Table 2.
Safety data
| Characteristics | No. (%) (n = 27) |
|---|---|
| Regorafenib AE | |
| HFRS (All grades) | 18 (66.7%) |
| Grade 1 | 6 (22.2%) |
| Grade 2 | 10 (37.0%) |
| Grade 3 | 2 (7.4%) |
| Hepatic dysfunction | 10 (37.0%) |
| Hypertension | 7 (25.9%) |
| Erythema multiforme | 3 (11.1%) |
| Nephropathy/proteinuria | 3 (11.1%) |
| Thrombocytopenia | 2 (7.4%) |
| Fatigue | 2 (7.4%) |
| Maculopapular drug eruption | 1 (3.7%) |
| Diarrhea | 1 (3.7%) |
| High fever | 1 (3.7%) |
| Nosebleed | 1 (3.7%) |
| Aluminum chloride AE | |
| Irritation (All grades) | 13 (48.1%) |
| Grade 1 | 9 (33.3%) |
| Grade 2 | 4 (14.8%) |
| Dry skin (All grades) | 16 (59.2%) |
| Grade 1 | 15 (55.6%) |
| Grade 2 | 1 (3.7%) |
| Duration of study treatment, median (range), weeks | 7.3 (2.1–12.0) |
| Study treatment | |
| Complete | 6 (22.2%) |
| Discontinue | 21 (77.8%) |
| Interruption | |
| Yes | 22 (81.4%) |
| No | 5 (18.5%) |
| Dose reduction | |
| Yes | 4 (14.8%) |
| No | 23 (85.2%) |
| Patients who continued regorafenib with neither dosage reduction nor interruption during first cycle | |
| Day 8 | 23 (85.2%) |
| Day 15 | 14 (51.8%) |
| Day 22 | 12 (44.4%) |
Abbreviations: AE, adverse event; HFSR, hand-foot syndrome