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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)