Table 1.
Patient demographics and baseline clinical characteristics (safety-assessable population)
| Parameter | FGFR2 fusions or rearrangements (n = 108) | Other FGF/FGFR alterations (n = 20) | No FGF/FGFR alterations (n = 17) | Total (N = 147)a |
|---|---|---|---|---|
| Age, median (range), years | 55.5 (26-77) | 63.0 (45-78) | 65.0 (49-78) | 59.0 (26-78) |
| <65, n (%) | 83 (76.9) | 10 (50.0) | 6 (35.3) | 101 (68.7) |
| 65-<75, n (%) | 20 (18.5) | 7 (35.0) | 8 (47.1) | 35 (23.8) |
| ≥75, n (%) | 5 (4.6) | 3 (15.0) | 3 (17.6) | 11 (7.5) |
| Sex, n (%) | ||||
| Female | 66 (61.1) | 11 (55.0) | 7 (41.2) | 85 (57.8) |
| Male | 42 (38.9) | 9 (45.0) | 10 (58.8) | 62 (42.2) |
| Region, n (%) | ||||
| North America | 64 (59.3) | 6 (30.0) | 17 (100.0) | 89 (60.5) |
| Western Europe | 32 (29.6) | 3 (15.0) | 0 | 35 (23.8) |
| Rest of worldb | 12 (11.1) | 11 (55.0) | 0 | 23 (15.6) |
| Race, n (%) | ||||
| White | 79 (73.1) | 9 (45.0) | 14 (82.4) | 104 (70.7) |
| Asian | 12 (11.1) | 11 (55.0) | 0 | 23 (15.6) |
| Black/African American | 7 (6.5) | 0 | 1 (5.9) | 8 (5.4) |
| American Indian/Alaska native | 0 | 0 | 1 (5.9) | 1 (0.7) |
| Other/missing | 10 (9.3) | 0 | 1 (5.9) | 11 (7.5) |
| Time since initial diagnosis, median (range), years | 1.3 (0.2-11.1) | 0.7 (0.2-2.5) | 1.0 (0.3-4.3) | 1.1 (0.2-11.1) |
| ECOG performance status, n (%) | ||||
| 0 | 46 (42.6) | 7 (35.0) | 6 (35.3) | 60 (40.8) |
| 1 | 57 (52.8) | 10 (50.0) | 8 (47.1) | 76 (51.7) |
| 2 | 5 (4.6) | 3 (15.0) | 3 (17.6) | 11 (7.5) |
| Metastatic disease,cn (%) | ||||
| Yes | 89 (82.4) | 20 (100.0) | 16 (94.1) | 126 (85.7) |
| No | 16 (14.8) | 0 | 1 (5.9) | 18 (12.2) |
| Missing or not evaluable | 3 (2.8) | 0 | 0 | 3 (2.0) |
| Prior systemic therapies, n (%) | ||||
| 1 | 65 (60.2) | 12 (60.0) | 11 (64.7) | 89 (60.5) |
| 2 | 30 (27.8) | 7 (35.0) | 2 (11.8) | 39 (26.5) |
| ≥3 | 13 (12.0) | 1 (5.0) | 4 (23.5) | 19 (12.9) |
| Prior cancer surgery, n (%) | 38 (35.2) | 6 (30.0) | 4 (23.5) | 48 (32.7) |
| Prior radiation, n (%) | 29 (26.9) | 3 (15.0) | 5 (29.4) | 37 (25.2) |
| CCA location, n (%) | ||||
| Intrahepatic | 107 (99.1) | 13 (65.0) | 10 (58.8) | 132 (89.8) |
| Extrahepatic | 1 (0.9) | 4 (20.0) | 7 (41.2) | 12 (8.2) |
| Other | 0 | 3 (15.0) | 0 | 3 (2.0) |
| History of hepatitis, n (%) | ||||
| Hepatitis B | 4 (3.7) | 1 (5.0) | 0 | 5 (3.4) |
| Hepatitis C | 1 (0.9) | 1 (5.0) | 0 | 2 (1.4) |
| Sites of disease at baseline, n (%)d | ||||
| Liver | 102 (94.4) | 17 (85.0) | 17 (100.0) | 138 (93.9) |
| Lymph nodes | 58 (53.7) | 11 (55.0) | 10 (58.8) | 80 (54.4) |
| Lung | 59 (54.6) | 9 (45.0) | 10 (58.8) | 78 (53.1) |
| Bone | 21 (19.4) | 4 (20.0) | 2 (11.8) | 27 (18.4) |
| Ascites | 8 (7.4) | 5 (25.0) | 2 (11.8) | 15 (10.2) |
| Pancreas | 7 (6.5) | 1 (5.0) | 2 (11.8) | 11 (7.5) |
CCA, cholangiocarcinoma; ECOG, Eastern Cooperative Oncology Group; FGF, fibroblast growth factor; FGFR, FGF receptor.
a
Total number includes two patients who did not have confirmed FGF/FGFR status by central laboratory testing and were not assigned to any cohort.
b
Rest of the world includes Israel, Japan, Republic of Korea, Taiwan, and Thailand.
c
Patients with nonmetastatic disease have no evidence of extrahepatic metastasis. Patients with metastatic disease may have had intrahepatic and extrahepatic metastases.
d
Specific sites reported in >5% of patients overall are shown.