Real-world evidence of systemic treatment practices for biliary tract cancer in Japan: Results of a database study

J Hepatobiliary Pancreat Sci. 2024 Jul;31(7):468-480. doi: 10.1002/jhbp.1418.

Abstract

Purpose: To describe the real-world treatment patterns of systemic therapies for biliary tract cancer (BTC) and to examine the frequency and management of biliary infection in Japan.

Methods: Patients diagnosed with BTC and prescribed systemic therapy between January 2011 and September 2020 were retrieved from the Japanese Medical Data Vision database. The look-back period was set to 5 years. Patient characteristics, treatment patterns, and biliary infection-induced treatment interruption were analyzed.

Results: The full analysis set comprised 22 742 patients with a mean age of 71.0 years and 61.6% were male. The most common BTC type was extrahepatic cholangiocarcinoma (44.6%). The three most common first-line regimens were S-1 monotherapy (33.0%), gemcitabine+cisplatin (32.5%), and gemcitabine monotherapy (18.7%) over the entire observation period (January 2011-September 2021). Patients who received monotherapies tended to be older. Biliary infection-induced treatment interruption occurred in 29.5% of patients, with a median time to onset of 64.0 (interquartile range 29.0-145.0) days. The median duration of intravenous antibiotics was 12.0 (interquartile range 4.0-92.0) days.

Conclusions: These results demonstrated potential challenges of BTC in Japanese clinical practice particularly use of multiple regimens, commonly monotherapies, which are not recommended as first-line treatment, and the management of biliary infections during systemic therapy.

Keywords: antibiotics; chemotherapy; cholangiocarcinoma; cholangitis; drug therapy.

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Biliary Tract Neoplasms* / drug therapy
  • Cisplatin / administration & dosage
  • Cisplatin / therapeutic use
  • Databases, Factual*
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Deoxycytidine / therapeutic use
  • Drug Combinations
  • Female
  • Gemcitabine
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Oxonic Acid / administration & dosage
  • Oxonic Acid / therapeutic use
  • Practice Patterns, Physicians' / statistics & numerical data
  • Retrospective Studies
  • Tegafur / administration & dosage
  • Tegafur / therapeutic use

Substances

  • Deoxycytidine
  • Gemcitabine
  • Tegafur
  • Drug Combinations
  • Cisplatin
  • Oxonic Acid
  • S 1 (combination)

Grants and funding