Risks and Benefits of Phase I Liver Dysfunction Studies

Clinical Pearls

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.
• 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 classified by severity of liver dysfunction: mild, moderate, and severe.
• Patients in the ‘severe’ cohort experienced the lowest clinical benefit rates (5%) and highest rates of death (24%).

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