Highlights
- •QoL assessment is crucial for a complete evaluation of anticancer treatments.
- •We described QoL adoption and reporting in randomized phase III lung cancer trials.
- •QoL is not assessed in a high proportion of trials, even in metastatic setting.
- •Timely inclusion of QoL results in primary publications is worsening in last years.
- •QoL is a tool for the selection of the most tailored therapy for every patient.
Abstract
Objectives
We previously reported that quality of life (QoL) is not included among trial endpoints
and QoL results are underreported in a significant proportion of phase III oncology
trials. Here we describe QoL adoption, reporting and methodology of QoL analysis in
lung cancer trials.
Materials and methods
We selected all primary publications of lung cancer phase III trials assessing anticancer
drugs published between 2012 and 2018 by 11 major journals.
Results
122 publications were included. In 39 (32.0%) publications, QoL was not listed among
endpoints: in 10/17 (58.8%) early stage/locally advanced NSCLC, in 15/54 (27.8%) first-line
of advanced NSCLC; in 10/41 (24.4%) second and further lines of advanced NSCLC, in
4/10 (40.0%) SCLC. Proportion of trials not including QoL was similar over time: 32.9%
publications in 2012–2015 vs. 30.6% in 2016–2018. Out of 83 trials including QoL among
endpoints, QoL results were absent in 36 primary publications (43.4%). Proportion
of trials without QoL results in primary publication increased over time (30.6% 2012–2015
vs. 61.8% 2016–2018, p = 0.005). Overall, QoL data were not available in 75/122 (61.5%)
primary publications, due to the absent endpoint or unpublished results. QoL data
were lacking in 48/68 (70.6%) publications of trials with overall survival as primary
endpoint, 27/54 (50.0%) with other primary endpoints and 28/54 (51.9%) publications
with a positive result. For trials including QoL among endpoints but lacking QoL results
in primary publication, probability of secondary publication was 6.3%, 30.1% and 49.8%
after 1, 2 and 3 years respectively, without evidence of improvement comparing 2012–2015
vs. 2016–2018.
Conclusion
QoL is not assessed or published in many phase III lung cancer trials, a setting where
QoL value should be highly considered, due to high symptom burden and generally limited
life expectancy. Timely inclusion of results in primary publications is worsening
in recent years.
Keywords
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Article Info
Publication History
Published online: October 30, 2019
Accepted:
October 23,
2019
Received in revised form:
October 20,
2019
Received:
August 17,
2019
Identification
Copyright
© 2019 Elsevier B.V. All rights reserved.
