Table 1.
Demographic, clinical characteristics and cytokines levels with in vitro stimulation, at baseline
| Characteristic | All (n=17) | Responders (n=11) | Non-responders (n=6) | P value |
| Median age (range) - years | 72 (53–88) | 73 (58–88) | 72 (53–81) | 0.84 |
| Sex (n) | ||||
| Male | 13 | 10 | 3 | 0.52 |
| Female | 4 | 1 | 3 | |
| ECOG-PS status (n (%)) | ||||
| 0 | 10 (59) | 8 | 2 | 0.28 |
| 1 | 5 (29) | 2 | 3 | |
| 2 | 2 (12) | 1 | 1 | |
| Metastasis stage (n (%)) | ||||
| M0, M1a, or M1b | 13 (76) | 8 | 5 | >0.99 |
| M1c | 4 (24) | 3 | 1 | |
| LDH (n) | ||||
| ≤ULN | 15 | 11 | 4 | 0.11 |
| >ULN | 2 | 0 | 2 | |
| BRAF status (n (%)) | ||||
| Mutation | 5 (29) | 2 | 3 | |
| No mutation | 12 (71) | 9 | 3 | 0.28 |
| Immune-related adverse events (n) | ||||
| Yes | 9 | 8 | 1 | |
| No | 8 | 3 | 6 | 0.04 |
| Last observation carried forward (days) | 540 (285; 735) | 600 (180; 750) | 360 (292; 810) | 0.94 |
| IL-1β/Monocytes (μg) | 6740 (2434; 12 572) | 6740 (1689; 20 266) | 5724 (2744; 8514) | 0.88 |
| TNF-α/Monocytes (μg) | 709 (261; 3373) | 1320 (537; 3899) | 2519 (371; 2519) | 0.29 |
| IL-6/Monocytes (μg) | 11857 (6321; 38 622) | 24280 (7170; 39 309) | 8529 (5827; 23 997) | 0.43 |
| IL-8/Monocytes (μg) | 4643 (3012; 10 859) | 3916 (3076; 12 219) | 5370 (2819; 13 909) | 0.66 |
| IFN-γ/Lymphocytes (μg) | 2639 (843; 11 479) | 3039 (941; 10 191) | 1656 (651; 11 864) | 0.86 |
| IL-12p70/Lymphocytes (μg) | 39 (15; 97) | 37 (16; 92) | 42 (14; 125) | 0.77 |
| IL-2/Lymphocytes (μg) | 60 (28; 129) | 70 (42; 137) | 34 (22; 98) | 0.25 |
| IL-17/Lymphocytes (μg) | 0.57 (0.54; 0.71) | 0.63 (0.56; 0.71) | 0.57 (0.40; 0.57) | 0.02* |
| IL-4/Lymphocytes (μg) | 21 (12; 51) | 25 (15; 63) | 17 (11; 109) | >0.99 |
| IL-5/Lymphocytes (μg) | 26 (19; 57) | 31 (22; 57) | 21 (18; 72) | 0.79 |
| IL-13/Lymphocytes (μg) | 18 (4; 78) | 20 (11; 76) | 8 (3; 93) | 0.67 |
Each result of baseline cytokines levels was divided by the baseline monocytes or lymphocytes counts.
*Tend to be stillstatistically significant with Bonferroni adjustment (p<0.02).
ECOG-PS, Eastern Cooperative Oncology Group - performance status; IFN, interferon; IL, interleukin; LDH, lactate dehydrogenase; TNF, tumor necrosis factor; ULN, Upper limit normal.