Modified Delphi Study on Oral Mucositis/Stomatitis Prevention and Management in Patients Receiving Datopotamab Deruxtecan

Background: Oral mucositis/stomatitis is a common adverse event during cancer treatment that can disrupt oral functioning and adherence to treatment. Datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate, has shown promise in treating solid tumors. It has been associated with oral mucositis/stomatitis in clinical trials for breast and lung cancer (TROPION program). Currently, there is a lack of formalized guidelines for managing Dato-DXd-associated oral mucositis/stomatitis. The present study employed a modified Delphi approach to establish expert consensus on preventing, diagnosing, monitoring, and treating oral mucositis/stomatitis secondary to Dato-DXd and to improve patient care and clinical outcomes. Materials and Methods: A four-stage modified Delphi study engaging 15 oncology experts from Europe and Canada was used to establish consensus on managing Dato-DXd-induced oral mucositis/stomatitis in lung and breast cancer patients. Experts were selected based on their roles as investigators in Dato-DXd clinical trials, including but not limited to TROPION-PanTumor01, TROPION-Lung01, TROPION-Lung05, and TROPION-Breast01, and their experience managing cancer treatment–associated oral mucositis/stomatitis. The Delphi process included an initial meeting, two anonymized surveys, an in-person consensus meeting, and virtual one-to-one sessions for absentees. Results: Expert consensus was reached on recommendations for managing Dato-DXd-associated oral mucositis/stomatitis, and experts highlighted the importance of establishing guidance to improve patient quality of life and clinical outcomes. Key recommendations included prophylactic dexamethasone mouthwash, patient education, and behavioral changes. Early detection through self-checks and monitoring was emphasized, and recommended treatment strategies were tailored to oral mucositis/stomatitis severity. Treatment recommendations included dose modifications and discontinuation for severe cases. Conclusions: This study offers expert guidance on managing Dato-DXd-associated oral mucositis/stomatitis, filling a crucial gap in patient care. Ongoing efforts to generate Dato-DXd-specific data will facilitate the creation of standardized, evidence-based protocols to improve patient safety and treatment outcomes.