Table 5.
Treatment-related adverse events, dose reductions, and discontinuations.
| Study group (TACE+RFA-S: n = 40) | Control group (TACE-S: n = 40) | |||
|---|---|---|---|---|
| All | Grade 3/4 | All | Grade 3/4 | |
| Drug-related, n (%)* | ||||
| AST elevation | 39 (97.5) | 11 (27.5) | 38 (95.0) | 8 (20.0) |
| ALT elevation | 39 (97.5) | 10 (25.0) | 37 (92.5) | 8 (20.0) |
| Fever | 25 (62.5) | 5 (12.5) | 27 (67.5) | 5 (12.5) |
| Anorexia | 25 (62.5) | 0 | 23 (57.5) | 0 |
| Abdominal pain | 22 (55.0) | 5 (12.5) | 21 (52.5) | 4 (10.0) |
| HFSR | 18 (45.0) | 0 | 20 (50.0) | 0 |
| Hypertension | 15 (37.5) | 0 | 17 (42.5) | 0 |
| Fatigue | 15 (37.5) | 0 | 15 (37.5) | 0 |
| Diarrhea | 14 (35.0) | 2(5.0) | 10 (25.0) | 1 (2.5) |
| Weight loss | 13 (32.5) | 0 | 11 (27.5) | 0 |
| Rash/desquamation | 9 (22.5) | 0 | 11 (27.5) | 0 |
| Bilirubin elevation | 6 (15.0) | 2(5.0) | 5 (12.5) | 1 (2.5) |
| Proteinuria | 3 (7.5) | 0 | 5 (12.5) | 0 |
| Dose reduction† | 12 (30.0) | 10 (25.0) | ||
| HFSR | 7 (17.5) | – | 8 (20.0) | – |
| Diarrhea | 3 (7.5) | 2 (5.0) | 2 (5.0) | 1 (2.5) |
| Fatigue | 2 (5.0) | – | 0 | – |
| Discontinuation‡ | 4 (10.0) | 3 (7.5) | ||
| Hemorrhage, upper GI | 2 (5.0) | 1 (2.5) | ||
| Diarrhea | – | 1 (2.5) | – | 1 (2.5) |
| Grade 3 platelet decrease | – | 1 (2.5) | – | – |
| Fatigue | – | – | 1(2.5) | – |
Data are numbers of patients, with percentages in parentheses.
*Drug-related adverse events in ≥10% of participants in any study group.
†Adverse events causing dose reduction in ≥5% of participants in either study group.
‡Adverse events causing discontinuation in ≥2.5% of participants in either study group.
RFA, radiofrequency ablation; TACE, transarterial chemoembolization; S, sorafenib; ALT, alanine transaminase; AST, aspartate transaminase; HFSR, hand-foot skin reaction; GI, gastrointestinal tract.
All of the p values > 0.10.