Long-Term Follow-Up of HLA-A2+ Patients with High-Risk, Hormone-Sensitive Prostate Cancer Vaccinated with the Prostate Specific Antigen Peptide Homologue (PSA146-154)
Table 1
Patient baseline characteristics.
Characteristic
Group A
Group B
Protocol-1
Protocol-2
Total
Age
median (average)
61.5 (62.2)
62 (64)
64.5 (65.2)
60.5 (61)
62
range
51–73
51–80
51–80
51–75
51–80
Race
white
10
13
12
11
23
black
2
1
1
2
3
other
2
0
1
1
2
ECOG PS
0 or 1
14
14
14
14
28
2 or 3
0
0
0
0
0
Disease status
undetectable (PSA 0)
3
4
5
2
7
measurable
0
7
2
5
7
increased PSA only
11
3
7
7
14
Sites of disease
bone
0
4
2
2
4
soft tissue
0
4
0
4
4
Family history
positive
4
3
5
2
8
negative
9
9
6
12
17
unknown
1
1
2
0
3
Gleason score
median (average)
7 (7.14)
7 (7.3)
7 (7.2)
7.5 (7.25)
7
range
4–9
5–10
5–10
4–9
4–10
PSA at diagnosis
median (average)
5.8 (9.1)
15.25 (28.4)
8.4 (12.3)
13.4 (24.3)
10.5
range
4–23.4
3.4–139
<4–23.4
3.4–139
3.4–139
PSA at study entry
median (average)
0.32 (3.66)
0.4 (2.6)
0.4 (2.75)
0.4 (3.5)
0.4
range
0–12.5
0–13.8
0–12.1
0–13.8
0–13.8
Local therapy
RPE
2
4
2
4
6
RPE + EBRT
7
4
8
3
11
EBRT, primary
2
4
2
4
6
other
3
2
2
3
5
Hormone Rx
none
10
0
5
5
10
first line
4
11
8
7
15
second line
0
2
1
1
2
≥3 therapies
0
1
0
1
1
Basal biochemistry
Alkaline phosphatase
48–90
49–105
49–90
50–105
48–105
Haemoglobin
12.8–16.6
11.5–16.9
11.5–15.7
12.2–16.9
11.5–16.9
Creatinine
0.7–1.3
0.8–1.2
0.8–1.3
0.7–1.3
0.7–1.3
All patients had completed primary therapy a minimum of 6 weeks prior to enrollment in the vaccine study.