Patients with hepatic adverse events of all causality, including hepatobiliary events, liver-related investigations, liver-related infections, thrombocytopenia, ascites, encephalopathy, bacterial peritonitis and GI hemorrhage
| All patients (n=42) | ALBI grade at baseline | SIRT design | Tumor burden | |||||||||||||
| 1 (n=21) | 2 (n=21) | Sublobar (n=7) | Lobar (n=23) | Whole-liver (n=12) | BCLC-B2 (n=31) | Unilobar PVI (n=11) | ||||||||||
| n | % | n | % | n | % | n | % | n | % | n | % | n | % | n | % | |
| Any grade | 32 | 76.2 | 16 | 76.2 | 16 | 76.2 | 5 | 71.4 | 15 | 65.2 | 12 | 100.0 | 25 | 80.6 | 7 | 63.6 |
| Grade 3–4 | 9 | 21.4 | 2 | 9.5 | 7 | 33.3 | 2 | 28.6 | 4 | 17.4 | 3 | 25.0 | 7 | 22.6 | 2 | 18.2 |
| Resulting in nivolumab dose delay | 11 | 26.2 | 1 | 4.8 | 10 | 47.6 | 2 | 28.6 | 5 | 21.7 | 4 | 33.3 | 8 | 25.8 | 3 | 27.3 |
| Related to SIRT | 14 | 33.3 | 6 | 28.6 | 8 | 38.1 | 1 | 14.3 | 6 | 26.1 | 7 | 58.3 | 13 | 41.9 | 1 | 9.1 |
| Related to nivolumab | 7 | 16.7 | 2 | 9.5 | 5 | 23.8 | 1 | 14.3 | 3 | 13.0 | 3 | 25.0 | 6 | 19.4 | 1 | 9.1 |
| Type of event | ||||||||||||||||
| Increased AST/ALT* | 18 | 42.9 | 9 | 42.9 | 9 | 42.9 | 4 | 57.1 | 6 | 26.1 | 8 | 66.7 | 16 | 51.6 | 2 | 18.2 |
| Increased bilirubin† | 16 | 38.1 | 4 | 19.0 | 12 | 57.1 | 0 | 0.0 | 8 | 34.8 | 8 | 66.7 | 14 | 45.2 | 2 | 18.2 |
| Thrombocytopenia | 12 | 28.6 | 7 | 33.3 | 5 | 23.8 | 1 | 14.3 | 7 | 30.4 | 4 | 33.3 | 11 | 35.5 | 1 | 9.1 |
| Ascites | 4 | 9.5 | 0 | 0.0 | 4 | 19.0 | 0 | 0.0 | 3 | 13.0 | 1 | 8.3 | 2 | 6.5 | 2 | 18.2 |
| Bacterial peritonitis | 3 | 7.1 | 0 | 0.0 | 3 | 14.3 | 0 | 0.0 | 3 | 13.0 | 0 | 0.0 | 1 | 3.2 | 2 | 18.2 |
| Encephalopathy | 3 | 7.1 | 0 | 0.0 | 3 | 14.3 | 0 | 0.0 | 2 | 8.7 | 1 | 8.3 | 3 | 9.7 | 0 | 0.0 |
| Hepatic function abnormal | 2 | 4.8 | 0 | 0.0 | 2 | 9.5 | 0 | 0.0 | 1 | 4.3 | 1 | 8.3 | 0 | 0.0 | 2 | 18.2 |
| Liver abscess | 2 | 4.8 | 1 | 4.8 | 1 | 4.8 | 1 | 14.3 | 1 | 4.3 | 0 | 0.0 | 2 | 6.5 | 0 | 0.0 |
| Hematemesis | 1 | 2.4 | 0 | 0.0 | 1 | 4.8 | 0 | 0.0 | 0 | 0.0 | 1 | 8.3 | 1 | 3.2 | 0 | 0.0 |
| Hepatitis immune | 1 | 2.4 | 1 | 4.8 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 8.3 | 1 | 3.2 | 0 | 0.0 |
| Increased GGT | 1 | 2.4 | 1 | 4.8 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 1 | 8.3 | 1 | 3.2 | 0 | 0.0 |
| Non-tumoral portal vein thrombosis | 1 | 2.4 | 1 | 4.8 | 0 | 0.0 | 0 | 0.0 | 1 | 4.3 | 0 | 0.0 | 1 | 3.2 | 0 | 0.0 |
*Includes events of ‘increased AST’, ‘increased ALT’ or ‘hypertransaminasemia’.
†Includes events of ‘increased bilirubin’ or ‘hyperbilirubinemia’.
ALBI, Albumin-Bilirubin; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BCLC, Barcelona Clinic Liver Cancer; GGT, Gamma-glutamyl transpeptidase; GI, gastrointestinal; PVI, portal vein invasion; SIRT, selective internal radiation therapy.