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dc.contributor.authorVogel, A.
dc.contributor.authorValle, Juan W
dc.contributor.authorvan Cutsem, E.
dc.contributor.authorRimassa, L.
dc.contributor.authorFuruse, J.
dc.contributor.authorIoka, T.
dc.contributor.authorMelisi, D.
dc.contributor.authorMacarulla, T.
dc.contributor.authorBridgewater, J.
dc.contributor.authorWasan, H. S.
dc.contributor.authorBorad, M. J.
dc.contributor.authorLihou, C. F.
dc.contributor.authorZhen, H.
dc.contributor.authorFeliz, L.
dc.contributor.authorAsatiani, E.
dc.contributor.authorJiang, P.
dc.contributor.authorBekaii-Saab, T. S.
dc.date.accessioned2020-11-16T07:49:18Z
dc.date.available2020-11-16T07:49:18Z
dc.date.issued2020en
dc.identifier.citationVogel A, Valle JW, van Cutsem E, Rimassa L, Furuse J, Ioka T, et al. FIGHT-302: Phase 3 study of first-line pemigatinib vs gemcitabine plus cisplatin for cholangiocarcinoma with FGFR2 fusions or rearrangement. Oncology Research and Treatment. 2020;43(SUPPL 4):122-en
dc.identifier.urihttp://hdl.handle.net/10541/623447
dc.description.abstractIntroduction: For advanced cholangiocarcinoma, standard-of-care firstline systemic treatment is gemcitabine + cisplatin. Genetic alterations in intrahepatic cholangiocarcinoma provide potential therapeutic targets. Fibroblast growth factor receptor (FGFR) 2 gene rearrangements driving cholangiocarcinoma tumorigenesis were identified almost exclusively in patients with intrahepatic cholangiocarcinoma (incidence, 10-16%). In phase 2, pemigatinib (INCB054828), a selective, potent, oral FGFR1-3 inhibitor elicited an objective response rate (ORR) of 35.5% and median progression-free survival (PFS) of 6.9 months in previously treated, locally advanced, or metastatic cholangiocarcinoma with FGFR2 rearrangements (FIGHT-202; NCT02924376). FIGHT-302, a randomized, open-label, phase 3 study, will evaluate efficacy and safety of first-line pemigatinib vs gemcitabine + cisplatin in unresectable/metastatic cholangiocarcinoma with documented FGFR2 fusions or rearrangements (NCT03656536). Methods: Eligible patients are adults who have confirmed, radiographically measurable/evaluable (per RECIST v1.1) unresectable/metastatic cholangiocarcinoma with documented FGFR2 fusions or rearrangements, received no prior systemic therapy for advanced disease < 6 months before enrollment, and have an ECOG PS ?1. Exclusion criteria include clinically significant corneal/retinal disorder, untreated CNS metastases, history of seizures, and history of calcium and phosphate homeostasis disorder or systemic mineral imbalance with ectopic soft tissue calcification. Patients are randomized (1:1; stratified by region and tumor burden) to pemigatinib 13.5 mg QD on a 21-day cycle or gemcitabine (1000 mg/m2) + cisplatin (25 mg/m2) on day 1 and day 8 of 21-day cycles (max 8). Crossover to pemigatinib is allowed after confirmed disease progression. Pemigatinib titration to 18 mg from cycle 2 is allowed for patients without hyperphosphatemia (serum phosphate >5.5 mg/dL) or grade ?2 treatment-related adverse events (cycle 1). Hyperphosphatemia will be managed with diet modifications, phosphate binders, diuretics, or dose adjustments. Treatment will continue until disease progression or unacceptable toxicity. Primary endpoint is PFS (independent review). Secondary endpoints are ORR, overall survival, duration of response, disease control rate, safety, and quality of life.en
dc.language.isoenen
dc.titleFIGHT-302: Phase 3 study of first-line pemigatinib vs gemcitabine plus cisplatin for cholangiocarcinoma with FGFR2 fusions or rearrangementen
dc.typeMeetings and Proceedingsen
dc.contributor.departmentHannover Med Sch, Hannover, Germanyen
dc.identifier.journalOncology Research and Treatmenten
dc.description.noteen]


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