Table 1 Overview of baseline characteristics

From: TEIPP-vaccination in checkpoint-resistant non-small cell lung cancer: a first-in-human phase I/II dose-escalation study

 

1 (20 µg)

2 (40 µg)

3 (100 µg)

4 (100 µg + pembrolizumab)

Total

Number of patients

6

7

7

6

26

Median age at inclusion (range)

65 (60–70)

62 (47–69)

64 (53–79)

65 (58–69)

64 (47–79)

Gender (%)

 Male

2 (33.3)

3 (42.9)

5 (71.4)

5 (83.3)

15 (57.7)

 Female

4 (66.7)

4 (57.1)

2 (28.6)

1 (16.7)

11 (42.3)

Smoking (%)

 Never

1 (16.7)

   

1 (3.8)

 Current

3 (50.0)

2 (28.6)

 

3 (50.0)

17 (65.4)

 Former

2 (33.3)

5 (71.4)

7 (100)

3 (50.0)

8 (30.8)

Histopathologic subtype (%)

 Adenocarcinoma

4 (66.7)

6 (85.7)

2 (28.6)

3 (50.0)

15 (57.7)

 Squamous cell

2 (33.3)

1 (14.3)

5 (71.4)

1 (16.7)

9 (34.6)

 Undifferentiated

   

2 (33.3)

2 (7.7)

Previous chemotherapya

5 (83.3)

7 (100)

7 (100)

6 (100)

25 (96.1)

Median # of cycles [range]

4 [4–9]

8 [4–10]

4 [2–4]

4 [3–10]

4 [2–10]

Previous immunotherapyb

6 (100)

7 (100)

7 (100)

6 (100)

26 (100)

Median # of cycles [range]

5 [4–14]

8 [4–42]

7 [4–12]

12 [2–23]

7.5 [2–42]

Median time interval start TEIPP24 in weeksc [range]

10 [7–24]

10 [2–38]

11 [6–37]

10 [5–54]

11 [2–54]

Combination chemo/immunotherapy

5 (83.3)

6 (85.7)

6 (85.7)

5 (83.3)

22 (84.6)

ECOG performance status (%)d

 0

4 (66.7)

 

1 (14.3)

3 (50.0)

8 (30.8)

 1

 

7 (100)

6 (85.7)

2 (33.3)

15 (57.7)

 2

2 (33.3)

  

1 (16.7)

3 (11.5)

T- staged

 X

2 (50.0)

 

1 (14.3)

2 (33.3)

5 (15.4)

 0

     

 1

1 (16.7)

1 (14.3)

1 (14.3)

3 (50.0)

6 (23.1)

 2

1 (16.7)

2 (28.6)

2 (28.6)

 

5 (19.2)

 3

 

1 (14.3)

  

1 (3.8)

 4

2 (33.3)

3 (42.9)

3 (42.9)

1 (16.7)

9 (34.6)

N- staged

 X

 

1 (14.3)

  

1 (3.8)

 0

1 (16.7)

  

1 (16.7)

2 (7.7)

 1

1 (16.7)

1 (14.3)

 

1 (16.7)

3 (11.5)

 2

2 (33.3)

3 (42.8)

3 (42.8)

1 (16.7)

9 (34.6)

 3

2 (33.3)

2 (28.6)

4 (57.1)

3 (50.0)

11 (42.3)

M- staged

 1a

2 (33.3)

 

1 (14.3)

 

3 (11.5)

 1b

 

2 (28.6)

1 (14.3)

 

3 (11.5)

 1c

4 (66.7)

5 (71.4)

5 (71.4)

6 (100)

20 (76.9)

Systemic metastasesd

4 (66.7)

6 (85.7)

5 (71.4)

5 (83.3)

21 (80.8)

Location systemic metastasesd

 Liver

3 (50.0)

1 (14.3)

2 (28.6)

3 (50.0)

9 (34.6)

 Brain

1 (16.7)

3 (42.9)

  

4 (15.4)

 Skeletal

4 (66.7)

3 (42.9)

3 (42.9)

2 (33.3)

11 (42.3)

 Adrenal glands

 

2 (28.6)

 

4 (66.7)

6 (23.1)

 Othere

 

1 (14.3)

1 (14.3)

2 (33.3)

4 (15.4)

  1. ECOG Eastern Cooperative Oncology Group.
  2. aChemotherapy regimens consisted of carboplatin, cisplatin, pemetrexed, paclitaxel, docetaxel gemcitabine or etoposide or a combination of any.
  3. bThe immunotherapy regimen consisted of pembrolizumab, durvalumab or nivolumab.
  4. cTime interval between last immunotherapy cycle and first TEIPP24 vaccination in weeks.
  5. dAt time of inclusion.
  6. ePleural, mediastinal and axillar metastases were not included under systemic metastases.
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