Abstract
Introduction
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.
Results
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.
Discussion
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.
Keywords
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Article info
Publication history
Published online: January 17, 2023
Accepted:
December 23,
2022
Received in revised form:
November 30,
2022
Received:
July 27,
2022
Identification
Copyright
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