINICAL TRIAL PARTICIPATION AND MULTIMODALITY THERAPY IN A RURAL PATIENT WITH STAGE 4 NON-SMALL CELL LUNG CANCER. - James M Clark;Laurence J Heifetz;Daphne Palmer;Lisa M Brown;David T Cooke;Elizabeth A David - Cancer treatment and research communications (2016)
  3. Enrollment of older patients in cancer treatment trials in Canada: why is age a barrier? - Karen W L Yee;Joseph L Pater;Lam Pho;Benny Zee;Lillian L Siu - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2003)
  4. Improving the quality of survivorship for older adults with cancer. - Supriya G Mohile;Arti Hurria;Harvey J Cohen;Julia H Rowland;Corinne R Leach;Neeraj K Arora;Beverly Canin;Hyman B Muss;Allison Magnuson;Marie Flannery;Lisa Lowenstein;Heather G Allore;Karen M Mustian;Wendy Demark-Wahnefried;Martine Extermann;Betty Ferrell;Sharon K Inouye;Stephanie A Studenski;William Dale - Cancer (2016)
  5. Functional versus chronological age: geriatric assessments to guide decision making in older patients with cancer. - Enrique Soto-Perez-de-Celis;Daneng Li;Yuan Yuan;Yat Ming Lau;Arti Hurria - The Lancet. Oncology (2018)
  6. Enrollment of older adults on oncology trials: An FDA perspective. - Harpreet Singh;Julia A Beaver;Geoffrey Kim;Richard Pazdur - Journal of geriatric oncology (2017)
  7. Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. - Carol A Townsley;Rita Selby;Lillian L Siu - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2005)
  8. A prospective analysis of the influence of older age on physician and patient decision-making when considering enrollment in breast cancer clinical trials (SWOG S0316). - Sara H Javid;Joseph M Unger;Julie R Gralow;Carol M Moinpour;Antoinette J Wozniak;J Wendall Goodwin;Primo N Lara;Pamela A Williams;Laura F Hutchins;Carolyn C Gotay;Kathy S Albain - The oncologist (2012)
  9. End points and trial design in geriatric oncology research: a joint European organisation for research and treatment of cancer--Alliance for Clinical Trials in Oncology--International Society Of Geriatric Oncology position article. - Hans Wildiers;Murielle Mauer;Athanasios Pallis;Arti Hurria;Supriya G Mohile;Andrea Luciani;Giuseppe Curigliano;Martine Extermann;Stuart M Lichtman;Karla Ballman;Harvey Jay Cohen;Hyman Muss;Ulrich Wedding - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2013)
  10. Breast cancer adjuvant chemotherapy decisions in older women: the role of patient preference and interactions with physicians. - Jeanne S Mandelblatt;Vanessa B Sheppard;Arti Hurria;Gretchen Kimmick;Claudine Isaacs;Kathryn L Taylor;Alice B Kornblith;Anne-Michelle Noone;Gheorghe Luta;Michelle Tallarico;William T Barry;Lisa Hunegs;Robin Zon;Michael Naughton;Eric Winer;Clifford Hudis;Stephen B Edge;Harvey Jay Cohen;Hyman Muss; - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2010)

引用本文的文献 ​

  1. Association of Age at Cancer Diagnosis and Clinical Trial Participation. - Jessica Keim-Malpass;Héctor E Alcalá - JAMA network open (2021)
  2. Different Impact of Definitions of Sarcopenia in Defining Frailty Status in a Population of Older Women with Early Breast Cancer. - Andrea Bellieni;Domenico Fusco;Alejandro Martin Sanchez;Gianluca Franceschini;Beatrice Di Capua;Elena Allocca;Enrico Di Stasio;Fabio Marazzi;Luca Tagliaferri;Riccardo Masetti;Roberto Bernabei;Giuseppe Ferdinando Colloca - Journal of personalized medicine (2021)
  3. Age Is Just a Number: Considerations for Older Adults in Cancer Clinical Trials. - Dany Habr;Lynn McRoy;Vassiliki A Papadimitrakopoulou - Journal of the National Cancer Institute (2021)
  4. Racial and socioeconomic disparities in lung cancer screening in the United States: A systematic review. - Ernesto Sosa;Gail D'Souza;Aamna Akhtar;Melissa Sur;Kyra Love;Jeanette Duffels;Dan J Raz;Jae Y Kim;Virginia Sun;Loretta Erhunmwunsee - CA: a cancer journal for clinicians (2021)
  5. Understanding Treatment Tolerability in Older Adults With Cancer. - Marie A Flannery;Eva Culakova;Beverly E Canin;Luke Peppone;Erika Ramsdale;Supriya G Mohile - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
  6. Decision Making in Older Adults With Cancer. - Clark DuMontier;Kah Poh Loh;Enrique Soto-Perez-de-Celis;William Dale - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
  7. Immunotherapy in Older Adults With Cancer. - Carolyn J Presley;Fabio Gomes;Christin E Burd;Ravindran Kanesvaran;Melisa L Wong - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
  8. Survivorship Care of Older Adults With Cancer: Priority Areas for Clinical Practice, Training, Research, and Policy. - Erin E Kent;Eliza M Park;William A Wood;Ashley Leak Bryant;Michelle A Mollica - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
  9. Models of Care in Geriatric Oncology. - Andrew E Chapman;Rawad Elias;Elana Plotkin;Lisa M Lowenstein;Kristine Swartz - Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
  10. Development and validation of a prediction model for 1-year mortality among older adults with Hodgkin Lymphoma who receive dose-intense chemotherapy. - Anita J Kumar;Jason Nelson;Angie Mae Rodday;Andrew M Evens;Jonathan W Friedberg;Tanya M Wildes;Susan K Parsons - Journal of geriatric oncology (2021)

... (199 更多 篇文献)

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