Table 1 Baseline Characteristics
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) |