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

ABSTRACT:

Purpose

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.

Methods

In patients for whom sunitinib was considered standard therapy or patients with advanced/metastatic tumors fo

SUBMITTER: Koldenhof JJ 

PROVIDER: S-EPMC6018583 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature