Table 6.
Adverse events | Any Grade | Grade 3/4 | ||||
---|---|---|---|---|---|---|
Combination Group (n = 56) | TACE Group (n = 54) | P value | Combination Group (n = 56) | TACE Group (n = 54) | P value | |
Treatment-related AEs, n (%) | ||||||
Hypertension | 25 (44.6) | 0 | <0.001 | 10 (17.9) | 0 | 0.003 |
Weight loss | 20 (35.7) | 8 (14.8) | 0.012 | 3 (5.4) | 1 (1.9) | 0.637 |
Diarrhea | 17 (30.4) | 0 | <0.001 | 2 (3.6) | 0 | 0.492 |
Appetite decreased | 16 (28.6) | 2 (3.7) | <0.001 | 2 (3.6) | 0 | 0.492 |
Fatigue | 20 (35.7) | 3 (5.6) | <0.001 | 2 (3.6) | 0 | 0.492 |
Rash | 7 (12.5) | 0 | 0.022 | 0 | 0 | – |
HFSR | 12 (21.4) | 0 | <0.001 | 0 | 0 | – |
Pruritus | 6 (10.7) | 0 | 0.040 | 0 | 0 | – |
Hypothyroidism | 5 (8.9) | 0 | 0.074 | 0 | 0 | – |
Gum bleeding | 3 (5.4) | 0 | 0.255 | 0 | 0 | – |
Constipation | 8 (14.3) | 2 (3.7) | 0.110 | 0 | 0 | – |
Diabete | 2 (3.6) | 0 | 0.492 | 0 | 0 | – |
Biloma | 0 | 2 (3.7) | 0.459 | 0 | 2 (3.7) | 0.459 |
Arthralgia | 3 (5.4) | 0 | 0.255 | 0 | 0 | – |
Hoarseness | 4 (7.1) | 0 | 0.136 | 0 | 0 | – |
laboratory-related AEs, n (%) | ||||||
Proteinuria | 10 (17.9) | 0 | 0.003 | 0 | 0 | – |
Decreased WBC | 20 (35.7) | 7 (13.3) | 0.006 | 3 (5.4) | 1 (1.9) | 0.637 |
Decreased PLT | 23 (41.1) | 12 (22.2) | 0.034 | 3 (5.4) | 1 (1.9) | 0.637 |
Elevated TB | 9 (16.1) | 12 (22.2) | 0.412 | 1 (1.8) | 2 (3.7) | 0.975 |
Decreased ALB | 25 (44.6) | 21 (38.9) | 0.541 | 2 (3.6) | 2 (3.7) | 1.000 |
Elevated ALT | 16 (28.6) | 20 (37.0) | 0.344 | 1 (1.8) | 3 (5.6) | 0.585 |
Elevated AST | 19 (33.9) | 24 (44.4) | 0.258 | 1 (1.8) | 3 (5.6) | 0.585 |
Elevated GGT | 15 (26.8) | 20 (37.0) | 0.249 | 0 | 3 (5.6) | 0.229 |
Elevated Cr | 2 (3.6) | 0 | 0.492 | 0 | 0 | – |
p-value was calculated by a two-sided Chi-square test.
HFSR, hand-foot skin reaction; WBC, white blood cell; PLT, platelet; TB, total bilirubin; ALB, albumin; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase; Cr, creatinine.