Table 2.
Baseline and treatment characteristics of the three metastatic melanoma cohorts
| 120Cy/125Flu patients | 60Cy/125Flu patients | TBI/75Flu patients | 120Cy/125Flu vs 60cy/125Flu | 120Cy/125Flu vs TBI/75Flu | 60Cy/125Flu vs TBI/75Flu | |
| N=103 | N=8 | N=9 | P value | P value | P value | |
| Baseline characteristics | ||||||
| Mean age, years | 51±12 | 53±9 | 51±12 | 0.646 | 1 | 1 |
| Male | 66 (64%) | 4 (50%) | 6 (67%) | 0.464 | 1 | 0.637 |
| ECOG performance status*, n (%) | ||||||
| 0 | 58 (56%) | 5 (62.5%) | 8 (89%) | 1 | 0.079 | 0.294 |
| 1 | 37 (36%) | 3 (37.5%) | 1 (11%) | 1 | 0.164 | 0.294 |
| 2 | 8 (8%) | 0 | 0 | 1 | 1 | 1 |
| M stage†, n (%) | ||||||
| IIIc | 1 (1%) | 0 | 0 | 1 | 1 | 1 |
| M1a | 7 (7%) | 0 | 0 | 1 | 1 | 1 |
| M1b | 12 (12%) | 1 (11%) | 1 (13%) | 1 | 1 | 1 |
| M1c | 83 (81%) | 8 (89%) | 7 (87%) | 1 | 1 | 1 |
| LDH level above normal, n (%) | 42 (41%) | 3 (37.5%) | 6 (67%) | 1 | 0.168 | 0.347 |
| CNS metastases at baseline, n (%) | 23 (22%) | 2 (25%) | 3 (33%) | 1 | 0.431 | 1 |
| More than 5 metastases, n (%) | 78 (76%) | 4 (50%) | 8 (89%) | 0.203 | 0.682 | 0.131 |
| HLA-A0201 positive, n (%) | 25 of 102 (25%) | 0 | 3 of 8 (38%) | 0.194 | 0.417 | 0.228 |
| Previous therapy for metastatic disease, n (%) | ||||||
| At least one prior therapy | 103 (100%) | 8 (100%) | 9 (100%) | 1 | 1 | 1 |
| Chemotherapy | 20 (19%) | 4 (50%) | 2 (22%) | 0.065 | 1 | 0.335 |
| Chemobiotherapy | 55 (53%) | 0 | 0 | 0.006 | 0.003 | 1 |
| High-dose bolus IL-2 therapy | 16 (16%) | 0 | 0 | 0.599 | 0.354 | 1 |
| Any other IL-2-based therapy | 10 (10%) | 0 | 0 | 1 | 1 | 1 |
| Anti-CTLA4 antibody single therapy | 34 (33%) | 0 | 2 (22%) | 0.104 | 0.716 | 0.471 |
| Anti-PD1 antibody single therapy | 15 (15%) | 0 | 4 (44%) | 0.595 | 0.044 | 0.082 |
| Anti-PD1+CTLA4 combo therapy | 2 (2%) | 0 | 7 (78%) | 1 | ≤0.001 | 0.002 |
| Targeted therapy (BRAFI±MEKI) | 15 (15%) | 1 (13%) | 3 (33%) | 1 | 0.157 | 0.577 |
| Other treatment | 3 (3%) | 7 (88%) | 1 (11%) | ≤0.001 | 0.288 | 0.003 |
| Infusion product characteristics | ||||||
| Total cell number (×109) | 49±24 | 40.5±19.7 | 44.9±22 | 0.332 | 0.622 | 0.672 |
| CD8 frequency (%) | 59±25 | 51.3±17.9 | 31.7±27.1 | 0.396 | 0.002 | 0.103 |
| CD4 frequency (%) | 41±25 | 48.2±17.4 | 66.3±28.3 | 0.427 | 0.005 | 0.139 |
| NMA-related adverse events, days of hospitalization and transfusion units | ||||||
| Days of hospitalization, median | 20.8±5.1 | 15.4±1.5 | 13.7±1.4 | 0.004 | ≤0.001 | 0.029 |
| Chemotherapy-related toxicity (grade 3–5) | ||||||
| Febrile neutropenia | 94 (91%) | 4 (50%) | 0 | 0.001 | ≤0.001 | 0.029 |
| Thyroid cancer | 1 (1%) | 0 | 0 | 1 | 1 | 1 |
| Fatal myelodysplastic syndrome | 1 (1%) | 0 | 0 | 1 | 1 | 1 |
| Chemotherapy-related toxicity (grade 5) | ||||||
| Cyclophosphamide-induced fatal cardiomyopathy | 3 additional, unevaluated patients | 0 | 0 | 1 | 1 | 1 |
| Transfusion data | ||||||
| No of RC units, average | 4.7±5.8 | 0.63±0.92 | 0 | 0.055 | 0.019 | 0.057 |
| No of PLT units, average | 24.8±35.4 | 0 | 0 | 0.051 | 0.039 | 1 |
*ECOG Eastern Cooperative Oncology Group (ECOG) status ranges from 0 to 5, with higher scores indicating greater impairment (5 indicates death).
†The metastasis (M) stage was classified according to the tumor-node-metastasis (TNM) categorization for melanoma of the American Joint Committee on Cancer.
CNS, central nervous system; CTLA4, cytotoxic T-lymphocyte-associated protein 4; Cy, cyclophosphamide; Flu, fludarabine; HLA, human leukocyte antigen; IL, interleukin; LDH, lactate dehydrogenase; NMA, non-myeloablative; PD1, Programmed cell death protein 1; PLT, platelets; RC, red cells; TBI, total body irradiation.