Dr. Stuart on Risks of Phase I Liver Dysfunction Studies

Selena Juarez Stuart, MD, hematology/oncology fellow, Cancer Therapy & Research Center, The University of Texas Health Science Center at San Antonio, discusses the risks and benefits of phase I liver dysfunction studies.

There is not much known about the outcomes of patients on liver dysfunction trials, Stuart says.

This analysis looked to evaluate clinical benefit rates, death on study rates, and rates of grade 3/4 toxicity for patients enrolled on 12 liver dysfunction phase I studies. Patients were stratified by severity of liver dysfunction into mild, moderate, and severe cohorts.

Patients in the ‘severe’ cohort experienced the lowest clinical benefit rates (5%) and highest rates of death (24%).