Pharmacogenomics Testing in Phase I Oncology Clinical Trials: Constructive Criticism Is Warranted.

ABSTRACT: While over ten-thousand phase I studies are published in oncology, fewer than 1% of these studies stratify patients based on genetic variants that influence pharmacology. Pharmacogenetics-based patient stratification can improve the success of clinical trials by identifying responsive patients who have less potential to develop toxicity; however, the scientific limits imposed by phase I study designs reduce the potential for these studies to make conclusions. We compiled all phase I studies in oncology with pharmacogenetics endpoints (n = 84), evaluating toxicity (n = 42), response or PFS (n = 32), and pharmacokinetics (n = 40). Most of these studies focus on a limited number of agent classes: Topoisomerase inhibitors, antimetabolites, and anti-angiogenesis agents. Eight genotype-directed

SUBMITTER: Sissung TM 

PROVIDER: S-EPMC8909728 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature