title: Ipilimumab administration for advanced melanoma in patients with pre-existing Hepatitis B or C infection: a multicenter, retrospective case series.
abstract: Ipilimumab is a fully human, monoclonal antibody directed against Cytotoxic T Lymphocyte Antigen-4 (CTLA-4) that has demonstrated a survival benefit and durable disease control in patients with advanced melanoma. Ipilimumab is associated with potentially serious immune-related adverse events, including autoimmune hepatitis. Because clinical trials of ipilimumab excluded patients with pre-existing hepatitis B or C infection, there is a paucity of data on the safety of ipilimumab administration to that patient population. Here, we report the largest case series to date of patients with hepatitis B or C who received ipilimumab for advanced melanoma. Two of the nine patients described in this case series experienced fluctuations in their liver function tests (LFTs) and were subsequently treated with corticosteroids. Although this is a small series, the rate of hepatotoxicity appears similar to what has been seen in the general population treated with ipilimumab, and the ability to administer ipilimumab did not appear to be affected by concomitant hepatitis B or C infection. The use of ipilimumab in patients with metastatic melanoma who have pre-existing hepatitis can be considered among other therapeutic options.
authors.affiliation: The Johns Hopkins University School of Medicine and Sidney Kimmel Comprehensive Cancer Center, 1550 Orleans St., Rm. 507, Baltimore, MD 21287 USA.
authors.forename: Sowmya
authors.initials: S
authors.lastname: Ravi
authors.affiliation: Rutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08901 USA.
authors.forename: Kristen
authors.initials: K
authors.lastname: Spencer
authors.affiliation: Bristol-Myers Squibb, Oncology Global Clinical Research, Route 206 and Provinceline Road, Princeton, NJ 08543 USA.
authors.forename: Mary
authors.initials: M
authors.lastname: Ruisi
authors.affiliation: Dana-Farber Cancer Institute Melanoma Disease Center, Harvard Medical School, 450 Brookline Ave, Boston, MA 02215 USA.
authors.forename: Nageatte
authors.initials: N
authors.lastname: Ibrahim
authors.affiliation: Dana-Farber Cancer Institute Melanoma Disease Center, Center for ImmunoOncology, Harvard Medical School, 450 Brookline Ave, Boston, MA 02215 USA.
authors.forename: Jason J
authors.initials: JJ
authors.lastname: Luke
authors.affiliation: Seattle Cancer Care Alliance, University of Washington, 825 Eastlake Ave. East, Seattle, WA 98109 USA.
authors.forename: John A
authors.initials: JA
authors.lastname: Thompson
authors.affiliation: Division of Hematology/Oncology, Medical University of South Carolina, 173 Ashley Ave., Basic Science Building, Suite 102, Charleston, SC 29425 USA.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Shirai
authors.affiliation: The Winship Cancer Institute of Emory University School of Medicine, 1365C Clifton Road, Atlanta, Georgia 30322 USA.
authors.forename: David
authors.initials: D
authors.lastname: Lawson
authors.affiliation: Bristol-Myers Squibb. Oncology Medical Strategy, 777 Scudders Mill Road, Plainsboro, NJ 08536 USA.
authors.forename: Heddy
authors.initials: H
authors.lastname: Bartell
authors.affiliation: The Winship Cancer Institute of Emory University School of Medicine, 1365C Clifton Road, Atlanta, Georgia 30322 USA.
authors.forename: Ragini
authors.initials: R
authors.lastname: Kudchadkar
authors.affiliation: The Winship Cancer Institute of Emory University School of Medicine, 1365C Clifton Road, Atlanta, Georgia 30322 USA.
authors.forename: Ngoc Thi
authors.initials: NT
authors.lastname: Gunter
authors.affiliation: Rutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08901 USA.
authors.forename: Janice M
authors.initials: JM
authors.lastname: Mehnert
authors.affiliation: The Johns Hopkins University School of Medicine and Sidney Kimmel Comprehensive Cancer Center, 1550 Orleans St., Rm. 507, Baltimore, MD 21287 USA.
authors.forename: Evan J
authors.initials: EJ
authors.lastname: Lipson
keywords: Hepatitis B; Hepatitis C; Ipilimumab; Melanoma