Clinical implications of drug-induced liver injury in early-phase oncology clinical trials.
Sebastian P MondacaDazhi LiuJessica R FlynnSandy BadsonStefan HamawayMrinal M GounderDanny N KhalilAlexander E DrilonBob T LiKomal L JhaveriAlison M SchramKatherine E KargusMary Kate KaslerNatalie M BlauveltNeil H SegalMarinela CapanuMargaret K CallahanDavid M HymanMaya Gambarin-GelwanJames J HardingPublished in: Cancer (2020)
In modern phase 1 oncology trials, DILI is uncommon, may occur at any time, and often resolves with supportive measures. Rechallenging after DILI is feasible; however, the high rate of DILI recurrence suggests that clinicians should consider the severity of the DILI episode and treatment alternatives.