Longitudinal patient-reported outcomes on genotype-guided irinotecan dosing: feasibility and clinical relevance.

ABSTRACT:

Introduction

Standard investigator-based adverse events (AE) assessment is via CTCAE for clinical trials. However, including the patient perspective through PRO (patient-reported outcomes) enhances clinicians' understanding of patient toxicity and fosters early detection of AEs. We assessed longitudinal integration of PRO-CTCAE within clinical workflow in a phase II trial.

Materials and methods

As a sub-study in a phase II trial of genotype-directed irinotecan dosing evaluating efficacy in patients with metastatic colorectal cancer receiving FOLFIRI and bevacizumab, patients reported on 13 AEs generating a PRO-CTCAE form. The primary objective was to estimate forms completed by patients and clinicians at least 80% of time. Secondary objectives were estimating concordance and

SUBMITTER: Sorah JD 

PROVIDER: S-EPMC11379639 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature