There is a great need for data based on clinical trials for the older population in order to improve treatment. Historically, the inclusion rate of older adults in clinical trials has been low, but the rate specific to lung cancer is unknown, as are the factors associated with enrolment.
Materials and Methods
We used the national Epidemio-Strategy and Medical Economics Advanced or Metastatic Lung Cancer (AMLC) Data Platform, a multicentre real-life database. Inclusion criteria were patients with advanced or metastatic non-small cell lung cancer (AMNSCLC) aged 70 years or older, with at least one line of systemic treatment from 01 January 2015 to 31 December 2018. The primary objective was to evaluate the proportion of older adults enrolled in clinical trials. Secondary objectives were to identify factors associated with enrolment in clinical trials for older patients and to compare the overall survival of older adults included in trials versus those not included.
There were 3488 patients aged ≥70 years (median age at AMNSCLC 75 years). Among older patients, 234 (6.7%) were enrolled in a clinical trial in the first-line setting. Significant factors associated with enrolment in the multivariable analysis in older patients were: good Eastern Cooperative Oncology Group (ECOG) Performance Status (PS 0) (p < 0.001), de novo versus recurrent presentation at diagnosis (p < 0.001), and non-central nervous system (CNS) metastases versus advanced setting or CNS metastases (p < 0.001). Medical history was associated with fewer inclusions (odds ratio [OR] = 0.74, 95% confidence interval [CI] [0.56; 0.99]). Among older patients, being enrolled in a trial in the first-line setting was not associated with better overall survival (OS) (hazard ratio [HR] = 1.03; 95%CI 0.86–1.22) in the multivariable analysis.
In this large database, few older AMNSCLC patients were enrolled in a trial. Factors associated with enrolment were: good ECOG PS, absence of medical history, de novo AMNSCLC, and presentation with non-CNS metastases.
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- Estimations nationales de l'incidence et de la mortalité par cancer en France métropolitaine entre 1990 et 2018.https://www.e-cancer.fr/Professionnels-de-sante/Les-chiffres-du-cancer-en-France/Epidemiologie-des-cancers/Les-cancers-les-plus-frequents/Cancer-du-poumonDate: 2022
- The clinical features of older patients with lung cancer in comparison with their younger counterparts.Respir Investig. 2019 Jan; 57 ([Epub 2018 Nov. 15. PMID: 30448243]): 40-48https://doi.org/10.1016/j.resinv.2018.10.003
- Pharmacology of cancer chemotherapy in the older person.Clin Geriatr Med. 1997 Feb; 13: 169-183
- Altered pharmacokinetics in the elderly.Clin Geriatr Med. 1990 May; 6 ([PMID: 2184922]): 257-267
- Frailty in elderly people.Lancet. 2013 Mar 2; 381 (Epub 2013 Feb 8. Erratum in: Lancet. 2013 Oct 19; 382(9901):1328. PMID: 23395245; PMCID: PMC4098658): 752-762https://doi.org/10.1016/S0140-6736(12)62167-9
- Factors associated with age disparities among cancer clinical trial participants.JAMA Oncol. 2019 Jun 3; ([Epub ahead of print])https://doi.org/10.1001/jamaoncol.2019.2055
- Representation of older patients in cancer treatment trials.Cancer. 1994; 74: 2208-2214
- Inclusion of elderly patients in oncology clinical trials.Ann Oncol. 2016; 27: 1799-1804
- Inclusion of older patients with Cancer in clinical trials: the SAGE prospective multicenter cohort survey.Oncologist. 2019 Jul 19; (Pii: theoncologist.2019-0166. [Epub ahead of print])https://doi.org/10.1634/theoncologist.2019-0166
- Underrepresentation of vulnerable older patients with cancer in phase II and III oncology registration trials: a case-control study.J Geriatr Oncol. 2020; 11: 320-326
- Physician-reported reasons for non-enrolment of older adults in cancer clinical trials.J Geriatr Oncol. 2020; 11: 31-36
- Enrolment of elderly patients in clinical trials for cancer drug registration: a 7-year experience by the US Food and Drug Administration.J Clin Oncol. 2004; 22: 4626-4631
- Anticancer drugs are not well tolerated in all older patients with cancer.Lancet Healthy Longev. 1 Oct 2020; 1: e43-e47
- Assessment of the external validity of the National Comprehensive Cancer Network and European Society for Medical Oncology guidelines for non-small-cell lung Cancer in a population of patients aged 80 years and older.Clin Lung Cancer. 2017 Sep; 18 (Epub 2017 Mar 21. PMID: 28416124): 460-471https://doi.org/10.1016/j.cllc.2017.03.005
- On behalf of the ESMO guidelines committee. Metastatic non-small cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up.Ann Oncol. 2018; 29 (accessed on 04 January 2022): iv192-iv237https://doi.org/10.1093/annonc/mdy275https://www.esmo.org/guidelines/lung-and-chest-tumours/clinical-practice-living-guidelines-metastatic-non-small-cell-lung-cancer
- Are clinical trial eligibility criteria representative of older patients with lung cancer? A population-based data linkage study.J Geriatr Oncol. 2021 Jul; 12 (Epub 2021 Jun 10. PMID: 34119452): 930-936https://doi.org/10.1016/j.jgo.2021.02.003
- Priorities for the global advancement of care for older adults with cancer: an update of the International Society of Geriatric Oncology Priorities Initiative.Lancet Oncol. 2021; 22: e29-e36
- Enrolment of older metastatic breast cancer patients in first-line clinical trials: 9-year experience of the large-scale real-life multicenter French ESME cohort.Breast Cancer Res Treat. 2022 Jan 5; (Epub ahead of print. PMID: 34984582)https://doi.org/10.1007/s10549-021-06467-2
- Practical assessment and management of vulnerabilities in older patients receiving chemotherapy: ASCO guideline for geriatric oncology.J Clin Oncol. 2018 Aug 1; 36 (Epub 2018 May 21. PMID: 29782209; PMCID: PMC6063790): 2326-2347https://doi.org/10.1200/JCO.2018.78.8687
- Multidisciplinary development of the geriatric Core dataset for clinical research in older patients with cancer: a French initiative with international survey.Eur J Cancer. 2018; 103: 61-68
Published online: January 17, 2023
Accepted: December 23, 2022
Received in revised form: November 30, 2022
Received: July 27, 2022
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