Table 6.
Adverse event | Toripalimab plus HAIC (n = 53) | Lenvatinib (n = 65) | P-value | |||
---|---|---|---|---|---|---|
Any grade (%) | Grade 3 to 4 (%) | Any grade (%) | Grade 3 to 4 (%) | Any grade | Grade 3 to 4 | |
Neutropenia | 24 (45.3%) | 3 (5.7%) | 11 (16.9%) | 1 (1.5%) | 0.001 | 0.47 |
Thrombocytopenia | 16 (30.2%) | 2 (3.8%) | 10 (15.4%) | 1 (1.5%) | 0.054 | 0.86 |
Fatigue | 36 (67.9%) | 3 (5.7%) | 26 (40%) | 2 (3.1%) | <0.001 | 0.71 |
Hypertension | 2 (3.8%) | 0 | 23 (35.4%) | 7 (10.8%) | <0.001 | 0.02 |
Weight loss | 18 (34.0%) | 2 (3.8%) | 19 (29.2%) | 1 (1.5%) | 0.58 | 0.44 |
Hypothyroidism | 2 (3.8%) | 0 | 10 (15.4%) | 0 | 0.04 | − |
Hand–foot skin reaction | 0 | 0 | 15 (23.1%) | 2 (3.1%) | <0.001 | 0.50 |
Rash | 4 (7.5%) | 0 | 8 (12.3%) | 0 | 0.45 | − |
Nausea | 16 (30.2%) | 1 (1.9%) | 12 (18.5%) | 0 | 0.14 | 0.92 |
Vomiting | 14 (26.4%) | 2 (3.8%) | 11 (16.9%) | 1 (1.5%) | 0.21 | 0.59 |
Diarrhea | 14 (26.4%) | 1 (1.9%) | 23 (35.4%) | 2 (3.1%) | 0.3 | 1.00 |
Abdominal pain | 17 (32.1%) | 2 (3.8%) | 12 (18.5%) | 0 | 0.09 | 0.2 |
Sensory neuropathy | 17 (32.1%) | 0 | 0 | 0 | <0.001 | − |
Proteinuria | 7 (13.2%) | 1 (1.9%) | 15 (23.1%) | 2 (3.1%) | 0.17 | 1.00 |
Elevated ALT | 36 (67.9%) | 6 (7.5%) | 19 (29.2%) | 2 (3.1%) | <0.001 | 0.14 |
Elevated AST | 38 (71.7%) | 7 (13.2) | 23 (35.4%) | 3 (4.6%) | <0.001 | 0.18 |
Hyperbilirubinemia | 20 (37.8%) | 2 (3.8%) | 17 (26.2%) | 1 (1.5%) | 0.18 | 0.59 |
Hypoalbuminemia | 37 (69.8%) | 1 (1.9%) | 3 (3.4%) | 0 | <0.001 | 0.92 |
Abbreviations: HAIC, hepatic arterial infusion chemotherapy; ALT, alanine aminotransferase; AST, aspartate aminotransferase.
P-value was calculated by a 2-sided chi-square test.
Listed are adverse events, as defined by the National Cancer Institute Common Terminology Criteria (version 4.03), that occurred in at least 10% of patients in either study group.