Health-related quality of life assessment in head and neck cancer: A systematic review of phase II and III clinical trials.

Autor:	Filippini DM; Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy., Carosi F; Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy., Panepinto O; Department of Oncology, University of Turin, AOU Città della Salute e della Scienza di Torino, Turin, Italy., Neri G; Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy., Nobili E; Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy., Tober N; Division of Oncology, Department of Translational Medicine, University of Piemonte Orientale, Novara, Italy.; Azienda Ospedaliera Maggiore Della Caritá, Novara, Italy., Giusti R; Medical Oncology Unit, Sant'Andrea Hospital of Rome, Italy., Di Maio M; Department of Oncology, University of Turin, AOU Città della Salute e della Scienza di Torino, Turin, Italy.
Jazyk:	angličtina
Zdroj:	Heliyon [Heliyon] 2024 Nov 24; Vol. 10 (23), pp. e40671. Date of Electronic Publication: 2024 Nov 24 (Print Publication: 2024).
DOI:	10.1016/j.heliyon.2024.e40671
Abstrakt:	Background: Patients with head and neck cancer (HNC) bear a significant load, due to both disease-related symptoms and to toxicities associated with treatments. Evaluating quality of life (QoL) is crucial to gauge the physical and psychological impact on these patients. Our primary aim was to assess whether QoL has been incorporated as an endpoint in phase II and III clinical trials for HNC patients in the last 15 years. Material and Methods: We investigated publications from 11 major journals to identify randomized and non-randomized phase II and phase III clinical trials assessing locoregional and systemic treatments as either single or multimodal strategies, published from 2008 to March 2023 in patients with HNC. Results: We screened 2045 studies and we selected 158 articles that met the eligibility criteria including a total of 31.734 patients. Globally, QoL was the primary end point in 2 publications (1 %), secondary in 38 (24 %), and exploratory in 7 (4 %). The quota of primary publications with QoL among endpoints increased over time: 14 (17 %) publications between 2008 and 2015 and 33 (42 %) between 2016 and 2023. Notably, in phase III trials, QoL was included among endpoints in 30 (49 %) publications, whereas in phase II studies, QoL was present in 17 (17 %). Conclusions: In HNC, the assessment of QoL as an endpoint in clinical trials is still missing, even in phase III trials. Efforts should be focused on the adoption of Patient-Reported Outcomes (PROs) in trials to improve the definition of treatment value in this vulnerable population. Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Daria Maria Filippini reports financial support was provided by 10.13039/501100003196Italian Ministry of Health, RC-2024-2790047 project. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2024 The Authors.)
Databáze:	MEDLINE
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