Table 4. Toxicity comparison of intermittent vs continuous dose schedule.
| DL 4, 5A, 5B (N=17) | DL 1, 2 (N=39) | |
|---|---|---|
| Toxicity grade G2–4 | No. of patients (%) | |
| Diarrhoea | 4/17 (24) | 7/39 (20) |
| Fatigue | 3/17 (18) | 15/39 (38) |
| Fistula | 1/17 (6) | 2/39 (5) |
| Mucositisa | 5/17 (29) | NA |
| Skin rashes | ||
| HFSRb | 8a/17 (47) | 23/39 (59) |
| Otherc | 2 | |
| Hypertension | 10/17 (59) | 26/39 (67) |
| Perforation | 1/17 (6) | 1/39 (3) |
| Proteinuria | 2/17 (12) | 6/39 (15) |
| Thrombocytopaenia | 0/17 (0) | 2/39 (5) |
| Thrombosis | 2/17 (12) | 3/39 (8) |
| Transaminitis | 4/17 (24) | 13/39 (33) |
DLs=dose levels; HFSR=hand–foot skin reaction; NA=not applicable.
a
One patient had mouth, tongue, throat, and anal mucositis.
b
Although the numbers are small, when the difference in HFSR is compared between those receiving intermittent and continuous sorafenib schedules using the χ2-test, P=0.08.
c
Ear and perirectal desquamation and rashes (separate patient with HFSR).