Abstract：
OBJECTIVE: 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.
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.
摘要：
目的：描述胆道癌（BTC）全身治疗的真实世界治疗模式，并检查日本胆道感染的频率和管理。
方法：从日本医学数据视觉数据库检索2011年1月至2020年9月期间诊断为BTC并进行全身治疗的患者。回顾期为5年。患者特征,治疗模式,并对胆道感染引起的治疗中断进行分析。
结果：整个分析集包括22742例患者，平均年龄71.0岁，61.6%为男性。最常见的BTC类型是肝外胆管癌（44.6%）。三种最常见的一线治疗方案是S-1单药治疗（33.0％），吉西他滨+顺铂（32.5%），和吉西他滨单药治疗(18.7%)在整个观察期间(2011年1月至2021年9月).接受单一疗法的患者往往年龄较大。29.5%的患者发生胆道感染引起的治疗中断,中位发病时间为64.0天（四分位距29.0-145.0天）。静脉注射抗生素的中位持续时间为12.0天（四分位距4.0-92.0天）。
结论：这些结果证明了BTC在日本临床实践中的潜在挑战，特别是使用多种方案，通常是单一疗法，不建议作为一线治疗，以及系统治疗期间胆道感染的管理。
方法：从日本医学数据视觉数据库检索2011年1月至2020年9月期间诊断为BTC并进行全身治疗的患者。回顾期为5年。患者特征,治疗模式,并对胆道感染引起的治疗中断进行分析。
结果：整个分析集包括22742例患者，平均年龄71.0岁，61.6%为男性。最常见的BTC类型是肝外胆管癌（44.6%）。三种最常见的一线治疗方案是S-1单药治疗（33.0％），吉西他滨+顺铂（32.5%），和吉西他滨单药治疗(18.7%)在整个观察期间(2011年1月至2021年9月).接受单一疗法的患者往往年龄较大。29.5%的患者发生胆道感染引起的治疗中断,中位发病时间为64.0天（四分位距29.0-145.0天）。静脉注射抗生素的中位持续时间为12.0天（四分位距4.0-92.0天）。
结论：这些结果证明了BTC在日本临床实践中的潜在挑战，特别是使用多种方案，通常是单一疗法，不建议作为一线治疗，以及系统治疗期间胆道感染的管理。
