Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018

Maria Lucia Reale, Emmanuele De Luca, Pasquale Lombardi, Laura Marandino, Clizia Zichi, Daniele Pignataro, Eleonora Ghisoni, Rosario F. Di Stefano, Annapaola Mariniello, Elena Trevisi, Gianmarco Leone, Leonardo Muratori, Anna La Salvia, Cristina Sonetto, Paolo Bironzo, Massimo Aglietta, Silvia Novello, Giorgio V. Scagliotti, Francesco Perrone, Massimo Di Maio

Research output: Contribution to journalArticle

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 Overall, QoL data were not available in 75/122 (61.5%) primary publications, due to the absent endpoint or unpublished results.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.

Original languageEnglish
Pages (from-to)47-54
Number of pages8
JournalLung Cancer
Volume139
DOIs
Publication statusPublished - Jan 2020

Fingerprint

Lung Neoplasms
Quality of Life
Publications
Life Expectancy

Keywords

  • Endpoints
  • Health-related quality of life
  • Lung cancer
  • Patient-reported outcomes
  • Phase III trials

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

Reale, M. L., De Luca, E., Lombardi, P., Marandino, L., Zichi, C., Pignataro, D., ... Di Maio, M. (2020). Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018. Lung Cancer, 139, 47-54. https://doi.org/10.1016/j.lungcan.2019.10.022

Quality of life analysis in lung cancer : A systematic review of phase III trials published between 2012 and 2018. / Reale, Maria Lucia; De Luca, Emmanuele; Lombardi, Pasquale; Marandino, Laura; Zichi, Clizia; Pignataro, Daniele; Ghisoni, Eleonora; Di Stefano, Rosario F.; Mariniello, Annapaola; Trevisi, Elena; Leone, Gianmarco; Muratori, Leonardo; La Salvia, Anna; Sonetto, Cristina; Bironzo, Paolo; Aglietta, Massimo; Novello, Silvia; Scagliotti, Giorgio V.; Perrone, Francesco; Di Maio, Massimo.

In: Lung Cancer, Vol. 139, 01.2020, p. 47-54.

Research output: Contribution to journalArticle

Reale, ML, De Luca, E, Lombardi, P, Marandino, L, Zichi, C, Pignataro, D, Ghisoni, E, Di Stefano, RF, Mariniello, A, Trevisi, E, Leone, G, Muratori, L, La Salvia, A, Sonetto, C, Bironzo, P, Aglietta, M, Novello, S, Scagliotti, GV, Perrone, F & Di Maio, M 2020, 'Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018', Lung Cancer, vol. 139, pp. 47-54. https://doi.org/10.1016/j.lungcan.2019.10.022
Reale, Maria Lucia ; De Luca, Emmanuele ; Lombardi, Pasquale ; Marandino, Laura ; Zichi, Clizia ; Pignataro, Daniele ; Ghisoni, Eleonora ; Di Stefano, Rosario F. ; Mariniello, Annapaola ; Trevisi, Elena ; Leone, Gianmarco ; Muratori, Leonardo ; La Salvia, Anna ; Sonetto, Cristina ; Bironzo, Paolo ; Aglietta, Massimo ; Novello, Silvia ; Scagliotti, Giorgio V. ; Perrone, Francesco ; Di Maio, Massimo. / Quality of life analysis in lung cancer : A systematic review of phase III trials published between 2012 and 2018. In: Lung Cancer. 2020 ; Vol. 139. pp. 47-54.
@article{f42757e58f3147c78ed287729c728147,
title = "Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018",
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 = "Endpoints, Health-related quality of life, Lung cancer, Patient-reported outcomes, Phase III trials",
author = "Reale, {Maria Lucia} and {De Luca}, Emmanuele and Pasquale Lombardi and Laura Marandino and Clizia Zichi and Daniele Pignataro and Eleonora Ghisoni and {Di Stefano}, {Rosario F.} and Annapaola Mariniello and Elena Trevisi and Gianmarco Leone and Leonardo Muratori and {La Salvia}, Anna and Cristina Sonetto and Paolo Bironzo and Massimo Aglietta and Silvia Novello and Scagliotti, {Giorgio V.} and Francesco Perrone and {Di Maio}, Massimo",
year = "2020",
month = "1",
doi = "10.1016/j.lungcan.2019.10.022",
language = "English",
volume = "139",
pages = "47--54",
journal = "Lung Cancer",
issn = "0169-5002",
publisher = "Elsevier Ireland Ltd",

}

TY - JOUR

T1 - Quality of life analysis in lung cancer

T2 - A systematic review of phase III trials published between 2012 and 2018

AU - Reale, Maria Lucia

AU - De Luca, Emmanuele

AU - Lombardi, Pasquale

AU - Marandino, Laura

AU - Zichi, Clizia

AU - Pignataro, Daniele

AU - Ghisoni, Eleonora

AU - Di Stefano, Rosario F.

AU - Mariniello, Annapaola

AU - Trevisi, Elena

AU - Leone, Gianmarco

AU - Muratori, Leonardo

AU - La Salvia, Anna

AU - Sonetto, Cristina

AU - Bironzo, Paolo

AU - Aglietta, Massimo

AU - Novello, Silvia

AU - Scagliotti, Giorgio V.

AU - Perrone, Francesco

AU - Di Maio, Massimo

PY - 2020/1

Y1 - 2020/1

N2 - 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.

AB - 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.

KW - Endpoints

KW - Health-related quality of life

KW - Lung cancer

KW - Patient-reported outcomes

KW - Phase III trials

UR - http://www.scopus.com/inward/record.url?scp=85074854112&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85074854112&partnerID=8YFLogxK

U2 - 10.1016/j.lungcan.2019.10.022

DO - 10.1016/j.lungcan.2019.10.022

M3 - Article

C2 - 31734586

AN - SCOPUS:85074854112

VL - 139

SP - 47

EP - 54

JO - Lung Cancer

JF - Lung Cancer

SN - 0169-5002

ER -