TY - JOUR
T1 - Safety and Efficacy of Immune Checkpoint Inhibitors in Patients with Cancer and Viral Hepatitis
T2 - The MD Anderson Cancer Center Experience
AU - Nardo, Mirella
AU - Yilmaz, Bulent
AU - Nelson, Blessie Elizabeth
AU - Torres, Harrys A.
AU - Wang, Lan Sun
AU - Granwehr, Bruno Palma
AU - Song, Juhee
AU - Dalla Pria, Hanna R.F.
AU - Trinh, Van A.
AU - Glitza Oliva, Isabella C.
AU - Patel, Sapna P.
AU - Tannir, Nizar M.
AU - Kaseb, Ahmed Omar
AU - Altan, Mehmet
AU - Lee, Sunyoung S.
AU - Miller, Ethan
AU - Zhang, Hao
AU - Stephen, Bettzy A.
AU - Naing, Aung
N1 - Publisher Copyright:
© The Author(s) 2023. Published by Oxford University Press.
PY - 2023/8
Y1 - 2023/8
N2 - 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.
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.
KW - advanced cancer
KW - advanced liver disease
KW - immune checkpoint inhibitors
KW - safety
KW - viral hepatitis
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U2 - 10.1093/oncolo/oyad039
DO - 10.1093/oncolo/oyad039
M3 - Article
C2 - 36952233
AN - SCOPUS:85166478096
SN - 1083-7159
VL - 28
SP - 714
EP - 721
JO - Oncologist
JF - Oncologist
IS - 8
ER -