FIGURE 1.
FIGURE 2.
FIGURE 3.
FIGURE 4.
FIGURE 5.
FIGURE 6.
FIGURE 7.
Patient demographics, cancer staging, treatment details, and outcomes
| Characteristics | No = 71 (%) |
|---|---|
| Age; mean (+/-SD) (yr) | 62 ± 12 |
| Gender | |
| Male | 43 (61) |
| Female | 28 (39) |
| ECOG performance status | |
| 0 | 30 (42) |
| 1 | 41 (58) |
| AJCC | |
| III.D | 1 (1) |
| M1a | 16 (23) |
| M1b | 10 (14) |
| M1c | 32 (45) |
| M1d | 12 (17) |
| Anatomic site of primary | |
| Cutaneous | 58 (82) |
| Ocular | 4 (6) |
| Mucosal | 3 (4) |
| Unknown primary | 6 (8) |
| Line of systemic treatment for metastatic disease | |
| 1st line | 63 (89) |
| 2nd line | 8 (11) |
| Baseline LDH | |
| Elevated | 23 (32) |
| Normal | 49 (68) |
| Number of organs with metastatic involvement | |
| 1 | 25 (35) |
| 2 | 21 (30) |
| 3 | 11 (15) |
| > 3 | 14 20) |
| Actionable mutation | |
| BRAF wild type | 21 (30) |
| BRAF V600E | 28 (39) |
| BRAF V600K | 10 (14) |
| BRAF V600 - others | 1 (1) |
| NRAS | 11 (16) |
| Type of systemic treatment | |
| PD-1 inhibitors | 47 (66) |
| Combination of PD-1 and CTLA-4 inhibitors | 24 (34) |
| Tumor response on week 4 18F-FDG PET/CT | |
| Complete metabolic response | 3 (4) |
| Partial metabolic response | 12 (17) |
| Stable metabolic disease | 10 (14) |
| Heterogenous response | 6 (8) |
| Possible pseudoprogression | 20 (28) |
| Progressive metabolic disease | 17 (24) |
Clinical diagnosis of immune-related adverse events
| Immune-related adverse event | Any grade No (%) | Grade 3-5 No (%) | Time to onset of irAE (mean ± SD) [weeks] |
|---|---|---|---|
| No. of pts with at least one irAE | 56 (79) | 13 (18) | - |
| Number of all irAE events | 144 | 14 | 144 ± 161 |
| Gastrointestinal | |||
| Diarrhea | 14 (20) | 2 (3) | 31.7 ± 30.6 |
| Colitis | 7 (10) | 2 (3) | 39 ± 32 |
| Xerostomia | 2 (3) | 0 | 30.1 ± 4.4 |
| Gastritis | 2 (3) | 0 | 64.4 ± 7.7 |
| Stomatitis | 1 (1) | 0 | 3 ± 0 |
| Respiratory | |||
| Pneumonitis | 5 (7) | 0 (0) | 40.9 ± 45.7 |
| Sarcoid reaction | 2 (3) | 0 (0) | 6.3 ± 0.3 |
| Hepatic | |||
| Increased AST/ALT | 16 (23) | 4 (6) | 7.7 ± 8.3 |
| Endocrine | |||
| Hypothyroidism | 10 (14) | 0 | 12.3 ± 6 |
| Hyperthyroidism | 7 (10) | 0 | 7.3 ± 7.1 |
| Adrenal insufficiency | 2 (3) | 2 (3) | 34.4 ± 20.1 |
| Diabetes mellitus | 1 (1) | 1 (1) | 72.7 ± 0 |
| Pancreatitis | 1 (1) | 1 (1) | 32.4 ± 0 |
| Cutaneous | |||
| Pruritus | 23 (32) | 0 | 10.7 ± 10 |
| Skin rash | 16 (23) | 0 | 14 ± 16.3 |
| Vitiligo | 9 (13) | 0 | 37.4 ± 31.6 |
| Poliosis of hair | 1 (1) | 0 | 34.7 ± 0 |
| Musculoskeletal | |||
| Arthritis | 10 (14) | 0 | 28.7 ± 27.3 |
| Myalgia | 2 (3) | 0 | 16.7 ± 12.3 |
| Arthralgia | 1 (1) | 0 | 14 ± 0 |
| Synovitis | 1 (1) | 0 | 65.4 ± 0 |
| Neurological | |||
| Encephalitis | 2 (3) | 1 (1) | 36.4 ± 32.9 |
| Psychosis | 1 (1) | 0 | 25.4 ± 0 |
| Other | |||
| Fatigue | 6 (8) | 0 | 6.5 ± 4.9 |
| Hypophosphatemia | 1 (1) | 0 | 17 ± 0 |