Table 4.
Efficacy results: evaluable and all treated patients
| Category | Evaluable patientsa treated with 20 mg/day | All patients treated with 20 mg/day |
|---|---|---|
| Original study | (n = 21) | (n = 28) |
| Best response by WHO Criteria n (%) | ||
| CR | – | – |
| PR | – | – |
| MR | – | – |
| SD (n) | 12 (57.1) | 12 (42.9) |
| PD (n) | 9 (42.9) | 11 (39.3) |
| Duration of stable disease for patients with SD (months) | ||
| Mean | 5.2 | NA |
| Median | 4.5 | NA |
| Standard deviation | 2.9 | NA |
| Range | 2.8–12 | NA |
| Overall survival (months) | ||
| Median survival | 19.2 | 12.7 |
| 95% CI | 10.4–27.6 | 8.8–22.7 |
| Retrospective reanalysis | (n = 20)b | (n = 27)b |
| Best response by modified RECIST Criteria, n (%) | ||
| CR | – | – |
| PR | 1 (5.0) | 1 (3.7) |
| MR | NA | NA |
| SD | 16 (80.0) | 17 (63.0) |
| PD | 3 (15.0) | 7 (25.9) |
| No post-baseline Assessments | – | 2 (7.4) |
| Progression free survival (months) | ||
| Median survival | 3.4 | 3.2 |
| 95% CI | 3.0–5.8 | 3.0–5.8 |
| Overall survival (months) | ||
| Median survival | 16.7 | 12.6 |
| 95% CI | 10.0–30.1 | 7.9–22.0 |
CR complete response, PR partial response, MR minor response, SD stable disease, PD progressive disease, NA data not available, CI confidence intervals
aEvaluable patients were defined as patients who participated in the Phase 1 study at the MTD, who received 21 or more doses of TAC-101, and had at least 1 tumor assessment 38 days or more after the initial dose
bOne patient with a mixed diagnosis at baseline was excluded from all retrospective efficacy analyses