Table 1
Demographic and disease characteristics of the patients
| Median age (range) – years | 65.4 (25-87) |
| Older than 70 years – n (%) | 47 (48.9%) |
| Male gender –n (%) | 84 (60.9) |
| Average body weight (range) – kilograms | 79.5 (46 – 138) |
| ECOG performance status –n (%) | |
| 0 | 53 (38.4) |
| 1 | 71 (51.4) |
| 2 | 12 (8.7) |
| 3 | 2 (1.4) |
| Anatomic site of primary | |
| Cutaneous | 116 (84.1) |
| Ocular | 8 (5.8) |
| Mucosal | 7 (5.1) |
| Unknown primary | 7 (5.1) |
| Actionable mutation –n (%) | |
| Wild type | 94 (68.1) |
| BRAF V600E | 22 (15.9) |
| BRAF V600K/M | 3 (2.2) |
| NRAS | 3 (2.2) |
| Not provided | 16 (11.6) |
| Elevated baseline LDH level (> 4.31 microkat/L) – n (%) | 36 (26.1) |
| Elevated baseline S100 level (> 0.105 microg/L) – n (%) | 72 (52.2) |
| Metastatic stage – n (%)* | |
| M1a (0) | 28 (20.3) |
| M1a (1) | 6 (4.3) |
| M1b (0) | 29 (21.0) |
| M1b (1) | 2 (1.4) |
| M1c (0) | 32 (23.2) |
| M1c (1) | 22 (15.9) |
| M1d (0) | 13 (9.4) |
| M1d (1) | 6 (4.3) |
| Organs with metastatic involvement –n (%) | |
| 1 | 47 (34.1) |
| 2 | 52 (37.7) |
| 3 | 19 (13.8) |
| >3 | 20 (14.5) |
| Further lines of systemic therapy – n (%) | 41 (29.7) |
| Radiotherapy during immunotherapy –n (%) | 38 (27.5) |
[i] LDH = lactate dehydrogenase
Following the 8th edition of the American Joint Committee on Cancer (AJCC) tumour, node, metastases (TNM) classification, to cases with normal level of the LDH are given the suffix (0) and to cases with elevated LDH level suffix (1).
Figure 1
Kaplan-Meier estimates for overall survival (A) and progression free survival (B) according to different metastatic stages (p < 0.001).
Figure 2
Kaplan-Meier estimates of overall survival according to best overall response (p < 0.001).
Table 2
Best overall responses and median overall survival for each group
| Response | n (%) |
|---|---|
| ORR | 60 (43.5) |
| DCR | 83 (60.2) |
| Best response | |
| CR | 29 (21.0) |
| PR | 31 (22.5) |
| SD | 23 (16.7) |
| PD | 54 (39.1) |
| No assessment | 1 (0.7) |
[i] CR = complete response; DCR = disease control rate; ORR = overall response rate;
PD = progressive disease; PR = partial response; SD = stable disease
Figure 3
Kaplan-Meier estimates of overall survival according to number of organs with metastatic involvement (p = 0.04).
Figure 4
Kaplan-Meier estimates of overall survival according to serum lactate dehydrogenase (LDH) (p < 0.001).
Table 3
Immune related adverse events
| Adverse event* | Any grade – no. (%) | Grade 3-4 – no. (%) |
|---|---|---|
| Any | 88 (63.8) | 12 (8.7) |
| High AST, ALT | 35 (25.4) | 3 (2.2) |
| Hypothyroidism | 33 (23.9) | 0 |
| Pruritus | 28 (20.3) | 0 |
| Rash | 25 (18.1) | 1 (0.7) |
| Arthralgia | 14 (10) | 2 (1.4) |
| Diarrhoea | 13 (9.4) | 1 (0.7) |
| Fatigue | 8 (5.8) | 0 |
| Pneumonitis | 7 (5.1) | 2 (1.4) |
| Vitiligo | 7 (5.1) | 0 |
| Other | 12 (8.7) | 4 (2.9) |
[i] AST = aspartate transaminase; ALT = alanine aminotransferase
*Events are listed in order of descending frequency.