Table 1.
Demographic and baseline characteristic of enrolled and treated subjects (total treated population)
| Parameter | GS+ (n = 71) | GS− (n = 50) | Totala (n = 123) | Kruit et al. (n = 36b) |
|---|---|---|---|---|
| Age in years | ||||
| Median (range) | 68 (28–91) | 63 (36–86) | 65 (28–91) | 69 (30–86) |
| Sex, n (%) | ||||
| Female | 42 (59) | 23 (46) | 65 (53) | 22 (61) |
| Male | 29 (41) | 27 (54) | 58 (47) | 14 (39) |
| ECOG statusc, n (%) | ||||
| 0 | 52 (73) | 40 (80) | 94 (76) | 35 (97) |
| 1 | 18 (25) | 10 (20) | 28 (23) | 1 (3) |
| Stage, n (%) | ||||
| IIIB | 11 (15) | 4 (8) | 16 (13) | NA |
| IIIC | 21 (30) | 19 (38) | 41 (33) | NA |
| IV-M1a | 39 (55) | 27 (54) | 66 (54) | NA |
| Lesion diameter, n (%) | ||||
| All <20 mm | 25 (35) | 14 (28) | 40 (33) | 14 (39) |
| All ≥20 mm | 24 (34) | 24 (48) | 48 (39) | — |
| Lesions < and ≥20 mm | 22 (31) | 12 (24) | 35 (29) | 22 (61) |
| Type of prior therapy, n (%) | ||||
| Interferon | 14 (20) | 16 (32) | 31 (25) | 11 (31) |
| Radiotherapy | 12 (17) | 5 (10) | 17 (14) | 2 (6) |
| Isolated limb perfusion | 5 (7) | 4 (8) | 9 (7) | 2 (6) |
| Cancer vaccine | 1 (1) | 0 | 1 (1) | — |
| Anti-CTLA-4-based therapy | 0 | 2 (4) | 2 (2) | — |
n, number of patients in each population.
n (%), number (percentage) of patients with the indicated characteristic.
aTotal include characteristics of two patients with unknown GS status.
bAS15 group.
cOne subject in the GS+ population had an ECOG score of 2.