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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)
  1. ITT = intention-to-treat; SD = standard deviation; ECOG = Eastern Cooperative Oncology Group
  2. a Per 2002 AJCC. Baseline LDH levels were used in this classification.