2020
Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Phase III Studies in Carcinoid Syndrome
Dillon JS, Kulke MH, Hörsch D, Anthony LB, Warner RRP, Bergsland E, Welin S, O’Dorisio T, Kunz PL, McKee C, Lapuerta P, Banks P, Pavel M. Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Phase III Studies in Carcinoid Syndrome. Journal Of Gastrointestinal Cancer 2020, 52: 212-221. PMID: 32146619, PMCID: PMC7714089, DOI: 10.1007/s12029-020-00375-2.Peer-Reviewed Original ResearchConceptsCarcinoid syndrome diarrheaBM frequencyPhase III studyTelotristat ethylBowel movementsCarcinoid syndromeIII studySomatostatin analoguesDouble-blind treatment periodBowel movement frequencyMajority of patientsLog-rank testCox regression modelTime of onsetPlacebo TIDHazard ratioPrespecified analysisMedian timeSustained responseTreatment periodSustained reductionPatientsConsecutive weeksTELESTARSurvival analysis methodsImpact 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 regression
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