|
Pt
|
Age
|
Cancer
|
Stage on enrollment
|
# of cycles
|
Off-study reason
|
PFS#(ms)
|
OS* (ms)
|
Immune response
|
|---|
|
Proliferative assay
|
Elispot
|
|---|
| | | | | | | | |
Pre-vaccine
|
Post-vaccine
|
Pre-vaccine
|
Post-vaccine
|
|---|
|
1B
|
55
|
Biliary
|
NED
|
3
|
PD
|
2.9
|
8.7
|
+
|
+
|
+
|
+
|
|
2B
|
33
|
Colon
|
IV
|
3
|
PD
|
2.9
|
16.9
|
-
|
+
|
NA
|
|
3B
|
51
|
Colon
|
IV
|
5
|
PPS/Lost to follow-up
|
9.2+
|
52.6
|
+
|
+
|
-
|
+
|
|
4B
|
48
|
Pancreatic
|
NED
|
13
|
Completed
|
35.4+
|
35.4
|
-
|
+
|
-
|
-
|
|
5B
|
51
|
Colon
|
IV
|
1
|
PD
|
1
|
1.5
|
ND
|
|
6B
|
38
|
Colon
|
IV
|
1
|
Refused further Tx
|
0.2+
|
8.3
|
ND
|
|
7B
|
60
|
Pancreatic
|
IV
|
3
|
PD
|
4.6
|
21
|
-
|
-
|
NA
|
|
8B
|
57
|
Colon
|
IV
|
3
|
PD
|
3.1
|
6.8
|
NA
|
|
9B
|
52
|
Colon
|
IV
|
3
|
PD
|
3.3
|
28.3
|
-
|
+
|
+
|
+
|
|
10B
|
58
|
Pancreatic
|
IV
|
3
|
PD
|
2.9
|
20.9
|
+
|
+
|
-
|
+
|
|
11B
|
45
|
Pancreatic
|
IV
|
2
|
PD
|
1
|
7.3
|
ND
|
|
12B
|
79
|
Colon
|
IV
|
3
|
PPS
|
12.9
|
42.1
|
-
|
+
|
-
|
+
|
|
13B
|
43
|
Colon
|
IV
|
3
|
PD
|
2.6
|
6.3
|
-
|
-
|
-
|
+
|
|
14B
|
78
|
Colon
|
NED
|
8
|
Left voluntarily
|
16.8
|
69
|
-
|
+
|
-
|
+
|
|
15B
|
63
|
Colon
|
IV
|
3
|
PD
|
2.8
|
11.6
|
+
|
+
|
-
|
+
|
|
16B
|
64
|
Colon
|
IV
|
6
|
PD
|
5.7
|
20.7
|
-
|
+
|
-
|
-
|
|
17B
|
71
|
Colon
|
IV
|
6
|
PD
|
5.6
|
25.9
|
-
|
+
|
-
|
+
|
|
18B
|
58
|
Pancreatic
|
IV
|
2
|
PD
|
2.6
|
3.3
|
ND
|
-
#Progression free survival was calculated as time from the date the consent was signed until evidence of disease progression or last follow-up without progression (+). *Overall Survival was calculated as time from consent date until death or last follow-up (+). ND, not done because patient received 2 or less vaccines; NA, sample not available. Arm B (Vaccine + GM-CSF): Patient Profiles, Clinical Data, and Immunological Outcomes.
-
Abbreviations: NED No Evidence of Disease, PD Progression of Disease, PPS Poor Performance Status, SD Stable Disease, PFS Progression Free Survival, OS Overall Survival, ms Months.
