Table 1.
Patient characteristics at baseline per dose level
|
Characteristics |
Dose level |
|
||
|---|---|---|---|---|
| 1 | 2 | 3 | Total | |
| Number of patients |
4 (100%) |
13 (100%) |
7 (100%) |
24 (100%) |
|
Age, years |
|
|
|
|
| N |
4 |
13 |
6 |
23 |
| Median (range) |
55.5 (38–75) |
65.0 (33–70) |
56.0 (44–63) |
62.0 (33–75) |
|
Gender, n (%) |
|
|
|
|
| Female |
1 (25%) |
2 (15%) |
|
3 (13%) |
| Male |
3 (75%) |
11 (85%) |
7 (100%) |
21 (88%) |
|
KPS |
|
|
|
|
| N |
3 |
12 |
7 |
22 |
| Median (range) |
100 (100–100) |
90 (90–100) |
100 (90–100) |
95 (90–100) |
|
Siewert classification |
|
|
|
|
| AEG II |
2 (50%) |
9 (69%) |
7 (100%) |
18 (75%) |
| AEG III |
2 (50%) |
4 (31%) |
|
6 (25%) |
|
T staging |
|
|
|
|
| 3 |
3 (75%) |
10 (77%) |
6 (86%) |
19 (79%) |
| 4 |
1 (25%) |
2 (15%) |
1 (14%) |
4 (17%) |
| X |
|
1 (8%) |
|
1 (4%) |
|
N staging |
|
|
|
|
| 0 |
|
2 (15%) |
|
2 (8%) |
| 1 |
2 (50%) |
5 (38%) |
4 (57%) |
11 (46%) |
| 2 |
2 (50%) |
4 (31%) |
2 (29%) |
8 (33%) |
| X |
|
2 (15%) |
1 (14%) |
3 (13%) |
|
M staging |
|
|
|
|
| 0 |
3 (75%) |
12 (92%) |
7 (100%) |
22 (92%) |
| X |
1 (25%) |
1 (8%) |
|
2 (8%) |
|
UICC staging |
|
|
|
|
| II A |
|
2 (15%) |
|
2 (8%) |
| III |
4 (100%) |
8 (62%) |
6 (86%) |
18 (75%) |
| NK | 3 (23%) | 1 (14%) | 4 (17%) | |
KPS, Karnofsky Performance Status.
UICC staging according to the 6th edition: NK in case of unknown T or N staging (Tx, Nx).