Table 3.
Adverse Events | RT+S+L (n = 39) | S+L (n = 105) | ||
---|---|---|---|---|
Grade 1/2.n (%) | Grade 3/4. n (%) | Grade 1/2.n (%) | Grade 3/4. n (%) | |
Any treatment-emergent adverse event | 21 (53.8%) | 17 (43.6%) | 51 (48.6%) | 42 (40.0%) |
Elevated TB | 15 (38.5%) | 4 (10.3%) | 31 (29.5%) | 8 (7.6%) |
Fatigue | 15 (38.5%) | 1 (2.6%) | 35 (33.3%) | 1 (1.0%) |
Elevated AST | 14 (35.9%) | 3 (7.7%) | 29 (27.6%) | 7 (6.7%) |
Proteinuria | 14 (35.9%) | 4 (10.3%) | 28 (26.7%) | 9 (8.6%) |
Decreased PLT | 13 (33.3%) | 5 (12.8%) | 28 (26.7%) | 10 (9.5%) |
Elevated ALT | 12 (30.8%) | 2 (5.1%) | 27 (25.7%) | 7 (6.7%) |
Hypertension | 9 (23.1%) | 7 (17.9%) | 24 (22.9%) | 16 (15.2%) |
Pyrexia | 9 (23.1%) | 1 (2.6%) | 20 (19.0%) | 4 (3.8%) |
Hypoalbuminaemia | 8 (20.5%) | 1 (2.6%) | 17 (16.2%) | 2 (1.9%) |
Bleeding (gingiva) | 7 (17.9%) | 0 (0.0%) | 16 (15.2%) | 0 (0.0%) |
Diarrhea | 5 (12.8%) | 1 (2.6%) | 14 (13.3%) | 2 (1.9%) |
Anaemia | 5 (12.8%) | 3 (7.7%) | 14 (13.3%) | 5 (4.8%) |
Hypothyroidism | 4 (10.3%) | 0 (0.0%) | 13 (12.4%) | 0 (0.0%) |
Gastrointestinal hemorrhage | 3 (7.7%) | 1 (2.6%) | 7 (6.7%) | 1 (1.0%) |
Hand-foot skin reaction | 3 (7.7%) | 1 (2.6%) | 7 (6.7%) | 1 (1.0%) |
Elevated creatinine | 3 (7.7%) | 1 (2.6%) | 7 (6.7%) | 0 (0.0%) |
Rash | 3 (7.7%) | 0 (0.0%) | 6 (5.7%) | 0 (0.0%) |
Abbreviations: RT+S+L, radiotherapy combine with sintilimab plus lenvatinib; S+L, sintilimab plus lenvatinib; PLT, platelet; AST, aspartate transaminase; ALT, alanine aminotransferase; TB, total bilirubin.