Abstract
BackgroundWe recently reported that self‐evaluation of the incidence and severity of treatment‐related side effects (TSEs) using a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0‐based questionnaire was feasible and more informative than doctor reports in patients undergoing standard adjuvant chemotherapy for operable breast cancer. Here, we compare self‐ and doctor‐evaluated day of onset and duration of TSEs in the same population.Patients and methodsSix hundred and four patients were enrolled at 11 sites in Italy. CTCAE v4.0 definitions of grade of severity of nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea were translated into Italian and rephrased. Questionnaires were administered after the first and third chemotherapy cycles. At each time‐point, information on TSEs was extracted from the medical charts and compared to patient questionnaires.ResultsA total of 594 and 573 paired patient and doctor questionnaires were collected after cycles one and three, respectively. TSE duration was significantly longer when reported by patients compared to doctors for six and seven of ten items after cycles one and three, respectively. Due to the combined effect of doctor underreporting of TSE incidence and duration, the mean percentages of cycle days with TSEs were significantly higher for all ten items when based on patient reports. Day of onset could not be evaluated because of insufficient numbers of complete records.ConclusionsSelf‐reporting TSE duration is feasible using a CTCAE‐derived questionnaire. As doctors tend to underestimate TSE incidence and duration, patient‐reported outcomes should be incorporated into clinical practice, perhaps using eHealth technologies, to harness their potential to better estimate total TSE burden.
Highlights
Systems like the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) are integral to clinical trials where measures of treatment-related toxicity are critical for establishing the risk-benefit ratio of new treatments
We showed that doctors underestimate treatment-related side effects (TSEs) incidence and severity in clinical practice, with a more pronounced effect in high-v olume centers
Of 604 patients with early breast cancer enrolled in the study at 11 Italian Institutions, three withdrew informed consent before the first cycle of chemotherapy
Summary
This work was supported by Rete Oncologica del Piemonte e della Valle d’Aosta 2010, FPRC (onlus) 5 X 1000 fondi Ministero della Salute 2013, FPRC (onlus) 5 X 1000 fondi Ministero della Salute 2014, and Associazione Italiana per la Ricerca sul Cancro (AIRC) IG 2016 (code 19174).
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