Ipilimumab administration for advanced melanoma in patients with pre-existing Hepatitis B or C infection: a multicenter, retrospective case series

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• 作者：Sowmya Ravi (1)
  Kristen Spencer (2)
  Mary Ruisi (3)
  Nageatte Ibrahim (4)
  Jason J Luke (5)
  John A Thompson (6)
  Keisuke Shirai (7)
  David Lawson (8)
  Heddy Bartell (9)
  Ragini Kudchadkar (8)
  Ngoc Thi Gunter (8)
  Janice M Mehnert (2)
  Evan J Lipson (1)
  
  1. The Johns Hopkins University School of Medicine and Sidney Kimmel Comprehensive Cancer Center ; 1550 Orleans St. ; Rm. 507 ; Baltimore ; MD ; 21287 ; USA
  2. Rutgers Cancer Institute of New Jersey ; 195 Little Albany Street ; New Brunswick ; NJ ; 08901 ; USA
  3. Bristol-Myers Squibb ; Oncology Global Clinical Research ; Route 206 and Provinceline Road ; Princeton ; NJ ; 08543 ; USA
  4. Dana-Farber Cancer Institute Melanoma Disease Center ; Harvard Medical School ; 450 Brookline Ave ; Boston ; MA ; 02215 ; USA
  5. Dana-Farber Cancer Institute Melanoma Disease Center ; Center for ImmunoOncology ; Harvard Medical School ; 450 Brookline Ave ; Boston ; MA ; 02215 ; USA
  6. Seattle Cancer Care Alliance ; University of Washington ; 825 Eastlake Ave. East ; Seattle ; WA ; 98109 ; USA
  7. Division of Hematology/Oncology ; Medical University of South Carolina ; 173 Ashley Ave. ; Basic Science Building ; Suite 102 ; Charleston ; SC ; 29425 ; USA
  8. The Winship Cancer Institute of Emory University School of Medicine ; 1365C Clifton Road ; Atlanta ; Georgia ; 30322 ; USA
  9. Bristol-Myers Squibb. Oncology Medical Strategy ; 777 Scudders Mill Road ; Plainsboro ; NJ ; 08536 ; USA
  
• 关键词：Ipilimumab ; Melanoma ; Hepatitis B ; Hepatitis C
• 刊名：Journal for Immunotherapy of Cancer
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：2
• 期：1
• 全文大小：428 KB
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• 刊物主题：Oncology;
• 出版者：BioMed Central
• ISSN：2051-1426

文摘

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.