Health-related quality of life is underestimated and underreported in phase III clinical trials in NSCLC. (December 2022)

• Record Type: Journal Article
• Authors: Salomone, Fabio; Di Costanzo, Fabrizio; Pecoraro, Giovanna; Viscardi, Giuseppe; Viggiano, Angela; Napolitano, Fabiana; Santaniello, Antonio; Formisano, Luigi; Bianco, Roberto; Servetto, Alberto
• Is Part Of: Lung cancer. Volume 174(2022)
• Page Start: 36
• Page End: 44
• Publication Date: 2022-12
• Subjects: QoL -- NSCLC -- Quality of Life -- Patient reported outcomes -- PRO -- Randomized controlled trials; 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.2022.10.003
• Languages: English
• ISSNs: 0169-5002

Abstract

Highlights: We found inadequate reporting of QoL in publications of phase III RCTs in metastatic NSCLC. QoL results were non-reported in 102/172 (59.3%) primary publications of RCTs. QoL data were non-reported in 52/95 (54.7%) primary manuscripts of positive RCTs. Secondary articles, if present, disclosed QoL results after a relevant delay. Underreporting of QoL hinders an accurate evaluation of novel treatments in NSCLC. Abstract: Major associations of medical oncologists remark that novel anticancer treatments should guarantee improvement of survival outcomes as well as of patients' quality of life (QoL). Herein, we investigated QoL assessment and reporting in phase III randomized controlled trials (RCTs) testing new drugs in metastatic non-small cell lung cancer (NSCLC), published between 2010 and 2021. We selected 172 RCTs for further analysis. Only 2/172 (1.2%) trial included QoL among primary study endpoints. Of note, 40/172 (23.3%) trials did not include QoL assessment among endpoints. The majority of RCTs (102/172, 59.3%) did not report QoL results in primary publications. Particularly, RCTs testing immunotherapy, target therapy and chemotherapy did not disclose QoL data in primary publications in 97.0%, 51.5% and 46.5% of cases, respectively. Next, we found that only 43/95 (45.3%) positive studies reported QoL results in primary articles. Of the 102 trials missing QoL data in primary manuscripts, only 21 (20.6%) disclosed QoL results in a secondary publication. Finally, we found a common fail in adherence to CONSORT-PROs items in publications reporting QoL results. In summary, our study reveals a relevant inadequate assessment and under-reporting of QoL in RCTs of novel systemic treatments for patients with metastatic NSCLC.