%0 Journal Article
%T Real-world evidence of systemic treatment practices for biliary tract cancer in Japan: Results of a database study.
%A Ueno M
%A Shirakawa S
%A Tokumaru J
%A Ogi M
%A Nishida K
%A Hirai T
%A Shinozaki K
%A Hamada Y
%A Kitagawa H
%A Horiguchi A
%J J Hepatobiliary Pancreat Sci
%V 31
%N 7
%D 2024 Jul 27
%M 38953871
%F 3.149
%R 10.1002/jhbp.1418
%X <B>OBJECTIVE: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>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.