Table 1.
Patient Characteristics
| Characteristic | Treatment Arm | P | |
|---|---|---|---|
| NMA | 1,200 TBI | ||
| Patients | 51 | 50 | |
| Sex | .54 | ||
| Female | 17 (33) | 20 (40) | |
| Male | 34 (67) | 30 (60) | |
| Age, years | |||
| Median | 45 | 47 | .73 |
| 18-30 | 8 (16) | 3 (6) | .19* |
| 31-45 | 18 (35) | 16 (32) | |
| 46-60 | 22 (43) | 29 (58) | |
| 61-65 | 3 (6) | 2 (4) | |
| HLA | .32 | ||
| A2 | 19 (37) | 24 (48) | |
| Non-A2 | 32 (63) | 26 (52) | |
| Stage† | .63 | ||
| M1a | 3 (6) | 6 (12) | |
| M1b | 8 (16) | 8 (16) | |
| M1c | 40 (78) | 36 (72) | |
| Prior systemic treatment | .44 | ||
| None | 14 (27) | 12 (24) | |
| 1 systemic therapy | 22 (43) | 19 (38) | |
| ≥ 2 systemic therapies | 15 (29) | 19 (38) | |
| Immunotherapy | |||
| High-dose IL-2 | 17 (33) | 12 (24) | .38 |
| Anti–CTLA-4 only | 13 (26) | 18 (36) | .29 |
| Anti–PD-1 only | 1 (2) | 2 (4) | .62 |
| Anti–CTLA-4 and anti–PD-1 | 6‡ (12) | 2 (4) | .27 |
| Adjuvant (IFN-α, vaccine, etc) | 20 (39) | 18 (36) | .84 |
| Chemotherapy | |||
| Dacarbazine or temozolomide | 3 (6) | 8 (16) | .12 |
| BRAF and/or MEK inhibitor | 4 (8) | 5 (10) | .74 |
| Other (including biochemotherapy) | 5 (10) | 5 (10) | 1.0 |
| Select baseline value, median (25th to 75th percentile) | |||
| LDH, U/L | 182 (152-238) | 198 (154-317) | .29 |
| NLR | 2.40 (1.46-4.02) | 3.02 (1.92-4.61) | .05 |
| Platelets, K/μL | 222 (193-313) | 242 (197-305) | .62 |
NOTE. Data are given as No. of patients (%) unless otherwise noted.
Abbreviations: CTLA, cytotoxic T-cell lymphocyte associated protein-4; IFN-α, interferon-alfa; IL-2, interleukin-2; LDH, lactate dehydrogenase; MEK, mitogen-activated kinase kinase; NLR, neutrophil-to-lymphocyte ratio; PD-1, programmed death-1.
*
P value applies to all age ranges given.
†
M1a, skin, subcutaneous or nodal metastases; M1b, lung; M1c, all other viscera or elevated LDH.
‡
Only two patients progressed through combination therapy, the others progressed sequentially.