Table 1.

Baseline characteristics

Enrolled patients (N = 80)Treated patients (N = 57)All dismissed patients (N = 22)Dismissed due to unavailable TIL or refusal (N = 11)
Mean age in years54545747
Female, n (%)30 (38%)20 (35%)9 (41%)6 (55%)
M stage, n (%)a
 M1a4 (5%)4 (7%)00
 M1b12 (15%)8 (14%)4 (18%)1 (9%)
 M1c64 (80%)45 (79%)18 (82%)10 (91%)
Treated patients (N = 57)Responders OR (N = 23)Nonresponders NR (N = 34)P value OR vs. NR
Treated and evaluated patients (N = 57)b
Mean age in years545354.360
Female, n (%)20 (35%)3 (13%)17 (50%).007
M stage, n (%)
 M1a4 (7%)3 (13%)1 (3%).292
 M1b8 (14%)5 (22%)3 (9%).247
 M1c45 (79%)15 (65%)30 (88%).051
ECOG performance status, n (%)c
 037 (65%)17 (74%)20 (59%).278
 118 (32%)6 (26%)12 (35%).569
 22 (4%)02 (6%).516
LDH level above top limit of the normal range, n (%)23 (40%)4 (17%)19 (56%).013
CNS metastases at baseline, n (%)11 (19%)6 (26%)5 (15%).322
More than 5 metastasis, n (%)45 (79%)20 (87%)25 (74%).231
BRAF V600E mutation, n (%)22 of 50 (44%)12 of 21 (57%)10 of 29 (35%).209
HLA-A0201 positive, n (%)13 of 56 (23%)4 (17%)9 of 33 (27%).525
Previous therapy for metastatic disease, n (%)57 (100%)23 (100%)34 (100%)1.0
Previous IL-2 therapy, n (%)54 (95%)21 (91%)33 (97%).362
Previous ipilimumab therapy, n (%)13 (23%)5 (22%)8 (24%).826

Abbreviations: M stage, metastasis stage; CNS, central nervous system; HLA, human leukocyte antigen; IL-2, interleukin-2, LDH, lactate dehydrogenase.

  • aThe metastasis (M) stage was classified according to the tumor-node-metastasis (TNM) categorization for melanoma of the American Joint Committee on Cancer.

  • bOne unevaluated patient died of cardiac arrest before cell infusion.

  • cEastern Cooperative Oncology Group (ECOG) status ranges from 0 to 5, with higher scores indicating greater impairment (5 indicates death).