A Review of the Evolution of Quality of Life Measures in Head and Neck Cancer Clinical Trials

Document Type

Conference Proceeding

Publication Date

5-1-2024

Publication Title

International Journal of Radiation Oncology Biology Physics

Abstract

Purpose/Objective(s): To best study the complex toxicity profiles experienced by patients treated with radiotherapy (RT) for head and neck (HN) cancer, a greater focus on quantifiable, reproducible quality of life (QOL) measures is needed. Both clinician-rated outcomes (CRO) and patient-reported outcome (PRO) measures of toxicity and QOL have been collected in HN clinical trials for over two decades. A clear understanding of existing PRO practices in these studies may inform future study design and spark innovative QOL-focused hypothesis-generating research. Materials/Methods: The protocol documents for HN-specific clinical trials activated within the National Cancer Institute (NCI) National Clinical Trials Network cooperative groups since 2002 were reviewed. Both active and closed trials were included, regardless of publication status. Phase I trials and those that were terminated without enrolling patients were excluded. All protocol specified QOL measures (CRO, PRO, and/or functional assessments [FA]) and the time points of these measurements were abstracted from the protocols, as were basic trial details. Data collection was performed between May 26 and October 12, 2023. Descriptive statistics were performed. Results: A total of 30 trials including 76 QOL (66 PRO, 10 CRO) and 10 FA were included. These trials were activated between 2002-2023; 13 were phase II, 9 phase II/III, and 8 phase III. The most common disease process studied was squamous cell carcinoma of the HN (n=12), oropharynx (n=6), and nasopharynx (n=5). Most studies enrolled patients treated with curative intent (n=20), while 10 enrolled patients with recurrent/metastatic disease. The most frequent study interventions were systemic (n=14) and RT (n=13). Across all studies, 27 distinct PRO measures were utilized, and the most frequent measures were EuroQol-5D (12 trials), FACT-HN (8), PRO-CTCAE (6), MDADI (6), and EORTC-QLQ-C30 (4). The most frequent CRO measure was PSS-HN (7); the most common functional assessment was audiogram (7) followed by modified barium swallow (n=2) and objective salivary flow (n=1). The median number of PRO measures per trial was 2 (range, 0-8) and the median number of data points was 11 (range, 0-35). In trials activated prior to 2012, 17 of 24 (71%) QOL measures (not including FA) were PROs compared to 49 of 52 (94%) measures in trials activated on or after 2012 (p=0.009). Conclusion: Over time, the use of patient-reported measures of QOL in HN cancer cooperative group clinical trials has increased. This reflects patients’ increasing prioritization of QOL as well as requirements by the NCI for increased standardization and quantitation of these impacts on patients in clinical trials. This dataset may inform future study of QOL in patients with HN cancer through a better understanding of specific PRO data that has been or will be collected within current and future NCI-supported clinical trials.

Volume

118

Issue

5

First Page

e61

Find It @ Sladen

Share

COinS