Patient-Reported Oral Adverse Events During Cancer Chemotherapy: Longitudinal Evaluation Using Patient- Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and Concordance with Clinician Assessments

Abstract Purpose This study aimed to (1) describe longitudinal trends in patient-reported oral adverse events using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in patients receiving multidisciplinary oral care during outpatient cancer drug therapy, and (2) evaluate concordance between PRO-CTCAE and clinician-reported CTCAE scores. Methods Conducted at the Outpatient Cancer Chemotherapy Center, Niigata University Medical and Dental Hospital (June–December 2023), oral adverse events were assessed using PRO-CTCAE and CTCAE at baseline and every 3 weeks up to 24 weeks. Concordance for dry mouth and oral mucositis was evaluated using paired same-day scores. Results Among patients receiving multidisciplinary oral care, 85.2% experienced at least one oral adverse event, most commonly dry mouth. Based on PRO-CTCAE, symptoms rated as moderate or higher were reported in fewer than 10% of cases for most items. Notably, over half of patients reported persistent dry mouth of at least mild severity, and 20–30% of other symptoms also remained. These findings suggest that even lower-grade symptoms may persist and affect quality of life. Concordance between PRO-CTCAE and CTCAE was limited, with 31.1% of patients reporting greater dry mouth severity than clinicians documented. Conclusions Patient-reported oral adverse events, as assessed by PRO-CTCAE, were frequently mild but persistent throughout outpatient chemotherapy, suggesting a cumulative impact on quality of life. Concordance between PRO-CTCAE and clinician-reported CTCAE was limited, indicating that clinician assessments may underestimate symptoms such as dry mouth. These findings underscore the need to integrate patient-reported outcomes into routine oral care.