Table 2.
Patient and treatment characteristics
| Patient Number | Age | Metastatic regions | Number of regions | Previous therapy (number of regimes) | p53 expr (%) | Total number of vacc | Clinical outcome after six vacc | Induced or increased p53 immune response | Survival after one vacc (months) | |
|---|---|---|---|---|---|---|---|---|---|---|
| Chemo | Endocrine | |||||||||
| Response at one evaluation | ||||||||||
| 14 | 58 | liver | 1 | 0 | 2 | 0 | 10 | SD | + | 14.5 |
| 15 | 47 | nodal | 1 | 0 | 0 | 80 | 9 | SD | + | 9 |
| 17 | 46 | nodal | 1 | 0 | 2 | 40 | 9 | SD | NA | 26.5 |
| 19 | 64 | nodal | 1 | 0 | 2 | 30 | >10 | SD | − | 21 |
| 21 | 44 | pleura, bone, nodal, ascites | 4 | 0 | 1 | 30 | 10 | PR minor | − | 12.5 |
| 29 | 58 | lung | 1 | 3 | 0 | 90 | >10 | SD | + | 13 |
| 35 | 74 | lung, liver | 2 | 2 | 2 | nd | 10 | SD | + | 5.5 |
| 37 | 66 | nodal, skin | 2 | 5 | 1 | nd | 8 | PR minor | − | >21 |
| PD at one evaluation | ||||||||||
| 13 | 72 | nodal, skin | 2 | 1 | 1 | 0 | 7 | PD | (+) | 4 |
| 16 | 54 | pleura, liver, bone | 3 | 2 | 2 | 0 | 5 | PD | − | 2 |
| 20 | 59 | skin, lung , bone, nodal | 4 | 3 | 1 | 100 | 6 | PD | NA | 7.5 |
| 22 | 33 | lung, pleura, liver, bone, nodal | 5 | 2 | 1 | 0 | 5 | PD | NA | 2 |
| 23 | 46 | nodal | 1 | 1 | 0 | 90 | 7 | PD | − | 13 |
| 26 | 51 | lung | 1 | 3 | 1 | 0 | 6 | PD | − | 10 |
| 27 | 64 | liver, bone | 2 | 2 | 2 | 0 | 6 | PD | − | 2 |
| 28 | 64 | lung, pleura, liver, bone, nodal, ascites | 6 | 2 | 1 | 50 | 5 | PD | − | 2 |
| 31 | 52 | bone | 1 | 0 | 2 | 10 | 7 | PD | − | 3 |
| 36 | 64 | skin | 1 | 1 | 2 | 0 | 6 | PD | − | >21 |
| 38 | 62 | pleura, liver, bone, nodal | 4 | 1 | 2 | 0 | 6 | PD | (+) | 9 |
| Early termination | ||||||||||
| 10 | 51 | lung, bone, nodal | 3 | 0 | 2 | 0 | 3 | PD | − | <1 |
| 11 | 61 | nodal | 1 | 2 | 1 | 80 | 3 | PD | ND | <1 |
| 12 | 56 | lung, liver, nodal | 3 | 1 | 1 | 100 | 4 | PD | + | 8 |
| 18 | 36 | liver, bone | 2 | 2 | 2 | 0 | 4 | PD | + | 4.5 |
| 30 | 44 | skin, lung, pleura, liver | 4 | 2 | 3 | 0 | 4 | PD | − | 4 |
| 32 | 58 | skin | 1 | 0 | 2 | 0 | 3 | PD | − | 4 |
| 33 | 56 | liver,bone, nodal | 3 | 1 | 0 | 0 | 4 | PD | − | 1.5 |
+ Only immune response to a single peptide (see Table 4)