Table 2.
Summary of cases of immune-related hepatitis grade ≥ 3 according to the CTCAE version 4.03.
| Patient | Gender | Age | HCC Etiology | Treatment | Baseline ALT Levels (IU/L) | Time to Grade ≥ 3 Hepatitis (Days) | Hepatitis Grade | Treatment Management | Steroids and Doses | Time to Hepatitis Resolution (Grade ≤ 1, Days) | Best Overall Response | Survival Status from Start of Treatment |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| #1 | Male | 76 | Alcohol | Anti-PD-1 + anti-CTLA4 + TA |
39 | 46 | 3 | Permanently discontinued | MP 2 mg/kg | 45 | SD | Died after 9.4 months |
| #2 | Male | 73 | HCV # | Anti-PD-1 + targeted agent | 147 | 85 | 3 | Permanently discontinued | PDN 1 mg/kg | Not resolved at last follow-up visit | SD | Died after 10.6 months |
| #3 | Female | 78 | HCV * | Anti-PD-1 + anti-CTL A4 + targeted agent |
88 | 14 | 3 | Temporarily suspended | - | 15 | SD | Alive at 11.6 months, PD after 8.1 months |
| #4 | Female | 58 | Unknown | Anti-PD-L1 + anti-CTLA4 | 123 | 27 | 3 | Temporarily suspended | - | 14 | PR | Alive after 12.8, treatment ongoing |
| #5 | Male | 65 | HBV ° | Anti-PD-1 + targeted agent | 13 | 70 | 3 | Temporarily suspended | - | 12 | SD | Alive after 12.6, PD after 2.7 months |
| #6 | Male | 72 | HCV # | Anti-PD-1 + targeted agent | 92 | 14 | 3 | Permanently discontinued | - | 14 | SD | Died at 9.4 months, PD after 6.6 months |
| #7 | Male | 64 | HCV * | Anti-PD-L1 | 29 | 28 | 3 | Temporarily suspended | PDN 2 mg/kg | 2 | SD | Alive after 4.1 months, treatment ongoing |
| #8 | Female | 84 | HCV * | Anti-PD-1 + anti-CTLA4 | 103 | 20 | 3 | Temporarily suspended | - | 28 | PR | Died after 9.6 months |
| #9 | Female | 71 | HCV * | Anti-PD-L1 + anti-CTLA4 | 62 | 30 | 3 | Temporarily suspended | - | 28 | SD | Alive after 2.8 months, treatment ongoing |
Abbreviations: HCV, chronic hepatitis C; HBV, chronic hepatitis B; PD-L1, programmed cell death receptor ligand 1; PD-1, programmed cell death receptor; CTLA-4, cytotoxic T-lymphocyte-associated antigen 4; MP, methylprednisolone; PDN, prednisone; SD: stable disease; PR, partial response. * Detectable HCV RNA at screening and at hepatitis onset. # No detectable HCV RNA at screening. ° No detectable HBV DNA at screening (patient receiving antiviral therapy prior to study treatment).