Randomized phase II trial of docetaxel with or without PSA-TRICOM vaccine in patients with castrate-resistant metastatic prostate cancer: A trial of the ECOG-ACRIN cancer research group (E1809)

Figures & data

Figure 1. Study schema.

Table 1. Patient demographics and disease characteristics at study entry

	Treatment Arm				Total
	A (n = 7)		B (n = 3)		n = 10
	N	%	N	%	N	%
Age (years)
Median	63		65		64
Range	56–72		65–73		56–73
Race
White	6	86	3	100	9	90
Unknown	1	14	—	—	1	10
ECOG Performance Status
0	5	71	2	67	7	70
1	2	29	—	—	2	20
Unknown	—	—	1	33	1	10
Gleason score
7	2	29	1	33	3	30
8	2	29	1	33	3	30
9	3	43	—	—	3	30
Unknown	—	—	1	33	1	10
Metastatic sites
Lung	—	—	1	33	1	10
Liver	—	—	1	33	1	10
Bone	6	86	2	67	8	80
Distant lymph nodes	4	57	2	67	6	60
Other	1	14	1	33	2	20
Prior treatment
Hormonal therapy	7	100	2	67	9	90
Radiation therapy	5	71	2	67	7	70
Surgery	2	29	1	33	3	30
Bisphosphonate therapy	2	29	1	33	3	30

Table 2. Adverse events. Shown are adverse events that were deemed treatment-related, and grade 3 or higher in severity, for the 8 subjects who received assigned treatment

	Toxicity type			Treatment Arm
	A (n = 6) Grade			B (n = 2) Grade
	3 (n)	4 (n)	5 (n)	3 (n)	4 (n)	5 (n)
Febrile neutropenia	1	—	—	1	—	—
Fatigue	1	—	—	—	—	—
Sepsis	—	—	1	—	—	—
Lymphocyte count decreased	1	—	—	—	—	—
Neutrophil count decreased	—	4	—	—	2	—
White blood cell count decreased	1	2	—	—	1	—
Dehydration	1	—	—	—	—	—
Syncope	1	—	—	—	—	—
Thromboembolic event	1	—	—	—	—	—
WORST DEGREE	—	4	1	—	2	—

Figure 2. Serum PSA response from patient treated on Arm A. Shown are the serum PSA values (ng/mL) from a patient treated on Arm A with respect to the treatments with the PSA-TRICOM vaccine and docetaxel.

Figure 3. T-cell response evaluation by IFNγ ELISPOT. Cyropreserved PBMC obtained from treated subjects were assessed for IFNγ release following culture with PSA (test antigen, left panel) or phytohemagglutinin (PHA, positive control, right panel) at the individual time points for each subject. Shown are the spot-forming units (sfu) per million PBMC for the antigen-specific conditions subtracting the sfu from media alone.

Figure 4. T-cell response evaluation by intracellular cytokine staining. Cryopreserved PBMC obtained from treated subjects were assessed for cytokine (IFNγ, TNFα, granzyme B (GrB), IL-2, IL-4, IL-10, and IL-17) production by CD4+ (top panels) and CD8+ (bottom panels) T cells following stimulation with PSA (test antigen, left panels) or prostatic acid phosphatase (PAP, control antigen, right panels). Shown is the percentage of CD4+ or CD8+ T cells expressing each cytokine or enzyme at the individual time points for each subject.