학술논문
Safety and Efficacy of Immune Checkpoint Inhibitors in Patients with Cancer and Viral Hepatitis: The MD Anderson Cancer Center Experience
Original Article
Original Article
Document Type
Report
Author
Nardo, Mirella; Yilmaz, Bulent; Nelson, Blessie Elizabeth; Torres, Harrys A.; Wang, Lan Sun; Granwehr, Bruno Palma; Song, Juhee; Pria, Hanna R.F. Dalla; Trinh, Van A.; Oliva, Isabella C. Glitza; Patel, Sapna P.; Tannir, Nizar M.; Kaseb, Ahmed Omar; Altan, Mehmet; Lee, Sunyoung S.; Miller, Ethan; Zhang, Hao; Stephen, Bettzy A.; Naing, Aung
Source
The Oncologist. August 2023, Vol. 28 Issue 8, p714, 8 p.
Subject
Language
English
ISSN
1083-7159
Abstract
Implications for Practice This article reports the institutional experience with the treatment of patients with viral hepatitis and advanced hepatic disease treated with immune checkpoint inhibitors outside a clinical trial [...]
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. Key words: immune checkpoint inhibitors; advanced cancer; viral hepatitis; advanced liver disease; safety.
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. Key words: immune checkpoint inhibitors; advanced cancer; viral hepatitis; advanced liver disease; safety.