Table 3. Response rates, progression-free and overall survival for all patients, in the RP2D cohort, borderline resectable and unresectable patients.
| All patients | RP2D | Borderline resectable | Unresectable | |||||
|---|---|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | No. | % | |
|
RECIST response (N=24; 16; 6; 18) | ||||||||
| Partial | 16 | 67 | 10 | 63 | 5 | 83 | 11 | 61 |
| Stable | 8 | 33 | 6 | 37 | 1 | 17 | 7 | 39 |
|
CA19-9 response (N=19; 13; 5; 14) | ||||||||
| Major | 8 | 42 | 6 | 46 | 2 | 40 | 6 | 43 |
| Minor | 10 | 53 | 7 | 54 | 2 | 40 | 8 | 57 |
|
FDG-PET response (N=21; 16; 5; 16) | ||||||||
| Complete | 9 | 43 | 7 | 44 | 3 | 60 | 6 | 38 |
| Partial | 10 | 48 | 7 | 44 | 2 | 40 | 8 | 50 |
| Stable | 2 | 9 | 2 | 13 | 0 | 0 | 2 | 12 |
|
Progression-free survival | ||||||||
| Median (mo.) | 12.0 | 11.1 | 12.5 | 9.8 | ||||
| 6-month (%) | 96 | 100 | 83 | 100 | ||||
| 12-month (%) | 50 |
50 |
83 |
44 |
||||
|
Overall survival | ||||||||
| Median (month) | 18.1 | 18.1 | 14.5 | 19.9 | ||||
| 1 year (%) | 83.3 | 81.3 | 67 | 89 | ||||
Abbreviations: CA19-9=carcinoma antigen 19-9; FDG-PET=18-fluorodeoxyglucose positron emission tomography; RECIST=Response Evaluation Criteria in Solid Tumours.