Clinical implications of drug-induced liver injury in early-phase oncology clinical trials.

ABSTRACT:

Background

Data on drug-induced liver injury (DILI) and acute liver failure (ALF) in modern phase 1 oncology trials are limited, specifically with respect to the incidence and resolution of DILI and the safety of drug rechallenge.

Methods

This study reviewed all patients who were recruited to phase 1 oncology trials between 2013 and 2017 at Memorial Sloan Kettering Cancer Center. Clinicopathologic data were extracted to characterize DILI, and attribution was assessed on the basis of data prospectively generated during the studies. Logistic regression models were used to explore factors related to DILI and DILI recurrence after drug rechallenge.

Results

Among 1670 cases recruited to 85 phase 1 trials, 81 (4.9%) developed DILI. The rate of DILI occurrence was similar fo

SUBMITTER: Mondaca SP 

PROVIDER: S-EPMC9004708 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature