5、消化系统肿瘤消化系统肿瘤 (17).pdf

Journal of Clinical Oncology List of Issues Volume 38,Issue 15_suppl Meeting Abstract|2020 ASCO Annual Meeting IGASTROINTESTINAL CANCERGASTROESOPHAGEAL,PANCREATIC,ANDHEPATOBILIARYA multicenter randomized phase II study ofnivolumab in combination withgemcitabine/cisplatin or ipilimumab as first-Rights&PermissionsOPTIONS&TOOLSExport CitationTrack CitationAdd To FavoritesADVERTISEMENTADADVERTISEMENTLog InSubmitE-AlertsCartOpenAthens/Shibboleth MENU Article Toolsline therapy for patients with advancedunresectable biliary tract cancer(BilT-01).Vaibhav Sahai,Kent A.Griffith,Muhammad Shaalan Beg,Walid Labib Shaib,Devalingam Mahalingam,David Bing Zhen,.Show MoreAbstract Disclosures4582Background:Patients(pts)with advanced biliarytract cancers(BTC)have poor prognosis with amedian overall survival(OS)less than 12 months(mos).This randomized phase 2,multi-institutional,study was designed to investigatethe role of combinational immunotherapy,usingnivolumab(nivo)with gemcitabine(gem)/cisplatin(cis),or nivo with ipilimumab(ipi)in pts withuntreated advanced BTC.Methods:Key eligibilitycriteria include histologically confirmedunresectable or metastatic BTC without priorCOMPANION ARTICLESNo companion articlesARTICLE CITATIONDOI:10.1200/JCO.2020.38.15_suppl.4582Journal of Clinical Oncology 38,no.15_suppl(May 20,2020)4582-4582.Published online May 25,2020.WE RECOMMENDADVERTISEMENTEmployer:Merritt HawkinsApply for this job Employer:Potomac Oncology&HematologyApply for this job Hematology-Oncology OpportunityJust Outside of ChicagoRockford,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,exceptional productivity incentives,and apartnership track.Hematology/Oncology-at the Beach inLow Tax Delaware!Delaware(US);Family-oriented resort area inbeautiful south coastal DelawareAbstractNivolumab Plus Ipilimumab forTreatment-Nave Metastatic UvealMelanoma:An Open-Label,Multicenter,Phase II Trial by theSpanish Multidisciplinary MelanomaGroup(GEM-1402)Jos Mara Piulats et al.,J Clin Oncol,2021Nivolumab Plus Ipilimumab inPatients With Advanced Melanoma:Updated Survival,Response,andSafety Data in a Phase I Dose-Escalation StudyMargaret K.Callahan et al.,J ClinOncol,2017Fixed dose-rate gemcitabine(GEM)infusion in advanced pancreaticsystemic therapy,measurable disease perRECISTv1.1,ECOG PS 0-1,and absence ofautoimmune disease or chronic steroid use.Arm Aincluded gem 1000 mg/m and cis 25 mg/m d1,8Q3w+nivo 360 mg d1 Q3w for 6 mos followed bynivo 240 mg Q2w monotherapy for a totalduration of 2 yrs;Arm B included nivo 240 mg Q2wand ipi 1 mg/kg Q6w for 2 yrs,in absence ofdisease progression.Primary endpoint isprogression-free survival(PFS)rate at 6 mos withan alternative hypothesis of 80%(null hypothesisof 59%,one-sided alpha 0.05,power 80%)for eachnon-comparative arm.Secondary endpointsinclude overall response rate(ORR)per immunerelated(ir)RECIST,median PFS and OS and safety.Exploratory objectives include biomarker analysisusing include sequential wholeexome/transcriptome and immune cell subsets intissue and blood.Results:71 eligible pts(49%male,83%Caucasian)with 35 in Arm and 36 inArm B with a median age of 62(range 20-80)yrs,and majority with metastatic disease(90%)wereenrolled across 6 US sites.PFS rate at 6 mos wasADVERTISEMENT22(PDAC)and biliary tree(BTC)carcinoma:A phase II studyA.Gelibter et al.,J Clin Oncol,20042018 Research Moves the Field ofRCC ForwardDaniel M.Geynisman et al.,ASCODaily News,2019Nivolumab and Ipilimumab inMetastatic Uveal Melanoma:ResultsFrom a Single-Arm Phase II StudyMeredith S.Pelster et al.,J Clin Oncol,2020Survival outcomes and independentresponse assessment withnivolumab plus ipilimumab versussunitinib in patients with advancedrenal cell carcinoma:42-monthfollow-up of a randomized phase 3clinical trialRobert J Motzer et al.,Jitc,2020277 Safety and efficacy ofintratumoral ipilimumab with IVnivolumab in metastatic melanoma.The NIVIPIT trialLambros Tselikas et al.,JitcNivolumab plus ipilimumab versussunitinib for first-line treatment ofadvanced renal cell carcinoma:extended 4-year follow-up of thephase III CheckMate 214 trialLaurence Albiges et al.,ESMO open,2020New First-Line Treatment Leads toImproved Survival in GastrointestinalCancersBy staff,US Pharmacist,202070%in Arm A and 18.6%in Arm B.The median PFSwas 8.8 mos(95%CI,6.1 to 11.3)in Arm A and 4.1mos(95%CI,2.4-5.2)in Arm B.Ten patients onArm A and 2 on Arm B remain on active treatment;additional 7 are in follow-up for OS.ORR,safetydata and median OS evaluation are underway andwill be presented at the meeting.Exploratoryanalyses are pending.Conclusions:The observedPFS rates at 6 mos in either arm are insufficient toreject the null hypothesis of 59%PFS at 6 months.While Arm B is inferior,Arm A appears to be aseffective as standard of care although OSestimates are pending maturity.Clinical trialinformation:NCT03101566.2020 American Society of Clinical OncologyResearch Sponsor:Bristol-Myers SquibbUniversity of Michigan Rogel Cancer CenterNab-Paclitaxel and Gemcitabine asFirst-line Treatment of Advanced orMetastatic Cholangiocarcinoma:APhase 2 Clinical TrialVaibhav Sahai et al.,JAMA Oncology,2018Powered byQUICK LINKSContentResourcesASCO FAMILY OF SITESJournalsEducationNewest Articles Archive Meeting AbstractsJournal InformationAbout Editorial Roster Contact Us PermissionsAuthors Reviewers Subscribers Institutions AdvertisersSubmit Your ManuscriptSubscribe to this JournalJournal of Clinical Oncology JCO Oncology Practice JCO Global Oncology JCO Clinical Cancer Informatics JCO Precision OncologyPublicationsASCO Educational Book ASCO Daily News ASCO Connection The ASCO Post ASCO eLearning ASCO Meetings Cancer.NetOther SitesASCO.org ASCO Author Services ASCO Career Center CancerLinQ Conquer Cancer Foundation TAPUR Study American Society of Clinical Oncology2318 Mill Road,Suite 800,Alexandria,VA 22314 2021 American Society of Clinical Oncology Terms of Use|Privacy Policy|Cookies