Table 1

Demographic, clinical characteristics and cytokines levels with in vitro stimulation, at baseline

CharacteristicAll (n=17)Responders (n=11)Non-responders (n=6)P value
Median age (range) - years72 (53–88)73 (58–88)72 (53–81)0.84
Sex (n)
 Male131030.52
 Female413
ECOG-PS status (n (%))
 010 (59)820.28
 15 (29)23
 22 (12)11
Metastasis stage (n (%))
 M0, M1a, or M1b13 (76)85>0.99
 M1c4 (24)31
LDH (n)
 ≤ULN151140.11
 >ULN202
BRAF status (n (%))
 Mutation5 (29)23
 No mutation12 (71)930.28
Immune-related adverse events (n)
 Yes981
 No8360.04
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.