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Stomatitis is a common adverse event in these trials, and there were no formal guidelines for prevention and management. Methods A modified three-round Delphi involved 15 experts, using anonymized surveys and later consensus meetings. Findings Experts emphasized education, oral hygiene, prophylactic mouthwashes, symptom monitoring, and timely steroid-containing mouthwash to maintain treatment schedules and quality of life. Interpretation Expert consensus generated guidance for patients treated with Dato-DXd.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/us-expert-delphi-consensus-on-the-prevention-and-management-of-stomatitis-in-patients-treated-with-datopotamab-deruxtecan/376269/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/us-expert-delphi-consensus-on-the-prevention-and-management-of-stomatitis-in-patients-treated-with-datopotamab-deruxtecan/376269.png","ImageObject",300,407,{"name":92,"@type":93},"Elsa","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-25","2026-09-24",true,{"@type":102,"interactionType":103,"userInteractionCount":44},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"Why was an expert consensus needed for stomatitis in patients treated with Dato-DXd?","Question",{"text":112,"@type":113},"Stomatitis was common in Dato-DXd phase III trials, but formalized guidelines for prevention and management were not available. 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Bruno3 · Vinicius Ernani4 · Erika Hamilton5 · Rebecca Heist2 · Komal Jhaveri6 · Benjamin Levy7 · Aaron Lisberg8 · Joyce O’Shaughnessy9 · Jacob Sands10 · Alexander Spira11 · Sara Tolaney12 · Nathaniel S. Treister12 · Cecile Matthews13 · Melissa Johnson5  \nReceived: 9 April 2025 / Accepted: 23 July 2025 / Published online: 5 August 2025 © The Author(s) 2025  \nSummary  \nBackground Datopotamab deruxtecan (Dato-DXd) is an investigational antibody–drug conjugate that has shown promising results in phase III clinical trials of lung and breast cancers. Stomatitis is a common adverse event associated with Dato-DXdin these trials, and there are currently no formalized guidelines for its prevention and management. An expert consensus was needed to establish these guidelines.  \nMethods Fifteen experts participated in a modified three-round Delphi to achieve consensus on the prevention and management of Dato-DXd-related stomatitis in lung and breast cancer patients. Fourteen experts had managed Dato-DXd-induced stomatitis and served as investigators in the TROPION-Lung01, TROPION-Lung05, and TROPION-Breast01 phase III clinical trials. The first two rounds consisted of anonymized surveys with a mixture of open-and closed-ended questions, and the third round consisted of a consensus group meeting and 1:1 follow-up meetings.  \nFindings Experts recognized stomatitis as an important adverse event associated with several anticancer treatments and its impact on patients’ quality of life. Lung and breast cancer specialists noted similar manifestations of stomatitis with DatoDXd, with breast cancer experts referencing similarities to everolimus-induced conditions and lung cancer experts reporting ulcerative lesions. There was consensus on the need for standardized guidelines to improve outcomes and reduce treatment disruptions. Agreed preventive measures emphasized patient education, oral hygiene, and prophylactic mouthwashes. Management strategies focused on patient-centered care, monitoring of symptoms, and timely interventions, such as the use of a steroid-containing mouthwash to maintain treatment schedules and quality of life.  \nInterpretation We used the expert consensus to provide guidelines for the prevention and management of stomatitis inpatients treated with Dato-DXd.  \nPutting research into context Evidence before this study Dato-DXd has shown promising results in clinical trials for lung and breast cancers. However, many patients in these trials developed stomatitis, an adverse event that may impact quality of life and disrupt treatment regimens. The lack of standardized guidelines for dealing with stomatitis in this context necessitated the establishment of best practices via expert consensus.  \nAdded value of this study This study provides peer-reviewed guidance for the prevention and management of stomatitis secondary to Dato-DXd. Most experts selected for this study had experience using this therapy and preventing and managing stomatitis associated with Dato-DXd and other anticancer treatments. Thus, the study has collected the perspectives of well-placed, expert clinicians and derived best practices pending the completion of clinical trials.  \nImplications of all the available evidence The development and implementation of this guidance and the education therein will lead to improved quality of life, greater treatment compliance, and better clinical outcomes.  \nKeywords Oral mucositis · Stomatitis · Adverse event management · Consensus · Dato-DXd · Dexamethasone mouthwash  \nExtended author information available on the last page of the article  \nIntroduction  \nOral mucositis/stomatitis (hereafter stomatitis) is an inflammation of the mucosa","cbCaiofQjVV0EXjX","https://ap.wps.com/l/cbCaiofQjVV0EXjX","pdf",1131093,14,"English","# Summary\n## Background\n## Methods\n## Findings\n## Interpretation\n## Putting research into context\n### Evidence before this study\n### Added value of this study\n### Implications of all the available evidence\n# Introduction\n## Stomatitis and its clinical impact\n## Overview of Dato-DXd and trial context","[{\"question\":\"Why was an expert consensus needed for stomatitis in patients treated with Dato-DXd?\",\"answer\":\"Stomatitis was common in Dato-DXd phase III trials, but formalized guidelines for prevention and management were not available. The consensus aimed to establish standardized best practices.\"},{\"question\":\"How was the consensus developed in the modified Delphi process?\",\"answer\":\"Fifteen experts participated in a modified three-round Delphi. The first two rounds used anonymized surveys with open- and closed-ended questions, and the third included a consensus group meeting plus 1:1 follow-ups.\"},{\"question\":\"What preventive and management strategies were agreed by experts?\",\"answer\":\"Experts highlighted patient education, oral hygiene, and prophylactic mouthwashes. Management focused on patient-centered care, symptom monitoring, and timely interventions, including steroid-containing mouthwash to help maintain treatment schedules and quality of life.\"}]","US expert Delphi consensus on the prevention and management of stomatitis in patients treated with datopotamab deruxtecan | PDF",1790217999,35]