Feasibility study of postoperative adjuvant chemotherapy with S-1 in patients with biliary tract cancer

Int J Clin Oncol. 2018 Oct;23(5):894-899. doi: 10.1007/s10147-018-1283-6. Epub 2018 Apr 28.


Background: The role of adjuvant chemotherapy has not yet been established for patients with resected biliary tract cancer. S-1 has been shown to exert activity against advanced biliary tract cancer. Therefore, we evaluated the feasibility of adjuvant chemotherapy with S-1 in patients with resected biliary tract cancer.

Methods: Patients with complete macroscopic resection of intrahepatic/extrahepatic bile duct, gall bladder, or ampullary cancer were eligible. S-1 was administered orally twice daily for 4 weeks every 6 weeks, up to 4 cycles. The treatment was continued up to 24 weeks or until recurrence/appearance of unacceptable toxicity. The primary endpoint was the treatment completion rate, which was defined as the percentage of patients who received a relative dose intensity of ≥ 75%. This trial was registered as UMIN000004051.

Results: Thirty-three patients were enrolled between June 2010 and March 2011. The relative dose intensity was ≥ 75% in 27 patients representing a treatment completion rate of 81.8%. The most common grade 3/4 adverse event was neutropenia (18%). Grade 2 nausea or diarrhea was observed in 12%. The 3-year relapse-free survival rate was 39.4%. The 3-year survival rate was 54.5%.

Conclusion: Adjuvant chemotherapy with S-1 is feasible treatment in patients with resected biliary tract cancer. It is necessary to conduct a phase III study to confirm the efficacy of adjuvant therapy of S-1 in patients with resected BTC.

Keywords: Adjuvant chemotherapy; Biliary tract cancer; Cholangiocarcinoma; S-1.

MeSH terms

  • Adult
  • Aged
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Biliary Tract Neoplasms / drug therapy*
  • Biliary Tract Neoplasms / pathology
  • Biliary Tract Neoplasms / surgery
  • Carcinoma, Papillary / drug therapy*
  • Carcinoma, Papillary / pathology
  • Carcinoma, Papillary / surgery
  • Carcinoma, Signet Ring Cell / drug therapy*
  • Carcinoma, Signet Ring Cell / pathology
  • Carcinoma, Signet Ring Cell / surgery
  • Chemotherapy, Adjuvant
  • Drug Combinations
  • Feasibility Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / diagnosis*
  • Neutropenia / chemically induced
  • Oxonic Acid / therapeutic use*
  • Postoperative Period
  • Prognosis
  • Survival Rate
  • Tegafur / therapeutic use*
  • Young Adult


  • Antimetabolites, Antineoplastic
  • Drug Combinations
  • S 1 (combination)
  • Tegafur
  • Oxonic Acid