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Biliary tract cancer (BTC) includes primary cancers of the hilar bile duct, common hepatic duct, and common bile duct.
The PRODIGE 38 AMEBICA trial is an open-label, randomized phase II-III study that recruited patients with locally advanced or metastatic biliary tract cancer with an ECOG performance status of 0 or 1.
This article reports the results of the Phase II study.
PFS and OS in the two treatment groups
A total of 191 patients were recruited from 43 clinical centers in France (185 in the adjusted intention-to-treat population: 92 in the mFOLFIRINOX group and 93 in the CISGEM group)
The PFS rates at 6 months in the mFOLFIRINOX group and CISGEM group were 44.
Occurrence of some side effects in the two treatment groups
The incidence of side effects of grade 3 and above in the mFOLFIRINOX group and the CISGEM group were 72.
In summary, in this study, the mFOLFIRINOX triple chemotherapy regimen did not reach the primary study endpoint
The CISGEM dual chemotherapy regimen is still the first-line standard treatment regimen for patients with advanced cholangiocarcinoma
Original source:
Jean marc Phelip, et al.
Modified FOLFIRINOX Versus CISGEM Chemotherapy for Patients With Advanced Biliary Tract Cancer (PRODIGE 38 AMEBICA): A Randomized Phase II Study
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