Table 4.
Treatment-Related Adverse Events.a,b
| Adverse event | FOLFOX-HAIC group (n = 55) | Sorafenib group (n = 59) | P value | |||
|---|---|---|---|---|---|---|
| Any grade | Grade 3-4 | Any grade | Grade 3-4 | Any grade | Grade 3-4 | |
| Total | 52 | 18 | 51 | 23 | .14 | .49 |
| Blood/bone marrow suppression | ||||||
| Neutropenia | 15 | 5 | 9 | 1 | .12 | .11 |
| Thrombocytopenia | 20 | 3 | 8 | 0 | .005 | .11 |
| Anemia | 22 | 3 | 18 | 2 | .29 | .67 |
| Cardiovascular system | ||||||
| Hypertension | 2 | 0 | 13 | 2 | .004 | .5 |
| Edema | 7 | 1 | 4 | 0 | .28 | .48 |
| Constitutional symptoms | ||||||
| Fatigue | 30 | 1 | 23 | 4 | .1 | .37 |
| Weight loss | 13 | 0 | 19 | 2 | .31 | .5 |
| Dermatologic events | ||||||
| Hand–foot skin reaction | 1 | 0 | 27 | 9 | <.001 | .003 |
| Alopecia | 2 | 0 | 14 | 0 | .002 | - |
| Rash | 2 | 0 | 16 | 2 | .001 | .5 |
| Gastrointestinal events | ||||||
| Nausea | 34 | 5 | 14 | 1 | <.001 | .11 |
| Vomiting | 32 | 7 | 12 | 1 | <.001 | .03 |
| Diarrhea | 20 | 1 | 24 | 3 | .64 | .62 |
| Abdominal pain | 22 | 2 | 2 | 0 | <.001 | .23 |
| Neurotoxicity | ||||||
| Sensory neuropathy | 21 | 0 | 0 | 0 | <.001 | - |
| Hepatic function | ||||||
| Elevated ALT | 33 | 4 | 40 | 6 | .82 | .74 |
| Elevated AST | 38 | 3 | 43 | 7 | .66 | .32 |
| Hyperbilirubinemia | 31 | 3 | 25 | 2 | .14 | .67 |
| Hypoalbuminemia | 40 | 2 | 20 | 0 | <.001 | .23 |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; FOLFOX-HAIC group, hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin group; Sorafenib group, sorafenib monotherapy group.
a
Data are expressed as n. The safety population comprised all randomized patients who received at least one dose of study treatment. P value was calculated by a 2-sided χ2 test.
b
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.