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 trial
2016
Telotristat Ethyl, a Tryptophan Hydroxylase Inhibitor for the Treatment of Carcinoid Syndrome
Kulke MH, Hörsch D, Caplin ME, Anthony LB, Bergsland E, Öberg K, Welin S, Warner RR, Lombard-Bohas C, Kunz PL, Grande E, Valle JW, Fleming D, Lapuerta P, Banks P, Jackson S, Zambrowicz B, Sands AT, Pavel M. Telotristat Ethyl, a Tryptophan Hydroxylase Inhibitor for the Treatment of Carcinoid Syndrome. Journal Of Clinical Oncology 2016, 35: 14-23. PMID: 27918724, DOI: 10.1200/jco.2016.69.2780.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Agents, HormonalDefecationDiarrheaDouble-Blind MethodFemaleGamma-GlutamyltransferaseGastrointestinal AgentsHumansHydroxyindoleacetic AcidMaleMalignant Carcinoid SyndromeMiddle AgedNauseaOctreotidePeptides, CyclicPhenylalaninePyrimidinesSomatostatinTryptophan HydroxylaseConceptsDouble-blind treatment periodOpen-label extensionTelotristat ethylTryptophan hydroxylase inhibitorBM frequencyCarcinoid syndromeWeek 12Treatment periodHydroxylase inhibitorPlacebo-controlled phase III studyPrimary end pointSomatostatin analogue therapyBowel movement frequencyNew safety signalsPhase III studyGamma-glutamyl transferaseAsymptomatic increaseMild nauseaAnalogue therapyIII studyMethods PatientsSomatostatin analoguesSafety signalsPlaceboPatients
2015
Carcinoid and Neuroendocrine Tumors: Building on Success
Kunz PL. Carcinoid and Neuroendocrine Tumors: Building on Success. Journal Of Clinical Oncology 2015, 33: 1855-1863. PMID: 25918282, DOI: 10.1200/jco.2014.60.2532.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoid TumorCell DifferentiationChemoembolization, TherapeuticChemotherapy, AdjuvantHumansNeoplasm StagingNeuroendocrine TumorsPatient SelectionPrecision MedicinePredictive Value of TestsRadiopharmaceuticalsTreatment OutcomeRole of somatostatin analogues in the treatment of neuroendocrine tumors.
Narayanan S, Kunz PL. Role of somatostatin analogues in the treatment of neuroendocrine tumors. Journal Of The National Comprehensive Cancer Network 2015, 13: 109-17; quiz 117. PMID: 25583773, DOI: 10.6004/jnccn.2015.0012.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalHumansNeuroendocrine TumorsRandomized Controlled Trials as TopicReceptors, SomatostatinSomatostatinTreatment OutcomeConceptsNeuroendocrine tumorsSomatostatin analoguesTumor controlTreatment of NETsSystemic tumor controlHormone-related symptomsManagement of patientsRare epithelial neoplasmAdvanced diseaseHormone excessSymptom managementNeuroendocrine differentiationEpithelial neoplasmsGastrointestinal tractPatientsTumorsTreatmentDiarrheaNeoplasmsLungSerotoninSyndromeSymptomsManagementMainstay