Table 5.
Comparison of Japanese and European populations from clinical studies of regorafenib
| Japan phase I study | European phase I study [5] | European phase II study [7] | |
|---|---|---|---|
| Patients (n) | 15 | 12a | 49 |
| Age (years) | |||
| Median (range) | 59 (34–68) | 60 (20–77)b | 62 (40–76) |
| European Cooperative Oncology Group performance status | 0–1 | 0–2b | 0–1 |
| Disease status | Advanced solid tumors | Advanced solid tumors | Advanced renal cell carcinoma |
| Treatment history | 0–4 previous systemic treatments | Previously treated | Untreated |
| Adverse events (%) | |||
| All grades (grade 3/4) | |||
| Hand–foot skin reaction | 67 (13) | 67 (25) | 71 (33) |
| Diarrhea | 67 (7) | 50 (17) | 45 (10) |
| Voice changes/hoarseness | 33 (0) | 42 (0) | 35 (0) |
| Hypertension | 33 (0) | 50 (17) | 49 (6) |
| Fatigue | 33 (0) | 17 (0) | 53 (8) |
| Alopecia | 40 (0) | 33 (0) | 45 (0) |
| Rash | 27 (0) | 50 (8) | 39 (6) |
| Anorexia | 33 (0) | 50 (8) | 29 (6) |
| Incidence of biochemical toxicities occurring at any time after start of study treatment, whether or not they were reported as an adverse event or related to study drug (%) | |||
| All grades (grade 3/4) | |||
| AST | 87 (20) | 75 (25) | 41 (2) |
| ALT | 87 (20) | 75 (25) | 39 (2) |
AST aspartate aminotransferase, ALT alanine aminotransferase
a160 mg cohort only
bIncludes 53 patients in all dose cohorts