PMID- 36952233 OWN - NLM STAT- MEDLINE DCOM- 20230807 LR - 20240105 IS - 1549-490X (Electronic) IS - 1083-7159 (Print) IS - 1083-7159 (Linking) VI - 28 IP - 8 DP - 2023 Aug 3 TI - Safety and Efficacy of Immune Checkpoint Inhibitors in Patients with Cancer and Viral Hepatitis: The MD Anderson Cancer Center Experience. PG - 714-721 LID - 10.1093/oncolo/oyad039 [doi] AB - BACKGROUND: Despite the clinical benefit of immune checkpoint inhibitors (ICIs), patients with a viral hepatitis have been excluded from clinical trials because of safety concerns. The purpose of this study was to determine the incidence rate of adverse events (AEs) in patients with viral hepatitis who received ICIs for cancer treatment. MATERIALS AND METHODS: We conducted a retrospective study in patients with cancer and concurrent hepatitis B or C, who had undergone treatment with ICI at MD Anderson Cancer Center from January 1, 2010 to December 31, 2019. RESULTS: Of the 1076 patients screened, we identified 33 with concurrent hepatitis. All 10 patients with HBV underwent concomitant antiviral therapy during ICI treatment. Sixteen of the 23 patients with HCV received it before the initiation of ICI. The median follow-up time was 33 months (95% CI, 23-45) and the median duration of ICI therapy was 3 months (IQR, 1.9-6.6). Of the 33 patients, 12 (39%) experienced irAEs (immune-related adverse events) of any grade, with 2 (6%) having grade 3 or higher. None of the patients developed hepatitis toxicities. CONCLUSION: ICIs may be a therapeutic option with an acceptable safety profile in patients with cancer and advanced liver disease. CI - (c) The Author(s) 2023. Published by Oxford University Press. FAU - Nardo, Mirella AU - Nardo M AUID- ORCID: 0000-0002-9396-7864 AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Yilmaz, Bulent AU - Yilmaz B AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Nelson, Blessie Elizabeth AU - Nelson BE AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Torres, Harrys A AU - Torres HA AD - Department of Infectious Diseases Infection Control and Employee Health, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Wang, Lan Sun AU - Wang LS AD - Department of Genitourinary Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Granwehr, Bruno Palma AU - Granwehr BP AD - Department of Infectious Diseases Infection Control and Employee Health, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Song, Juhee AU - Song J AUID- ORCID: 0000-0002-8688-4104 AD - Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Dalla Pria, Hanna R F AU - Dalla Pria HRF AD - Department of Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Trinh, Van A AU - Trinh VA AD - Department of Melanoma Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Glitza Oliva, Isabella C AU - Glitza Oliva IC AD - Department of Melanoma Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Patel, Sapna P AU - Patel SP AD - Department of Melanoma Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Tannir, Nizar M AU - Tannir NM AD - Department of Genitourinary Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Kaseb, Ahmed Omar AU - Kaseb AO AD - Department of Genitourinary Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Altan, Mehmet AU - Altan M AD - Department of Genitourinary Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. AD - Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston TX, USA. FAU - Lee, Sunyoung S AU - Lee SS AD - Department of Gastrointestinal Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Miller, Ethan AU - Miller E AD - Department of Gastrointestinal Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Zhang, Hao AU - Zhang H AD - Department of Gastrointestinal Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Stephen, Bettzy A AU - Stephen BA AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Naing, Aung AU - Naing A AD - Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. LA - eng GR - P30 CA016672/CA/NCI NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural PL - England TA - Oncologist JT - The oncologist JID - 9607837 RN - 0 (Immune Checkpoint Inhibitors) RN - 0 (Antiviral Agents) SB - IM EIN - Oncologist. 2023 May 15;:. PMID: 37186675 MH - Humans MH - Immune Checkpoint Inhibitors/adverse effects MH - Retrospective Studies MH - *Neoplasms/drug therapy MH - Antiviral Agents MH - *Hepatitis, Viral, Human PMC - PMC10400154 OTO - NOTNLM OT - advanced cancer OT - advanced liver disease OT - immune checkpoint inhibitors OT - safety OT - viral hepatitis COIS- Harrys A. Torres is or has been the principal investigator for research grants from Gilead Sciences and Merck & Co., Inc., with all funds paid to MD Anderson Cancer Center, and is or has been a paid scienti fi c advisor for Dynavax Technologies, AbbVie, Inc., Gilead Sciences, Janssen Pharmaceuticals, Inc., and Merck & Co., Inc.; MD Anderson Cancer Center is managing the terms of these arrangements in accordance with its conflict-of-interest policies. Isabella C. Glitza Oliva reported grants to institution from BMS, Pfizer, and Merck, consulting fees from BMS, Pfizer, Novartis, and EnClear Therapeutics, honoraria from Novartis, and support for attending meetings and/or travel from BMS. Sapna P. Patel reported institutional clinical trial support from Bristol Myers Squibb, Foghorn Therapeutics, Ideaya, InxMed, Lyvgen Biopharma, Novartis, Provectus Biopharmaceuticals, Seagen, Syntrix Bio, and TriSalus Life Sciences, honoraria for advisory board, data safety monitoring board, consultative role from Advance Knowledge in Healthcare, Bristol Myers Squibb, Cardinal Health, Castle Biosciences, Delcath, Immatics, Immunocore, Novartis, Replimune, and TriSalus Life Sciences. Nizar M. Tannir reported consulting/advisory relationships with Bristol-Myers-Squibb, Eisai Medical Research, Eli Lilly, Oncorena, and Merck Sharp & Dohme, research funding from Bristol-Myers-Squibb, Nektar Therapeutics, Arrowhead Pharmaceuticals, Novartis, and Calithera Bioscienses, honoraria from Eisai Medical Research, -Bristol-Myers-Squibb, Intellisphere, Oncorena, Merck Sharp & Dohme, Deka Biosciences, Calithera, Neoleukin, Exelixis, and Ono Pharmaceutical, and Scientific Advisory Committee member for Nektar Therapeutics, Pfizer, Oncorena, Eli Lilly, and Eisai Medical Research. Ahmed Omar Kaseb reported consulting relationships with BMS, Merck, Bayer, Roche/Genentech, Eisai, and Exelixis and research support from BMS, Merck, Bayer, Roche/Genentech, Eisai, Exelixi, Immatics, and AdaptImmune. Mehmet Altan reported research funding (to institution) from Genentech, Nektar Therapeutics, Merck, GlaxoSmithKline, Novartis, Jounce Therapeutics, Bristol Myers Squibb, Eli Lilly, Adaptimmune, Shattuck Lab, and Gilead and serving as advisory board member for GlaxoSmithKline, Shattuck Lab, Bristol Myers Squibb, and AstraZeneca. Aung Naing reported research funding from NCI, EMD Serono, MedImmune, Healios Onc. Nutrition, Atterocor/Millendo, Amplimmune, ARMO BioSciences, Karyopharm Therapeutics, Incyte, Novartis, Regeneron, Merck, Bristol-Myers Squibb, Pfizer, CytomX Therapeutics, Neon Therapeutics, Calithera Biosciences, TopAlliance Biosciences, Eli Lilly, Kymab, PsiOxus, Arcus Biosciences, NeoImmuneTech, Immune-Onc Therapeutics, Surface Oncology, Monopteros Therapeutics, BioNTech SE, Seven & Eight Biopharma, SOTIO Biotech AG, and Tiantian; serving on advisory board for and consulting fees from Deka Biosciences, NGM Bio, PsiOxus Therapeutics, Immune-Onc Therapeutics, STCube Pharmaceuticals, OncoSec KEYNOTE-695, Genome & Company, CytomX Therapeutics, Nouscom, Merck Sharp & Dohme Corp, OncoNano, Servier, Lynx Health, AbbVie, and PsiOxus; travel and accommodation expenses from ARMO BioSciences, NeoImmuneTech, and NGM Biopharmaceuticals; honoraria for speaking engagements fromAKH Inc, The Lynx Group, Society for Immunotherapy of Cancer (SITC), Korean Society of Medical Oncology (KSMO), Scripps Cancer Care Symposium, ASCO Direct Oncology Highlights, European Society for Medical Oncology (ESMO), and CME Outfitters. The other authors indicated no financial relationships. EDAT- 2023/03/24 06:00 MHDA- 2023/08/07 06:42 PMCR- 2023/03/23 CRDT- 2023/03/23 12:32 PHST- 2022/10/16 00:00 [received] PHST- 2023/01/24 00:00 [accepted] PHST- 2023/08/07 06:42 [medline] PHST- 2023/03/24 06:00 [pubmed] PHST- 2023/03/23 12:32 [entrez] PHST- 2023/03/23 00:00 [pmc-release] AID - 7084884 [pii] AID - oyad039 [pii] AID - 10.1093/oncolo/oyad039 [doi] PST - ppublish SO - Oncologist. 2023 Aug 3;28(8):714-721. doi: 10.1093/oncolo/oyad039.