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Table 1 Baseline characteristics

From: Larotinib in patients with advanced and previously treated esophageal squamous cell carcinoma with epidermal growth factor receptor overexpression or amplification: an open-label, multicenter phase 1b study

Characteristics

250 mg (n = 3)

300 mg (n = 25)

350 mg (n = 53)

All (n = 81)

Age

    

Median (range)

55 (52, 58)

63 (47, 71)

59 (38, 75)

61 (38, 75)

< 65

3 (100)

17 (68.0)

41 (77.4)

61 (75.3)

≥ 65

0

8 (32.0)

12 (22.6)

20 (24.7)

Sex, n (%)

    

Male

2 (66.7)

19 (76)

49 (92.5)

70 (86.4)

Female

1 (33.3)

6 (24)

4 (7.5)

11(13.6)

Race, n (%)

    

Asian

3 (100)

25 (100)

53 (100)

81 (100)

Others

0

0

0

0

Height, n (%)

    

Median (range)

170.0 (150, 176)

167.0 (140–178)

170.0 (147, 180)

170.0 (140, 180)

Mean (SD)

165.3 (13.61)

166.1 (8.36)

168.8 (7.17)

167.9 (7.80)

Weight, n (%)

    

Median (range)

62.00 (42.0, 75.0)

56.00 (42.0, 88.0)

59.00 (40.0, 82.0)

59.00 (40.0, 88.0)

Mean (SD)

59.67 (16.623)

58.95 (10.086)

60.85 (9.649)

60.22 (9.936)

BMI (kg/m2), n (%)

    

Median (range)

20.00 (18.7, 26.0)

20.70 (16.8, 29.0)

20.80 (14.3, 26.8)

20.80 (14.3, 29.0)

Mean (SD)

21.57 (3.894)

21.32 (2.877)

21.35 (3.179)

21.35 (3.071)

ECOG, n (%)

    

0

0

2 (8.0)

9 (17.0)

11 (13.6)

1

1 (100)

23 (92.0)

44 (83.0)

70 (86.4)

TNM classification

    

III

  

3 ( 5.7)

3 ( 3.7)

IV

3 (100)

25 (100)

47 (88.7)

78 (96.3)

Metastases, n (%)

    

M0

1 (33.3)

0

8 (15.1)

9 (11.1)

M1

2 (66.7)

25(100)

45 (84.9)

72 (88.9)

Prior lines of systemic therapy, n (%)

    

1

2 (66.7)

13 (52.0)

16 (30.2)

31 (38.3)

2

0

7 (28.0)

28 (52.8)

35 (43.2)

≥ 3

1(33.3)

5 (20.0)

9 (17.0)

15 (18.5)

Prior therapies for ESCC

    

Surgery

1 (33.3)

12 (48.0)

29 (54.7)

42 (51.9)

Radiotherapy

2 (66.7)

18 (72.0)

30 (56.6)

50 (61.7)

Chemotherapy

3 (100)

25 (100)

53 (100)

81 (100)

PD-1/PD-L1 antibodies

0

4 (16.0)

11 (20.8)

15 (18.5)

Target therapy

0

3 (37.5)

5 (25.0)

8 (28.6)

Traditional medicine

0

1 (12.5)

5 (25.0)

6 (21.4)

Other

0

1 (12.5)

0

1 ( 3.6)

Duration of advanced disease from first diagnosis to informed consent (months)

    

Median (range)

10.3 (3.7, 33.5)

13.2 (4.9, 45.6)

16.0 (3.7, 74.6)

15.3 (3.7, 74.6)

EGFR IHC staining, n (%)

    

3+

3 (100)

23 (92.0)

51 (96.2)

77 (95.1)

2+

0

2 (8.0)

2 (3.8)

4 (4.9)

EGFR FISH, n (%)

    

Positive

0

6(24)

14 (29.2)

20 (26.3)

Negative

3 (100)

19(76.0)

34 (70.8)

56 (73.7)