Table 1.
Breakdown of patient characteristics
| Demographics | n (tot = 23) | % |
|---|---|---|
| Age, years (median) | 54 (33–78) | – |
|
Sex | ||
| Male | 17 | 74% |
| Female | 6 | 26% |
| BMI, kg/m2 (range) | 26.6 (23.2–33.6) | – |
|
RECIST 1.1 (median OS, PFS, months) | ||
| CR | 7 (108, 50) | 30% |
| PR | 6 (104, 36) | 26% |
| SD | 4 (53, 21) | 18% |
| PD | 6 (25, 2) | 26% |
|
ECOG performance score | ||
| 0–1 | 18 | 79% |
| 2 | 3 | 13% |
| NA | 2 | 8% |
|
Tumor stage at study entry (AJCC 8th Edition) | ||
| Unresectable stage III (M0) | 3 | 13% |
| Skin, soft tissue ± nonregional nodes (M1a) | 1 | 4% |
| Distant metastasis to lung (M1b) | 2 | 8% |
| Metastases to visceral non-CNS (M1C) | 12 | 53% |
| Metastases CNS (M1d) | 4 | 18% |
| NA | 1 | 4% |
|
BRAF mutated | ||
| Yes | 9 | 39% |
| No | 12 | 53% |
| NA | 2 | 8% |
|
Previous adjuvant therapy | ||
| Vemurafenib | 1 | 4% |
| Tafinlar | 1 | 4% |
| Ipilumab | 1 | 4% |
| Target therapy | 2 | 8% |
| ORR | – | 56% |
| DCR | – | 74% |
|
Adverse event | ||
| G1-G2 | 10 | 43% |
| G3 | 1 | 4% |
| NA | 12 | 53% |
BMI, body mass index; BOR, best overall response (RECIST 1.1); CR, complete response; PR, partial response; SD, stable disease; PD, disease progression; OS, overall survival; PFS, progression-free survival; DRR, durable response rate (CR/PR); DCR, disease control rate (CR/PR/SD).