Table A1.
Treatment Characteristics by Arm
| Characteristic | Total, No. | NMA, No. (%) | 1,200 TBI, No. (%) | P* |
|---|---|---|---|---|
| Patients treated | 99 | 51 | 48 | |
| Source of TIL | ||||
| Subcutaneous deposit | 31 | 16 (52) | 15 (48) | .96 |
| Lymph node | 33 | 16 (48) | 17 (52) | |
| Viscera | 35 | 19 (54) | 16 (46) | |
| Fresh TIL | 15 | 7 (47) | 8 (53) | .78 |
| Cryopreserved TIL | 84 | 44 (52) | 40 (48) | |
| Treatment characteristics | ||||
| CD3+ cells | ||||
| < 5 × 1010 | 21 | 13 (62) | 8 (38) | .94 |
| 5.1-7.0 × 1010 | 26 | 12 (46) | 14 (54) | |
| 7.1-9.0 × 1010 | 18 | 7 (39) | 11 (61) | |
| 9.1-11.0 × 1010 | 16 | 9 (56) | 7 (44) | |
| > 11 × 1010 | 18 | 10 (56) | 8 (44) | |
| Cell phenotype, median (25th to 75th percentile ×10−9) | ||||
| CD3+ | 70.1 (49.4-104) | 73.1 (56.6-104) | .83 | |
| CD8+ | 41.3 (28.7-78.9) | 56.5 (33.4-90.9) | .22 | |
| CD4+ | 12.6 (7.4-22.7) | 10.4 (4.2-18.1) | .09 | |
| T-cell subsets, median (25th to 75th percentile), % | ||||
| TN | 0.03 (0.01-0.16) | 0.02 (0.007-0.14) | .32 | |
| TCM | 0.36 (0.26-0.44) | 0.31 (0.19-0.51) | .50 | |
| TEM | 94.9 (82-97) | 96.6 (89.6-98.6) | .014 | |
| TEMRA | 4.6 (2.8-17.1) | 3.2 (1.0-9.1) | .014 | |
| IL-2 doses | ||||
| 0-2 | 11 | 4 (36) | 7 (64) | .32 |
| 3-5 | 39 | 20 (51) | 19 (49) | |
| 6-8 | 41 | 22 (54) | 19 (46) | |
| > 8 | 8 | 5 (63) | 3 (37) | |
| Median (25th to 75th percentile) | 6 (4-7) | 5 (3.3-6) | .15 | |
| Laboratory characteristics | ||||
| Day 0 IL-7, median (25th to 75th percentile), pg/mL | 37 (31.0-51.5) | 39 (29.8-48) | .70 | |
| Day 0 IL-15, median (25th to 75th percentile), pg/mL | 34 (29.5-44.5) | 39 (33-53.5) | .05 |
Abbreviations: IL, interleukin; NMA, nonmyeloablative chemotherapy; TBI, total body irradiation; TCM, CD3+CD45RA−CCR7+; TEM, CD3+CD45RA−CCR7−; TEMRA, CD3+CD45RA+CCR7−; TIL, tumor-infiltrating lymphocyte; TN, CD3+CD45RA+CCR7+.
*
All P values are uncorrected.