Table 4. Treatment Efficacy.
This table describes the efficacy and outcomes seen in patients treated
| Overall | Arm A (Docetaxel) | Arm B (Pulse Dose AT-101) | Arm C (Metronomic AT-101) | ||
|---|---|---|---|---|---|
| Patients | 35 | 13 | 11 | 11 | |
| Median PFS, months (range1) | 4.3 (0.7–13.71) | 4.5 (2.6–9.91) | 2.8 (1.2–6) | 4.2 (0.8–13.71) | |
| 6 month PFS (95% CI)3 | 24% (9,42) | 45% (15,71) | 33% (6, 65) | 12% (1,41) | |
| Median OS, months (range) | 5.5 (0.4–24) | 8.3 (5.5–9.9) | 4.9 (1.2–22.9) | 5.0 (4.2–24.0) | |
| Best Overall Response Evaluation | |||||
| Progressive Disease (PD), n (%) | 6 (17%) | 0 (0%) | 3 (27%) | 3 (27%) | |
| Stable Disease (SD), n (%) | 22 (66%) | 10 (77%) | 6 (55%) | 6 (55%) | |
| Partial Response (PR), n (%) | 4 (11%) | 1 (8%) | 1 (9%) | 2 (18%) | |
| Complete Response (CR), n (%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | |
| NA2 | 3 (9%) | 2 (15%) | 1 (9%) | 0 (0%) | |
| Overall Response Rate (PR+ CR), n (%) | 4 (11%) | 2 (15%) | 1 (9%) | 0 (0%) | |
| Clinical Benefit (SD+PR+CR), n (%) | 74% (57%,88%) | 85% (55%, 98%) | 64% (31%,89%) | 73% (39%, 94%) | |
1
Denotes that the highest observation was censored at maximum
2
NA=not assessed. All three patients came off treatment before cycle 3 for reasons other than disease progression and have no recorded response assessment.
3
PFS and 95% confidence interval estimated using life-table method.