2024
[177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high‑dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2–3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study
Singh S, Halperin D, Myrehaug S, Herrmann K, Pavel M, Kunz P, Chasen B, Tafuto S, Lastoria S, Capdevila J, García-Burillo A, Oh D, Yoo C, Halfdanarson T, Falk S, Folitar I, Zhang Y, Aimone P, de Herder W, Ferone D, Investigators A. [177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high‑dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2–3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study. The Lancet 2024, 403: 2807-2817. PMID: 38851203, DOI: 10.1016/s0140-6736(24)00701-3.Peer-Reviewed Original ResearchGastroenteropancreatic neuroendocrine tumorsProgression-free survivalAdvanced gastroenteropancreatic neuroendocrine tumorsLong-acting octreotideLu-DOTATATENeuroendocrine tumorsGrade 2Open-labelControl groupTreated patientsWell-differentiatedStandard first-line treatment optionMedian progression-free survivalProgression-free survival eventsTreatment periodFirst-line treatment optionProgression-free survival analysisNeuroendocrine tumor gradingSomatostatin receptor-positiveFirst-line therapyInteractive response technologyHigh-dose octreotidePhase 3 studyPhase 3 trialStandard of careSafety and time to response of [177Lu]Lu-DOTATATE in patients with newly diagnosed advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Sub-analysis of the phase 3 randomized NETTER-2 study.
Kunz P, Ferone D, Halperin D, Myrehaug S, Herrmann K, Pavel M, Chasen B, Capdevila J, Tafuto S, Oh D, Yoo C, Falk S, Halfdanarson T, Folitar I, Zhang Y, de Herder W, Singh S. Safety and time to response of [177Lu]Lu-DOTATATE in patients with newly diagnosed advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Sub-analysis of the phase 3 randomized NETTER-2 study. Journal Of Clinical Oncology 2024, 42: 4131-4131. DOI: 10.1200/jco.2024.42.16_suppl.4131.Peer-Reviewed Original ResearchTime to responseObjective response rateGastroenteropancreatic neuroendocrine tumorsLu-DOTATATEGEP-NETsAdverse eventsHematologic toxicityNeuroendocrine tumorsSafety profileSub-analysisMedian time to responseCases of myelodysplastic syndromeOctreotide long-actingHematologic adverse eventsProgression-free survivalTime to first occurrenceRandomized treatment periodFatal adverse eventsInfection rateDose interruptionCTCAE gradeRadioligand therapyMyelodysplastic syndromeEligible ptsLaboratory abnormalitiesPhase Ib portion of the ACTION-1 phase Ib/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Safety and efficacy findings.
Halperin D, Morris M, Ulaner G, Strosberg J, Mehr S, Li D, Soares H, Anthony L, Kotiah S, Jacene H, Tesselaar M, Kunz P, Ferreira D, Li J, Ma K, Rearden J, Moran S, Hope T, Singh S. Phase Ib portion of the ACTION-1 phase Ib/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Safety and efficacy findings. Journal Of Clinical Oncology 2024, 42: 3091-3091. DOI: 10.1200/jco.2024.42.16_suppl.3091.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPhase Ib portionDose-limiting toxicitySerious adverse eventsGEP-NETsSomatostatin analoguesAdverse eventsFrequent treatment-emergent adverse eventsEfficacy dataData review committeePlanned dose levelsProgression-free survivalDuration of responseGastroenteropancreatic neuroendocrine tumorsLonger-term safetyAlpha-emitting radiopharmaceuticalStandard of careDose holdRECIST v1.1Stable diseasePartial responseStarting doseTumor responseDose modificationNeuroendocrine tumors[177Lu]Lu-DOTA-TATE in newly diagnosed patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Primary analysis of the phase 3 randomized NETTER-2 study.
Singh S, Halperin D, Myrehaug S, Herrmann K, Pavel M, Kunz P, Chasen B, Capdevila J, Tafuto S, Oh D, Yoo C, Falk S, Halfdanarson T, Folitar I, Zhang Y, Santoro P, Aimone P, de Herder W, Ferone D. [177Lu]Lu-DOTA-TATE in newly diagnosed patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Primary analysis of the phase 3 randomized NETTER-2 study. Journal Of Clinical Oncology 2024, 42: lba588-lba588. DOI: 10.1200/jco.2024.42.3_suppl.lba588.Peer-Reviewed Original ResearchProgression-free survivalObjective response rateOctreotide long-acting releaseLong-acting releaseGastroenteropancreatic neuroendocrine tumorsRadioligand therapyGEP-NETsLu-DOTATATENeuroendocrine tumorsControl armEfficacy of radioligand therapyMedian progression-free survivalProlonged progression-free survivalCases of myelodysplastic syndromeAdvanced GEP-NETsMedian cumulative doseStratified hazard ratioStratified odds ratiosMonths prior to enrollmentLu-DOTATATE treatmentUnmet medical needG3 tumorsMyelodysplastic syndromePrognostic subgroupsEligible pts
2023
Novel use of alternate (Alt) response (Rp) criteria (Cr) for early prediction of outcomes in pancreatic (P) neuroendocrine tumors (NETs): Utilizing banked imaging data from the ECOG-ACRIN E2211 study.
Vijayvergia N, Handorf E, Kunz P, Alkim E, Burke L, Catalano P, Graham N, Levin L, Li W, Meeker C, Rubin D, Narasimhan Sridharan A, O'Dwyer P, Wong T, Anaokar J. Novel use of alternate (Alt) response (Rp) criteria (Cr) for early prediction of outcomes in pancreatic (P) neuroendocrine tumors (NETs): Utilizing banked imaging data from the ECOG-ACRIN E2211 study. Journal Of Clinical Oncology 2023, 41: 4133-4133. DOI: 10.1200/jco.2023.41.16_suppl.4133.Peer-Reviewed Original ResearchProgression-free survivalImproved progression-free survivalNeuroendocrine tumorsStable diseaseProgressive diseaseRadiomic featuresCT/MRI scansPancreatic neuroendocrine tumorsPortal venous phaseShort-term imagingSmaller threshold changesInter-reader agreementTumor sizeC-statisticFirst disease assessmentPotential adjunctTreatment decisionsVenous phasePD casesTime-varying outcomeMRI scansClinical practicePredictive valueTumor densityInter-reader variability
2022
Randomized Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors (ECOG-ACRIN E2211)
Kunz PL, Graham NT, Catalano PJ, Nimeiri HS, Fisher GA, Longacre TA, Suarez CJ, Martin BA, Yao JC, Kulke MH, Hendifar AE, Shanks JC, Shah MH, Zalupski MM, Schmulbach EL, Reidy-Lagunes DL, Strosberg JR, O'Dwyer PJ, O'Dwyer P, Benson A. Randomized Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors (ECOG-ACRIN E2211). Journal Of Clinical Oncology 2022, 41: 1359-1369. PMID: 36260828, PMCID: PMC9995105, DOI: 10.1200/jco.22.01013.Peer-Reviewed Original ResearchConceptsAdvanced pancreatic neuroendocrine tumorsProgression-free survivalPancreatic neuroendocrine tumorsMedian progression-free survivalPrimary end pointNeuroendocrine tumorsResponse rateObjective responseOverall survivalRandomized studyIntermediate-grade pancreatic neuroendocrine tumorsLonger progression-free survivalEnd pointMGMT deficiencyMedian overall survivalPrimary analysis populationKey eligibility criteriaPhase II trialSmall prospective studiesHigh response rateMethylguanine methyltransferaseCapecitabine/Eligible patientsSecondary endpointsII trialA randomized study of temozolomide or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors: Final analysis of efficacy and evaluation of MGMT (ECOG-ACRIN E2211).
Kunz P, Graham N, Catalano P, Nimeiri H, Fisher G, Longacre T, Suarez C, Rubin D, Yao J, Kulke M, Hendifar A, Shanks J, Shah M, Zalupski M, Schmulbach E, Reidy D, Strosberg J, Wong T, O'Dwyer P, Benson A. A randomized study of temozolomide or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors: Final analysis of efficacy and evaluation of MGMT (ECOG-ACRIN E2211). Journal Of Clinical Oncology 2022, 40: 4004-4004. DOI: 10.1200/jco.2022.40.16_suppl.4004.Peer-Reviewed Original ResearchProgression-free survivalPancreatic neuroendocrine tumorsMedian progression-free survivalAdvanced pancreatic neuroendocrine tumorsCombination of capecitabineNeuroendocrine tumorsResponse rateEligible patientsPrimary endpointOverall survivalIntermediate-grade pancreatic neuroendocrine tumorsTwo-sided log-rank testLonger progression-free survivalEfficacy analysis populationObjective tumor responsePhase II trialLog-rank testHigh response rateSecondary endpointsII trialProspective studyAnalysis populationTreatment optionsTumor responseInterim analysisEverolimus with or without bevacizumab in advanced pNET: CALGB 80701 (Alliance).
Kulke MH, Ou FS, Niedzwiecki D, Huebner L, Kunz P, Kennecke HF, Wolin EM, Chan JA, O'Reilly EM, Meyerhardt JA, Venook A. Everolimus with or without bevacizumab in advanced pNET: CALGB 80701 (Alliance). Endocrine Related Cancer 2022, 29: 335-344. PMID: 35324465, PMCID: PMC9257687, DOI: 10.1530/erc-21-0239.Peer-Reviewed Original ResearchConceptsAdvanced pancreatic neuroendocrine tumorsProgression-free survivalPancreatic neuroendocrine tumorsVEGF pathway inhibitorsCombination armPrimary endpointMedian overall survival durationTreatment-related adverse eventsImproved progression-free survivalRandomized phase II studySuperior progression-free survivalPathway inhibitorOverall survival durationPhase II studyTreatment-related toxicityCombination of everolimusMTOR inhibitor everolimusHigh response rateAdverse eventsII studyInvestigator reviewCombination therapyStandard doseInhibitor everolimusNeuroendocrine tumors
2021
177Lu-Dotatate plus long-acting octreotide versus high‑dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial
Strosberg JR, Caplin ME, Kunz PL, Ruszniewski PB, Bodei L, Hendifar A, Mittra E, Wolin EM, Yao JC, Pavel ME, Grande E, Van Cutsem E, Seregni E, Duarte H, Gericke G, Bartalotta A, Mariani MF, Demange A, Mutevelic S, Krenning EP, investigators N. 177Lu-Dotatate plus long-acting octreotide versus high‑dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial. The Lancet Oncology 2021, 22: 1752-1763. PMID: 34793718, DOI: 10.1016/s1470-2045(21)00572-6.Peer-Reviewed Original ResearchConceptsMedian overall survivalMidgut neuroendocrine tumorsTreatment-related serious adverse eventsLong-term safety resultsFinal overall survivalPrespecified final analysisPhase 3 trialProgression-free survivalSerious adverse eventsOverall survivalLu-DOTATATE treatmentAdverse eventsNeuroendocrine tumorsLu-DOTATATESecondary endpointsLast patientMyelodysplastic syndromeSafety resultsInteractive web-based response systemControl groupAdvanced midgut neuroendocrine tumorsFinal overall survival analysisWeb-based response systemFinal analysisNETTER-1 trialComparison of Design, Eligibility, and Outcomes of Neuroendocrine Neoplasm Trials Initiated From 2000 to 2009 vs 2010 to 2020
Das S, Du L, Lee CL, Arhin ND, Chan JA, Kohn EC, Halperin DM, Berlin J, LaFerriere H, Singh S, Kunz PL, Dasari A. Comparison of Design, Eligibility, and Outcomes of Neuroendocrine Neoplasm Trials Initiated From 2000 to 2009 vs 2010 to 2020. JAMA Network Open 2021, 4: e2131744. PMID: 34705010, PMCID: PMC8552059, DOI: 10.1001/jamanetworkopen.2021.31744.Peer-Reviewed Original ResearchConceptsNeuroendocrine neoplasmsClinical trialsNational Cancer Institute Clinical TrialsEU Clinical Trials RegisterCoprimary end pointsObjective response rateProgression-free survivalClinical Trials RegisterKi-67 indexAllied Health LiteratureQuality improvement studyPhase IISpecific disease populationsWeb of ScienceDrug licensureTrials RegisterCochrane DatabaseTumor differentiationNovel agentsDisease populationInclusion criteriaMAIN OUTCOMECumulative IndexEnrollment periodResponse rateRapid Progression After 177Lu-DOTATATE in Patients With Neuroendocrine Tumors
Assi HA, Hornbacker K, Shaheen S, Wittenberg T, Silberman R, Kunz PL. Rapid Progression After 177Lu-DOTATATE in Patients With Neuroendocrine Tumors. Pancreas 2021, 50: 890-894. PMID: 34398071, DOI: 10.1097/mpa.0000000000001841.Peer-Reviewed Original ResearchConceptsPeptide receptor radionuclide therapyProgressive diseaseNeuroendocrine tumorsBiopsy-proven neuroendocrine tumorHigher disease control rateMedian progression-free survivalShorter progression-free intervalStanford Cancer CenterDisease control rateMetastatic neuroendocrine tumorsMonths of therapyProgression-free survivalProgression-free intervalReceptor radionuclide therapyBetter patient selectionLarge patient cohortHigh-grade componentHigher disease gradeLow-grade componentRepeat biopsyMedian timePatient selectionInitial pathologyPredictive factorsCancer CenterFinal overall survival in the phase 3 NETTER-1 study of lutetium-177-DOTATATE in patients with midgut neuroendocrine tumors.
Strosberg J, Caplin M, Kunz P, Ruszniewski P, Bodei L, Hendifar A, Mittra E, Wolin E, Yao J, Pavel M, Grande E, Van Cutsem E, Seregni E, Duarte H, Gericke G, Bartalotta A, Demange A, Mutevelic S, Krenning E, group O. Final overall survival in the phase 3 NETTER-1 study of lutetium-177-DOTATATE in patients with midgut neuroendocrine tumors. Journal Of Clinical Oncology 2021, 39: 4112-4112. DOI: 10.1200/jco.2021.39.15_suppl.4112.Peer-Reviewed Original ResearchProgression-free survivalMedian overall survivalFinal overall survivalNETTER-1 studyNETTER-1 trialNew safety signalsOverall survivalMidgut neuroendocrine tumorsControl armMyelodysplastic syndromeNeuroendocrine tumorsLu-DOTATATEPrimary endpointLast patientSafety signalsFurther anti-cancer treatmentBest supportive careKey secondary endpointOpen-label trialLutetium-177 DOTATATEAnti-cancer treatmentEligible patientsNETTER-1RECIST 1.1Secondary endpoints
2020
Cost-Effectiveness of Initial Versus Delayed Lanreotide for Treatment of Metastatic Enteropancreatic Neuroendocrine Tumors.
Barnes JI, Lin JK, Gupta D, Owens DK, Goldhaber-Fiebert JD, Kunz PL. Cost-Effectiveness of Initial Versus Delayed Lanreotide for Treatment of Metastatic Enteropancreatic Neuroendocrine Tumors. Journal Of The National Comprehensive Cancer Network 2020, 18: 1200-1209. PMID: 32886901, DOI: 10.6004/jnccn.2020.7563.Peer-Reviewed Original ResearchConceptsIncremental cost-effectiveness ratioMetastatic enteropancreatic neuroendocrine tumorsEnteropancreatic neuroendocrine tumorsNeuroendocrine tumorsInitial therapyActive surveillanceNCCN Clinical Practice GuidelinesProlonged progression-free survivalProgression-free survivalClinical practice guidelinesActive surveillance strategyLifetime time horizonCost-effectiveness ratioHealthcare sector perspectiveProbabilistic sensitivity analysesCLARINET trialPostprogression treatmentPlacebo armAdrenal tumorsTumor trialsTreatment optionsPractice guidelinesLanreotideSurveillance strategiesQALYA PHASE IIA STUDY REPOSITIONING DESIPRAMINE IN SMALL CELL LUNG CANCER AND OTHER HIGH-GRADE NEUROENDOCRINE TUMORS
Riess JW, Jahchan NS, Das M, Koontz M, Kunz PL, Wakelee HA, Schatzberg A, Sage J, Neal JW. A PHASE IIA STUDY REPOSITIONING DESIPRAMINE IN SMALL CELL LUNG CANCER AND OTHER HIGH-GRADE NEUROENDOCRINE TUMORS. Cancer Treatment And Research Communications 2020, 23: 100174. PMID: 32413603, PMCID: PMC7572629, DOI: 10.1016/j.ctarc.2020.100174.Peer-Reviewed Original ResearchSmall cell lung cancerCell lung cancerMetastatic small cell lung cancerRadiographic progression-free survivalHigh-grade neuroendocrine carcinomaMedian overall survivalProgression-free survivalTricyclic antidepressantsClinical trialsLung cancerPrior chemotherapyFree survivalStable doseOverall survivalRadiographic benefitStudy entryNeuroendocrine carcinomaPreclinical modelsAntitumor effectsGrade 1Phase IIa clinical trialDose-escalation clinical trialHigh-grade neuroendocrine tumorsNeurocognitive adverse eventsEscalation clinical trialImpact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with 177Lu-Dotatate: an analysis of the NETTER-1 study
Strosberg J, Kunz PL, Hendifar A, Yao J, Bushnell D, Kulke MH, Baum RP, Caplin M, Ruszniewski P, Delpassand E, Hobday T, Verslype C, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Paganelli G, Severi S, Morse M, Metz DC, Ansquer C, Courbon F, Al-Nahhas A, Baudin E, Giammarile F, Taïeb D, Mittra E, Wolin E, O’Dorisio T, Lebtahi R, Deroose CM, Grana CM, Bodei L, Öberg K, Polack BD, He B, Mariani MF, Gericke G, Santoro P, Erion JL, Ravasi L, Krenning E. Impact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with 177Lu-Dotatate: an analysis of the NETTER-1 study. European Journal Of Nuclear Medicine And Molecular Imaging 2020, 47: 2372-2382. PMID: 32123969, PMCID: PMC7396396, DOI: 10.1007/s00259-020-04709-x.Peer-Reviewed Original ResearchConceptsLiver tumor burdenProgression-free survivalLargest target lesionHigher liver tumour burdenTumor burdenMidgut neuroendocrine tumorsAlkaline phosphatase elevationNeuroendocrine tumorsTarget lesionsLesion sizeHazard ratioTreatment outcomesAnalysis of PFSHigh-dose octreotide LARMedian progression-free survivalImproved progression-free survivalNETTER-1 studyNETTER-1 trialLiver function abnormalitiesKaplan-Meier estimatesOctreotide LARPrimary endpointFunction abnormalitiesBaseline factorsCox regressionSingle institution experience with peptide receptor radionuclide therapy (PRRT) in neuroendocrine tumors (NET).
Duan H, Ninatti G, Girod B, Ferri V, Kunz P, Fisher G, Moradi F, Davidzon G, Franc B, Iagaru A, Mari C. Single institution experience with peptide receptor radionuclide therapy (PRRT) in neuroendocrine tumors (NET). Journal Of Clinical Oncology 2020, 38: 623-623. DOI: 10.1200/jco.2020.38.4_suppl.623.Peer-Reviewed Original ResearchPeptide receptor radionuclide therapyNETTER-1 trialObjective response rateProgression-free survivalNETTER-1 studyReceptor radionuclide therapyNeuroendocrine tumorsCycles of PRRTRadionuclide therapyInterim overall survival analysisProgressive neuroendocrine tumorsLines of therapySingle institution experienceOnly side effectMidgut neuroendocrine tumorsTreatment of patientsCourse of treatmentOverall survival analysisPFS ratesMetastatic diseaseCurative treatmentInstitution experiencePatient cohortSide effectsVs. 18
2019
Prognostic value of somatostatin receptor expressing tumor volume calculated from 68Ga-DOTATATE PET/CT in patients with well-differentiated neuroendocrine tumors
Toriihara A, Baratto L, Nobashi T, Park S, Hatami N, Davidzon G, Kunz PL, Iagaru A. Prognostic value of somatostatin receptor expressing tumor volume calculated from 68Ga-DOTATATE PET/CT in patients with well-differentiated neuroendocrine tumors. European Journal Of Nuclear Medicine And Molecular Imaging 2019, 46: 2244-2251. PMID: 31350603, DOI: 10.1007/s00259-019-04455-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overDisease ProgressionDisease-Free SurvivalFemaleHumansImage Processing, Computer-AssistedKaplan-Meier EstimateLiver NeoplasmsMaleMiddle AgedMultivariate AnalysisNeoplasm MetastasisNeuroendocrine TumorsOrganometallic CompoundsPositron Emission Tomography Computed TomographyPrognosisProgression-Free SurvivalProportional Hazards ModelsProspective StudiesReceptors, SomatostatinRetrospective StudiesConceptsProgression-free survivalProportional hazards modelPET/CTPrognostic valueTumor volumeNeuroendocrine tumorsTumor gradeSomatostatin receptorsKaplan-Meier survival analysisCox proportional hazards modelPositron emission tomography/Volume of interestMaximum standardized uptake valueMethodsNinety-two patientsWHO tumor gradeLog-rank testSomatostatin receptor expressionEmission tomography/Standardized uptake valueSignificant differencesVolumetric parametersPrimary endpointIndependent predictorsResultsUnivariate analysisTomography/Evaluating the Role of Theranostics in Grade 3 Neuroendocrine Neoplasms
Waseem N, Aparici CM, Kunz PL. Evaluating the Role of Theranostics in Grade 3 Neuroendocrine Neoplasms. Journal Of Nuclear Medicine 2019, 60: 882-891. PMID: 30850504, DOI: 10.2967/jnumed.118.217851.Peer-Reviewed Original ResearchConceptsPeptide receptor radionuclide therapyG3 neuroendocrine neoplasmsNeuroendocrine neoplasmsOverall survivalRole of PRRTUse of PRRTPhase III clinical trialsGrade 3 neuroendocrine neoplasmsLeast stable diseaseMidgut neuroendocrine neoplasmsProgression-free survivalLonger overall survivalReceptor radionuclide therapyShorter overall survivalHigh Ki-67Gastroenteropancreatic neuroendocrine neoplasmsNew histologic classificationSomatostatin receptor expressionF-FDG PETDrug Administration approvalLow proliferation indexRole of theranosticsRadiologic responseStable diseasePartial response
2018
Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial
Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum RP, Kunz P, Hobday T, Hendifar A, Oberg K, Sierra ML, Thevenet T, Margalet I, Ruszniewski P, Krenning E, Group O. Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial. Journal Of Clinical Oncology 2018, 36: jco.2018.78.586. PMID: 29878866, PMCID: PMC6366953, DOI: 10.1200/jco.2018.78.5865.Peer-Reviewed Original ResearchConceptsNETTER-1 trialPhase III studyGlobal health statusHealth-related QoL.Quality of lifeMidgut NETQoL deteriorationIII studyLu-DOTATATEPhysical functioningHealth statusEuropean OrganizationTumor progressionInternational phase III studyDisease-related worriesSignificant QOL benefitsProgression-free survivalMidgut neuroendocrine tumorsNeuroendocrine tumor progressionImpact of treatmentLu-DOTATATE treatmentTreat populationQLQ CCancer QualityQOL scoresPhase II study of epacadostat with pembrolizumab in metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma requiring paired biopsies.
Kardosh A, Tseng D, Sahaf B, Zomet A, Krupa J, Fisher G, Wang D, Mackall C, Kunz P. Phase II study of epacadostat with pembrolizumab in metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma requiring paired biopsies. Journal Of Clinical Oncology 2018, 36: tps191-tps191. DOI: 10.1200/jco.2018.36.4_suppl.tps191.Peer-Reviewed Original ResearchProgression-free survivalGastroesophageal junctionOverall survivalResponse rateGastric adenocarcinomaECOG performance status 0Phase II clinical trialPDL-1 expressionPerformance status 0Single-agent pembrolizumabMedian overall survivalPD-1 inhibitorsPhase II studyIncidence of adenocarcinomaGastroesophageal junction adenocarcinomaComprehensive immune profilingMajor health problemCombination immunotherapyEligible patientsKEYNOTE-059PFS ratesPrior therapyPrior trastuzumabStatus 0Advanced disease