Table 1.
Patient Characteristics
| Patient Characteristics | Previously treated Patients (Cohort 1) n=34 | Chemotherapy Naïve Patients (Cohort 2) n=39 |
|---|---|---|
| Median age (range) | 60 years (28–84) | 59 years (23–91) |
| Male | 23 (67.6%) | 23 (59.0%) |
| M stage | ||
| M1a | 5 (14.7%) | 7 (18.0%) |
| M1b | 11 (32.4%) | 13 (33.3%) |
| M1c | 18 (52.9%) | 19 (48.7%) |
| ECOG performance status | ||
| 0 | 22 (64.7%) | 24 (61.5%) |
| 1 | 11 (32.4%) | 13 (33.3%) |
| 2 | 1 (2.9%) | 2 (5.1%) |
| Pre-existing signs and symptoms | ||
| grade 3 fatigue | 1 (2.9%) | -------- |
| grade 2 fatigue | 3 (8.8%) | 4 (10.3%) |
| grade 1 neuro-sensory difficulties | 5 (14.7%) | 5 (12.8%) |
| Prior therapies | ||
| radiation therapy | 16 (47.1%) | 8 (20.5%) |
| immunologic therapy | 8 (23.5%) | 10 (25.6%) |
| hormonal therapy | -------- | 2 (5.1%) |
| vaccine therapy | 3 (8.8%) | 2 (5.1%) |
| chemotherapy * | 34 (100%) | 0 |
| Temozolomide | 23 (67.6%) | |
| Temozolomide + thalidomide | 2(5.8%) | |
| Everolimus | 4(11.8%) | |
| Dacarbazine | 7 (20.5%) | |
| Elevated LDH at time of registration | ||
| Yes | 8 (24%) | 16 (41%) |
| No | 19 (56%) | 18 (46%) |
| Baseline LDH not provided | 7 (20%) | 5 (13%) |
*
Two patients had received 2 prior chemotherapy regimens