Table 1:
Baseline demographics and disease characteristics
| FGFR2 fusions or rearrangements (n=107) | Other FGF/FGFR alterations (n=20) | No FGF/FGFR alterations (n=18) | All patients (N=146)* | |
|---|---|---|---|---|
| Age, median (range), years | 56 (26 to 77) | 63 (45 to 78) | 65 (31 to 78) | 59 (26 to 78) |
| <65 | 82 (77%) | 10 (50%) | 7 (39%) | 100 (68%) |
| 65 to <75 | 20 (19%) | 7 (35%) | 8 (44%) | 35 (24%) |
| ≥75 | 5 (5%) | 3 (15%) | 3 (17%) | 11 (8%) |
| Sex | ||||
| Male | 42 (39%) | 9 (45%) | 10 (56%) | 62 (42%) |
| Female | 65 (61%) | 11 (55%) | 8 (44%) | 84 (58%) |
| Region | ||||
| North America | 64 (60%) | 6 (30%) | 18 (100%) | 89 (61%) |
| Western Europe | 32 (30%) | 3 (15%) | 0 | 35 (24%) |
| Rest of world† | 11 (10%) | 11 (55%) | 0 | 22 (15%) |
| Race | ||||
| White | 79 (74%) | 9 (45%) | 15 (83%) | 104 (71%) |
| Asian | 11 (10%) | 11 (55%) | 0 | 22 (15%) |
| Black or African American | 7 (7%) | 0 | 1 (6%) | 8 (6%) |
| American Indian or Alaska | 0 | 0 | 1 (6%) | 1 (1%) |
| Native | ||||
| Other or data missing | 10 (9%) | 0 | 1 (6%) | 11 (8%) |
| ECOG performance status | ||||
| 0 | 45 (42%) | 7 (35%) | 7 (39%) | 59 (40%) |
| 1 | 57 (53%) | 10 (50%) | 8 (44%) | 76 (52%) |
| 2 | 5 (5%) | 3 (15%) | 3 (17%) | 11 (8%) |
| Metastatic disease | ||||
| Yes | 88 (82%) | 20 (100%) | 16 (89%) | 125 (86%) |
| No | 16 (15%) | 0 | 2 (11%) | 18 (12%) |
| Missing or not evaluable | 3 (3%) | 0 | 0 | 3 (2%) |
| Number of previous systemic therapies for advanced metastatic disease‡ | ||||
| l | 65 (61%) | 12 (60%) | 12 (67%) | 89 (61%) |
| 2 | 29 (27%) | 7 (35%) | 2 (11%) | 38 (26%) |
| ≥3 | 13 (12%) | 1 (5%) | 4 (22%) | 19 (13%) |
| Previous cancer surgery | 38 (36%) | 6 (30%) | 4 (22%) | 48 (33%) |
| Previous radiotherapy | 28 (26%) | 3 (15%) | 5 (28%) | 36 (25%) |
| Cholangiocarcinoma location§ | ||||
| Intrahepatic | 105 (98%) | 13 (65%) | 11 (61%) | 130 (89%) |
| Extrahepatic | 1 (1%) | 4 (20%) | 7 (39%) | 12 (8%) |
| Other or data missing | l (l%)§ | 3 (15%)¶ | 0 | 4 (3%) |
| History of hepatitis | ||||
| Hepatitis B | 4 (4%) | 1 (5%) | 0 | 5 (3%) |
| Hepatitis C | 1 (1%) | 1 (5%) | 0 | 2 (1%) |
| Sites of disease | ||||
| Liver | 101 (94%) | 17 (85%) | 18 (100%) | 136 (93%) |
| Lymph nodes | 57 (53%) | 11 (55%) | 10 (56%) | 78 (53%) |
| Lung | 58 (54%) | 9 (45%) | 10 (56%) | 77 (53%) |
| Bone | 21 (20%) | 4 (20%) | 2 (11%) | 27 (18%) |
| Ascites | 8 (7%) | 5 (25%) | 2 (11%) | 15 (10%) |
| Pancreas | 7 (7%) | 1 (5%) | 2 (11%) | 10 (7%) |
| Pleural effusion | 4 (4%) | 2 (10%) | 0 | 6 (4%) |
| Skin or subcutaneous tissue | 2 (2%) | 0 | 0 | 2 (1%) |
| Bladder | 0 | 1 (5%) | 0 | 1 (1%) |
| Colon | 1 (1%) | 0 | 0 | 1 (1%) |
| Other | 31 (29%) | 7 (35%) | 12 (67%) | 51 (35%) |
Data are n (%) unless otherwise stated. FGFR=fibroblast growth factor receptor. ECOG=Eastern Cooperative Oncology Group.
The total includes one patient who did not have confirmed FGFftGFR status by central laboratory and was not assigned to any cohort.
Rest of world consists of Israel, South Korea, Taiwan, Thailand, and Japan.
Maximum number of five therapies in patients with FGFR2 fusions or rearrangements and three in the other patient cohorts.
Cholangiocarcinoma location was initially missing for one patient at the data cutoff date; however, this patient was later assessed as having intrahepatic cholangiocarcinoma after the data cutoff date.
The other locations were the gallbladder (n=2) and ampulla of Vater (n=1).