Table 2.
Patient characteristics and clinical responses
| No. | Age | Sex | Target lesion | Dose of peptide (mg) | Number of injection | Clinical response* | Objective Response | Response lesion | Injection site reaction(Grade) |
CTL response |
PFS(day) |
OS (day) |
Pre-vaccination |
Post-vaccination |
|||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-vaccination | Post-vaccination** | WBC(/mm 3 ) | Lymphocyte (%) | Lymphocyte (/mm 3 ) | WBC(/mm 3 ) | Lymphocyte (%) | Lymphocyte (/mm 3 ) | ||||||||||||
| 1 |
75 |
M |
Local LNs |
1 |
4 |
PD |
|
|
0 |
N.A. |
+ |
36 |
36 |
7300 |
7 |
511 |
5300 |
10.5 |
557 |
| 2 |
57 |
F |
Local |
1 |
11 |
PD |
|
|
1 |
++ |
++ |
26 |
108 |
7400 |
13 |
962 |
7900 |
8 |
632 |
| 3 |
72 |
M |
Liver |
1 |
3 |
- |
|
|
0 |
N.T. |
N.T. |
31 |
31 |
7800 |
11 |
858 |
16200 |
10.5 |
1701 |
| 4 |
60 |
M |
Lung, local LNs |
1 |
19 |
SD |
Yes |
Lung metastasis |
2 |
+ |
- |
223 |
283 |
5100 |
21 |
1071 |
5200 |
10.5 |
546 |
| 5 |
72 |
F |
Primary , liver |
1 |
12 |
PD |
|
|
1 |
+ |
+++ |
24 |
128 |
2400 |
25.5 |
612 |
4200 |
10.8 |
454 |
| 6 |
65 |
F |
Liver |
1 |
4 |
PD |
|
|
0 |
+ |
+ |
26 |
40 |
4500 |
16.5 |
743 |
8000 |
4.1 |
328 |
| 7 |
61 |
F |
Local , liver |
3 |
14 |
SD |
|
|
2 |
+ |
+++ |
55 |
155 |
4000 |
25 |
1000 |
6400 |
18.3 |
1171 |
| 8 |
57 |
F |
Primary, liver |
3 |
10 |
SD |
|
|
2 |
++ |
+++ |
56 |
145 |
4500 |
33 |
1485 |
14100 |
16 |
2256 |
| 9 |
33 |
F |
Paraaortic LNs |
3 |
29 |
SD |
Yes(CR) |
Liver metastasis |
3 |
N.A. |
+++ |
>1219 |
>1219 |
2500 |
44.5 |
1113 |
3600 |
33 |
1188 |
| 10 |
76 |
M |
Liver |
3 |
12 |
PD |
|
|
2 |
- |
++ |
27 |
142 |
2300 |
29.5 |
679 |
5800 |
11.5 |
667 |
| 11 |
55 |
F |
Primary, lung |
3 |
17 |
SD |
|
|
1 |
+ |
- |
112 |
225 |
2600 |
9 |
234 |
2200 |
11.5 |
253 |
| 12 |
58 |
M |
Primary |
3 |
5 |
PD |
|
|
0 |
- |
- |
32 |
32 |
4500 |
30 |
1350 |
2400 |
10.7 |
257 |
| 13 |
58 |
F |
Live, lung, LNs |
3 |
10 |
SD |
|
|
1 |
- |
++ |
57 |
97 |
7100 |
15.5 |
1101 |
9100 |
10.5 |
956 |
| 14 |
60 |
M |
Liver, LNs |
3 |
17 |
SD |
Yes |
Liver metastasis, LNs |
2 |
+++ |
+++ |
169 |
220 |
2300 |
27 |
621 |
4100 |
19.5 |
800 |
| 15 |
80 |
F |
Liver, LNs, lung |
3 |
5 |
PD |
|
|
0 |
- |
+ |
24 |
44 |
8500 |
9.5 |
808 |
13300 |
4.8 |
638 |
| 16 |
58 |
M |
Primary, liver, lung |
3 |
13 |
PD |
|
|
1 |
- |
++ |
28 |
182 |
4800 |
27 |
1296 |
6400 |
19.3 |
1235 |
| 17 |
49 |
M |
Parimary |
3 |
17 |
SD |
|
|
2 |
+ |
+++ |
169 |
309 |
6200 |
26.5 |
1643 |
7900 |
17.5 |
1383 |
| 18 |
62 |
M |
Primary, liver, LNs |
3 |
7 |
SD |
|
|
1 |
- |
+++ |
93 |
93 |
4200 |
28 |
1176 |
6600 |
18.6 |
1228 |
| 19 |
61 |
M |
Primarym, liver, lung, LNs |
3 |
11 |
SD |
|
|
2 |
- |
+ |
57 |
105 |
10200 |
20.5 |
2091 |
28700 |
9 |
2583 |
| 20 |
58 |
M |
LNs, lung |
3 |
25 |
SD |
|
|
2 |
+ |
+++ |
169 |
332 |
10100 |
34 |
3434 |
7600 |
19.5 |
1482 |
| 21 |
47 |
M |
Primary, liver |
3 |
13 |
SD |
|
|
1 |
- |
+ |
56 |
249 |
6000 |
27.5 |
1650 |
9600 |
8 |
768 |
| 22 |
71 |
F |
Liver, local LNs |
3 |
7 |
SD |
Yes |
Liver metastasis |
2 |
N.A. |
++ |
89 |
89 |
7000 |
11.5 |
805 |
5200 |
20 |
1040 |
| 23 |
50 |
M |
Local, LNs |
3 |
6 |
SD |
|
|
0 |
N.A. |
- |
148 |
148 |
7900 |
20 |
1580 |
11200 |
19 |
2128 |
| 24 |
74 |
M |
Bone |
3 |
21 |
SD |
Yes |
Bone metastasis |
2 |
N.A. |
+++ |
415 |
495 |
3800 |
16 |
608 |
5600 |
17.8 |
997 |
| 25 |
69 |
F |
Primary |
3 |
2 |
- |
|
|
0 |
N.T. |
N.T. |
11 |
11 |
7600 |
21.5 |
1634 |
7400 |
20.5 |
1517 |
| 26 |
80 |
M |
Liver, lung |
3 |
18 |
SD |
|
|
1 |
+ |
+++ |
112 |
207 |
6600 |
24 |
1584 |
7500 |
21.5 |
1613 |
| 27 |
44 |
M |
Liver, lung, local LNs |
3 |
24 |
SD |
Yes |
Lung and liver metastasis |
1 |
+ |
- |
115 |
317 |
2900 |
23.5 |
682 |
4000 |
25.5 |
1020 |
| 28 |
61 |
F |
Peritoneal, local LNs |
3 |
9 |
SD |
Yes |
Peritoneal metastasis |
0 |
- |
- |
69 |
69 |
9000 |
26.5 |
2385 |
11200 |
7.5 |
840 |
| 29 |
46 |
M |
Liver |
3 |
10 |
SD |
|
|
2 |
- |
+++ |
52 |
388 |
4000 |
26 |
1040 |
5600 |
24.6 |
1378 |
| 30 |
64 |
F |
Liver |
3 |
9 |
SD |
|
|
2 |
- |
+++ |
56 |
69 |
4800 |
26.5 |
1272 |
8900 |
7.1 |
632 |
| 31 | 68 | F | Liver | 3 | 9 | SD | Yes | Liver metastasis | 2 | + | +++ | 56 | 82 | 6800 | 33 | 2244 | 8300 | 19.5 | 1619 |
*Clinical response was evaluated one month after vaccination. PD, Progressive disease; SD, Stable disease; CR, Complete response; OR, Objective response.
**Best CTL response after vaccination. CTL responses were evaluated and classified based on the algorithm as described in Methods.
N.T. (Not Tested); CTL response was not tested in the samples in which PD was observed within one course of the treatment.
N.A. (Not Analyzed); CTL response was not analyzed because of the poor viability during the in vitro stimulation.