All cohorts | Leeds | PRIMM-NL | PRIMM-UK | P | |
---|---|---|---|---|---|
N (pre-treatment) | 88 | 14 | 40 | 34 | - |
N (follow-up) | 66 | 11 | 28 | 27 | - |
Sex | |||||
Male | 57 (64.8%) | 9 (64.3%) | 23 (57.5%) | 25 (73.5%) | 0.35 |
Female | 31 (35.2%) | 5 (35.7%) | 17 (42.5%) | 9 (26.5%) | |
Age (years) | 60.5 ± 15.0 | 57.4 ± 14.6 | 59.4 ± 12.7 | 66.0 ± 16.8 | 0.08 |
BMI (kg/m 2 ) | 28.0 ± 5.4 | 27.6 ± 5.2 | 27.6 ± 5.5 | 28.5 ± 5.4 | 0.72 |
BRAF mutant | 40 (45.5%) | 8 (61.5%) | 23 (57.5%) | 9 (26.5%) | 0.01 |
LDH (≤ULN) | 58 (65.9%) | 5 (35.7%) | 30 (75.0%) | 23 (67.6%) | 0.03 |
Metastatic stage | |||||
Stage III unresectable | 2 (2.3%) | 1 (7.1%) | 1 (2.5%) | 0 (0.0%) | 2.2 × 10− 4 |
M1a | 14 (15.9%) | 2 (14.3%) | 2 (5.0%) | 10 (29.4%) | |
M1b | 17 (19.3%) | 3 (21.4%) | 4 (10.0%) | 10 (29.4%) | |
M1c | 32 (36.4%) | 6 (42.9%) | 14 (35.0%) | 12 (35.3%) | |
M1d | 23 (26.1%) | 2 (14.3%) | 19 (47.5%) | 2 (5.9%) | |
ECOG performance status | |||||
0 | 47 (53.4%) | 12 (85.7%) | 25 (62.5%) | 10 (29.4%) | 5.9 × 10− 3 |
1 | 31 (35.2%) | 2 (14.3%) | 10 (25.0%) | 19 (55.9%) | |
2 | 8 (9.1%) | 0 (0.0%) | 4 (10.0%) | 4 (11.8%) | |
3 | 2 (2.3%) | 0 (0.0%) | 1 (2.5%) | 1 (2.9%) | |
ICI therapy | |||||
Ipilimumab | 1 (1.1%) | 0 (0.0%) | 1 (2.5%) | 0 (0.0%) | 0.02 |
Pembrolizumab | 20 (22.7%) | 2 (14.3%) | 7 (17.5%) | 11 (32.4%) | |
Nivolumab | 30 (34.1%) | 5 (37.5%) | 20 (50.0%) | 5 (14.7%) | |
Ipilimumab + Nivolumab | 37 (42.0%) | 7 (50.0%) | 12 (30.0%) | 18 (52.9%) | |
ORR | 49 (55.7%) | 9 (64.3%) | 21 (52.5%) | 19 (55.9%) | 0.77 |
PFS (months) | 5.6 ± 5.3 | 7.0 ± 9.3 | 5.3 ± 4.3 | 5.7 ± 5.0 | 0.74 |
OS (months) | 9.0 ± 6.6 | 3.8 ± 1.4 | 11.0 ± 7.1 | 7.8 ± 5.7 | 0.08 |