Effects of immune checkpoint inhibitors on the quality of life of patients with metastatic or recurrent head and neck cancer: a systematic review protocol.

Objective: The objective of this review is to evaluate the effect of immune checkpoint inhibitors compared to radiation and other systemic therapies, such as chemotherapy and targeted therapies, on the quality of life of patients with metastatic or recurrent head and neck cancer.

Introduction: Recurrent and metastatic head and neck cancers are associated with high morbidity and mortality. The treatment modalities including radiation and chemotherapy have considerable negative effects on quality of life. Immunotherapy, in particular immune checkpoint inhibitors, is a promising treatment option, offering effective disease control with improved patient-reported outcomes.

Inclusion criteria: The review will include experimental or observational studies that compare the effect of immune checkpoint inhibitors with either radiation therapy or systemic therapies (eg, chemotherapy, targeted molecular agents) on the quality of life of patients (aged >18 years) with head and neck cancer.

Methods: The databases to be searched include MEDLINE (Ovid), Embase, Scopus, Web of Science Core Collection, and the Cochrane Central Register of Controlled Trials (CENTRAL). Sources of unpublished studies and gray literature to be searched will include ClinicalTrials.gov and ProQuest Dissertations and Theses. Titles and abstracts will be screened, and full texts of articles that meet the inclusion criteria will be retrieved for further assessment. Two independent reviewers will appraise eligible studies using the JBI tools for experimental and observational research, and will extract data. Where appropriate, meta-analysis will be conducted. The certainty of the findings will be evaluated following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

Review registration: PROSPERO CRD42024567283.