Table 1.
Baseline characteristics of COMBI-MB trial.
| Cohort A (n=76) | Cohort B (n=16) | Cohort C (n=16) | Cohort D (n=17) | Total (n=125) | ||
|---|---|---|---|---|---|---|
|
|
||||||
| Age | Median (range) | 52·0 (23–84) | 54·5 (36–74) | 63·0 (44–84) | 46·0 (23–68) | |
| <65 | 60 (79%) | 12 (75%) | 9 (56%) | 16 (94%) | 97 (78%) | |
| ≥65 | 16 (21%) | 4 (25%) | 7 (44%) | 1 (6%) | 28 (22%) | |
|
| ||||||
| Sex | Male | 40 (53%) | 10 (63%) | 11 (69%) | 11 (65%) | 72 (58%) |
| Female | 36 (47%) | 6 (38%) | 5 (31%) | 6 (35%) | 53 (42%) | |
|
| ||||||
| ECOG | 0 | 50 (66%) | 11 (69%) | 12 (75%) | 9 (53%) | 82 (66%) |
| 1 | 25 (33%) | 5 (31%) | 4 (25%) | 6 (35%) | 40 (32%) | |
| 2 | 1 (1%)* | 0 | 0 | 2 (12%) | 3 (2%) | |
|
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| BRAF genotype | V600E | 73 (96%) | 16 (100%) | 0 | 15 (88%) | 104 (83%) |
| V600K | 3 (4%)† | 0 | 14 (88%) | 1 (6%) | 18 (14%) | |
| V600R | 0 | 0 | 2 (13%) | 1 (6%) | 3 (2.4%) | |
| V600D | 0 | 0 | 0 | 0 | 0 | |
|
| ||||||
| Target brain metastases | 1 | 41 (54%) | 7 (44%) | 7 (44%) | 7 (41%) | 62 (49.6%) |
| 2 | 20 (26%) | 7 (44%) | 6 (38%) | 7 (41%) | 40 (32%) | |
| 3 | 7 (9%) | 2 (13%) | 2 (13%) | 1 (6%) | 12 (9.6%) | |
| 4 | 4 (5%) | 0 | 0 | 1 (6%) | 5 (4%) | |
| 5 | 4 (5%) | 0 | 1 (6%) | 1 (6%) | 6 (4.8%) | |
|
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| SLD of target intracranial lesions (mm) | 20 (6–117) | 14 (5–40) | 20 (5–61) | 33 (10–84) | ||
|
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| Extracranial metastases | No | 8 (11%) | 4 (25%) | 0 | 5 (29%) | 17 (14%) |
| Yes | 68 (89%) | 12 (75%) | 16 (100%) | 12 (71%) | 108 (86%) | |
|
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| Lactate dehydrogenase concentration | Normal (≤ULN) | 48 (63%) | 13 (81%) | 10 (63%) | 12 (71%) | 83 (66%) |
| Elevated (>ULN) | 28 (37%) | 3 (19%) | 6 (38%) | 5 (29%) | 42 (34%) | |
|
| ||||||
| Receiving steroid therapy | Yes | 13 (17%) | 3 (19%) | 3 (19%) | 14 (82%) | 33 (26%) |
| No | 63 (83%) | 13 (81%) | 13 (81%) | 3 (18%) | 92 (74%) | |
|
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| Previous systemic anticancer treatment | No | 59 (78%) | 11 (69%) | 13 (81%) | 10 (59%) | 93 (74%) |
| Yes | 17 (22%) | 5 (31%) | 3 (19%) | 7 (41%) | 32 (26%) | |
Data are median (range) or n (%). Cohort A= BRAF V600E -mutant, asymptomatic melanoma brain metastases, without previous local brain-directed therapy, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Cohort B= BRAF V600E -mutant, asymptomatic melanoma brain metastases, with previous local therapy, ECOG performance status of 0 or 1. Cohort C= BRAF V600D/K/R -mutant, asymptomatic melanoma brain metastases, with or without previous local therapy, ECOG performance status of 0 or 1. Cohort D= BRAF V600D/E/K/R -mutant, symptomatic melanoma brain metastases, with or without previous local therapy ECOG performance status of 0, 1, or 2. ECOG=Eastern Cooperative Oncology Group. SLD=sum of lesion diameters. ULN=upper limit of normal.
Patient had ECOG performance status 1 at time of screening and enrolment.
Patients were enrolled based on BRAF V600E status but were found to be BRAF V600K on central confirmation.