Table 2.

Cell and treatment characteristics of treated patients

All patients (N = 57)Responders OR (N = 23)Nonresponders NR (N = 34)P-value OR vs. NR
TIL and infusion product characteristics
Days to TIL culture generation, average15.9 ± 4.813.5 ± 2.817.5 ± 5.1.005
Fold expansion of TIL during REP, average1145 ± 4551280 ± 3421053 ± 503.074
Infusion product, average
 Total cell number (×10e9)52 ± 2460 ± 1946 ± 25.040
 CD8+ frequency (%)a62 ± 2571 ± 1755 ± 27.019
 Total CD8+ number (×10e9)35 ± 2444 ± 2029 ± 25.026
Treatment characteristics
Days of hospitalizationb, median (range)19 (14–44)20 (16–36)19 (14–44).472
No. of IL-2 doses, average6.7 ± 3.06.8 ± 2.96.6 ± 3.2.824
Patients receiving G-CSF mobilized cells, n (%)7 (12%)1 (4%)6 (17%).222
Units RBC transfusion, median (range)4 (0–40)3 (0–13)4 (0–40).618
Units PLT transfusion, median (range)18 (0–300)16 (0–48)21 (0–300).483
Absolute lymphocyte count, average
 1 month before TIL (K/μL)1.96 ± 0.711.96 ± 0.741.96 ± 0.70.859
 2 weeks after TIL (K/μL)0.90 ± 0.821.16 ± 0.860.69 ± 0.73.066
 1 month after TIL (K/μL)1.39 ± 0.981.49 ± 0.691.31 ± 1.16.989

Abbreviations: IL-2, interleukin-2; REP, rapid expansion procedure; TIL, tumor infiltrating lymphocyte; NMA, nonmyeloablative lympho-depletion; GCSF, granulocyte colony stimulating factor; RBC, red blood cells; PLT, platelets.

  • aPercent CD8+ cytotoxic T cells, all other cells are CD4+ T helper cells.

  • bDays of hospitalization include 7 days of NMA preconditioning.