Table 1 Baseline characteristics of patients by treatment arm
Variable | FM+DTIC | FM+DTIC+IFN | DTIC | DTIC+IFN | Total |
|---|---|---|---|---|---|
(N=64) | (N=68) | (N=70) | (N=58) | (N=260) | |
Male gender | 42 (66%) | 35 (51%) | 42 (60%) | 38 (66%) | 157 (60%) |
Age years, mean (SD) | 54 (13) | 50 (15) | 59 (15) | 56 (14) | 55 (15) |
Adjuvant immunotherapy | |||||
Yes | 20 (31%) | 24 (35%) | 21 (30%) | 8 (14%) | 73 (28%) |
No | 43 (67%) | 43 (63%) | 49 (70%) | 49 (84%) | 184 (71%) |
Missing | 1 (2%) | 1 (1%) | 0 (0%) | 1 (2%) | 3 (1%) |
Performance Status | |||||
0 | 45 (70%) | 52 (76%) | 55 (79%) | 41 (71%) | 193 (74%) |
1 | 16 (25%) | 12 (18%) | 14 (20%) | 15 (26%) | 57 (22%) |
2 | 2 (3%) | 4 (6%) | 1 (1%) | 1 (2%) | 8 (3%) |
Missing | 1 (2%) | 0 (0%) | 0 (0%) | 1 (2%) | 2 (1%) |
Histology | |||||
Superficial spreading melanoma | 13 (20%) | 8 (12%) | 7 (10%) | 6 (10%) | 34 (13%) |
Nodular melanoma | 27 (42%) | 36 (53%) | 36 (51%) | 31 (53%) | 130 (50%) |
Lentigo malignant melanoma | 0 (0%) | 0 (0%) | 1 (1%) | 0 (0%) | 1 (0%) |
Acral lentiginous melanoma | 1 (2%) | 2 (3%) | 5 (7%) | 1 (2%) | 9 (3%) |
Other | 22 (34%) | 22 (32%) | 21 (30%) | 19 (33%) | 84 (32%) |
Missing | 1 (2%) | 0 (0%) | 0 (0%) | 1 (2%) | 2 (1%) |
Breslow | |||||
<2 | 18 (28%) | 17 (25%) | 10 (14%) | 10 (17%) | 55 (21%) |
≥2 and ≤4 | 30 (47%) | 27 (40%) | 36 (51%) | 28 (48%) | 121 (47%) |
>4 | 15 (23%) | 24 (35%) | 24 (34%) | 20 (34%) | 83 (32%) |
Unknown | 1 (2%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (0%) |
Ulceration | |||||
Yes | 28 (44%) | 27 (40%) | 28 (40%) | 24 (41%) | 107 (41%) |
No | 23 (36%) | 29 (43%) | 35 (50%) | 27 (47%) | 114 (44%) |
Unknown | 13 (20%) | 12 (18%) | 7 (10%) | 7 (12%) | 39 (15%) |
LDH | |||||
Normal | 28 (44%) | 31 (46%) | 23 (33%) | 17 (29%) | 99 (38%) |
>1 UNL and ≤ 2UNL | 25 (39%) | 24 (35%) | 19 (27%) | 22 (38%) | 90 (35%) |
>2 UNL | 11 (17%) | 13 (19%) | 28 (40%) | 19 (33%) | 71 (27%) |
Visceral disease | |||||
Yes | 51 (80%) | 49 (72%) | 53 (76%) | 47 (81%) | 200 (77%) |
No | 12 (19%) | 19 (30%) | 17 (24%) | 10 (17%) | 58 (22%) |
Missing | 1 (2%) | 0 (0%) | 0 (0%) | 1 (2%) | 2 (1%) |
Site of metastases | |||||
M1A | 6 (9%) | 11 (16%) | 6 (9%) | 3 (5%) | 26 (10%) |
M1B | 8 (12%) | 2 (3%) | 7 (10%) | 4 (7%) | 21 (8%) |
M1C | 49 (77%) | 55 (81%) | 57 (81%) | 50 (86%) | 211 (81%) |
Missing | 1 (2%) | 0 (0%) | 0 (0%) | 1 (2%) | 2 (1%) |
Brain metastases | |||||
Yes | 11 (17%) | 13 (19%) | 4 (6%) | 5 (9%) | 33 (13%) |
No | 53 (83%) | 55 (81%) | 66 (94%) | 53 (91%) | 227 (87%) |