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 trialRapid 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 Center
2020
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
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 ResearchMeSH KeywordsAlkaline PhosphataseHumansLiver NeoplasmsNeuroendocrine TumorsOctreotideOrganometallic CompoundsTreatment OutcomeConceptsLiver 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 regressionNANETS/SNMMI Consensus Statement on Patient Selection and Appropriate Use of 177Lu-DOTATATE Peptide Receptor Radionuclide Therapy
Hope TA, Bodei L, Chan JA, El-Haddad G, Fidelman N, Kunz PL, Mailman J, Menda Y, Metz DC, Mittra ES, Pryma DA, Reidy-Lagunes DL, Singh S, Strosberg JR. NANETS/SNMMI Consensus Statement on Patient Selection and Appropriate Use of 177Lu-DOTATATE Peptide Receptor Radionuclide Therapy. Journal Of Nuclear Medicine 2020, 61: 222-227. PMID: 32015164, PMCID: PMC9364765, DOI: 10.2967/jnumed.119.240911.Peer-Reviewed Original ResearchMeSH KeywordsConsensusHumansNeuroendocrine TumorsNuclear MedicineOctreotideOrganometallic CompoundsPatient SelectionReceptors, PeptideSocieties, Medical
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/
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 ResearchMeSH KeywordsHumansNeuroendocrine TumorsOctreotideOrganometallic CompoundsQuality of LifeSurveys and QuestionnairesConceptsNETTER-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 scores
2017
Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors
Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Öberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. New England Journal Of Medicine 2017, 376: 125-135. PMID: 28076709, PMCID: PMC5895095, DOI: 10.1056/nejmoa1607427.Peer-Reviewed Original ResearchConceptsMidgut neuroendocrine tumorsProgression-free survivalAdvanced midgut neuroendocrine tumorsOverall survivalNeuroendocrine tumorsControl groupInterim analysisResponse rateLu-DOTATATEHigh-dose octreotide LARLonger progression-free survivalEnd pointMetastatic midgut neuroendocrine tumorsFinal analysisData cutoff dateObjective response rateOverall survival benefitPrimary end pointSecondary end pointsSomatostatin analogue therapyPhase 3 trialSide effect profileRenal toxic effectsHigh response rateOctreotide LAR