Baseline demographics and prior treatment for patients with BRAF V600–mutant LCH
| Category . | CDRB436A2102 (dabrafenib monotherapy) (n = 13) . | CTMT212X2101 (dabrafenib + trametinib) (n = 12) . |
|---|---|---|
| Age, median (range), y | 3 (1-11) | 4 (2-13) |
| <2 y, n (%) | 3 (23.1) | 0 |
| From 2 to <6 y, n (%) | 5 (38.5) | 8 (66.7) |
| From 6 to <12 y, n (%) | 5 (38.5) | 3 (25.0) |
| ≥12 y, n (%) | 0 | 1 (8.3) |
| Male, n (%) | 8 (61.5) | 8 (66.7) |
| Karnofsky/Lansky PS, n (%) | ||
| 100 | 6 (46.2) | 8 (66.7) |
| 90 | 4 (30.8) | 2 (16.7) |
| 80 | 1 (7.7) | 1 (8.3) |
| 70 | 1 (7.7) | 0 |
| <70 | 1 (7.7) | 1 (8.3) |
| Risk organ involvement, n (%)∗ | 3 (23.1) | N/A |
| Time since initial diagnosis, median (range), mo | 36.3 (1-116) | 33.9 (3.8-137) |
| Prior therapy, n (%) | 13 (100) | 12 (100) |
| Chemotherapy | 13 (100) | 12 (100) |
| Biologic therapy† | 1 (7.7) | 0 |
| Immunotherapy‡ | 1 (7.7) | 0 |
| Prior radiotherapy, n (%) | ||
| Yes | 0 | 0 |
| No | 9 (69.2) | 12 (100) |
| Missing | 4 (30.8) | 0 |
| Prior lines of chemotherapy | ||
| 0 | 0 | 0 |
| 1 | 2 (15.4) | 3 (25.0) |
| 2 | 1 (7.7) | 2 (16.7) |
| ≥3 | 10 (76.9) | 7 (58.3) |
| Category . | CDRB436A2102 (dabrafenib monotherapy) (n = 13) . | CTMT212X2101 (dabrafenib + trametinib) (n = 12) . |
|---|---|---|
| Age, median (range), y | 3 (1-11) | 4 (2-13) |
| <2 y, n (%) | 3 (23.1) | 0 |
| From 2 to <6 y, n (%) | 5 (38.5) | 8 (66.7) |
| From 6 to <12 y, n (%) | 5 (38.5) | 3 (25.0) |
| ≥12 y, n (%) | 0 | 1 (8.3) |
| Male, n (%) | 8 (61.5) | 8 (66.7) |
| Karnofsky/Lansky PS, n (%) | ||
| 100 | 6 (46.2) | 8 (66.7) |
| 90 | 4 (30.8) | 2 (16.7) |
| 80 | 1 (7.7) | 1 (8.3) |
| 70 | 1 (7.7) | 0 |
| <70 | 1 (7.7) | 1 (8.3) |
| Risk organ involvement, n (%)∗ | 3 (23.1) | N/A |
| Time since initial diagnosis, median (range), mo | 36.3 (1-116) | 33.9 (3.8-137) |
| Prior therapy, n (%) | 13 (100) | 12 (100) |
| Chemotherapy | 13 (100) | 12 (100) |
| Biologic therapy† | 1 (7.7) | 0 |
| Immunotherapy‡ | 1 (7.7) | 0 |
| Prior radiotherapy, n (%) | ||
| Yes | 0 | 0 |
| No | 9 (69.2) | 12 (100) |
| Missing | 4 (30.8) | 0 |
| Prior lines of chemotherapy | ||
| 0 | 0 | 0 |
| 1 | 2 (15.4) | 3 (25.0) |
| 2 | 1 (7.7) | 2 (16.7) |
| ≥3 | 10 (76.9) | 7 (58.3) |