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

• Published in: Journal of hepato-biliary-pancreatic sciences Vol. 31; no. 7; pp. 468 - 480
• Main Authors: Ueno, Makoto, Shirakawa, Sachiyo, Tokumaru, Jumpei, Ogi, Mizue, Nishida, Kenichiro, Hirai, Takehiro, Shinozaki, Kenta, Hamada, Yoko, Kitagawa, Hiroshi, Horiguchi, Akihiko
• Format: Journal Article
• Language: English
• Published: Japan Wiley Subscription Services, Inc 01.07.2024
• Subjects: Aged; antibiotics; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biliary Tract Neoplasms - drug therapy; chemotherapy; Cholangiocarcinoma; cholangitis; Cisplatin - administration & dosage; Cisplatin - therapeutic use; Databases, Factual; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Drug Combinations; drug therapy; Female; Gemcitabine; Humans; Infections; 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; Japan; drug therapy; antibiotics; chemotherapy; cholangiocarcinoma; cholangitis
• ISSN: 1868-6974; 1868-6982; 1868-6982
• DOI: 10.1002/jhbp.1418

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. This large‐scale database study provides a comprehensive overview of the systemic therapies for biliary tract cancer and biliary infections in real‐world clinical practice in Japan prior to the immunotherapy era. Ueno and colleagues identified some challenges related to multiple first‐line treatments and the management of biliary infections during systemic therapy.