2018
Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial
Pavel M, Gross DJ, Benavent M, Perros P, Srirajaskanthan R, Warner RRP, Kulke MH, Anthony LB, Kunz PL, Hörsch D, Weickert MO, Lapuerta P, Jiang W, Kassler-Taub K, Wason S, Fleming R, Fleming D, Garcia-Carbonero R. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial. Endocrine Related Cancer 2018, 25: 309-322. PMID: 29330194, PMCID: PMC5811631, DOI: 10.1530/erc-17-0455.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsOpen-label extensionCarcinoid syndromeTelotristat ethylSomatostatin analoguesWeek 12Rates of TEAEsDouble-blind treatment periodPhase 3 trialTryptophan hydroxylase inhibitorMedian treatment differencesCS diarrheaBowel movementsEfficacy endpointAdverse eventsPrimary safetyTreatment periodHydroxylase inhibitorPatientsSerious eventsPercent changeTreatment differencesPlaceboEfficacySignificant reduction
2017
Lanreotide depot (LAN) for symptomatic control of carcinoid syndrome (CS) in neuroendocrine tumor (NET) patients previously responsive to octreotide (OCT): Subanalysis of patient-reported symptoms from the phase III elect study.
Fisher G, Pommier R, Wolin E, Kunz P, Liyanage N, Pitman Lowenthal S, Mirakhur B, Shaheen M, Vinik A. Lanreotide depot (LAN) for symptomatic control of carcinoid syndrome (CS) in neuroendocrine tumor (NET) patients previously responsive to octreotide (OCT): Subanalysis of patient-reported symptoms from the phase III elect study. Journal Of Clinical Oncology 2017, 35: 4088-4088. DOI: 10.1200/jco.2017.35.15_suppl.4088.Peer-Reviewed Original ResearchLanreotide depotCarcinoid syndromeSymptomatic controlOCT useInteractive voice/web response systemPatient-reported symptomsWeb response systemNeuroendocrine tumor patientsSeverity of symptomsPercentage of daysPlasma chromograninRescue therapyNET patientsWeek 12Severe diarrheaTumor patientsCgA levelsLAN treatmentNaive groupCS symptomsWk 12Symptom dataPlaceboMean differenceSymptomsEfficacy of lanreotide depot (LAN) for symptomatic control of carcinoid syndrome (CS) in patients with neuroendocrine tumor (NET) previously responsive to octreotide (OCT): Subanalysis of patient-reported symptoms from the phase III ELECT study.
Pommier R, Fisher G, Wolin E, Kunz P, Liyanage N, Pitman Lowenthal S, Mirakhur B, Shaheen M, Vinik A. Efficacy of lanreotide depot (LAN) for symptomatic control of carcinoid syndrome (CS) in patients with neuroendocrine tumor (NET) previously responsive to octreotide (OCT): Subanalysis of patient-reported symptoms from the phase III ELECT study. Journal Of Clinical Oncology 2017, 35: 378-378. DOI: 10.1200/jco.2017.35.4_suppl.378.Peer-Reviewed Original ResearchLanreotide depotCarcinoid syndromeNeuroendocrine tumorsSymptomatic controlSevere diarrheaOCT useInteractive voice/web response systemPatient-reported symptomsWeb response systemSeverity of symptomsOCT-LARRescue medicationNET patientsWeek 12LAN treatmentPlaceboCS symptomsWk 12Symptom dataDiarrheaMean percentageSymptomsPatientsEfficacyBiochemical responses
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 signalsPlaceboPatients438P Efficacy of lanreotide autogel/depot (LAN) vs placebo (PBO) for symptomatic control of carcinoid syndrome (CS) in neuroendocrine tumor (NET) patients from the ELECT study
Wolin E, Fisher G, Kunz P, Liyanage N, Lowenthal S, Mirakhur B, Pommier R, Shaheen M, Vinik A. 438P Efficacy of lanreotide autogel/depot (LAN) vs placebo (PBO) for symptomatic control of carcinoid syndrome (CS) in neuroendocrine tumor (NET) patients from the ELECT study. Annals Of Oncology 2016, 27: vi143. DOI: 10.1093/annonc/mdw369.23.Peer-Reviewed Original ResearchEfficacy of Lanreotide Autogel/Depot (LAN) vs Placebo (PBO) for Symptomatic Control of Carcinoid Syndrome (CS) in Neuroendocrine Tumor (NET) Patients from the ELECT Study
Wolin E, Fisher G, Kunz P, Liyanage N, Lowenthal S, Mirakhur B, Pommier R, Shaheen M, Vinik A. Efficacy of Lanreotide Autogel/Depot (LAN) vs Placebo (PBO) for Symptomatic Control of Carcinoid Syndrome (CS) in Neuroendocrine Tumor (NET) Patients from the ELECT Study. The American Journal Of Gastroenterology 2016, 111: s468. DOI: 10.14309/00000434-201610001-01076.Peer-Reviewed Original Research
2015
Safety and Efficacy of Lanreotide Depot Versus Placebo in Neuroendocrine Tumor Patients With a History of Carcinoid Syndrome and Prior Octreotide Therapy
Fisher G, Wolin E, Kunz P, Liyanage N, Gomez-Panzani E, Lowenthal S, Pommier R, Shaheen M, Vinik A. Safety and Efficacy of Lanreotide Depot Versus Placebo in Neuroendocrine Tumor Patients With a History of Carcinoid Syndrome and Prior Octreotide Therapy. The American Journal Of Gastroenterology 2015, 110: s1007. DOI: 10.14309/00000434-201510001-02424.Peer-Reviewed Original Research