Table 1.
Patient demographics and treatment
| Patient Study no. | Sex | Age | Prior treatments | Active metastatic sites | Stage | % MART-1+ cells | IFN-γ with K562-A2–MART-1 (pg/mL/106) | Peak of MART-1+ T cells, % | Persistence of MART-1+ T cells, % | IL-2 doses administered, n | Best decrease of tumor sizes from baseline, % | Toxicities | Response at EOS (day 90) | Skin and/or hair depigmentation | Increased TIL infiltrates |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| F5-1 | M | 60 | No | Lung, stomach, liver, pancreas, peritoneum, soft tissues | M1c | 84.3 | 2.2 × 105 | 56 (at day 9) | 18.5 (at 3 mo) | 12 | −33 | Grade 3 rash, NPF | PD | Yes | Yes |
| F5-2 | F | 46 | Prime-boost vaccine, HD IL-2 | Skin, LN, bone | M1c | 74.1 | 1.5 × 105 | 59 (at day 9) | 11 (at 6 mo) | 6 | −22 | Grade 3 rash, NPF | SD | Yes | Yes |
| F5-8 | M | 44 | No | LN, liver | M1c | 66.7 | 7.8 × 105 | 51 (at day 7) | 15.5 (at 5 mo) | 11 | −13 | Grade 3 rash, NPF | SD | Yes | NA |
NOTE: EOS, end of study; F, female; HD, high-dose; LN, lymph nodes; M, male; NA, not available; NPF, neutropenic fevers; PD, progressive disease; SD, stable disease.