Table 2.
Baseline characteristics and immune checkpoint inhibitor (ICI)‐induced adverse events in cancer patients positive for hepatitis C virus (HCV)‐related markers
| HCV RNA‐positive (n = 5) | Anti‐HCV‐positive/HCV RNA‐negative (n = 21) | Negative for HBV‐ and HCV‐related markers (n = 820) | P‐value | |
|---|---|---|---|---|
| Age (years) | 73 (63–83) | 72 (53–83) | 67 (22–89) | 0.004 † |
| Sex: male/female | 5/0 | 13/8 | 538/282 | 0.299 |
| Platelets (× 104/μL) | 29.1 (13.2–41.1) | 20.4 (11.2–39.5) | 25.4 (13.9–69.8) | 0.072 |
| PT ‡ (%) | 98.0 (85–103) | 87 (72–105) | 95 (51–149) | 0.142 |
| AST (IU/L) | 28 (22–42) | 21 (11–40) | 21 (8–175) | 0.140 |
| ALT (IU/L) | 26 (12–32) | 13 (4–31) | 15 (4–95) | 0.075 |
| Total bilirubin (mg/dL) | 0.6 (0.4–0.7) | 0.5 (0.3–1.0) | 0.4 (0.2–2.8) | 0.332 |
| Albumin (g/dL) | 4.0 (3.8–4.3) | 3.7 (2.5–5.0) | 3.8 (2.3–5.1) | 0.346 |
| HCV RNA (log IU/mL) | 6.3 (5.2–6.8) | — | — | |
| Anti‐HCV treatment history (no treatment/IFN/DAA) | 5/0/0 | 19/1/1 | — | |
| Liver metastasis, with/without | 0/5 | 3/18 | 137/683 | 0.685 |
| Treatment regimen | 0.335 | |||
| Anti‐PD‐(L)1 monotherapy | 3 | 16 | 674 | |
| Anti‐PD‐(L)1 in combination with anti‐CTLA‐4 | 0 | 1 | 26 | |
| Anti‐PD‐(L)1 in combination with chemotherapy | 2 | 4 | 120 | |
| The number of ICI administrations | 5 (1–72) | 4 (1–32) | 5 (1–88) | 0.847 |
| Duration of ICI treatments, days | 248 (20–1170) | 146 (14–709) | 98 (14–1527) | 0.556 |
| Observation period, days | 491 (138–1350) | 259 (21–1058) | 245 (16–2044) | 0.540 |
| ICI‐induced liver injury | ||||
| Yes/no | 3/2 | 2/19 | 171/649 | 0.045 § |
| Gr. 2 or above | 2 | 2 | 66 | 0.059 |
| ICI‐induced adverse events except for liver injury | ||||
| Yes/no | 1/4 | 8/13 | 185/635 | 0.389 |
Post hoc analysis showed that the patients in the negative for HBV‐ and HCV‐related markers group were younger than the patients in the anti‐HCV‐positive/HCV RNA‐negative group (P = 0.005).
Thirty eight patients who are taking anticoagulants were excluded.
In post hoc analysis, there were no significant differences in any two groups' comparison.
Continuous variables are shown as median (range). Bold numbers indicate the P‐value <0.05. The details about ICI‐induced adverse events except for liver injury are shown in Table S6.
—, none; ALT, alanine aminotransferase; AST, aspartate transaminase; DAA, direct acting antiviral; IFN, interferon; PD, programmed cell death; PT, prothrombin time.