Trial reportESMO open2026
Concordance between clinician-reported toxicities and patient-reported symptom severity in early-stage breast cancer: an analysis of the randomized phase III PANTHER trial.
Trial report in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough advances in systemic therapy have markedly improved survival in breast cancer, treatment-related toxicities remain a major determinant of health-related quality of life (HRQoL). Clinician reports may not fully capture the symptom burden experienced by patients. This study examined the concordance between clinician-reported toxicities and patient-reported symptom scores during adjuvant chemotherapy for early-stage, high-risk breast cancer in a randomized phase III clinical trial. PATIENTS AND
methodsClinician-reported toxicities were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and patient-reported symptom scores were obtained with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC QLQ-BR23 questionnaires at mid- and end-of-treatment. Analyses focused on six symptomatic domains with conceptual overlap between CTCAE and EORTC measures: diarrhea, nausea, vomiting, mucositis, pain, and fatigue. Concordance between clinician- and patient-reported scores was evaluated using weighted Cohen's kappa coefficients.
resultsA total of 1566 patients with available CTCAE and HRQoL data were included in the analysis. Agreement between clinician-reported toxicities and patient-reported symptom scores was low across all symptoms and time points, with kappa values indicating no to minimal concordance (kappa = 0.07-0.34). Clinician-assigned CTCAE grades were predominantly lower than patient-reported symptom severity. The highest discrepancy rates were observed for fatigue (36%-54%) and pain (23%-38%) across treatment arms and time points. Except for nausea and vomiting, the magnitude of the discrepancy increased from mid- to end-of-treatment in both study arms. Binary analyses comparing the presence of any versus no symptom confirmed persistently low agreement between clinicians and patients (kappa = 0.03-0.35).
conclusionClinician-reported toxicities showed poor concordance with patient-reported symptom severity, and the discrepancy increased over time. Incorporating patient-reported assessments into both clinical trials and routine care is essential to ensure more accurate evaluation of treatment tolerability.
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