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dc.contributor.authorFuruse, J.
dc.contributor.authorGoyal, L.
dc.contributor.authorMeric-Bernstam, F.
dc.contributor.authorHollebecque, A.
dc.contributor.authorValle, Juan W
dc.contributor.authorMorizane, C.
dc.contributor.authorKarasic, T. B.
dc.contributor.authorAbrams, T. A.
dc.contributor.authorKelley, R. K.
dc.contributor.authorCassier, P. A.
dc.contributor.authorKlumpen, H. J.
dc.contributor.authorUboha, N.
dc.contributor.authorMahipal, A.
dc.contributor.authorMitchell, E.
dc.contributor.authorAhn, E.
dc.contributor.authorChang, H. M.
dc.contributor.authorMasuda, K.
dc.contributor.authorHe, Y.
dc.contributor.authorBenhadji, K. A.
dc.contributor.authorBridgewater, J. A.
dc.date.accessioned2021-01-25T01:13:38Z
dc.date.available2021-01-25T01:13:38Z
dc.date.issued2020en
dc.identifier.citationFuruse J, Goyal L, Meric-Bernstam F, Hollebecque A, Valle JW, Morizane C, et al. 116MO Efficacy, safety, and quality of life (QoL) with futibatinib in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/rearrangements: FOENIX-CCA2. Annals of Oncology. 2020;31:S1288-S9.en
dc.identifier.doi10.1016/j.annonc.2020.10.137en
dc.identifier.urihttp://hdl.handle.net/10541/623692
dc.description.abstractBackground: iCCA has a poor prognosis and its incidence is higher in Asian vs Western countries. Futibatinib is an oral, highly selective, irreversible FGFR1e4 inhibitor that demonstrated safety and preliminary efficacy in pts with iCCA harboring FGFR2 aberrations. This study evaluated safety, efficacy, and QoL with futibatinib treatment in pts with iCCA and FGFR2 fusions/rearrangements. Methods: FOENIX-CCA2 (NCT02052778), a global phase II study, enrolled pts with unresectable/metastatic iCCA harboring an FGFR2 fusion/rearrangement and disease progression after 1 line of systemic therapy (including gemcitabineecisplatin) but no prior FGFR inhibitors. Pts received futibatinib 20 mg once daily until disease progression/ intolerability. The primary endpoint was objective response rate (ORR) per independent central radiology review and RECIST v1.1; secondary endpoints were disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), safety, and patient-reported outcomes (PROs). ORRs of subgroups by baseline demographic, fusion partner, and other molecular alteration (eg, TP53) were also determined. Results: Of 103 enrolled pts, planned interim data are reported for 67 pts (54% white, 24% Asian) with 6mo of follow-up; 55% of pts received 2 prior therapy lines, and 82% had tumors harboring an FGFR2 fusion (BICC1, n¼15). ORR was 37.3%, DCR was 82.1%, and median DOR was 8.3 mo. Objective responses occurred regardless of baseline characteristic (subgroup: 65 y, ORR: 57.1%), FGFR2 fusion partner (BICC1, 33.3%), or other genetic mutation (TP53, 16.7%). Median PFS was 7.2 mo. The most common treatment-related adverse events (TRAEs; any grade/grade 3) were hyperphosphatemia (81%/27%), diarrhea (37%/0%), and dry mouth (33%/0%); no grade 4e5 TRAEs occurred. TRAEs were managed with dose interruption/reduction (55%/51%); only 1 pt discontinued due to a TRAE. PROs were stable through 273 days (13 cycles) of treatment. Conclusions: Futibatinib resulted in durable objective responses in pts with iCCA and FGFR2 fusions/rearrangements, including within pt subgroups. Adverse events were manageable, and QoL was maintained.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1016/j.annonc.2020.10.137en
dc.titleEfficacy, safety, and quality of life (QoL) with futibatinib in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/rearrangements: FOENIX-CCA2en
dc.typeMeetings and Proceedingsen
dc.contributor.departmentDepartment of Medical Oncology, Kyorin University Hospital, Tokyo, Japan;en
dc.identifier.journalAnnals of Oncologyen
dc.description.noteen]
refterms.dateFOA2021-01-25T13:29:48Z


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