Abbreviations
- AE:
-
Adverse event
- ALT:
-
Alanine aminotransferase
- AP:
-
Alkaline phosphatase
- AST:
-
Aspartate aminotransferase
- CTLA-4:
-
Cytotoxic T-lymphocyte antigen-4
- ULN:
-
Upper limit of normal
References
Fong L, Small EJ. Anti-cytotoxic T-lymphocyte antigen-4 antibody: the first in an emerging class of immunomodulatory antibodies for cancer treatment. J Clin Oncol. 2008;26:5275–5283.
Wolchok JD, Saenger Y. The mechanism of anti-CTLA-4 activity and the negative regulation of T-cell activation. Oncologist. 2008;13:2–9.
Weber J, Thompson JA, Hamid O, et al. A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res. 2009;15:5591–5598.
Wolchok JD, Neyns B, Linette G, et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010;11:155–164.
O’Day SJ, Maio M, Chiarion-Sileni V, et al. Efficacy and safety of ipilimumab monotherapy in patients with previously treated, advanced melanoma: a multicenter, single-arm phase II study. Ann Oncol. 2010;21:1712–1717.
Maio M, Lebbé C, Neyns B, et al. Three-Year Survival Rates for Patients with Advanced Melanoma Who Received Ipilimumab at 10 mg/kg in Phase II Trials [Abstract]. In: Presented at the XIV annual meeting of the perspectives in melanoma, 2010 September 17–18, Amsterdam, The Netherlands. 2010.
Hodi FS, O’Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711–723.
Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011;364:2517–2526. doi:10.1056/NEJMoa1104621.
Weber J. Review: anti-CTLA-4 antibody ipilimumab: case studies of clinical response and immune-related adverse events. Oncologist. 2007;12:864–872.
Hoos A, Ibrahim R, Korman A, et al. Development of ipilimumab: contribution to a new paradigm for cancer immunotherapy. Semin Oncol. 2010;37:533–546.
Phan GQ, Yang JC, Sherry RM, et al. Cancer regression and autoimmunity induced by cytotoxic T lymphocyte-associated antigen 4 blockades in patients with metastatic melanoma. Proc Natl Acad Sci USA. 2003;100:8372–8377.
Attia P, Phan GQ, Maker AV, et al. Autoimmunity correlates with tumor regression in patients with metastatic melanoma treated with anti-cytotoxic T-lymphocyte antigen-4. J Clin Oncol. 2005;23:6043–6053.
Qiu D, Wang Q, Wang H, et al. Validation of the simplified criteria for diagnosis of autoimmune hepatitis in Chinese patients. J Hepatol. 2011;54:340–347.
Aithal GP, Watkins PB, Andrade RJ, et al. Case definition and phenotype standardization in drug-induced liver Injury. Clin Pharmacol Ther. 2011;89:806–815.
Czaja AJ. Drug-induced autoimmune-like hepatitis. Dig Dis Sci. 2011;56:958–976.
Suriawinata AA, Thung SN. Acute and chronic hepatitis. Semin Diagn Pathol. 2006;23:132–148.
Lucey MR, Mathurin P, Morgan TR. Alcoholic hepatitis. N Engl J Med. 2009;360:2758–2769.
Krawitt EL. Autoimmune hepatitis. N Engl J Med. 2006;354:54–66.
Suzuki A, Brunt EM, Kleiner DE, et al. The use of liver biopsy evaluation in discrimination of idiopathic autoimmune hepatitis versus drug-induced liver injury. Hepatology. 2011;54:931–939.
Berman D, Parker SM, Siegel J, et al. Blockade of cytotoxic T-lymphocyte antigen-4 by ipilimumab results in dysregulation of gastrointestinal immunity in patients with advanced melanoma. Cancer Immun. 2010;10:11–21.
Sulz MC, Gerlach TJ. Autoimmune hepatitis. Ther Umsch. 2011;68:189–194.
Ishak K, Baptista A, Bianchi L, et al. Histological grading and staging of chronic hepatitis. J Hepatol. 1995;22:696–699.
Acknowledgments
Editorial and writing assistance was provided by StemScientific, funded by Bristol-Myers Squibb Co. This research was supported in part by the Intramural Research Program of the US National Institutes of Health (National Cancer Institute).
Conflict of interest
David E. Kleiner: No financial, professional or personal conflicts of interest exist with respect to this work. David Berman is an employee of Bristol-Myers Squibb Company and discloses ownership of equity in the company.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Kleiner, D.E., Berman, D. Pathologic Changes in Ipilimumab-Related Hepatitis in Patients with Metastatic Melanoma. Dig Dis Sci 57, 2233–2240 (2012). https://doi.org/10.1007/s10620-012-2140-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10620-012-2140-5