Table 1.
Patient demographics, disease characteristics and prior treatment by initial sorafenib dose, Child-Pugh status and BCLC stage
| Total | Initial sorafenib dose* | Child-Pugh status†,‡ | BCLC stage†,§ | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 400 mg | 800 mg | A (< 7) | B (7–9) | C (> 9) | A | B | C | D | ||
| Patients, n (% of total) | 1571 (100) | 347 (22) | 1161 (74) | 957 (61) | 367 (23) | 35 (2) | 115 (7) | 298 (19) | 851 (54) | 92 (6) |
| Median age, years (range) | 62 (18–98) | 63 (19–89) | 62 (18–98) | 64 (18–94) | 61 (23–86) | 58 (39–82) | 67 (33–87) | 66 (25–98) | 60 (18–89) | 61 (33–82) |
| Gender, n (%) | ||||||||||
| Men | 1285 (82) | 279 (80) | 963 (83) | 790 (83) | 297 (81) | 29 (83) | 76 (66) | 238 (80) | 724 (85) | 72 (78) |
| Women | 286 (18) | 68 (20) | 198 (17) | 167 (17) | 70 (19) | 6 (17) | 39 (34) | 60 (20) | 127 (15) | 20 (22) |
| ECOG PS, n (%)†,¶ | ||||||||||
| 0 | 627 (40) | 106 (31) | 499 (43) | 478 (50) | 96 (26) | 5 (14) | 65 (57) | 178 (60) | 302 (36) | 23 (25) |
| 1 | 670 (43) | 170 (49) | 472 (41) | 370 (39) | 171 (47) | 19 (54) | 43 (37) | 98 (33) | 412 (48) | 29 (32) |
| ≥ 2 | 183 (12) | 44 (13) | 133 (11) | 68 (7) | 75 (20) | 10 (29) | 4 (4) | 19 (6) | 94 (11) | 40 (44) |
| TNM status, n (%)†,** | ||||||||||
| I | 105 (7) | 28 (8) | 62 (5) | 67 (7) | 25 (7) | 4 (11) | 63 (55) | 27 (9) | 7 (1) | 3 (3) |
| II | 177 (11) | 43 (12) | 124 (11) | 128 (13) | 34 (9) | 3 (9) | 30 (26) | 101 (34) | 27 (3) | 4 (4) |
| III | 534 (34) | 109 (31) | 417 (36) | 327 (34) | 142 (39) | 12 (34) | 14 (12) | 139 (47) | 322 (38) | 27 (29) |
| IV | 561 (36) | 129 (37) | 411 (35) | 352 (37) | 113 (31) | 12 (34) | 5 (4) | 13 (4) | 440 (52) | 52 (57) |
| Extrahepatic spread, n (%)† | 612 (39) | 141 (41) | 453 (39) | 382 (40) | 127 (35) | 11 (31) | 1 (1) | 5 (2) | 503 (59) | 50 (54) |
| Prior surgery, n (%) | 294 (19) | 66 (19) | 221 (19) | 218 (23) | 34 (9) | 1 (3) | 13 (11) | 59 (20) | 168 (20) | 7 (8) |
| Prior LRT, n (%)†† | 871 (55) | 221 (64) | 610 (53) | 585 (61) | 166 (45) | 9 (26) | 76 (66) | 178 (60) | 466 (55) | 36 (39) |
| Prior TACE, n (%) | 722 (46) | 183 (53) | 511 (44) | 485 (51) | 140 (38) | 7 (20) | 58 (50) | 151 (51) | 388 (46) | 29 (32) |
BCLC, Barcelona Clinic Liver Cancer; ECOG PS, Eastern Cooperative Oncology Group performance status; LRT, locoregional treatment; TACE, transarterial chemoembolisation; TNM, tumour node metastasis.
Data missing for eight patients; data not shown for 55 patients (4%) who received an initial dose of 100, 200 or 600 mg sorafenib.
Recorded at study entry (which is defined as start of therapy and is indicated by the initial visit).
Child-Pugh status unknown for five patients; 207 patients not evaluable and not tabulated.
Data missing for 13 patients; 202 patients not evaluable and not tabulated.
Data missing for 91 patients.
Data missing for 14 patients; 180 patients not evaluable and not tabulated.
Patients may have received more than one prior treatment. Other LRT received included radiofrequency ablation (15%), hepatic arterial infusion (5%), percutaneous ethanol injection (4%) and other (9%).