402P - Detailed clinical course of immune-related hepatotoxicity in advanced melanoma patients using immune checkpoint inhibitors

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Complications/Toxicities of treatment
Skin cancers
Presenter Yuta Maruki
Citation Annals of Oncology (2016) 27 (suppl_9): ix123-ix125. 10.1093/annonc/mdw588
Authors Y. Maruki1, S. Kondo1, Y. Oshiro1, F. Yutaka1, K. Namikawa1, A. Takahashi1, A. Tsutsumida1, N. Yamazaki2
  • 1Medical Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 2Dermatology Division, Dermatologic Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP



Hepatotoxicity caused by immune checkpoint inhibitors is a type of immune-related adverse event (irAE) that occurs at a frequency of about 10%. The present retrospective analysis aims to reveal the clinical characteristics of immune checkpoint inhibitor-induced hepatotoxicity in melanoma patients.


A retrospective analysis from patients who were administered immune checkpoint inhibitors for melanoma treatment at the National Cancer Center Hospital, Japan. Treatments included common practice single therapy with nivolumab (NIVO) or ipilimumab (IPI), and combined therapy with IPI plus dacarbazine (DTIC). Hepatotoxicity was defined as an elevation in AST or ALT hepatic enzymes (provide range) over grade 3, occurring after immune checkpoint inhibitor administration.


Of the 121 patients included in this analysis, 10 patients developed hepatotoxicity. The patient characteristics of both groups were well matched with: median age, 65 years with all 10 patients having a PS 0 and 5 of these patients had received prior therapy with another immune checkpoint inhibitor. Of the 10 patients with grade 3 hepatotoxicity, 5patients who affected during ipi + DTIC, had no pretreatment history. Four patients who affected during monotherapy, had received another immune checkpoint inhibitor. One patient who affected during monotherapy, had no pretreatment history of immune checkpoint inhibitor. In all patients with hepatotoxicity, immune checkpoint inhibitor therapy was discontinued, and they were treated with high dose prednisolone (1 mg/kg). Six patients received mofetil in addition to prednisolone. The median time to onset of hepatotoxicity was 41 days (range: 7-78 days). The median time needed to recover from grade3 hepatitis to grade 1 was 31 days (range: 15-103 days).


Herein, we report the detailed clinical course of hepatotoxicity as an irAE in patients treated with immune checkpoint inhibitors. Sharing this information will help us understand irAEs and determine their optimal management and treatment course.

Clinical trial indentification

Currently pending

Legal entity responsible for the study

National Cancercenter


National Cancer Center


All authors have declared no conflicts of interest.