Table 3.
Response, 6-month PFS, cycles of treatment and status.
| Endpoint | Category | n | % |
|---|---|---|---|
| Off study therapy Cycles of Treatment | Yes | 28 | 100.0 |
| 1 | 1 | 3.6 | |
| 2 | 12 | 42.9 | |
| 3 | 3 | 10.7 | |
| 4 | 4 | 14.3 | |
| 5 | 1 | 3.6 | |
| 6 | 3 | 10.7 | |
| 8 | 1 | 3.6 | |
| 11 | 1 | 3.6 | |
| 12 | 2 | 7.1 | |
| Reason off therapy | Disease Progression | 24 | 85.7 |
| Patient Refused | 1 | 3.6 | |
| Toxicity | 2 | 7.1 | |
| Death | 1 | 3.6 | |
| RECIST 1.1 Response | Complete or partial response | 0 | 0.0 |
| Stable Disease | 16 | 57.1 | |
| Disease Progression | 11 | 39.3 | |
| Indeterminate | 1 | 3.6 | |
| PFS ≥ 6 months | No | 23 | 82.1 |
| Yes | 5 | 17.9 | |
| TPFS ≥ 6 months | No | 25 | 89.3 |
| Yes | 3 | 10.7 | |
| Survival status | Alive | 10 | 35.7 |
| Dead – Treatment-related | 1 | 3.6 | |
| Dead – Disease-related | 17 | 60.7 |