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Table 1 Baseline Characteristics

From: Phase 2 study of lenvatinib monotherapy as second-line treatment in unresectable biliary tract cancer: primary analysis results

Category Patients Treated With Lenvatinib 24 mg Once Daily (N = 26)
Median age, years (range) 64 (41–78)
Age group, n (%)
  < 65 years 14 (53.8)
  ≥ 65 years 12 (46.2)
Median weight, kg (range) 56.9 (41.5–77.8)
Sex, n (%)
 Male 15 (57.7)
 Female 11 (42.3)
ECOG PS, n (%)
 0 19 (73.1)
 1 7 (26.9)
Primary tumor location, n (%)
 Intrahepatic bile duct 6 (23.1)
 Extrahepatic bile duct 8 (30.8)
  Perihilar 1 (3.8)
  Distal 7 (26.9)
 Gallbladder 10 (38.5)
 Ampulla of Vater 2 (7.7)
Tumor lesions at screening, n (%)
 Adrenal 2 (7.7)
 Ascites 2 (7.7)
 Bile ducta 4 (15.4)
 Gallbladdera 8 (30.8)
 Bone 1 (3.8)
 Breast 1 (3.8)
 Liver 15 (57.7)
 Lung 5 (19.2)
 Lymph node 16 (61.5)
 Peritoneal 6 (23.1)
Lesion sizeb, n (%)
  < 20 mm 1 (3.8)
  ≥ 20 mm 25 (96.2)
Median lesion sizeb, mm (range) 35 (16–117)
Tumor marker (CA 19–9), median U/mL (range) 175.2 (0.6–105,050.1)
Tumor marker (CA 19–9), n (%)
  ≤ 152 U/mL 12 (46.2)
  > 152 U/mL 14 (53.8)
White blood cell count
 Median, /mm3 (range) 5465 (3340–8900)
  ≤ 10,000/mm3, n (%) 26 (100.0)
Hemoglobin
 Median, g/dL (range) 12.05 (9.4–15)
  ≤ 12 g/dL, n (%) 13 (50.0)
  > 12 g/dL, n (%) 13 (50.0)
Total bilirubin
 Median, mg/dL (range) 0.6 (0.3–1.2)
  ≤ 0.66 mg/dL, n (%) 16 (61.5)
  > 0.66 mg/dL, n (%) 10 (38.5)
Alkaline phosphatase
 Median, U/L (range) 321 (136–1235)
  ≤ 247 U/L, n (%) 6 (23.1)
  > 247 U/L, n (%) 20 (76.9)
Albumin
 Median, g/dL (range) 4.1 (2.7–4.7)
  ≤ 3.56 g/dL, n (%) 1 (3.8)
  > 3.56 g/dL, n (%) 25 (96.2)
Previous anticancer surgery, n (%)
 No 20 (76.9)
 Yes 6 (23.1)
Prior chemotherapy to biliary tract cancer, n (%)
 Adjuvant 2 (7.7)
  S-1c 1 (3.8)
  Gemcitabine 1 (3.8)
 Therapeutic 26 (100.0)
  Gemcitabine + cisplatin 20 (76.9)
  Gemcitabine + S-1c 6 (23.1)
Duration of the previous gemcitabine-based combination chemotherapy, n (%)
  < 6 months 13 (50.0)
  ≥ 6 months 13 (50.0)
  1. CA cancer antigen, ECOG PS Eastern Cooperative Oncology Group performance status
  2. a14 Patients did not have lesions at the bile duct or gallbladder upon screening
  3. bPer investigator assessment
  4. cCombination treatment consisting of tegafur, gimeracil, and oteracil
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