Table 1.
Characteristics of 125 Advanced BTC Patients Treated with GEMOX with or without Erlotinib
| ITT Population |
Mutation Analysis Population |
|||
|---|---|---|---|---|
| GEMOX (n = 133) | GEMOX Plus Erlotinib (n = 135) | GEMOX (n = 64) | GEMOX Plus Erlotinib (n = 61) | |
| Age, years | ||||
| Median | 61 (55-68) | 59 (54-66) | 61 (45-77) | 58 (39-77) |
| Sex | ||||
| Male | 79 (59%) | 91 (67%) | 42 (65.6%) | 39 (63.9%) |
| Female | 54 (41%) | 44 (33%) | 22 (34.4%) | 22 (36.1%) |
| Primary site | ||||
| Cholangiocarcinoma (intra-hepatic and extra-hepatic) | 84 (63%) | 96 (71%) | 43 (67.2%) | 44 (72.1%) |
| Gallbladder | 47 (35%) | 35 (26%) | 20 (31.3%) | 14 (23.0%) |
| AoV | 2 (2%) | 4 (3%) | 1 (1.6%) | 3 (4.9%) |
| Differentiation | ||||
| Well | 6 (5%) | 11 (8%) | 3 (4.7%) | 7 (11.5%) |
| Moderate | 92 (69%) | 91 (67%) | 36 (56.3%) | 28 (45.9%) |
| Poorly or unknown | 35 (26%) | 33 (24%) | 25 (39.1%) | 26 (42.6%) |
| EOCG performance status | ||||
| 0 | 20 (15%) | 26 (19%) | 5 (7.8%) | 7 (11.5%) |
| 1 | 100 (75%) | 104 (77%) | 56 (87.5%) | 54 (88.5%) |
| 2 | 13 (10%) | 5 (4%) | 1 (1.6%) | - |
| Disease status | ||||
| Recurrent | 23 (17%) | 31 (23%) | 16 (25.0%) | 22 (36.1%) |
| Primarily metastatic | 110 (83%) | 104 (77%) | 48 (75.0%) | 39 (63.9%) |
| Liver-only metastasis | ||||
| Yes | 46 (35%) | 42 (31%) | 13 (20.3%) | 10 (16.4%) |
| No | 87 (65%) | 93 (69%) | 51 (79.7%) | 51 (83.6%) |
| Number of metastatic sites | ||||
| 1 | 82 (62%) | 84 (62%) | 52 (81.3%) | 52 (85.2%) |
| 2 ≤ | 51 (38%) | 51 (38%) | 12 (18.8%) | 9 (14.7%) |