Phase II study of trifluridine/tipiracil (TAS-102) therapy in elderly patients with colorectal cancer (T-CORE1401): geriatric assessment tools and plasma drug concentrations as possible predictive biomarkers.

ABSTRACT:

Purpose

The current study aimed to determine the efficacy of trifluridine/tipiracil for elderly patients with advanced colorectal cancer.

Methods

This single-arm, open-label, multicenter, phase II study included elderly patients aged 65 years or more who had fluoropyrimidine-refractory advanced colorectal cancer and received trifluridine/tipiracil (70 mg/m², days 1-5 and 8-12, every 4 weeks). The primary endpoint was progression-free survival (PFS), while secondary endpoints included overall survival (OS), overall response rate (ORR), toxicities, association between efficacy and geriatric assessment scores, and association between toxicity and plasma drug concentrations.

Results

A total of 30 patients with a mean age of 73 years were enrolled. Median PFS wa

SUBMITTER: Takahashi M 

PROVIDER: S-EPMC8316169 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature