부산대학교 도서관

INTRODUCTION: We conducted this study to characterize the incidence, clinical features, treatment, and outcomes of immune checkpoint inhibitor (ICI) hepatotoxicity. METHODS: Patients who received ICIs (with either single-agent or combination regimens) from January 1, 2010, to March 31, 2018, were identified. Hepatotoxicity was defined as alanineaminotransferase (ALT)>5timesthe upper limit of normal (ULN), in the absence of an alternate cause, and categorized as grade 3 (ALT 5-203 ULN) or grade 4 (ALT >203 ULN), according to Common Terminology Criteria for Adverse Events 4.03. RESULTS: Among 5,762 patients, 100 (2%) developed hepatotoxicity, occurring in a higher proportion of recipients of combination therapy (9.2%) compared with monotherapy (up to 1.7%, P < 0.001). ICIs were discontinued permanently in69and temporarily in31patients. Sixty-seven patients receivedsteroids, 10 of whom(14%) had recurrent hepatotoxicity after the steroid taper. Thirty-one patients resumed ICIs after ALT improvement, 8 of whom (26%) developed recurrent hepatotoxicity. Characteristics of liver injury, response to steroids, and outcomeswere similar between38individualswith and 62 without possible preexisting liver disease. The severity and outcome of hepatotoxicity due to combination therapy were not significantly different frommonotherapy. Therewere 36 deaths. Two had liver failure at the time of death, both with progression of liver metastases and grade 3 hepatotoxicity. DISCUSSION: Clinically significant ICI-related hepatotoxicity was uncommon but led to permanent ICI discontinuation in the majority. ICIs were restarted in a sizable proportion of patients, most of whom did not experience recurrent hepatotoxicity. [ABSTRACT FROM AUTHOR]