Table 1.
Baseline characteristics
| Cohort A (n=76) |
Cohort B (n=16) |
Cohort C (n=16) |
Cohort D (n=17) |
|
|---|---|---|---|---|
|
| ||||
| Age (range), years | 52·0 (23–84) | 54·5 (36–74) | 63·0 (44–84) | 46·0 (23–68) |
|
| ||||
| Age category, n (%) | ||||
| <65 years | 60 (79) | 12 (75) | 9 (56) | 16 (94) |
| ≥65 years | 16 (21) | 4 (25) | 7 (44) | 1 (6) |
|
| ||||
| Sex, n (%) | ||||
| Male | 40 (53) | 10 (63) | 11 (69) | 11 (65) |
| Female | 36 (47) | 6 (38) | 5 (31) | 6 (35) |
|
| ||||
| ECOG performance status, n (%) | ||||
| 0 | 50 (66) | 11 (69) | 12 (75) | 9 (53) |
| 1 | 25 (33) | 5 (31) | 4 (25) | 6 (35) |
| 2 | 1 (1) | 0 | 0 | 2 (12) |
|
| ||||
| BRAF genotype, n (%) | ||||
| V600E | 73 (96) | 16 (100) | 0 | 15 (88) |
| V600K | 3 (4) | 0 | 14 (88) | 1 (6) |
| V600R | 0 | 0 | 2 (13) | 1 (6) |
| V600D | 0 | 0 | 0 | 0 |
|
| ||||
| Target brain metastases, n (%) | ||||
| 1 | 41 (54) | 7 (44) | 7 (44) | 7 (41) |
| 2 | 20 (26) | 7 (44) | 6 (38) | 7 (41) |
| 3 | 7 (9) | 2 (13) | 2 (13) | 1 (6) |
| 4 | 4 (5) | 0 | 0 | 1 (6) |
| 5 | 4 (5) | 0 | 1 (6) | 1 (6) |
|
| ||||
| Median SLD of target intracranial lesions (range), mm | 19·5 (6–117) | 14·0 (5–40) | 20·0 (5–61) | 33·0 (10–84) |
|
| ||||
| Extracranial metastases, n (%) | ||||
| No | 8 (11) | 4 (25) | 0 | 5 (29) |
| Yes | 68 (89) | 12 (75) | 16 (100) | 12 (71) |
|
| ||||
| Lactate dehydrogenase level, n (%) | ||||
| Normal (≤ULN) | 48 (63) | 13 (81) | 10 (63) | 12 (71) |
| Elevated (>ULN) | 28 (37) | 3 (19) | 6 (38) | 5 (29) |
|
| ||||
| Receiving steroid therapy, n (%) | ||||
| Prior treatment | 3 (4) | 1 (6) | 0 | 5 (29) |
| On-treatment or post-treatment | 38 (50) | 8 (50) | 9 (56) | 15 (88) |
|
| ||||
| Previous systemic anticancer treatment, n (%) | ||||
| No | 59 (78) | 11 (69) | 13 (81) | 10 (59) |
| Yes | 17 (22) | 5 (31) | 3 (19) | 7 (41) |
ECOG=Eastern Cooperative Oncology Group. SLD=sum of lesion diameters. ULN=upper limit of normal.