Table 2.
Summary of sorafenib administration by initial sorafenib dose, Child-Pugh status and BCLC stage
| Sorafenib administration | Total (n = 1571) | Initial sorafenib dose | Child-Pugh status*,† | BCLC stage*,‡ | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 400 mg (n = 347) | 800 mg (n = 1161) | A (< 7) (n = 957) | B (7) (n =196) | B (8) (n = 96) | B (9) (n = 69) | B (7–9) (n = 367) | C (> 9) (n = 35) | A (n = 115) | B (n = 298) | C (n = 851) | D (n = 92) | ||
| Duration of treatment ≤ 4 weeks, n (%)§,¶ | 265 (17) | 69 (20) | 183 (16) | 120 (13) | 43 (22) | 21 (22) | 20 (29) | 86 (23) | 16 (46) | 15 (13) | 26 (9) | 150 (18) | 27 (29) |
| Median treatment duration, weeks | 11.7 | 9.7 | 12.3 | 13.7 | 9.0 | 8.5 | 6.7 | 8.6 | 4.1 | 19.6 | 16.3 | 10.1 | 7.2 |
| Median daily dose, mg**,†† | 693.0 | 400.0 | 800.0 | 680.0 | 718.0 | 729.0 | 749.0 | 721.0 | 679.5 | 696.5 | 669.0 | 718.0 | 800.0 |
| Initial dose of 800 mg/day, n (%)‡‡ | 1161 (74) | NA | 1161 (100) | 733 (77) | 143 (73) | 66 (69) | 46 (67) | 260 (71) | 24 (69) | 77 (67) | 227 (76) | 659 (77) | 67 (73) |
BCLC, Barcelona Clinic Liver Cancer; NA, not available.
At start of therapy.
Child-Pugh status unknown for five patients; 207 patients not evaluable and not tabulated; six patients documented as having Child-Pugh B but specific score not recorded.
Data missing for 13 patients; 202 patients not evaluable and not tabulated.
Time in weeks from initial visit to last dosing date (for ongoing patients to last visit date) +1.
1283 patients received > 4 weeks of sorafenib treatment and data missing for 23 patients.
Determined within patient based on actual days on study drug (interruptions excluded).
Based on 1243 patients.
402 patients received ≤ 600 mg/day and data missing for eight patients.