Table 1.
Demographic characteristics, treatment details, and response by RECIST v1.1 of 87 patients with advanced melanoma from the UK and the NL.
| All | UK | NL | p | pORR | pOS | |
|---|---|---|---|---|---|---|
| Clinical details | ||||||
| N | 87 | 48 | 39 | |||
| Sex (males) | 57 (65.5%) | 35 (72.9%) | 22 (56.4%) | 0.119 | <0.01 | <0.05 |
| Age | 62 [53–73] | 63 [52–80] | 59 [54–67] | 0.235 | 0.459 | 0.134 |
| BMI (kg/m2) | 27.1 [24.4– 32.0] | 28.2 [24.5– 32.1] | 26.4 [24.1–30.6] | 0.234 | <0.05 | 0.389 |
| Tumour BRAF mutant | 40 (46.5%) | 17 (36.2%) | 23 (59.0%) | 0.050 | 0.387 | 0.844 |
| Elevated LDH | 30 (34.5%) | 20 (41.7%) | 10 (25.6%) | 0.173 | 0.259 | <0.01 |
| Metastatic stage | ||||||
| III unresectable | 5 (5.7%) | 4 (8.3%) | 1 (2.6%) | <0.001 | <0.05 | <0.05 |
| IV M1a | 12 (13.8%) | 10 (20.8%) | 2 (5.1%) | |||
| IV M1b | 15 (17.2%) | 12 (25.0%) | 3 (7.7%) | |||
| IV M1c | 32 (36.8%) | 18 (37.5%) | 14 (35.9%) | |||
| IV M1d | 23 (26.4%) | 4 (8.3%) | 19 (48.7%) | |||
| ECOG performance status | ||||||
| 0 | 46 (52.9%) | 21 (43.8%) | 25 (64.1%) | 0.190 | 0.287 | 0.114 |
| 1 | 32 (36·8%) | 22 (45.8%) | 10 (25.6%) | |||
| 2 | 7 (8.0%) | 4 (8.3%) | 3 (7.7%) | |||
| 3 | 2 (2.3%) | 1 (2.1%) | 1 (2.6%) | |||
| Treatment | ||||||
| Nivolumab & ipilimumab | 39 (44.8%) | 27 (56.2%) | 12 (30.8%) | <0.01 | 0.831 | 0.089 |
| Pembrolizumab | 21 (24.1%) | 14 (14.6%) | 7 (17.9%) | |||
| Nivolumab | 26 (29.9%) | 7 (29.2%) | 19 (48.7%) | |||
| Ipilimumab | 1 (1.1%) | 0 (0.0%) | 1 (2.6%) | |||
| Outcome | ||||||
| Responders | 46 (52.9%) | 23 (47.9%) | 23 (59.0%) | 0.389 | n.a. | <0.001 |
| Responders classification | ||||||
| Complete response | 6 (13.0%) | 5 (21.7%) | 1 (4.3%) | 0.068 | n.a. | n.a. |
| Partial response | 25 (54.3%) | 14 (60.9%) | 11 (47.8%) | |||
| Late response | 3 (6.5%) | 0 (0.0%) | 3 (13.0%) | |||
| Stable disease | 12 (26.1%) | 4 (17.4%) | 8 (34.8%) | |||
For continuous variables, median and IQR range (within brackets) are shown, whereas absolute count and percentage (within parentheses) are shown for categorical variables. P-values of the association between clinical variables and study centre (p), ORR (pORR), and OS (pOS) are shown. Differences between study centres were tested using Kruskal-Wallis’ test (for continuous variables) and Fisher's exact test (for categorical variables). Association between age and ORR and OS was evaluated using Kruskal-Wallis’ test and log-rank test, respectively. For the log-rank test, age was dichotomized at the median value. Associations between sex, LDH levels, BRAF mutation status, ECOG-PS (ECOG-PS=0 vs ECOG-PS≥1), and treatment type (single vs combined) were assessed using Fisher's exact test and log-rank test for ORR and OS, respectively. Association between BMI and ORR and OS was assessed using logistic regression and Cox regression, respectively, while accounting for patients’ age and sex. Association between metastatic stage and ORR and OS was assessed using logistic regression and Cox regression, respectively, while accounting for patients’ age, sex, and BMI.