Work

Concordance between patient-reported outcomes and CTCAE clinician-reported toxicities during outpatient chemotherapy courses: a retrospective cohort study in routine care

Year: 2025

Type: article

Abstract: Background: Patient-reported outcomes (PROs) are increasingly used but often correlate poorly with physicians' assessment of adverse events. Yet, discordance has been associated with poorer prognosis. Methods: Single-centre retrospective study of patient and physician assessment of five chemotherapy-induced toxicities (mucositis, nausea, vomiting, peripheral neuropathy, diarrhoea) in routine care. Electronic PRO (e-PRO)-Common Terminology Criteria for Adverse Events (CTCAE) questionnaires were administered between outpatient chemotherapy sessions, using an online telehealth program. PRO-CTCAE grades were converted to CTCAE scale using the published composite grade of PRO-CTCAE, and compared with CTCAE grading of toxicities by physicians. We calculated Cohen's weighted Kappa and counted discordances on severe (CTCAE grade >2) and milder (grade 2) toxicities. Results: A total of 122 patients filled electronically 519 PRO-CTCAE e-questionnaires for which physicians had rated at least one corresponding CTCAE item. Agreement between patients' composite grades of PRO-CTCAE and clinicians CTCAE grades was moderate for four symptoms, and fair for one (κ between 0.23 and 0.43). The incidence of serious toxicity varied across symptoms, from 0.22% to 2.50% of questionnaires. Both patient and clinician scored a severe toxicity in only one case. Among 2076 symptom assessments, we counted 27 disagreements on severe toxicities (1.30%). Conclusion: Patient-physician agreement is imperfect, but severe toxicities are rare, including in PROs. PRO-CTCAE and CTCAE remain complementary, and e-PRO-CTCAE tools help monitor symptoms.

Source: ESMO Real World Data and Digital Oncology

DOI: 10.1016/j.esmorw.2025.100127

Authors: S. Huynh-Dagher, T.-A. Duong, C. Tournigand, E. Kempf, G. Lamé