Baseline clinical and pathological characteristics of patients included in the study
Part I | Part II | Part III | ||||||
(n=16) | (n=12) | (n=14) | ||||||
I-1 | I-2 | I-3 | I-4 | II-1 | II-2 | III-1 | III-2 | |
1×1011 vp | 1×1012 vp | 3.3×1012 vp | 1×1013 vp | 3.3×1012 vp | 1×1013vp | 3.3×1012 vp | 1×1013vp | |
(n=3) | (n=4) | (n=3) | (n=6) | (n=6) | (n=6) | (n=8) | (n=6) | |
Characteristics | ||||||||
Median age, years (range) | 66 (37–77) | 60 (35–75) | 66 (49–86) | |||||
67 (60–69) | 70 (67–77) | 72 (64–75) | 54 (37–63) | 61 (46–75) | 59 (35–73) | 64 (49–86) | 68 (51–77) | |
Sex (male/female) | 2/1 | 3/1 | 2/1 | 5/1 | 3/3 | 4/2 | 3/5 | 2/4 |
ECOG | ||||||||
0 | 1 | 2 | 1 | 1 | 2 | 2 | 2 | 2 |
1 | 2 | 2 | 2 | 5 | 4 | 4 | 4 | 4 |
Primary disease | ||||||||
Colorectal—stage IV | 3 | 4 | 3 | 5 | 0 | 0 | 0 | 0 |
Head and neck | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Pancreas–stage III | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 0 |
Pancreas–stage IV | 0 | 0 | 0 | 0 | 5 | 5 | 6 | 6 |
Site of metastatic disease | ||||||||
Liver (only) | 1 | 2 | 0 | 1 | 4 | 3 | 2 | 4 |
Lung (only) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Liver and lung (and other) | 1 | 0 | 1 | 5 | 1 | 1 | 1 | 0 |
Liver (and other) | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 |
Other | 1 | 2 | 2 | 0 | 0 | 0 | 2 | 0 |
Previous antineoplastic treatment (yes/no) | ||||||||
3/0 | 4/0 | 3/0 | 6/0 | 2/4 | 2/4 | 0/8 | 2/4 |
ECOG, Eastern Cooperative Oncology Group Performance Status Scale; vp, viral particles .