Table 2.
Tumor and disease characteristics of US patients enrolled in GIDEON at diagnosis and at the start of sorafenib by TACE subgroup
| n (%) | At Diagnosis |
At Start of Sorafenib Therapy |
||||||
|---|---|---|---|---|---|---|---|---|
| No TACE n=318 | Group A Prior TACE n=158 | Group B Concomitant TACE n=29 | Group C Prior and Concomitant TACE n=38 | No TACE n=318 | Group A Prior TACE n =158 | Group B Concomitant TACE n=29 | Group C Prior and Concomitant TACE n=38 | |
| Child-Pugh scorea | ||||||||
| A | 113 (36) | 56 (35) | 6 (21) | 17 (45) | 105 (33) | 56 (35) | 10 (34) | 14 (37) |
| B | 99 (31) | 31 (22) | 9 (31) | 9 (24) | 101 (32) | 45 (29) | 10 (34) | 14 (37) |
| C | 31 (10) | 8 (5) | 2 (7) | 1 (3) | 27 (9) | 9 (6) | 4 (14) | 1 (3) |
| UK/NE | 75 (24) | 60 (38) | 12 (41) | 11 (29) | 85 (27) | 48 (30) | 5 (17) | 8 (21) |
| BCLC stagea,b | ||||||||
| A | 30 (9) | 43 (27) | 8 (28) | 11 (29) | 14 (4) | 27 (17) | 7 (24) | 7 (18) |
| B | 33 (10) | 19 (12) | 3 (10) | 7 (18) | 34 (11) | 19 (12) | 4 (14) | 8 (21) |
| C | 112 (35) | 23 (15) | 1 (3) | 7 (18) | 139 (44) | 45 (29) | 5 (17) | 10 (26) |
| D | 22 (7) | 7 (4) | 2 (7) | 1 (3) | 40 (13) | 18 (11) | 4 (14) | 2 (5) |
| UK/NE | 104 (33) | 55 (35) | 11 (38) | 10 (26) | 91 (29) | 49 (31) | 9 (31) | 10 (26) |
| Portal vein thrombosisc | 93 (29) | 17 (11) | 6 (21) | 4 (11) | 92 (29) | 33 (21) | 7 (24) | 7 (18) |
| Number of lesionsd | ||||||||
| 1-3 | 202 (64) | 122 (77) | 22 (76) | 27 (71) | 171 (54) | 92 (58) | 22 (76) | 27 (71) |
| >3 | 101 (32) | 29 (18) | 6 (21) | 10 (26) | 115 (36) | 52 (33) | 7 (24) | 10 (26) |
| AFPe, ng/mL | ||||||||
| <400 | 151 (48) | 81 (51) | 13 (45) | 21 (55) | 152 (48) | 78 (49) | 15 (52) | 24 (63) |
| ≥400 | 112 (35) | 39 (25) | 11 (38) | 8 (21) | 109 (34) | 54 (34) | 11 (38) | 6 (16) |
| Extrahepatic spread | NR | NR | NR | NR | 112 (35) | 45 (29) | 4 (14) | 5 (13) |
Data refer to the safety population (n=563).
a
Missing for 1 patient at the start of therapy.
b
Missing for 35 patients at diagnosis.
c
Unknown 121 patients at diagnosis and 94 patients at the start of therapy (data missing for 1).
d
Missing for 24 patients at diagnosis and 49 patients at the start of therapy.
e
Unknown for 114 patients at diagnosis and 97 patients at the start of therapy. AFP=alpha-fetoprotein; NR=not recorded; UK/NE=unknown or not evaluable.