Table 1 Demographic and baseline characteristics
From: Dabrafenib plus trametinib in BRAFV600E-mutated rare cancers: the phase 2 ROAR trial
ATC (n = 36) | BTC (n = 43) | GIST (n = 1) | LGG (n = 13) | HGG (n = 45) | ASI (n = 3) | HCL (n = 55) | MM (n = 10) | Total (n = 206) | |
|---|---|---|---|---|---|---|---|---|---|
Age (years) | |||||||||
Mean (s.d.) | 69.6 (9.53) | 57.0 (11.88) | 77.0 () | 33.1 (11.51) | 41.9 (14.70) | 58.3 (3.21) | 64.8 (10.77) | 66.9 (6.89) | 57.1 (16.40) |
Age group (years) | |||||||||
<18 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
18–64 | 9 (25%) | 29 (67%) | 0 | 13 (100%) | 43 (96%) | 3 (100%) | 21 (38%) | 4 (40%) | 122 (59%) |
65–74 | 13 (36%) | 13 (30%) | 0 | 0 | 2 (4%) | 0 | 24 (44%) | 5 (50%) | 57 (28%) |
75–84 | 12 (33%) | 1 (2%) | 1 (100%) | 0 | 0 | 0 | 9 (16%) | 1 (10%) | 24 (12%) |
≥85 | 2 (6%) | 0 | 0 | 0 | 0 | 0 | 1 (2%) | 0 | 3 (1%) |
Sex | |||||||||
Male | 16 (44%) | 19 (44%) | 0 | 4 (31%) | 23 (51%) | 2 (67%) | 47 (85%) | 5 (50%) | 116 (56%) |
Female | 20 (56%) | 24 (56%) | 1 (100%) | 9 (69%) | 22 (49%) | 1 (33%) | 8 (15%) | 5 (50%) | 90 (44%) |
Baseline ECOG | |||||||||
0 | 4 (11%) | 17 (40%) | 1 (100%) | 5 (38%) | 14 (31%) | 3 (100%) | 25 (45%) | 3 (30%) | 72 (35%) |
1 | 30 (83%) | 24 (56%) | 0 | 7 (54%) | 24 (53%) | 0 | 27 (49%) | 6 (60%) | 118 (57%) |
2 | 2 (6%) | 2 (5%) | 0 | 1 (8%) | 7 (16%) | 0 | 3 (5%) | 1 (10%) | 16 (8%) |
Time since diagnosis (days) | 125.0 | 347.0 | 325.0 | 2536.0 | 525 | 595 | 4578 | 2359 | — |
Median (range) | (14.0–4,606.0) | (26.0–3,224.0) | (−) | (45–9,367) | (59–9,549) | (147–1,014) | (88–12,126) | (1,107–5,740) | |
Measurable disease at screening | 36 (100) | 43 (100) | 1 (100) | 13 (100) | 43 (96%) | 3 (100%) | — | — | — |
Non-target lesions at screening | 29 (81) | 31 (72) | 0 | 3 (23) | 10 (22%) | 1 (33%) | — | — | — |
Stage, n (%) | |||||||||
I | 0 | 0 | 0 | 6 (46) | 0 | 0 | — | — | |
II | 0 | 1 (2) | 0 | 7 (54) | 0 | 0 | — | — | |
III | 0 | 0 | 0 | 0 | 13 (29%) | 0 | — | — | |
IV | 1 (3) | 1 (2) | 1 (100) | 0 | 31 (69%) | 2 (67%) | — | — | — |
IVA | 0 | 0 | 0 | — | — | 1 (33%) | — | — | — |
IVB | 0 | 40 (93) | 0 | — | — | 0 | − | — | — |
IVC | 35 (97) | 0 | 0 | — | — | 0 | — | — | — |
Missing | 0 | 1 (2) | 0 | 0 | 1 (2%) | 0 | — | — | — |
Prior radiotherapy regimens | |||||||||
0 | 7 (19) | 38 (88) | 1 (100) | 5 (38) | 1 (2%) | 3 (100%) | — | — | — |
1 | 18 (50) | 4 (9) | 0 | 7 (54) | 36 (80%) | 0 | — | — | — |
2 | 11 (31) | 1 (2) | 0 | 1 (8) | 7 (16%) | 0 | — | — | — |
3 | 0 | 0 | 0 | 0 | 1 (2%) | 0 | — | — | — |
Prior anti-cancer therapy | |||||||||
Any therapy | 36 (100) | 43 (100) | 1 (100) | 12 (92) | 45 (100) | 3 (100) | 55 (100) | 10 (100) | 205 (>99) |
Biologic therapy | 0 | 5 (12) | 0 | 2 (15) | 7 (16) | 2 (67) | 45 (82) | 4 (40) | 65 (32) |
Chemotherapy | 15 (42) | 42 (98) | 0 | 5 (38) | 42 (93) | 3 (100) | 55 (100) | 10 (100) | 172 (83) |
Hormonal therapy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Immunotherapy | 4 (11) | 2 (5) | 0 | 0 | 1 (2) | 0 | 15 (27) | 10 (100) | 32 (16) |
Radioactive therapy | 11 (31) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 11 (5) |
Small molecule targeted therapy | 7 (19) | 3 (7) | 1 (100) | 0 | 3 (7) | 0 | 5 (9) | 10 (100) | 29 (14) |
Radiotherapy | 30 (83) | 5 (12) | 0 | 8 (62) | 44 (98) | 0 | 1 (2) | 7 (70) | 95 (46) |
Surgery | 30 (83) | 24 (56) | 1 (100) | 12 (92) | 42 (93) | 3 (100) | 6 (11) | 3 (30) | 121 (59) |
