Patient-reported outcome measures in a pharmacokinetic study with sunitinib, a prospective cohort study

Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer
J J KoldenhofP O Witteveen

Abstract

During treatment with tyrosine kinase inhibitors, such as sunitinib, patients experience treatment and/or disease-related symptoms. Although application of patient-reported outcome measures (PROMs) enhances early recognition of symptoms, early clinical trials are focused on symptom severity objectified by the Common Terminology Criteria for Adverse Events (CTCAE) in order to evaluate drug safety and to determine a personalized and/or safe dosage range. To gain insight into patient-reported symptoms in addition to healthcare professional-reported adverse events (AEs), a substudy was conducted in an ongoing pharmacokinetic-guided sunitinib dosing study. In patients for whom sunitinib was considered standard therapy or patients with advanced/metastatic tumors for whom no standard therapy was available, patient-reported symptoms and well-being besides healthcare professional-reported AEs were assessed. Twenty-nine patients were included for analysis. Over 50% of them experienced a decreased well-being, caused by symptoms of mild and moderate intensity. Compared to healthcare professionals, all measured symptoms, with the exception of fatigue and vomiting, were reported statistically significantly more often by patients. Application...Continue Reading

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Citations

Jul 10, 2020·Cancer Medicine·Frederieke H van der BaanSaskia C Teunissen

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Clinical Trials Mentioned

NCT01286896

Software Mentioned

SPSS

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