Table 1. Demographic data and disease characteristics.
Onapristone Dose | |||||||
---|---|---|---|---|---|---|---|
Overall (n = 52) |
10 mg BID (n = 12 a) |
20 mg BID (n = 12 a) |
30 mg BID (n = 6) |
40 mg BID (n = 10) |
50 mg BID (n = 6) |
100 mg QD (n = 6) |
|
Age (years) | |||||||
Median | 64 | 67 | 63 | 65 | 65 | 63 | 61 |
Range | 36–84 | 42–81 | 36–78 | 59–68 | 45–82 | 46–84 | 53–77 |
Race n(%) | |||||||
White | 52 (100) | 12 (100) | 12 (100) | 6 (100) | 10 (100) | 6 (100) | 6 (100) |
BMI (kg/m2) | |||||||
Median | 25 b | 25 | 23 | 26 b | 25 | 25 | 26 |
Range | 18–35 b | 19–35 | 18–35 | 20–32 b | 20–35 | 20–26 | 22–29 |
Weight (kg) | |||||||
Median | 66 | 68 | 63 | 65 | 68 | 61 | 65 |
Range | 40–91 | 45–86 | 40–78 | 50–91 | 46–90 | 52–66 | 51–72 |
ECOG status [n(%)] | |||||||
0 | 23 (44) | 7 (58) | 4 (33) | 2 (33) | 3 (30) | 4 (67) | 3 (50) |
1 | 29 (56) | 5 (42) | 8 (67) | 4 (67) | 7 (70) | 2 (33) | 3 (50) |
Primary tumor [n(%)] | |||||||
Breast | 20 (38) | 5 (42) | 5 (42) | 2 (33) | 5 (50) | 3 (50) | 0 |
Ovarian | 13 (25) | 4 (33) | 3 (25) | 1 (17) | 4 (40) | 1 (17) | 0 |
Endometrium | 13 (25) | 3 (25) | 3 (25) | 1 (17) | 0 | 1 (17) | 5 (83) |
Other c | 6 (12) | 0 | 1 (8) | 2 (33) | 1 (10) | 1 (17) | 1 (17) |
Metastatic sites [n (%)] | |||||||
Lymph nodes | 28 (54) | 7 (58) | 6 (50) | 3 (50) | 5 (50) | 3 (50) | 4 (67) |
Liver | 26 (50) | 6 (50) | 6 (50) | 4 (67) | 6 (60) | 3 (50) | 1 (17) |
Bone | 23 (44) | 5 (42) | 5 (42) | 5 (83) | 4 (40) | 4 (67) | 0 |
Peritoneum | 20 (39) | 4 (33) | 7 (58) | 2 (33) | 4 (40) | 1 (17) | 2 (33) |
Lung | 15 (29) | 3 (25) | 5 (42) | 2 (33) | 1 (10) | 2 (33) | 2 (33) |
Pleura | 8 (15) | 3 (25) | 2 (17) | 0 | 2 (20) | 0 | 1 (17) |
Ovarian | 2 (4) | 1 (8) | 1 (8) | 0 | 0 | 0 | 0 |
Spleen | 4 (8) | 1 (8) | 0 | 1 (17) | 0 | 0 | 2 (33) |
Other | 16 (31) | 4 (33) | 4 (33) | 1 (17) | 4 (40) | 1 (17) | (33) |
a. 1 patient randomized to 20mg was treated at 10mg BID and is included in all data tables as being at the 10mg dose level
b. 1 patient missing BMI (minor protocol deviation)
c. 2 uterine leiomyosarcomas, 2 endometrial stromal sarcomas, 1 uterine cancer, 1 vertex apocrine carcinoma