Table 1 Baseline characteristics of the study population

From: Nivolumab plus platinum-doublet chemotherapy in treatment-naive patients with advanced grade 3 Neuroendocrine Neoplasms of gastroenteropancreatic or unknown origin: The multicenter phase 2 NICE-NEC trial (GETNE-T1913)

Characteristics

G3 NENs

G3 NETs

NECs

N = 37

N = 12

N = 25

Age, years

Median (range)

61 (28–84)

58 (38–78)

61 (28–84)

Gender, n (%)

Male

25 (67.6)

9 (75.0)

16 (64.0)

Female

12 (32.4)

3 (25.0)

9 (36.0)

ECOG PS, n (%)

0

11 (29.7)

3 (25.0)

8 (32.0)

1

22 (59.5)

9 (75.0)

13 (52.0)

2

4 (10.8)

0 (0.0)

4 (16.0)

Stage at diagnosis, n (%)

I

1 (2.7)

1 (8.3)

0 (0.0)

III

1 (2.7)

0 (0.0)

1 (4.0)

IV

35 (94.6)

11 (91.7)

24 (96.0)

Differentiation, n (%)

NET

12 (32.4)

–

–

NEC

25 (67.6)

–

–

Ki 67, n (%)

21–55%

12 (32.4)

8 (66.0)

4 (16.0)

>55%

25 (67.6)

4 (33.3)

21 (84.0)

Primary site, n (%)

Esophageal

2 (5.4)

0 (0.0)

2 (8.0)

Gastric

6 (16.2)

1 (8.3)

5 (20.0)

Pancreatic

15 (40.5)

6 (50.0)

9 (36.0)

Colonic

4 (10.8)

1 (8.3)

3 (12.0)

Rectal

2 (5.4)

0 (0.0)

2 (8.0)

Small intestine

2 (5.3)

2 (16.7)

0 (0.0)

Unknown

6 (16.2)

2 (16.7)

4 (16.0)

Metastatic sites number, n (%)

1

10 (27.0)

5 (41.7)

5 (20.0)

≥2

27 (73.0)

7 (58.3)

20 (80.0)

Metastasis sites, n (%)

Liver

31 (83.8)

11 (91.7)

20 (80.0)

Lung

9 (24.3)

2 (16.7)

7 (28.0)

Lymph nodes

18 (48.6)

2 (16.7)

16 (64.0)

Bone

10 (27.0)

4 (33.3)

6 (24.0)

Previous surgery, n (%)

Yes

6 (16.2)

4 (33.3)

2 (8.0)

No

30 (81.1)

8 (66.7)

22 (88.0)

Unknown

1 (2.7)

0 (0.0)

1 (4.0)

CgA, n (%)

<2x ULN

7 (18.9)

0 (0.0)

7 (28.0)

≥2x ULN

27 (73.0)

11 (91.7)

16 (64.0)

Unknown

3 (8.1)

1 (8.3)

2 (8.0)

Enolase, n (%)

<2x ULN

13 (35.1)

4 (33.3)

9 (36.0)

≥2x ULN

21 (56.8)

8 (66.7)

13 (52.0)

Unknown

3 (8.1)

0 (0.0)

3 (12.0)

LDH, n (%)

<2x ULN

9 (24.3)

8 (66.7)

20 (80.0)

≥2x ULN

28 (75.7)

4 (33.3)

5 (20.0)

PD-L1; n (%)

Positive

2 (5.4)

2 (16.7)

0 (0.0)

Negative

31 (83.8)

10 (83.3)

21 (84.0)

Unknown

4 (10.8)

0 (0.0)

4 (16.0)

MSI; n (%)

Positive

1 (2.7)

1 (8.3)

0 (0.0)

Negative

13 (35.1)

4 (33.3)

9 (36.0)

Unknown

23 (34.3)

7 (58.3)

16 (64.0)

  1. CGA Chromogranin A, ECOG PS Eastern Cooperative Oncology Group Performance Status, LDH lactate dehydrogenase, MSI microsatellite instability, NEC neuroendocrine carcinoma, NET neuroendocrine tumor, PD-L1 programmed death ligand 1.
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