Health-related Quality of Life Assessment in Head and Neck Cancer: A Systematic Review of Phase II and III Clinical Trials

Overview

Journal Heliyon

Specialty Social Sciences

Date 2024 Dec 17

PMID 39687101

Authors

Daria Maria Filippini

Francesca Carosi

Olimpia Panepinto

Giacomo Neri

Elisabetta Nobili

Nastassja Tober

Raffaele Giusti

Massimo Di Maio

Affiliations

Soon will be listed here.

Abstract

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.

References

Gould L, Lewis S . Care of head and neck cancer patients with swallowing difficulties. Br J Nurs. 2006; 15(20):1091-6. DOI: 10.12968/bjon.2006.15.20.22291. View

Cavalieri S, Filippini D, Ottini A, Bergamini C, Resteghini C, Colombo E . Immunotherapy in head and neck squamous cell carcinoma and rare head and neck malignancies. Explor Target Antitumor Ther. 2022; 2(6):522-542. PMC: 9400733. DOI: 10.37349/etat.2021.00062. View

Rosenthal D, Mendoza T, Chambers M, Asper J, Gning I, Kies M . Measuring head and neck cancer symptom burden: the development and validation of the M. D. Anderson symptom inventory, head and neck module. Head Neck. 2007; 29(10):923-31. DOI: 10.1002/hed.20602. View

Terrell J, Nanavati K, Esclamado R, Bishop J, Bradford C, Wolf G . Head and neck cancer-specific quality of life: instrument validation. Arch Otolaryngol Head Neck Surg. 1997; 123(10):1125-32. DOI: 10.1001/archotol.1997.01900100101014. View

Garcia-Peris P, Paron L, Velasco C, de la Cuerda C, Camblor M, Breton I . Long-term prevalence of oropharyngeal dysphagia in head and neck cancer patients: Impact on quality of life. Clin Nutr. 2007; 26(6):710-7. DOI: 10.1016/j.clnu.2007.08.006. View

Mehanna H, Robinson M, Hartley A, Kong A, Foran B, Fulton-Lieuw T . Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV): an open-label randomised controlled phase 3 trial. Lancet. 2018; 393(10166):51-60. PMC: 6319250. DOI: 10.1016/S0140-6736(18)32752-1. View

Hutcheson K, Lewin J, Barringer D, Lisec A, Gunn G, Moore M . Late dysphagia after radiotherapy-based treatment of head and neck cancer. Cancer. 2013; 118(23):5793-9. PMC: 4034519. DOI: 10.1002/cncr.27631. View

Zimmaro L, Sephton S, Siwik C, Phillips K, Rebholz W, Kraemer H . Depressive symptoms predict head and neck cancer survival: Examining plausible behavioral and biological pathways. Cancer. 2018; 124(5):1053-1060. PMC: 5821545. DOI: 10.1002/cncr.31109. View

Epstein J, Hong C, Logan R, Barasch A, Gordon S, Oberle-Edwards L . A systematic review of orofacial pain in patients receiving cancer therapy. Support Care Cancer. 2010; 18(8):1023-31. DOI: 10.1007/s00520-010-0897-7. View

10.

Di Maio M, Basch E, Bryce J, Perrone F . Patient-reported outcomes in the evaluation of toxicity of anticancer treatments. Nat Rev Clin Oncol. 2016; 13(5):319-25. DOI: 10.1038/nrclinonc.2015.222. View

11.

Hwang T, Gyawali B . Association between progression-free survival and patients' quality of life in cancer clinical trials. Int J Cancer. 2018; 144(7):1746-1751. DOI: 10.1002/ijc.31957. View

12.

Langius J, Bakker S, Rietveld D, Kruizenga H, Langendijk J, Weijs P . Critical weight loss is a major prognostic indicator for disease-specific survival in patients with head and neck cancer receiving radiotherapy. Br J Cancer. 2013; 109(5):1093-9. PMC: 3778304. DOI: 10.1038/bjc.2013.458. View

13.

Lin Y, Chang K, Lin Y, Chang T . Evaluation of effect of body mass index and weight loss on survival of patients with nasopharyngeal carcinoma treated with intensity-modulated radiation therapy. Radiat Oncol. 2015; 10:136. PMC: 4486696. DOI: 10.1186/s13014-015-0443-3. View

14.

Weymuller Jr E, Alsarraf R, Yueh B, Deleyiannis F, Coltrera M . Analysis of the performance characteristics of the University of Washington Quality of Life instrument and its modification (UW-QOL-R). Arch Otolaryngol Head Neck Surg. 2001; 127(5):489-93. DOI: 10.1001/archotol.127.5.489. View

15.

Marandino L, Salvia A, Sonetto C, De Luca E, Pignataro D, Zichi C . Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016. Ann Oncol. 2018; 29(12):2288-2295. DOI: 10.1093/annonc/mdy449. View

16.

Kyte D, Reeve B, Efficace F, Haywood K, Mercieca-Bebber R, King M . International Society for Quality of Life Research commentary on the draft European Medicines Agency reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies. Qual Life Res. 2015; 25(2):359-362. DOI: 10.1007/s11136-015-1099-z. View

17.

Rejeski W, Mihalko S . Physical activity and quality of life in older adults. J Gerontol A Biol Sci Med Sci. 2001; 56 Spec No 2:23-35. DOI: 10.1093/gerona/56.suppl_2.23. View

18.

Di Maio M, Perrone F . Lessons from clinical trials on quality-of-life assessment in ovarian cancer trials. Ann Oncol. 2016; 27(6):961-962. DOI: 10.1093/annonc/mdw153. View

19.

Vangelov B, Venchiarutti R, Smee R . Critical Weight Loss in Patients With Oropharynx Cancer During Radiotherapy (± Chemotherapy). Nutr Cancer. 2017; 69(8):1211-1218. DOI: 10.1080/01635581.2017.1367943. View

20.

Sroussi H, Epstein J, Bensadoun R, Saunders D, Lalla R, Migliorati C . Common oral complications of head and neck cancer radiation therapy: mucositis, infections, saliva change, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis. Cancer Med. 2017; 6(12):2918-2931. PMC: 5727249. DOI: 10.1002/cam4.1221. View