Table 1.
Patient characteristics
Characteristic | All (n=18) | TILs (n=10) | TIL+DC (n=8) | P value |
Median age (range), years | 43 (18–64) | 49 (32–63) | 38 (18–64) | 0.2 |
Sex | ||||
Female | 9 | 4 | 5 | 0.6 |
Male | 9 | 6 | 3 | |
White race | 18 | 10 | 8 | – |
Melanoma type | ||||
Cutaneous | 14 | 8 | 6 | 0.8 |
Acral | 1 | 0 | 1 | |
Undetermined | 3 | 2 | 1 | |
Stage | ||||
4 M1b | 2 | 0 | 2 | 0.2 |
4 M1C | 16 | 10 | 6 | |
ECOG* | ||||
0 | 9 | 2 | 7 | 0.02 |
1 | 9 | 8 | 1 | |
LDH | ||||
Normal | 15 | 8 | 7 | 1.0 |
High | 3 | 2 | 1 | |
BRAF mutation | ||||
BRAF V600 E | 10 | 7 | 3 | 0.3 |
BRAF non-V600 E | 2 | 2 | 0 | |
WT | 4 | 1 | 3 | |
NRAS mutation | ||||
Q61K | 3 | 1 | 2 | 0.5 |
WT | 9 | 6 | 3 | |
KIT mutation | ||||
c-KIT | 1 | 1 | 0 | 1.0 |
WT | 11 | 7 | 4 | |
Prior systemic therapies | ||||
None | 2 | 0 | 2 | 0.07 |
1 | 7 | 3 | 4 | |
2 | 7 | 6 | 1 | |
3 | 1 | 1 | 0 | |
4 | 1 | 0 | 1 | |
No of infused TILs (range) | 60.7 (1.7–130) | 38.2 (1.7–99) | 83.2 (16.3–130) | 0.04 |
No of doses of IL-2 infused | 14 (3–17) | 14 (11–17) | 12.5 (3–17) | 0.3 |
*ECOG status: 0=asymptomatic, 1=symptomatic and ambulatory.
CR, complete response; DC, dendritic cells; ECOG, Eastern Cooperative Oncology Group; IL-2, interleukin-2; irRC, immune-related response criteria; PD, progressive disease; PR, partial response; SD, stable disease; TIL, tumor-infiltrating lympocytes; WT, wild type.