Table 2.
Tumor response
| Variables | All patients (n = 35) | |
|---|---|---|
| RECIST v1.1 (n = 35) | mRECIST (n = 35) | |
| Best objective response, n (%) | ||
| Complete response | 0 | 4 (11.4%) |
| Partial response | 27 (77.1%) | 27 (77.1%) |
| Stable disease | 7 (20.0%) | 3 (8.6%) |
| Progressive disease | 1 (2.9%) | 1 (2.9%) |
| Objective response rate, n (%) | 27 (77.1%) | 31 (88.6%) |
| 95% CI | (59.9%, 89.6%) | (73.3%, 96.8%) |
| Disease control ratea, n (%) | 34 (97.1%) | 34 (97.1%) |
| 95% CI | (85.1%, 99.9%) | (85.1%, 99.9%) |
| TTR, months, median (95% CI) | 2.66 (2.10, 2.89) | 2.63 (1.38, 2.73) |
| DOR, months, median (95% CI) | 7.52 (4.83, 12.52) | 6.70 (5.09, 9.66) |
| PFS, months, median (95% CI) | 10.38 (7.79, 12.45) | 9.53 (7.10, 11.50) |
| 6-month PFS rate | 85.0% | 85.0% |
| 12-month PFS rate | 34.2% | 28.9% |
| 18-month PFS rate | 22.8% | 19.3% |
| Liver-specific PFS, months, median (95% CI) | 10.68 (8.90, 15.15) | 10.38 (8.90, 15.15) |
| 6-month PFS rate | 85.0% | 85.0% |
| 12-month PFS rate | 39.9% | 36.3% |
| 18-month PFS rate | 28.8% | 25.9% |
TTR time to response, DOR duration of response, PFS progression-free survival, CI confidence interval, RECIST Response Evaluation Criteria in Solid Tumors, mRECIST modified Response Evaluation Criteria in Solid Tumors
aFor patients with stable disease, it should persist for a minimum of 6 weeks