Table 3.
Treatment-related adverse events*.
| Adverse event | SoraOXA group (n = 46) |
Sorafenib group (n = 58) |
P value |
|||
|---|---|---|---|---|---|---|
| Any grade | Grades 3–4 | Any grade | Grades 3–4 | Any grade | Grades 3–4 | |
| Overall incidence | 40 | 20 | 49 | 27 | 0.79 | 0.84 |
| Blood/bone marrow suppression | ||||||
| Neutropenia | 19 | 3 | 17 | 2 | 0.67 | 0.65 |
| Thrombocytopenia | 21 | 4 | 25 | 2 | 0.84 | 0.4 |
| Anemia | 22 | 1 | 21 | 1 | 0.32 | 0.75 |
| Systemic toxicity | ||||||
| Hypertension | 10 | 1 | 16 | 2 | 0.65 | 1.00 |
| Edema | 7 | 1 | 5 | 1 | 0.36 | 1.00 |
| Fatigue | 27 | 1 | 25 | 1 | 0.17 | 1.00 |
| Weight loss | 14 | 0 | 19 | 1 | 0.84 | 1.00 |
| Sensory neuropathy | 15 | 0 | 2 | 0 | <0.001 | – |
| Dermatologic events | ||||||
| Hand–foot skin reaction | 18 | 4 | 24 | 7 | 0.84 | 0.75 |
| Alopecia | 6 | 0 | 10 | 0 | 0.6 | – |
| Rash | 7 | 0 | 11 | 1 | 0.8 | 1.00 |
| Gastrointestinal events | ||||||
| Nausea | 21 | 3 | 19 | 1 | 0.23 | 0.32 |
| Vomiting | 16 | 1 | 12 | 0 | 0.12 | 0.44 |
| Diarrhea | 12 | 3 | 17 | 6 | 0.83 | 0.73 |
| Hepatic function | ||||||
| Elevated ALT | 27 | 5 | 36 | 7 | 0.84 | 1.00 |
| Elevated AST | 30 | 5 | 33 | 8 | 0.43 | 0.77 |
| Hyperbilirubinemia | 21 | 1 | 31 | 1 | 0.55 | 1.00 |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.
SoraOXA group = sorafenib plus hepatic arterial infusion of oxaliplatin. Sorafenib group = sorafenib monotherapy group.
P value was calculated by a two-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.