01.12.2017 | Research | Ausgabe 1/2017 Open Access

Vaccination with poly(IC:LC) and peptide-pulsed autologous dendritic cells in patients with pancreatic cancer
- Zeitschrift:
- Journal of Hematology & Oncology > Ausgabe 1/2017
Electronic supplementary material
Background
Methods
Patient selection
Study design
DC expansion and differentiation
Vaccination
Flow cytometry
IFNγ ELISA/ELISPOT
Statistical considerations
Results
Patients and treatment
Characteristic
|
Study population (
n = 12)
|
---|---|
Median age, years (range)
|
64 (50–72)
|
Male:female
|
4:8
|
Race
|
|
Caucasian
|
10
|
Black
|
2
|
ECOG performance status
|
|
0
|
2
|
1
|
10
|
Disease burden at enrollment
|
|
Locally advanced
|
3
|
Metastatic
|
9
|
Prior surgery
|
|
Yes
|
1
|
No
|
11
|
Prior radiation
a
|
|
Yes
|
6
|
No
|
6
|
Number of prior systemic regimens
b
|
|
0
|
0
|
1
|
6
|
2
|
5
|
3
|
1
|
Patient
|
Disease burden at day -35
|
Prior chemotherapy
|
Response at day 56
|
PFS (months)
|
OS (months)
|
First treatment after DC vaccine
|
---|---|---|---|---|---|---|
1
|
Metastatic
|
Gemcitabine +/- trametinib
|
PD
|
3.0
|
5.3
|
None
|
2
|
Metastatic
|
Gemcitabine
FOLFIRINOX
|
Not done
|
2.1
|
2.1
|
None
|
3
|
Metastatic
|
Gemcitabine + nab-paclitaxel
Capecitabine with radiation
erlotinib
FOLFIRINOX
|
Not done
|
1.8
|
2.1
|
None
|
4
|
Metastatic
|
Gemcitabine + nab-paclitaxel
Capecitabine with radiation
FOLFIRINOX
|
PD
|
3.0
|
6.3
|
ABC294640
a
|
5
|
Metastatic
|
Gemcitabine +/- ganitumab
Gemcitabine + nab-paclitaxel
|
SD
|
4.6
|
13.0
|
Gemcitabine + nab-paclitaxel
|
6
|
Metastatic
|
FOLFIRINOX
capecitabine with radiation
|
PD
|
3.0
|
9.8
|
FOLFIRINOX
|
8
|
Locally advanced
|
Gemcitabine + nab-paclitaxel
capecitabine with radiation
|
Not done
|
1.9
|
1.9
|
None
|
9
|
Metastatic
|
FOLFIRINOX
gemcitabine + nab-paclitaxel
|
not done
|
2.3
|
2.3
|
None
|
10
|
Locally advanced
|
FOLFIRINOX
capecitabine with radiation
|
SD
|
8.3
|
13.1
|
Gemcitabine + nab-paclitaxel
|
11
|
Metastatic
|
FOLFIRINOX
capecitabine
|
SD
|
4.6
|
9.1
|
Gemcitabine + nab-paclitaxel
|
12
|
Metastatic
|
Gemcitabine + nab-paclitaxel + ODSH
b
|
PD
|
3.0
|
10.1
|
None
|
13
|
Locally advanced
|
FOLFIRINOX
Capecitabine with radiation
|
SD
|
34.3
|
34.3
|
Gemcitabine + nab-paclitaxel
|
Safety and tolerability
Adverse event
|
Number of patients experiencing adverse event
|
||||
---|---|---|---|---|---|
Grade 1
|
Grade 2
|
Grade 3
|
Grade 4
|
Total (%)
|
|
Fatigue
|
5
|
1
|
0
|
0
|
6 (50)
|
Hypoalbuminemia
|
2
|
4
|
0
|
0
|
6 (50)
|
Hyponatremia
|
6
|
0
|
0
|
0
|
6 (50)
|
Anemia
|
3
|
1
|
1
|
0
|
5 (42)
|
Elevated transaminases
|
3
|
2
|
0
|
0
|
5 (42)
|
Fever
|
4
|
1
|
0
|
0
|
5 (42)
|
Elevated alkaline phosphatase
|
2
|
0
|
2
|
0
|
4 (33)
|
Lymphopenia
|
3
|
1
|
0
|
0
|
4 (33)
|
Injection site reaction
|
3
|
1
|
0
|
0
|
4 (33)
|
Hypocalcemia
|
2
|
1
|
0
|
0
|
3 (25)
|
Myalgia
|
3
|
0
|
0
|
0
|
3 (25)
|
Neutropenia
|
3
|
0
|
0
|
0
|
3 (25)
|
Chills
|
2
|
0
|
0
|
0
|
2 (17)
|
Flu-like symptoms
|
2
|
0
|
0
|
0
|
2 (17)
|
Leukopenia
|
2
|
0
|
0
|
0
|
2 (17)
|
Arthritis
|
1
|
0
|
0
|
0
|
1 (8)
|
Decreased BUN
|
1
|
0
|
0
|
0
|
1 (8)
|
Hypertension
|
0
|
0
|
1
|
0
|
1 (8)
|
Hot flashes
|
1
|
0
|
0
|
0
|
1 (8)
|
Hyperbilirubinemia
|
1
|
0
|
0
|
0
|
1 (8)
|
Hypercalcemia
|
1
|
0
|
0
|
0
|
1 (8)
|
Night sweats
|
1
|
0
|
0
|
0
|
1 (8)
|
Pain
|
1
|
0
|
0
|
0
|
1 (8)
|
Pain in extremity
|
1
|
0
|
0
|
0
|
1 (8)
|
DC preparation, characterization
DC quality parameter
|
Mean
|
Median
|
Range
|
---|---|---|---|
CD14 (<25%)
|
4.33
|
0.2
|
(0, 29.5)
|
CD86 (>50%)
|
83.9
|
87.5
|
(60.7, 99.6)
|
CD11c (>50%)
|
97.1
|
99.0
|
(81.5, 99.6)
|
HLA-DR (>50%)
|
85.1
|
86.5
|
(71.9, 95.4)
|
Percent viability (>70%)
|
89.8
|
90.0
|
(78.9, 96.8)
|