2024
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.
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 abnormalities[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
2021
Comparison 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 rate
2020
Single 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
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
2016
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.
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
2013
Phase II Study Evaluating 2 Dosing Schedules of Oral Foretinib (GSK1363089), cMET/VEGFR2 Inhibitor, in Patients with Metastatic Gastric Cancer
Shah MA, Wainberg ZA, Catenacci DV, Hochster HS, Ford J, Kunz P, Lee FC, Kallender H, Cecchi F, Rabe DC, Keer H, Martin AM, Liu Y, Gagnon R, Bonate P, Liu L, Gilmer T, Bottaro DP. Phase II Study Evaluating 2 Dosing Schedules of Oral Foretinib (GSK1363089), cMET/VEGFR2 Inhibitor, in Patients with Metastatic Gastric Cancer. PLOS ONE 2013, 8: e54014. PMID: 23516391, PMCID: PMC3597709, DOI: 10.1371/journal.pone.0054014.Peer-Reviewed Original ResearchConceptsObjective response rateMetastatic gastric cancerStable diseaseMET amplificationPhospho-METGastric adenocarcinomaIntermittent dosingGastric cancerTreatment-related adverse eventsPhase II studyMetastatic gastric adenocarcinomaRates of hypertensionElevated aspartate aminotransferaseOral multikinase inhibitorEndothelial cell growth factorVascular endothelial cell growth factorCell growth factorEvaluable patientsForetinib treatmentPrior therapyAdverse eventsII studyUnselected patientsDosing schedulesMedian age