| Phase I | Phase II | ||
---|---|---|---|---|
Number of patients | 12 | 35* | ||
Age (years) | ||||
 median | 72 | 75 | ||
 range | 70–81 | 70–86 | ||
Sex | ||||
 male | 9 | 75% | 25 | 71% |
 female | 3 | 25% | 10 | 29% |
ECOG PS | ||||
 0/1/2 | 8/4/0 | 17/17/1 | ||
TNM factors | ||||
 T 1/2/3/4 | 2/6/0/4 | 10/14/5/6 | ||
 N 0/1/2/3 | 0/4/5/3 | 2/8/17/8 | ||
Brinkman’s index | ||||
 median | 1000 | 1000 | ||
 range | 0–3600 | 0–2950 |