Table 1.
Patient demographics and baseline disease characteristics
| Parameter | Module 1 (n = 29) |
Module 2 (n = 30) |
|---|---|---|
| Median age, years (range) | 73 (59 − 90) | 72 (53 − 86) |
| Race, n (%) | ||
| White | 23 (79.3) | 24 (80.0) |
| Black | 5 (17.2) | 3 (10.0) |
| Other | 1 (3.4) | 3 (10.0) |
| ECOG performance status, n (%) | ||
| 0 | 7 (24.1) | 7 (23.3) |
| 1 | 22 (75.9) | 22 (73.3) |
| 2 | 0 | 1 (3.3) |
| Number of prior systemic regimens, median (range) | 4 (1 − 9) | 4 (2 − 8) |
| Number of prior systemic regimens, patient n (%) | ||
| 1 | 1 (3.4) | 0 |
| 2 | 1 (3.4) | 4 (13.3) |
| 3 | 3 (10.3) | 9 (30.0) |
| 4 | 10 (34.5) | 6 (20.0) |
| 5 | 7 (24.1) | 6 (20.0) |
| 6 | 5 (17.2) | 2 (6.7) |
| > 6 | 2 (6.9) | 3 (10.0) |
| Type of prior therapy, n (%) | ||
| Chemotherapy | 21 (72.4) | 15 (50.0) |
| Hormonal therapy | 27 (93.1) | 29 (96.7) |
| Supportive | 12 (41.4) | 13 (43.3) |
| Vaccine | 8 (27.6) | 10 (33.3) |
| Othera | 4 (13.8) | 3 (10.0) |
| Histology, n (%) | ||
| Adenocarcinoma | 27 (93.1) | 29 (96.7) |
| Carcinoma | 1 (3.4) | 0 |
| Missing | 1 (3.4) | 1 (3.3) |
| Number of metastatic sites, patient n (%) | ||
| 1 | 10 (34.5) | 11 (36.7) |
| 2 | 8 (27.6) | 6 (20.0) |
| > 2 | 11 (37.9) | 13 (43.3) |
| Metastatic sites, patient n (%) | ||
| Bone | 25 (86.2) | 25 (83.3) |
| Distant lymph nodes | 16 (55.2) | 9 (30.0) |
| Liver | 7 (24.1) | 8 (26.7) |
| Local or regional lymph nodes | 14 (48.3) | 11 (36.7) |
| Lung | 3 (10.3) | 10 (33.3) |
| Other | 3 (10.3) | 7 (23.3) |
ECOG Eastern cooperative oncology group
aIncludes investigational agents