LAUSR

Instances of stomatitis are very painful and compromise nutrition and oral hygiene as well as induce an increased risk for local and systemic infection. Stomatitis is a well-known toxicity of radiotherapy, chemotherapy and other targeted therapies and is associated with dose interruptions, reductions, and treatment discontinuation. For upcoming Dato DXd phase III trials, the mitigation strategies included patient education delivered at the site and supported by printed material to foster continued adherence to an oral care protocol (OCP). The study team thought to leverage digital technology, namely patient-provisioned smartphones to bring the OCP right “to the patients’ fingertips”, while enabling health care providers at the site to monitor onset or worsening of stomatitis for each patient. The digital solution consists of a patient interface for data acquisition and personalized education/behavioral reinforcement, and a clinician interactive data dashboard to access, in real time, patients’ records of stomatitis-related symptoms and their impact on nutrition and hydration, respectively. For a few days post infusion, the solution surfaces personalized illustrated vignettes to provide the participant with simple recommendations for self-care and probe to contact the clinical site team when symptom(s) reach a given morbidity threshold. The clinical team can visualize data on demand or upon being prompted, to quickly assess trends towards stomatitis worsening and decide on the next course of action. This solution for remote patient monitoring of stomatitis risk is deployed in four studies and is planned for an additional three, reaching approximately a total of 7,000 patients across 49 sites in 16 countries. Early feedback from patients confirmed the engaging design, the low burden daily usage, and the perceived utility of the solution. Patients who had experienced stomatitis previously indicated that such a solution would have given them confidence to engage with their site sooner to receive care. Further structured feedback from clinical study teams and analyses of clinical trial data are planned to inform patients’ sustained compliance using the solution and its effectiveness in mitigating high grade of stomatitis and helping patients to better manage their treatment and outcomes. Citation Format: Rebecca H. Wray, Elisabeth Piault, Lucie Miller-Potucka, Jill A. Bell, Rick Fairhurst, Sabrina S. Khan, Micah J. Maxwell, Neelima Denduluri, Leora Horn. Improving treatment outcomes: a digital solution for remote patient monitoring of stomatitis for patients receiving Dato-DXd [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr LB143.