2021
DOI: 10.1016/j.annonc.2021.08.327
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48P (BREGO) Regorafenib combined with modified m-GEMOX in patients with advanced biliary tract cancer (BTC): A phase II randomized trial

Abstract: Background: FGFR2 fusions/rearrangements (FGFR2 fus ) occur in w15% of patients (pts) with intrahepatic cholangiocarcinoma (iCCA), a disease with poor outcomes upon progression after 1L standard treatment. Derazantinib is a potent FGFR1-3 kinase inhibitor that has shown broad clinical activity in iCCA pts with FGFR2 fusions, mutations and amplifications. Here, we present efficacy and safety data for the completed FGFR2 fus+ cohort from study FIDES-01.Methods: Eligible pts with advanced iCCA, 1L of prior treatm… Show more

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“…Based on these findings, a phase III randomized trial comparing nab-paclitaxel to placebo with gemcitabine and cisplatin is currently being conducted (SWOG S1815 trial). Other combinations such as FOLFIRINOX, NUC-1031 (activated form of gemcitabine) plus cisplatin, and gemcitabine/regorafenib were not beneficial over gemcitabine and cisplatin combination (25)(26)(27)(28).…”
Section: First Line Systemic Therapymentioning
confidence: 95%
“…Based on these findings, a phase III randomized trial comparing nab-paclitaxel to placebo with gemcitabine and cisplatin is currently being conducted (SWOG S1815 trial). Other combinations such as FOLFIRINOX, NUC-1031 (activated form of gemcitabine) plus cisplatin, and gemcitabine/regorafenib were not beneficial over gemcitabine and cisplatin combination (25)(26)(27)(28).…”
Section: First Line Systemic Therapymentioning
confidence: 95%