Background: In clinical cancer research of morbidity, low associations between clinician-assessed toxicity/morbidity and patient-reported symptoms are consistently described in the literature. While morbidity grading systems are supposed to follow more or less objective criteria, patient reported symptoms inherently are based on a subjective self-evaluation of the impact on quality of life. The aim of this study was to focus on major discrepancies with high clinical relevance and to evaluate its impact with regard to underreporting of morbidity.
Material and methods: Early morbidity assessed by clinicians with CTCAEv.3 and patient reported quality of life (EORTC-QLQ-C30/CX24) were compared regarding 12 overlapping symptoms in 223 patients with uterine cervical cancer 3 months after definitive radio(chemo)therapy in the ongoing EMBRACE study. Mismatches showing discrepancies between both grading systems were classified, if patients reported substantial symptoms (quite a bit/very much) and CTCAE grading was rated G0.
Results: In total, 360 substantial symptoms were reported by patients by EORTC-QLQ; 159 (44%) of those were not recognized by CTCAE. Symptoms with the highest occurrence of mismatches overall are urinary frequency, fatigue, and insomnia. Large institutional differences were found, showing two centers with 4 vs. 71% of patients with at least one mismatch.
Conclusion: Analysis of mismatches indicated a high risk of underestimation of early morbidity. Thus, nearly half of the patient-reported substantial symptoms were not recognized by CTCAE scoring (G0) 3 months after treatment. Prospective assessment of morbidity in clinical studies should, therefore, integrate patient reported symptoms to receive a complete and comprehensive picture.