Table 1 Baseline demographic data and disease characteristics of enrolled patients.
From: Phase II assessment of talabostat and cisplatin in second-line stage IV melanoma
ITT Population (N = 74) | Evaluable Population (N = 40) | |
|---|---|---|
Age, yrs | ||
Median (range) | 58.0 (27–79) | 58.0 (32–79) |
Mean (SD) | 57.6 (12.79) | 58.9 (13.08) |
Race, n (%) | ||
White, Non-Hispanic | 69 (93.2) | 39 (97.5) |
Black, Non-Hispanic | 2 (2.7) | 1 (2.5) |
Hispanic | 2 (2.7) | 0 |
Asian or Pacific Islander | 1 (1.4) | 0 |
Gender, n (%) | ||
Male | 50 (67.6) | 28 (70.0) |
Female | 24 (32.4) | 12 (30.0) |
Tobacco use, n (%) | ||
Never | 32 (43.2) | 14 (35.0) |
Past | 26 (35.1) | 17 (42.5) |
Current | 16 (21.6) | 9 (22.5) |
ECOG performance status, n (%) | ||
0 | 32 (43.2) | 20 (50.0) |
1 | 42 (56.8) | 20 (50.0) |
Time since initial melanoma diagnosis, months | ||
Median (range) | 28.0 (1–420) | 30.5 (3–225) |
Mean (SD) | 50.1 (66.28) | 45.5 (45.43) |
Time since first diagnosis of Stage IV melanoma, months | ||
Median (range) | 4.0 (0–89) | 5.0 (0–30) |
Mean (SD) | 9.3 (15.66) | 7.5 (7.61) |
Stage at original diagnosis, n (%) | ||
Stage 0 | 1 (1.4) | 0 |
Stage I | 10 (13.5) | 3 (7.5) |
Stage II | 16 (21.6) | 8 (20.0) |
Stage III | 26 (35.1) | 15 (37.5) |
Stage IV | 18 (24.3) | 11 (27.5) |
Stage unknown | 3 (4.1) | 3 (7.5) |
Histologic subtype, n (%) | ||
Superficial spreading melanoma | 17 (23.0) | 7 (17.5) |
Nodular melanoma | 30 (40.5) | 20 (50.0) |
Acral lentiginous melanoma | 3 (4.1) | 0 |
Other | 24 (32.4) | 13 (32.5) |
Current M classification by sites of metastases a , n (%) | ||
M1a: Distant skin, subcutaneous, or nodal metastases | 7 (9.5) | 4 (10.0) |
M1b: Lung metastases | 13 (17.6) | 7 (17.5) |
M1c: All other visceral metastases | 54 (73.0) | 29 (72.5) |