Quality of life analysis in lung cancer: A systematic review of phase III trials published between 2012 and 2018. (January 2020)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Lung cancer. Volume 139(2020)
• Page Start: 47
• Page End: 54
• Publication Date: 2020-01
• Subjects: Lung cancer -- Health-related quality of life -- Patient-reported outcomes -- Phase III trials -- Endpoints; Lungs -- Cancer -- Periodicals; Lung Neoplasms -- Abstracts; Lung Neoplasms -- Periodicals; Poumons -- Cancer -- Périodiques; Lungs -- Cancer; Periodicals; Electronic journals; Electronic journals; 616.99424
• DOI: 10.1016/j.lungcan.2019.10.022
• Languages: English
• ISSNs: 0169-5002

Abstract

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.