A comprehensive review and characterization of nasopharyngeal carcinoma clinical trials.

Abstract

Objective: Although standard of care for primary nasopharyngeal carcinoma (NPC) is chemoradiotherapy, there remains no consensus on management of recurrent or metastatic disease. We characterized recent clinical trials on NPC to assess trends in NPC treatment and establish promising areas for future research.

Study design: Retrospective database study.

Setting: ClinicalTrials.gov database.

Methods: Retrospective review of all NPC trials from November 1999 to June 2021. For each study, the following variables were extracted: study characteristics, intervention, outcome measures, and inclusion criteria. Secondary searches via PubMed and Google scholar determined trial publication status.

Results: A total of 448 clinical trials were identified: 72 (16%) observational and 376 (84%) interventional, of which there were 30 (8%) Phase I, 183 (49%) Phase II, 86 Phase III (23%), and 5 (1%) Phase IV trials. Fifty-four percent of trials included only primary NPC while 111 (25%) exclusively studied recurrent cancers. The most common interventions were cisplatin (n = 64) and intensity modulated radiation therapy (n = 54); there were 38 trials involving PD-1 monoclonal antibodies. Thirty-four studies examined quality of life measures, including xerostomia and mucositis. Of the completed studies, 53.2% have published manuscripts. Poor patient accrual was the most common reason for premature study termination.

Conclusions: Novel immunotherapies have been increasingly incorporated into NPC studies in recent years, however, chemotherapy and radiation, despite their numerous side effects, are still widely used due to their clinical effectiveness. Future trials are warranted to determine the optimal therapeutic regimens to decrease relapse rates and side effects.