Unresectable or recurrent biliary tract cancer
Conditions
Interventions
None listed
Sponsors
Yamaguchi University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who met all of the following criteria and were examined at a participating institution between June 1, 2021 and January 31, 2024. 1. Diagnosis of biliary tract cancer (Intrahepatic bile duct cancer, hilar bile duct cancer, distal bile duct cancer, gallbladder cancer, and duodenal papilla cancer) by histology or cytology (class IV or V). 2. Patients with FGFR2 fusion gene or FGFR2 gene rearrangement positive biliary tract cancer who were initially prescribed pemigatinib as health insurance treatment after June 1, 2021. 3. Over 18 years of age at the time of initial pemigatinib prescription.
Exclusion criteria
Exclusion criteria: i) Patients who received pemigatinib prior to the period of this observational study. ii) Patients who have received chemotherapy for a malignancy other than biliary tract cancer within 12 months before the first prescription of pemigatinib. iii) Patients who had a history of prescription of pemigatinib but could not confirm oral administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are pemigatinib objective response rate and overall survival for the FGFR treatment-naive population at 3 years after marketing and a final analysis at 4 years after marketing | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include correlation of efficacy with clinicopathologic characteristics of the overall population, correlation of efficacy with comorbid genetic abnormalities, tolerability of pemigatinib, and efficacy in populations previously treated with other FGFR inhibitors. | — |
Countries
Japan
Contacts
Public ContactYuuta Kimura
Yamaguchi University Hospital Department of Gastroenterological, Breast and Endocrine Surgery
Outcome results
None listed