Table 1.
Patient characteristics at study entry, treatment details and outcomes by RECIST v1.1
| PRIMM-UK (n = 55) | PRIMM-NL (n = 55) | Manchester (n = 25) | Leeds (n = 18) | Barcelona (n = 12) | All cohorts (n = 165) | |
|---|---|---|---|---|---|---|
| Gender, n (%) | ||||||
| Male | 36 (65%) | 31 (56%) | 16 (64%) | 11 (61%) | 6 (50%) | 100 (61%) |
| Female | 19 (35%) | 24 (44%) | 9 (36%) | 7 (39%) | 6 (50%) | 65 (39%) |
| Age (yr) at stage IV diagnosis, median (range) | 65 (19-94) | 61 (25-85) | 66 (36-87) | 60 (35-88) | 64 (37-88) | 63 (19-94) |
| Metastatic stage | ||||||
| Stage 3 unresectable | 5 (9%) | 1 (2%) | 0 (0%) | 1 (6%) | 0 (0%) | 7 (4%) |
| M1a | 13 (24%) | 7 (13%) | 5 (20%) | 3 (17%) | 4 (33%) | 32 (20%) |
| M1b | 12 (22%) | 9 (16%) | 6 (24%) | 5 (27%) | 5 (42%) | 37 (22%) |
| M1c | 20 (36%) | 18 (33%) | 11 (44%) | 6 (33%) | 3 (25%) | 58 (35%) |
| M1d | 5 (9%) | 20 (36%) | 3 (12%) | 3 (17%) | 0 (0%) | 31 (19%) |
| BRAF mutant, n (%) | 17 (31%) | 30 (55%) | 3 (12%) | 8 (44%) | 3 (25%) | 61 (37%) |
| Previous systemic antimelanoma therapy, n (%) | 11 (20%) | 22 (40%) | 7 (28%) | 0 (0%) | 1 (8%) | 41 (25%) |
| Performance status | ||||||
| 0 | 17 (31%) | 36 (65%) | 15 (60%) | 16 (89%) | 7 (58%) | 91 (55%) |
| 1 | 32 (58%) | 12 (22%) | 9 (36%) | 2 (11%) | 1 (8%) | 56 (34%) |
| 2 | 5 (9%) | 4 (7%) | 0 (0%) | 0 (0%) | 0 (0%) | 9 (5%) |
| 3 | 1 (2%) | 1 (2%) | 1 (4%) | 0 (0%) | 0 (0%) | 3 (2%) |
| Unknown | 0 (0%) | 2 (4%) | 0 (0%) | 0 (0%) | 4 (34%) | 6 (4%) |
| BMI (kg m−2), mean (range) | 28.7 (18.8–47.7) | 27.3 (18.8–40.7) | 26.9 (19.0–35.8) | 30.2 (21.6–38.6) | 27.1 (21.0–36.1) | 28 (18.8–47.7) |
| Antibiotic use within 3 months of ICI, n (%) | 9 (16%) | 11 (20%) | 4 (16%) | 2 (11%) | 0 (0%) | 26 (16%) |
| PPI use within 3 months of ICI, n (%) | 14 (25%) | 20 (36%) | 4 (16%) | 5 (28%) | 1 (8%) | 44 (27%) |
| Treatment details | ||||||
| ICI used | ||||||
| Ipilimumab and nivolumab | 29 (53%) | 12 (22%) | 2 (8%) | 10 (56%) | 1 (8%) | 54 (32%) |
| Pembrolizumab | 18 (33%) | 10 (18%) | 13 (52%) | 3 (17%) | 9 (75%) | 53 (37%) |
| Nivolumab | 8 (14%) | 32 (58%) | 0 (0%) | 5 (27%) | 2 (17%) | 48 (24%) |
| Ipilimumab | 0 (0%) | 1 (2%) | 10 (40%) | 0 (0%) | 0 (0%) | 11 (7%) |
| Outcomes following ICI | ||||||
| RECIST v1.1 response at 6 months | ||||||
| Complete response | 8 (15%) | 6 (11%) | 4 (16%) | 2 (12%) | 2 (17%) | 22 (13%) |
| Partial response | 16 (29%) | 16 (29%) | 6 (24%) | 4 (22%) | 1 (8%) | 43 (26%) |
| Stable disease | 9 (16%) | 11 (20%) | 3 (52%) | 4 (22%) | 2 (17%) | 29 (18%) |
| Progressive disease | 22 (40%) | 22 (40%) | 12 (48%) | 8 (44%) | 7 (58%) | 71 (43%) |
| PFS12, n (%) | 28 (51%) | 30 (55%) | 13 (52%) | 8 (44%) | 7 (58%) | 86 (52%) |
BMI, body mass index; PFS12, PFS at 12 months; PPI, proton pump inhibitor.