Radiotherapy-induced severe oral mucositis: Pharmacotherapies in recent and current clinical trials by Alessandro Villa

Expert Opin Investig Drugs. 2023 Mar 18. doi: 10.1080/13543784.2023.2193324. Online ahead of print.

ABSTRACT

INTRODUCTION: Oral mucositis (OM) is among the most common, damaging, and intolerable side effects of radiation therapy to the head and neck. The ulcerative lesions associated with the condition are of such intensity as to interfere with patients’ ability to comply with optimal treatment.

AREAS COVERED: The increasing unmet clinical need, recent clinical trial successes and the commercial potential have catalyzed interest in the development of effective intervention for OM associated with radiation therapy for cancers of the head and neck. A range of small molecules are under development – some still in the pre-clinical stage, but others close to NDA submission. This review will focus on those drugs which have recently been assessed in a clinical trial and those which are still under clinical study as a prevention or treatment for radiation-associated OM.

EXPERT OPINION: In response to the unmet clinical need, the commercial potential, and the breadth and value of halo indications of a successful OM product, both the biotechnology and pharmacological industries have been actively pursuing an agent to prevent/treat radiation-associated OM. This effort has been catalyzed by the identification of multiple drug targets which contribute to OM’s pathogenesis. The lessons learned from the many trials which have previously stumbled, has led to standardization of clinical trial design, endpoint efficacy definitions, rater assessment and data interpretation over the past decade. Consequently, results of recently completed clinical trials provide optimism that effective treatment options should be available in the not-too-distant future.

PMID:36932830 | DOI:10.1080/13543784.2023.2193324