Table 1.
Background of eight cancer patients with ir‐hepatitis who underwent MMF treatment
| Overall | Good responders | Poor responders | P‐value | |
|---|---|---|---|---|
| Number of cases | 8 | 4 | 4 | — |
| Age (years) | 60 (27–72) † | 64 (50–69) | 53 (27–72) | 0.387 |
| Sex (male/female) | 7/1 | 4/0 | 3/1 | 1.000 |
| Type of malignancy (renal cell carcinoma/malignant melanoma/non‐small‐cell lung cancer) | 5/2/1 | 3/1/0 | 2/1/1 | 0.549 |
| History of chronic liver disease (yes/no) | 0/8 | 0/4 | 0/4 | 1.000 |
| ICI that caused ir‐hepatitis (nivolumab/ipilimumab + nivolumab/pembrolizumab) | 3/3/2 | 2/2/0 | 1/1/2 | 0.264 |
| Duration of ICI treatment (days) | 53 (21–582) | 84 (21–582) | 42.5 (21–309) | 0.554 |
| Time from the commencement of ICI treatment to the onset of ir‐hepatitis (days) | 63 (4–721) | 134.5 (19–691) | 55 (4–721) | 0.772 |
| At baseline | ||||
| T‐Bil (mg/dL) | 0.5 (0.3–0.7) | 0.4 (0.3–0.6) | 0.5 (0.3–0.7) | 0.448 |
| AST (IU/L) | 21.5 (17–58) | 49 (20–58) | 20 (17–26) | 0.169 |
| ALT (IU/L) | 54.5 (12–330) | 89 (25–103) | 28 (12–330) | 0.655 |
| ALP (IU/L) | 230 (187–450) | 276 (201–450) | 230 (187–264) | 0.177 |
| At onset of ir‐hepatitis | ||||
| T‐Bil (mg/dL) | 1.25 (0.6–2.7) | 1.7 (0.6–2.7) | 1.0 (0.7–1.9) | 0.387 |
| AST (IU/L) | 345 (99–1243) | 345 (99–686) | 318 (128–1243) | 0.773 |
| ALT (IU/L) | 404 (116–1136) | 337.5 (202–606) | 423 (116–1136) | 0.564 |
| ALP (IU/L) | 829.5 (235–2370) | 1468 (638–2370) | 614 (235–927) | 0.083 |
| CTCAE grade of liver injury (3/4) | 6/2 | 3/1 | 3/1 | 1.000 |
| Duration from the onset of ir‐hepatitis to initial MMF administration (days) | 14.5 (2–42) | 3 (2–15) | 25.5 (14–42) | 0.042 |
| Starting dose of MMF (500 mg/1000 mg/2000 mg) | 1/1/6 | 1/0/3 | 0/1/3 | 0.368 |
| Duration of MMF administration (days) | 59 (29–90) | 45.5 (30–69) | 77 (29–90) | 0.248 |
†
Data expressed as median (range).
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate transaminase; CTCAE, Common Terminology Criteria for Adverse Events; ICI, immune checkpoint inhibitor, ir‐hepatitis, immune‐related hepatitis; MMF, mycophenolate mofetil; T‐Bil, total bilirubin.