T-Cell Heterogeneity in Baseline Tumor Samples: Implications for Early Clinical Trial Design and Analysis.

ABSTRACT:

Background

In early stage clinical trials, changes to levels of tumor infiltrating lymphocytes (TILs) in the tumor microenvironment (TME) are critical biomarkers of the mechanism of action of novel immunotherapies. However, baseline heterogeneity of tumor samples, both between and within patients, and the resultant impact on the validity of clinical trial data is not well defined. Here we identify and quantify the impact of baseline variables on the heterogeneity of FoxP3+ and proliferating CD8+ T-cells levels (MKi67+CD8A+) in the TME both between and within patients for the purpose of informing clinical trial design and analysis.

Methods

We compared levels of FoxP3+ and MKi67+CD8+ cell densities (counts/mm²) from >1000 baseline tumor samples from clinical trials

SUBMITTER: Brennan L 

PROVIDER: S-EPMC9086966 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature