2025
ACTION-1 phase Ib/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors progressing after 177Lu somatostatin analogue therapy: phase 1b safety/efficacy
Halperin D, Morris M, Ulaner G, Strosberg J, Mehr S, Li D, Soares H, Covington M, Anthony L, Kotiah S, Jacene H, E.T. T, Kunz P, Ferreira D, Li J, Ma K, Rearden J, Moran S, Hope T, Singh S. ACTION-1 phase Ib/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors progressing after 177Lu somatostatin analogue therapy: phase 1b safety/efficacy. Endocrine Abstracts 2025 DOI: 10.1530/endoabs.108.c17.Peer-Reviewed Original ResearchGastroenteropancreatic neuroendocrine tumorsSomatostatin analogue therapyAnalogue therapyNeuroendocrine tumorsPhase 1b portion of the ACTION-1 phase 1b/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Safety and efficacy findings.
Strosberg J, Morris M, Ulaner G, Halperin D, 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 1b portion of the ACTION-1 phase 1b/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 2025, 43: 661-661. DOI: 10.1200/jco.2025.43.4_suppl.661.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPhase 1b portionDose-limiting toxicitySerious adverse eventsGEP-NETsSomatostatin analoguesAdverse eventsFrequent treatment-emergent adverse eventsNo treatment emergent adverse eventsMedian duration of responseTime of data cutoffPlanned dose levelsProgression-free survivalGastroenteropancreatic neuroendocrine tumorsDuration of responseAlpha-emitting radiopharmaceuticalStandard of careDose holdRECIST v1.1Stable diseaseData cutoffDose delaysTumor responseDose modificationPartial response
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 care211MO First-line efficacy of [177Lu]Lu-DOTA-TATE in patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors by tumor grade and primary origin: Subgroup analysis of the phase III 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, de Herder W, Ferone D. 211MO First-line efficacy of [177Lu]Lu-DOTA-TATE in patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors by tumor grade and primary origin: Subgroup analysis of the phase III NETTER-2 study. Annals Of Oncology 2024, 35: s92-s93. DOI: 10.1016/j.annonc.2024.05.219.Peer-Reviewed Original ResearchFirst-line efficacyGastroenteropancreatic neuroendocrine tumorsNeuroendocrine tumorsTumor gradeGrade 3Subgroup analysisGrade 2TumorPrimary originSafety 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
Ferone D, 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 H, Singh S. [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. Endocrine Abstracts 2024 DOI: 10.1530/endoabs.99.oc7.2.Peer-Reviewed Original ResearchGastroenteropancreatic neuroendocrine tumorsNeuroendocrine tumorsGrade 3Diagnosed patientsGrade 2Primary analysis[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
1198P 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
Strosberg J, Ulaner G, Halperin D, Mehr S, Li D, Soares H, Anthony L, Kotiah S, Jacene H, Kunz P, Ferreira D, Li J, Ma K, Rearden J, Moran S, Hope T, Singh S, Morris M. 1198P 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. Annals Of Oncology 2023, 34: s707. DOI: 10.1016/j.annonc.2023.09.731.Peer-Reviewed Original ResearchPhase Ib portionSomatostatin analogue therapyGastroenteropancreatic neuroendocrine tumorsAnalogue therapyEfficacy findingsNeuroendocrine tumorsTherapyTumorsTrialsACTION-1 phase Ib/3 trial of RYZ101 in somatostatin receptor subtype 2–expressing (SSTR2+) gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Initial safety analysis.
Morris M, Ulaner G, Halperin D, Strosberg J, Mehr S, Li D, Soares H, Anthony L, Kotiah S, Jacene H, Pavel M, Kunz P, Ferreira D, Li J, Ma K, Rearden J, Moran S, Hope T, Singh S. ACTION-1 phase Ib/3 trial of RYZ101 in somatostatin receptor subtype 2–expressing (SSTR2+) gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Initial safety analysis. Journal Of Clinical Oncology 2023, 41: 4132-4132. DOI: 10.1200/jco.2023.41.16_suppl.4132.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAdverse eventsGEP-NETsTarget dose-limiting toxicity (DLT) rateDose de-escalation studyTreatment-related serious AEsDose-limiting toxicity rateData review committeeDe-escalation studiesECOG PS 0Phase 3 doseSomatostatin analogue therapySerious adverse eventsGastroenteropancreatic neuroendocrine tumorsStandard of careSomatostatin receptor subtypesInitial safety analysisSerious AEsAnalogue therapyPS 0Dose escalationKBq/Neuroendocrine tumorsToxicity ratesDisease progression
2022
92: [177Lu]Lu-Dota-Tate as First-Line Therapy for Patients with Grade 2 and 3 Advanced Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETS): The NETTER-2 Study
Myrehaug S, Singh S, Pavel M, Kunz P, de Herder W, Herrmann K, D’Amelio A, Santoro P, Folitar I, Ferone D. 92: [177Lu]Lu-Dota-Tate as First-Line Therapy for Patients with Grade 2 and 3 Advanced Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETS): The NETTER-2 Study. Radiotherapy And Oncology 2022, 174: s40-s41. DOI: 10.1016/s0167-8140(22)04371-7.Peer-Reviewed Original ResearchAdvanced gastroenteropancreatic neuroendocrine tumorsGastroenteropancreatic neuroendocrine tumorsLine therapyNeuroendocrine tumorsGrade 2DOTA-TATEPatientsTherapyTumors
2020
Evaluation of the incidence of acute nausea and vomiting after administration of an amino acid solution containing only arginine and lysine with lutetium Lu-177 dotatate.
Alonzo N, Seyer M, Kim E, Keshavarzi R, Yee K, Kunz P. Evaluation of the incidence of acute nausea and vomiting after administration of an amino acid solution containing only arginine and lysine with lutetium Lu-177 dotatate. Journal Of Clinical Oncology 2020, 38: 12113-12113. DOI: 10.1200/jco.2020.38.15_suppl.12113.Peer-Reviewed Original ResearchLu-177 DOTATATEAA infusionAmino acid solutionRates of nauseaPercentage of patientsRetrospective chart reviewGastroenteropancreatic neuroendocrine tumorsAcute nauseaSecondary endpointsAdult patientsChart reviewNeuroendocrine tumorsNormal salinePatientsInfusion timeAA solutionIncidenceDOTATATEInfusionHistorical incidenceAmino acids 10NauseaVomitingAdministrationEssential AA
2017
Intra-arterial therapy of neuroendocrine tumour liver metastases: comparing conventional TACE, drug-eluting beads TACE and yttrium-90 radioembolisation as treatment options using a propensity score analysis model
Do Minh D, Chapiro J, Gorodetski B, Huang Q, Liu C, Smolka S, Savic LJ, Wainstejn D, Lin M, Schlachter T, Gebauer B, Geschwind JF. Intra-arterial therapy of neuroendocrine tumour liver metastases: comparing conventional TACE, drug-eluting beads TACE and yttrium-90 radioembolisation as treatment options using a propensity score analysis model. European Radiology 2017, 27: 4995-5005. PMID: 28677067, PMCID: PMC5675796, DOI: 10.1007/s00330-017-4856-2.Peer-Reviewed Original ResearchConceptsMultivariate Cox proportional hazards modelConventional transarterial chemoembolisationMedian overall survivalPropensity score analysisHepatic progression-free survivalDrug-eluting beads TACEYttrium-90 radioembolisationProgression-free survivalDEB-TACELiver metastasesOverall survivalBeads TACENeuroendocrine tumor liver metastasesWorld Health Organization criteriaCox proportional hazards modelIntra-arterial therapyMethodsThis retrospective analysisResponse Evaluation CriteriaScore analysisSignificant survival benefitLonger overall survivalGastroenteropancreatic neuroendocrine tumorsLog-rank testEntire study populationProportional hazards model
2015
New and Emerging Treatment Options for Gastroenteropancreatic Neuroendocrine Tumors.
Phan AT, Kunz PL, Reidy-Lagunes DL. New and Emerging Treatment Options for Gastroenteropancreatic Neuroendocrine Tumors. Clinical Advances In Hematology And Oncology 2015, 13: 1-18; quiz 1 p following 18. PMID: 26430956.Peer-Reviewed Original ResearchConceptsGastroenteropancreatic neuroendocrine tumorsGEP-NETsSomatostatin analoguesTreatment optionsNeuroendocrine tumorsPancreatic NETsLanreotide depot/autogelClassical carcinoid syndromeExtent of metastasisFirst-line treatmentHepatic arterial embolizationMetastatic carcinoid tumorsValvular heart diseasePrimary tumor siteComplex of symptomsAgents everolimusUnresectable diseaseCarcinoid syndromeCytoreductive surgeryArterial embolizationLiver metastasesPalliative treatmentCarcinoid tumorsClinical symptomsAblative therapy
2013
Gastroenteropancreatic neuroendocrine neoplasms: Historical context and current issues
Yang Z, Tang L, Klimstra D. Gastroenteropancreatic neuroendocrine neoplasms: Historical context and current issues. Seminars In Diagnostic Pathology 2013, 30: 186-196. PMID: 24144288, DOI: 10.1053/j.semdp.2013.06.005.Peer-Reviewed Original ResearchConceptsNeuroendocrine tumorsProliferative rateDiverse group of tumorsWorld Health Organization classificationClassification of neuroendocrine tumorsGastroenteropancreatic neuroendocrine tumorsGroup of tumorsDigestive organsDiffuse neuroendocrine systemPrognostic parametersKi67 indexHistological gradeOrganization classificationPrognostic valueMitotic countClinical outcomesOptimal treatmentIntratumoral heterogeneityTNM stageTumorNeuroendocrine cellsGrading criteriaNeuroendocrine systemCut-pointsMultiple studies
2012
Heat shock protein 90 is a promising target for effective growth inhibition of gastrointestinal neuroendocrine tumors.
Gloesenkamp C, Nitzsche B, Lim A, Normant E, Vosburgh E, Schrader M, Ocker M, Scherübl H, Höpfner M. Heat shock protein 90 is a promising target for effective growth inhibition of gastrointestinal neuroendocrine tumors. International Journal Of Oncology 2012, 40: 1659-67. PMID: 22246317, DOI: 10.3892/ijo.2012.1328.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsApoptosisBenzoquinonesCell Cycle CheckpointsCell Line, TumorCell MovementCell ProliferationChick EmbryoChorioallantoic MembraneDose-Response Relationship, DrugFlow CytometryGastrointestinal NeoplasmsGene Expression ProfilingGene Expression Regulation, NeoplasticHSP90 Heat-Shock ProteinsHumansLactams, MacrocyclicNeuroendocrine TumorsPhosphatidylinositol 3-KinaseProtein Kinase InhibitorsProto-Oncogene Proteins c-aktReceptor, IGF Type 1Signal TransductionTOR Serine-Threonine KinasesConceptsShock protein 90IGF-1 receptorIPI-504Protein 90GEP-NETsNeuroendocrine tumorsHsp90 inhibitor IPI-504Heat shock protein 90Antiproliferative effectsGEP-NET cellsDose-dependent growth inhibitionGEP-NET treatmentPI3K/AKT/mTOR pathwayGastrointestinal neuroendocrine tumorsGastroenteropancreatic neuroendocrine tumorsAKT/mTOR pathwayCancer gene expressionAdditive antiproliferative effectsCell cycle arrestInnovative therapeutic approachesTyrosine kinase inhibitionGrowth inhibitionMechanism of actionGene expressionHsp90 inhibition
2011
Effect of Tumor Heterogeneity on the Assessment of Ki67 Labeling Index in Well-differentiated Neuroendocrine Tumors Metastatic to the Liver
Yang Z, Tang L, Klimstra D. Effect of Tumor Heterogeneity on the Assessment of Ki67 Labeling Index in Well-differentiated Neuroendocrine Tumors Metastatic to the Liver. The American Journal Of Surgical Pathology 2011, 35: 853-860. PMID: 21566513, DOI: 10.1097/pas.0b013e31821a0696.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBiomarkers, TumorBiopsyCarcinoma, NeuroendocrineFemaleHepatectomyHumansImage Processing, Computer-AssistedKaplan-Meier EstimateKi-67 AntigenLiver NeoplasmsMaleMiddle AgedNew YorkPrognosisReproducibility of ResultsRetrospective StudiesSurvival RateTissue Array AnalysisConceptsKi67 labeling indexWell-differentiated neuroendocrine tumorsMetastatic neuroendocrine tumorsNeuroendocrine tumorsKi67 indexKi67 gradeLabeling indexOverall survivalCore biopsyPatient survivalTumor heterogeneityIntratumoral heterogeneityStatistically significant prognostic valueSurgically resected liver metastasesVirtual biopsySignificant prognostic valueKaplan-Meier survival analysisProgression-free survivalWhole slidesEffect of tumor heterogeneityDisease-free survivalGastroenteropancreatic neuroendocrine tumorsNeedle core biopsyChoice of treatmentHigher proliferative rateRecent progress in the understanding, diagnosis, and treatment of gastroenteropancreatic neuroendocrine tumors
Turaga K, Kvols L. Recent progress in the understanding, diagnosis, and treatment of gastroenteropancreatic neuroendocrine tumors. CA A Cancer Journal For Clinicians 2011, 61: 113-132. PMID: 21388967, DOI: 10.3322/caac.20097.Peer-Reviewed Original ResearchConceptsGastroenteropancreatic neuroendocrine tumorsGEP-NETsNeuroendocrine tumorsTreatment of gastroenteropancreatic neuroendocrine tumorsManagement of GEP-NETsTreatment of metastatic diseaseHeterogeneous group of tumorsTarget of rapamycin inhibitorsMammalian target of rapamycin inhibitorsGroup of tumorsSurvival of patientsTyrosine kinase inhibitorsInterventional radiology techniquesDiffuse neuroendocrine systemMetastatic diseaseRapamycin inhibitorsRare tumorPathological diagnosisEndoscopic ultrasoundKinase inhibitorsRadiological techniquesTumorHeterogeneous groupMammalian targetNeuroendocrine system
2010
Advances in the treatment of gastroenteropancreatic neuroendocrine tumors
Kunz PL, Fisher GA. Advances in the treatment of gastroenteropancreatic neuroendocrine tumors. Clinical And Experimental Gastroenterology 2010, 3: 79-86. PMID: 21694850, PMCID: PMC3108662, DOI: 10.2147/ceg.s5928.Peer-Reviewed Original ResearchGastroenteropancreatic neuroendocrine tumorsSomatostatin analoguesNeuroendocrine tumorsTumor growthExcellent performance statusMainstay of treatmentNon-surgical therapyEnd-organ effectsExternal beam radiationNovel therapeutic trialsTyrosine kinase inhibitorsEarly promising resultsSecretion of peptidesSystemic chemotherapyLocoregional therapyPerformance statusMetastatic diseaseStandard chemotherapySurgical resectionMedical therapyTherapeutic trialsGEP-NETsTumor massMTOR inhibitorsAngiogenesis inhibitors
2007
Primary presacral neuroendocrine tumor associated with imperforate anus
Kim T, Grobmyer S, Liu C, Hochwald S. Primary presacral neuroendocrine tumor associated with imperforate anus. World Journal Of Surgical Oncology 2007, 5: 115. PMID: 17931412, PMCID: PMC2092435, DOI: 10.1186/1477-7819-5-115.Peer-Reviewed Original ResearchNeuroendocrine tumorsImperforate anusPresacral regionPrimary gastroenteropancreatic neuroendocrine tumorsPrimary neuroendocrine tumorGastroenteropancreatic neuroendocrine tumorsRectal wall involvementCarcinoid syndrome
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