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Table 1 Patient demographics and disease characteristics, by treatment group

From: A phase I open-label dose-escalation study of the anti-HER3 monoclonal antibody LJM716 in patients with advanced squamous cell carcinoma of the esophagus or head and neck and HER2-overexpressing breast or gastric cancer

  3 mg/kg QW
n = 1
10 mg/kg QW
n = 5
20 mg/kg QW
n = 6
40 mg/kg QW
RDE, n = 36
20 mg/kg Q2W
n = 6
All patients N = 54
Age, years  
 Median (range) 57.0 (57.0–57.0) 55.0 (48.0–66.0) 56.5 (43.0–69.0) 60.5 (36.0–77.0) 54.5 (49.0–78.0) 58.0 (36.0–78.0)
 <65 years, n (%) 1 (100) 3 (60) 5 (83) 24 (67) 5 (83) 38 (70)
 ≥65 years, n (%) 0 2 (40) 1 (17) 12 (33) 1 (17) 16 (30)
Sex, n (%)  
 Female 0 2 (40) 2 (33) 11 (31) 2 (33) 17 (31)
 Male 1 (100) 3 (60) 4 (67) 25 (69) 4 (67) 37 (69)
Race, n (%)  
 Asian 0 0 0 17 (47) 0 17 (31)
 Black 0 0 0 1 (3) 0 1 (2)
 Caucasian 1 (100) 5 (100) 6 (100) 18 (50) 5 (83) 35 (65)
 Other 0 0 0 0 1 (17) 1 (2)
ECOG PS, n (%)  
 0 0 1 (20) 1 (17) 7 (19) 2 (33) 11 (20)
 1 1 (100) 4 (80) 5 (83) 26 (72) 4 (67) 40 (74)
 2 0 0 0 3 (8) 0 3 (6)
Initial diagnosis, n (%)  
 Head and neck 1 (100) 4 (80) 2 (33) 12 (33) 2 (33) 21 (39)
 Esophageal 0 0 1 (17) 12 (33) 2 (33) 15 (28)
 Breast 0 1 (20) 2 (33) 5 (14) 2 (33) 10 (19)
 Gastric 0 0 1 (17) 7 (19) 0 8 (15)
Primary tumor histology, n (%)  
 Squamous cell carcinoma 1 (100) 4 (80) 2 (33) 22 (61) 2 (33) 31 (57)
 Other 0 1 (20) 4 (67) 14 (39) 4 (67) 23 (43)
Stage at study entry, n (%)  
 III–IIIC 0 1 (20) 0 4 (11) 0 5 (9)
 IV–IVB 1 (100) 4 (80) 6 (100) 32 (89) 6 (100) 49 (91)
Prior antineoplastic regimen(s), n (%)  
 No 0 0 0 1 (3) 0 1 (2)
 Yes 1 (100) 5 (100) 6 (100) 35 (97) 6 (100) 53 (98)
Prior EGFR or HER2-directed therapy, n (%)  
 Cetuximab 1 (100) 3 (60) 2 (33) 8 (22) 2 (33) 16 (30)
 Pertuzumab 0 0 0 1 (3) 0 1 (2)
 Trastuzumab 0 1 (20) 4 (67) 11 (31) 2 (33) 18 (33)
 Trastuzumab emtansine 0 1 (20) 0 1 (3) 1 (17) 3 (6)
 Number of prior regimens, median (range) 5.0 (5.0–5.0) 4.0 (2.0–7.0) 2.5 (2.0–5.0) 3.0 (1.0–12.0) 3.0 (1.0–4.0) 3.0 (1.0–12.0)
  1. ECOG Eastern Cooperative Oncology Group, EGFR epidermal growth factor receptor, HER2 human epidermal growth factor receptor 2
  2. PS performance status, Q2W once every two weeks, QW once weekly, RDE recommended dose for expansion
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