# 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

**Authors:** Yuki Sakai, Kouji Katsura, Yoshitomi Kanemitsu, Masaaki Kotake, Akira Toyama

PMC · DOI: 10.1007/s00520-025-10126-3 · 2025-11-13

## TL;DR

This study tracks how cancer patients report oral side effects during chemotherapy and finds that mild symptoms often persist, affecting quality of life, with patient reports differing from clinician assessments.

## Contribution

The study provides new insights into longitudinal patient-reported oral adverse events and highlights discrepancies between patient and clinician assessments during chemotherapy.

## Key findings

- Over 85% of patients experienced at least one oral adverse event, with dry mouth being the most common.
- Persistent mild symptoms, like dry mouth, were reported by more than half of patients throughout treatment.
- Only 31.1% concordance was found between patient-reported and clinician-assessed dry mouth severity.

## Abstract

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.

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.

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.

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.

## Linked entities

- **Diseases:** cancer (MONDO:0004992)

## Full-text entities

- **Diseases:** Cancer (MESH:D009369), oral mucositis (MESH:D013280), dry mouth (MESH:D014987)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Figures

5 figures with captions in the complete paper: https://tomesphere.com/paper/PMC12615575/full.md

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Source: https://tomesphere.com/paper/PMC12615575