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1、 Journal of Clinical Oncology List of Issues Volume 39,Issue 3_suppl Meeting Abstract|2021 Gastrointestinal Cancers SymposiumHEPATOBILIARY CANCERFinal results from a phase II study ofinfigratinib(BGJ398),an FGFR-selectivetyrosine kinase inhibitor,in patients withpreviously treated advancedRights&Per

2、missionsOPTIONS&TOOLSExport CitationTrack CitationAdd To FavoritesCOMPANION ARTICLESADVERTISEMENTADADVERTISEMENTLog InSubmitE-AlertsCartOpenAthens/Shibboleth MENU Article Toolscholangiocarcinoma harboring an FGFR2gene fusion or rearrangement.Milind M.Javle,Sameek Roychowdhury,Robin Kate Kelley,Saeed

3、 Sadeghi,Teresa Macarulla,Dirk Thomas Waldschmidt,.Show MoreAbstract Disclosures265Background:Treatment options forcholangiocarcinoma(CCA)after progression onfirst-line gemcitabine-based therapy are limited.Fibroblast growth factor receptor 2(FGFR2)genefusions occur in 1317%of intrahepatic CCA.Asing

4、le-arm,phase II study(NCT02150967)evaluated infigratinib,an ATP-competitive FGFR13-selective oral tyrosine kinase inhibitor,inpreviously-treated advanced CCA with FGFRfusions/rearrangements.Methods:Adult patientswith advanced/metastatic CCA with progressionNo companion articlesARTICLE CITATIONDOI:10

5、.1200/JCO.2021.39.3_suppl.265Journal of Clinical Oncology 39,no.3_suppl(January 20,2021)265-265.Published online January 22,2021.WE RECOMMENDADVERTISEMENTEmployer:Merritt HawkinsApply for this job Employer:Potomac Oncology&HematologyApply for this job Hematology-Oncology OpportunityJust Outside of C

6、hicagoRockford,Illinois N/AA reputable integrated health system seekinga board-certified or board-eligiblehematologist-oncologist to join its team.Oncology&Hematology AssociatePositionRockville,Maryland Competitive SalaryThis position offers a competitive base salary,a comprehensive benefits package

7、,exceptional productivity incentives,and apartnership track.Hematology/Oncology-at the Beach inLow Tax Delaware!Delaware(US);Family-oriented resort area inbeautiful south coastal DelawareAbstractFinal Phase II Data SupportInfigratinib in Chemotherapy-refractory CholangiocarcinomaHarboring FGFR2 Fusi

8、onsASCO Daily News,2021Phase II Study of BGJ398 in PatientsWith FGFR-Altered AdvancedCholangiocarcinomaMilind Javle et al.,J Clin Oncol,2017FGFR Kinase Inhibitor in FGFR-Altered AdvancedCholangiocarcinomaBy Matthew Stenger et al.,Hepatobiliary CancerLack of Targetable FGFR2 Fusions inEndemic Fluke-A

9、ssociatedCholangiocarcinomaSarinya Kongpetch et al.,JCO GlobalOncology,2020Cholangiocarcinoma With FGFRGenetic Aberrations:A UniqueClinical Phenotypeon 1 line of systemic therapy received infigratinib125 mg orally for 21 days of each 28-day cycle untilunacceptable toxicity or disease progression.All

10、patients received prophylaxis with the oralphosphate binder sevelamer.Primary endpoint:objective response rate(ORR)by independentcentral review per RECIST v1.1,with duration ofresponse(DOR).Secondary endpoints:progression-free survival(PFS),disease controlrate,overall survival,safety,pharmacokinetic

11、s.Approximately 160 patients are planned(120/20/20 patients in Cohorts 1/2/3).This analysisfocuses on Cohort 1(patients with FGFR2 genefusions or rearrangements without receiving aprior FGFR inhibitor).Results:As of 31 March 2020,108 patients,including 83(77%)with FGFR2fusions,received infigratinib:

12、median age 53 years(range 2381 years);54%had received 2 priortreatment lines.Median follow-up was 10.6months(range 1.155.9 months).96 patients(88.9%)discontinued treatment(12 ongoing).Centrally reviewed ORR was 23.1%(95%CI 15.632.2)including 1 CR and 24 PRs;median DOR wasADVERTISEMENTApurva Jain et

13、al.,JCO PO,2018Systemic therapy for advancedcholangiocarcinoma:new options onthe horizonSaleh A.Alqahtani et al.,HepatomaResearch-OAE Publishing,2020Efficacy and safety of copanlisib inpatients with relapsed or refractorymarginal zone lymphomaPanayiotis Panayiotidis et al.,BloodAdvances,2021Metastat

14、ic Calcinosis CutisAssociated With a Selective FGFRInhibitorDavid R.Carr et al.,JAMADermatology,2018Precision Approach to BladderCancerFeyza Sancar et al.,Journal ofAmerican Medical Association,2019Durable ibrutinib responses inrelapsed/refractory marginal zonelymphoma:long-term follow-up andbiomark

15、er analysisAriela Noy et al.,Blood Advances,2020Powered by5.0 months(range 0.919.1 months).Amongresponders,8(32.0%)patients had a DOR of 6months.Median PFS was 7.3 months(95%CI 5.67.6 months).Prespecified subgroup analysis:ORRwas 34%(17/50)in the second-line setting and13.8%(8/58)in the third-/later

16、-line setting(38prior treatments).Most common treatment-emergent adverse events(TEAEs,any grade)werehyperphosphatemia(76.9%),eye disorders(67.6%,excluding central serous retinopathy/retinalpigment epithelium detachment CSR/RPED),stomatitis(54.6%),and fatigue(39.8%).CSR/RPEDoccurred in 16.7%of patien

17、ts(including 1 G3event;0 G4).Other common grade 3/4 TEAEs werestomatitis(14.8%;all G3),hyponatremia(13.0%;allG3),and hypophosphatemia(13.0%;13 G3,1 G4).Conclusions:Infigratinib is associated withpromising anticancer activity and a manageableAE profile in patients with advanced,refractoryCCA with an

18、FGFR2 gene fusion or rearrangement.A phase III study of infigratinib versusgemcitabine/cisplatin is ongoing in the front-linesetting(NCT03773302).Clinical trial information:NCT02150967.2021 American Society of Clinical OncologyResearch Sponsor:QED Therapeutics Inc.QUICK LINKSContentNewest Articles A

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