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1、 Journal of Clinical Oncology List of Issues Volume 38,Issue 15_suppl Meeting Abstract|2020 ASCO Annual Meeting IGASTROINTESTINAL CANCERGASTROESOPHAGEAL,PANCREATIC,ANDHEPATOBILIARYPhase II study assessing tolerability,efficacy,and biomarkers for durvalumab(D)tremelimumab(T)and gemcitabine/cisplatinR

2、ights&PermissionsOPTIONS&TOOLSExport CitationTrack CitationAdd To FavoritesADVERTISEMENTADADVERTISEMENTLog InSubmitE-AlertsCartOpenAthens/Shibboleth MENU Article Tools(GemCis)in chemo-nave advanced biliarytract cancer(aBTC).Do-Youn Oh,Kyung-Hun Lee,Dae-Won Lee,Tae Yong Kim,Ju-Hee Bang,Ah-Rong Nam,.S

3、how MoreAbstract Disclosures4520Background:In aBTC,GemCis is the standard ofcare as 1-line treatment.Immunotherapies haveshown early promising efficacy in some BTCpatients(pts).We assessed D(anti-PD-L1)T(anti-CTLA-4)and GemCis in 1L BTC pts,includingan extensive biomarker analysis(NCT03046862).Metho

4、ds:Pts were first enrolled in the biomarkercohort(BMC)to receive 1 cycle of Gem 1000mg/m +Cis 25 mg/m on D1&D8,followed byGemCis+D 1120 mg and T 75 mg,Q3W untildisease progression(PD).Subsequent pts wereCOMPANION ARTICLESNo companion articlesARTICLE CITATIONDOI:10.1200/JCO.2020.38.15_suppl.4520Journ

5、al of Clinical Oncology 38,no.15_suppl(May 20,2020)4520-4520.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

6、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,an

7、d apartnership track.Hematology/Oncology-at the Beach inLow Tax Delaware!Delaware(US);Family-oriented resort area inbeautiful south coastal DelawareAbstractst22Standard cisplatin/infusional 5-fluorouracil(PF)vs docetaxel(T)plusPF(TPF)as neoadjuvantchemotherapy for nonresectablelocally advanced squam

8、ous cellcarcinoma of the head andneck(LA-SCCHN):a phase III trial of theEORTC Head and Neck Cancer Group(EORTC#24971)J.B.Vermorken et al.,J Clin Oncol,2004Kinetics of Liquid Biopsies inPredicting Response toImmunotherapyPashtoon M.Kasi et al.,ASCO DailyNews,2020allocated to GemCis+D(3 combo cohort 3

9、C)orGemCis+D+T(4 combo cohort 4C)until PD.In allcohorts,tumor biopsies were obtained pre-treatment,after 1 cycle,and at PD.Blood samplesfor ctDNA were obtained every cycle.Results:121pts were enrolled.Median follow-up durationswere 28.5 months(m;95%CI,26.5-30.5),11.3 m(95%CI,9.1-13.5),and 11.9m(95%C

10、I,8.4-15.4)inthe BMC,3C,and 4C arms,respectively.Efficacydata are shown(Table).The most commonadverse events(AEs,any grade)were neutropenia(54.5%),nausea(59.5%),and pruritus(55.44%).The most common grade 3/4 AEs wereneutropenia(50.4%),anemia(35.5%),andthrombocytopenia(16.5%).In the BMC cohort,freque

11、nt mutations were found in DNA damagerepair,cell cycle regulation,and genomeinstability genes(eg,ATM,BRCA2,POLE,MSH2,CDKN2A).Distinct somatic variants were detectedin responders vs non-responders.Baseline tissueTMB did not correlate with PFS or OS.Reductionsin ctDNA variant allele frequency(VAF)were

12、 moreprominent among responders during early D+TADVERTISEMENTEpirubicin(E),cisplatin(C)andcapecitabine(X)in first-linechemotherapy for patients withadvanced gastric cancerE.K.Cho et al.,J Clin Oncol,2004Dynamic Changes of CirculatingTumor DNA Predict Clinical Outcomein Patients With Advanced NonSmal

13、l-Cell Lung Cancer Treated WithImmune Checkpoint InhibitorsSabrina Weber et al.,JCO PO,2021TOMOX compared to FOLFOX4 asfirst-line treatment in patients(pts)with advanced colorectal cancer(ACRC):Preliminary results of amulticenter randomized phase II trialC.Grvalos et al.,J Clin Oncol,2004Camrelizuma

14、b plus gemcitabine andoxaliplatin(GEMOX)in patients withadvanced biliary tract cancer:asingle-arm,open-label,phase II trialXiaofeng Chen et al.,Jitc,2020Efficacy and biomarker analysis ofnivolumab plus gemcitabine andcisplatin in patients withunresectable or metastatic biliarytract cancers:results f

15、rom a phase IIstudyKaichao Feng et al.,Jitc,2020Novel biomarkers predict benefitwith immunotherapy in metastaticbreast cancerMedicalXpress,2020Assessment of Blood TumorMutational Burden as a Potentialcycles.ctDNA VAF on C3,D1 was significantlycorrelated with ORR(P 0.015).Pretreatment PD-L1 expressio

16、n was not associated with efficacy,butPD-L1 expression after 1 GemCis cycle trendedwith improved PFS.Conclusions:These are thefirst clinical data of DT plus chemotherapy inchemo-nave aBTC pts.The addition ofimmunotherapy to chemotherapy was tolerableand showed very promising efficacy.Biomarkeranalys

17、es show early signs of markers associatedwith response.The combination of GemCis+D isbeing investigated in the Phase 3 TOPAZ-1 trial(NCT03875235).Clinical trial information:NCT03046862.BMC(n=30)3C(n=45)4C(n=46)ORR(95%CI),%50.0(32.1-67.9)73.4(60.5-86.3)73.3(60.4-86.2)DCR(95%CI),%96.7(90.3-100)100(100

18、-100)97.8(93.5-100)mDOR(95%CI),m11.0(3.9-11.8)9.8(8.1-11.4)9.1(4.5-15.0)mPFS(95%CI),m13.0(10.1-15.9)11.0(7.0-15.0)11.9(10.1-13.7)stBiomarker for Immunotherapy inPatients With NonSmall Cell LungCancer With Use of a Next-Generation Sequencing Cancer GenePanelZhijie Wang et al.,JAMA Oncology,2019Prospe

19、ct of liquid biopsy applicationfor precise medication of PD-1/PD-L1inhibitorYuehua Wang et al.,Chinese ScienceBulletin,2018Powered byBMC(n=30)3C(n=45)4C(n=46)mOS(95%CI),m15.0(10.7-19.3)18.1(11.3-24.9)20.7(13.8-27.6)2020 American Society of Clinical OncologyResearch Sponsor:AstraZenecaQUICK LINKSCont

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