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 trial1102P The phase III NETTER-1 study of 177Lu-DOTATATE in patients with midgut neuroendocrine tumours: Further survival analyses
Ruszniewski P, Caplin M, Kunz P, Bodei L, Hendifar A, Mittra E, Wolin E, Yao J, Pavel M, Grande E, Van Cutsem E, Seregni E, Duarte H, Demange A, Mutevelic S, Krenning E, Strosberg J. 1102P The phase III NETTER-1 study of 177Lu-DOTATATE in patients with midgut neuroendocrine tumours: Further survival analyses. Annals Of Oncology 2021, 32: s911-s912. DOI: 10.1016/j.annonc.2021.08.184.Peer-Reviewed Original ResearchFinal 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
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 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
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 scores
2017
438PD Improved time to quality of life deterioration in patients with progressive midgut neuroendocrine tumors treated with 177Lu-DOTATATE: The NETTER-1 phase III trial
Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum R, Kunz P, Hobday T, Hendifar A, Öberg K, Sierra M, Ruszniewski P, Krenning E. 438PD Improved time to quality of life deterioration in patients with progressive midgut neuroendocrine tumors treated with 177Lu-DOTATATE: The NETTER-1 phase III trial. Annals Of Oncology 2017, 28: v146. DOI: 10.1093/annonc/mdx368.010.Peer-Reviewed Original ResearchPhase III trialsMidgut neuroendocrine tumorsIII trialsNeuroendocrine tumorsLife deteriorationPatientsTumorsTrialsThe North American Neuroendocrine Tumor Society Consensus Guidelines for Surveillance and Medical Management of Midgut Neuroendocrine Tumors
Strosberg JR, Halfdanarson TR, Bellizzi AM, Chan JA, Dillon JS, Heaney AP, Kunz PL, O’Dorisio T, Salem R, Segelov E, Howe JR, Pommier RF, Brendtro K, Bashir MA, Singh S, Soulen MC, Tang L, Zacks JS, Yao JC, Bergsland EK. The North American Neuroendocrine Tumor Society Consensus Guidelines for Surveillance and Medical Management of Midgut Neuroendocrine Tumors. Pancreas 2017, 46: 707-714. PMID: 28609356, PMCID: PMC5642985, DOI: 10.1097/mpa.0000000000000850.Peer-Reviewed Original ResearchConceptsMidgut neuroendocrine tumorsNeuroendocrine tumorsNorth American Neuroendocrine Tumor Society Consensus GuidelinesNorth American Neuroendocrine Tumor SocietyNETTER-1 trialRADIANT-4 studyRefractory carcinoid syndromePhase 3 studyNonfunctioning neuroendocrine tumorEnteropancreatic neuroendocrine tumorsConsensus-based guidelinesCLARINET trialRADIANT-2Carcinoid syndromeTelotristat ethylMedical managementTherapeutic optionsConsensus guidelinesSurgical guidelinesLu-DOTATATEMultidisciplinary panelProximal colonGastrointestinal tractSmall intestinePatientsQuality-of-life findings in patients with midgut neuroendocrine tumors: Results of the NETTER-1 phase III trial.
Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum R, Kunz P, Hobday T, Hendifar A, Oberg K, Lopera Sierra M, Kwekkeboom D, Ruszniewski P, Krenning E. Quality-of-life findings in patients with midgut neuroendocrine tumors: Results of the NETTER-1 phase III trial. Journal Of Clinical Oncology 2017, 35: 348-348. DOI: 10.1200/jco.2017.35.4_suppl.348.Peer-Reviewed Original ResearchGlobal health statusMidgut NETHealth statusHigh-dose octreotide LARNETTER-1 trialPhase III trialsProgression-free survivalEORTC QLQ-30Health-related qualityHormone-related symptomsMidgut neuroendocrine tumorsNeuroendocrine tumor progressionImpact of treatmentQuality of lifeOctreotide LARIII trialsQLQ-30Patients' QoLNeuroendocrine tumorsQOL analysisLu-DOTATATEDisease progressionLife findingsPatientsBaseline scoresPhase 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
2016
NETTER-1 Phase III in Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-Dotatate: Efficacy, Safety, QoL Results and Subgroup Analysis
Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum R, Kunz P, Hobday T, Hendifar A, Oberg K, Lopera S, Kwekkeboom D, Ruszniewski P, Krenning E. NETTER-1 Phase III in Patients with Midgut Neuroendocrine Tumors Treated with 177Lu-Dotatate: Efficacy, Safety, QoL Results and Subgroup Analysis. Endocrine Abstracts 2016 DOI: 10.1530/endoabs.47.oc8.Peer-Reviewed Original ResearchMidgut neuroendocrine tumorsQoL resultsNeuroendocrine tumorsSubgroup analysisPhase IIIPatientsTumors420PD NETTER-1 phase III in patients with midgut neuroendocrine tumors treated with 177Lu-dotatate: Efficacy, safety, QoL results and subgroup analysis
Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum R, Kunz P, Hobday T, Hendifar A, Oberg K, Sierra M, Kwekkeboom D, Ruszniewski P, Krenning E. 420PD NETTER-1 phase III in patients with midgut neuroendocrine tumors treated with 177Lu-dotatate: Efficacy, safety, QoL results and subgroup analysis. Annals Of Oncology 2016, 27: vi137. DOI: 10.1093/annonc/mdw369.05.Peer-Reviewed Original ResearchMidgut neuroendocrine tumorsQoL resultsNeuroendocrine tumorsSubgroup analysisPhase IIIPatientsTumorsO-009 NETTER-1 phase III: efficacy and safety results in patients with midgut neuroendocrine tumors treated with 177Lu-dotatate
Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Chaplin M, Baum R, Kunz P, Hobday T, Oberg K, Sierra M, Kwekkeboom D, Ruszniewski P, Krenning E, Hendifar A. O-009 NETTER-1 phase III: efficacy and safety results in patients with midgut neuroendocrine tumors treated with 177Lu-dotatate. Annals Of Oncology 2016, 27: ii121. DOI: 10.1093/annonc/mdw198.09.Peer-Reviewed Original ResearchNETTER-1 phase III: Efficacy and safety results in patients with midgut neuroendocrine tumors treated with 177 Lu-DOTATATE.
Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum R, Hobday T, Hendifar A, Oberg K, Lopera Sierra M, Kwekkeboom D, Ruszniewski P, Krenning E, Kunz P. NETTER-1 phase III: Efficacy and safety results in patients with midgut neuroendocrine tumors treated with 177 Lu-DOTATATE. Journal Of Clinical Oncology 2016, 34: 4005-4005. DOI: 10.1200/jco.2016.34.15_suppl.4005.Peer-Reviewed Original ResearchNETTER-1 phase III: Progression-free survival, radiographic response, and preliminary overall survival results in patients with midgut neuroendocrine tumors treated with 177-Lu-Dotatate.
Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum R, Kunz P, Hobday T, Hendifar A, Oberg K, Lopera Sierra M, Kwekkeboom D, Ruszniewski P, Krenning E. NETTER-1 phase III: Progression-free survival, radiographic response, and preliminary overall survival results in patients with midgut neuroendocrine tumors treated with 177-Lu-Dotatate. Journal Of Clinical Oncology 2016, 34: 194-194. DOI: 10.1200/jco.2016.34.4_suppl.194.Peer-Reviewed Original ResearchOctreotide LARMidgut neuroendocrine tumorsMidgut NETOverall survivalNeuroendocrine tumorsAdvanced midgut neuroendocrine tumorsFirst phase IIIIndependent reading centerNETTER-1 trialRECIST 1.1 criteriaObjective response rateSomatostatin analogue therapyProgression-free survivalHealth-related qualityOverall survival resultsNumber of deathsMedian PFSNETTER-1Primary endpointAnalogue therapyHazard ratioRadiographic responseSurvival benefitTherapeutic optionsTumor response