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Table 1 Patient demographics and baseline characteristics

From: Phase 1 studies of the safety and immunogenicity of electroporated HER2/CEA DNA vaccine followed by adenoviral boost immunization in patients with solid tumors

Baseline characteristic

Study 1

Study 2a

 

V930 DNA-EP

V930 DNA-EP

V932 Ad

V932 Ad

 

0.25 mg

2.5 mg

0.5 × 109vg/injection

0.5 × 1011vg/injection

 

(n=6)

(n=22)

(n=6)

(n=5)

Age, years (mean ± SD)

66.8 ± 9.2

58.6 ± 15.9

58.8 ± 12.9

54.4 ± 8.6

Gender, n (%)

    

 Male

2 (33)

8 (36)

2 (33)

4 (80)

 Female

4 (67)

14 (64)

4 (67)

1 (20)

Race, n (%)

    

 White

6 (100)

21 (96)

5 (83)

5 (100)

 Other

0

1 (4.5)

1 (16.7)

0

KPS, n (%)

    

 100

6 (100)

17 (77)

6 (100)

5 (100)

 90

0

5 (23)

0

0

Tumor diagnosis, n (%)

    

 Adenocarcinoma NOS

1 (17)

1 (5)

0

0

 Breast cancer

0

7 (32)

3 (50)

0

 Colorectal cancer

4 (67)

6 (27)

1 (17)

1 (20)

 Non-small cell lung cancer

1 (17)

5 (23)

2 (33)

1 (20)

 Ovarian cancer

0

1 (5)

0

0

 Pancreatic cancer

0

1 (5)

0

0

 Squamous cell carcinoma

0

1 (5)

0

0

 NOS

0

0

0

1 (20)

 Renal cancer

0

0

0

2 (40)

 Bladder cancer

0

0

0

1 (20)

Prior lines of chemotherapy, n (%)

    

 0

0

0

0

1 (20)

 1

6 (100)

11 (50)

2 (33)

1 (20)

 2

0

5 (23)

3 (50)

1 (20)

 ≥3

0

6 (27)

1 (17)

2 (40)

Stage IV cancer

0 (0)

11 (50)

4 (67)

3 (60)

  1. aSix eligible patients from Study 1 were enrolled into Study 2. Therefore, only 5 patients that had not previously participated in Study 1 were enrolled into Study 2. Overall 33 patients (not 39) were enrolled in both studies.
  2. KPS: Karnofsky performance status; NOS, not otherwise specified; SD, standard deviation.