Prophylaxis, clinical management, and monitoring of datopotamab deruxtecan-associated oral mucositis/stomatitis.

Abstract

Oral mucositis/stomatitis (hereafter stomatitis) is a common dose-limiting toxicity seen with various classes of cancer treatment. Symptoms associated with stomatitis, primarily oral pain, may impact patient quality of life and may lead to dose delay and reduction or treatment discontinuation. Datopotamab deruxtecan (Dato-DXd) is a novel trophoblast cell surface antigen 2-directed antibody-drug conjugate undergoing clinical investigation in multiple solid tumor types. Stomatitis is among the most reported adverse events associated with Dato-DXd, with most cases being grades 1-2. This article reviews the incidence of stomatitis seen with Dato-DXd, including in the phase III pivotal studies TROPION-Lung01 and TROPION-Breast01 (in patients with non-small cell lung cancer and hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer, respectively), both studies met a dual primary endpoint of statistically significant improvement in progression-free survival compared to standard-of-care chemotherapies. Developing new cancer therapies requires evidence-based strategies to successfully prevent, monitor, and manage adverse events. Accordingly, a thorough evaluation of potential underlying mechanisms, risk factors, available clinical data, and adequacy of preventive and management recommendations for stomatitis is presented here. Prophylaxis recommendations for a daily oral care plan include oral hygiene education and the use of a prophylactic steroid-containing mouthwash. Ongoing studies continue to collect data on Dato-DXd-associated stomatitis to further characterize clinical features and possible mechanisms of this toxicity. Appropriate management may reduce the incidence, duration, and severity of events, improve quality of life, and support patient adherence to treatment.