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 methods
2018
Changes in Weight Associated With Telotristat Ethyl in the Treatment of Carcinoid Syndrome
Weickert MO, Kaltsas G, Hörsch D, Lapuerta P, Pavel M, Valle JW, Caplin ME, Bergsland E, Kunz PL, Anthony LB, Grande E, Öberg K, Welin S, Lombard-Bohas C, Ramage JK, Kittur A, Yang QM, Kulke MH. Changes in Weight Associated With Telotristat Ethyl in the Treatment of Carcinoid Syndrome. Clinical Therapeutics 2018, 40: 952-962.e2. PMID: 29724499, DOI: 10.1016/j.clinthera.2018.04.006.Peer-Reviewed Original ResearchConceptsMetastatic neuroendocrine tumorsTelotristat ethylCarcinoid syndromePlacebo TIDWeek 12Neuroendocrine tumorsMetabolic parametersNutritional statusDouble-blind treatment periodWeight gainWeight lossUncontrolled carcinoid syndromeSomatostatin analogue therapyBowel movement frequencyStatistical analysis planOverall nutritional statusAnalogue therapyDiarrhea severityTreatment periodPatientsSyndromeWeight changeAnalysis planMovement frequencyTumorsTelotristat 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
Efficacy and safety of telotristat ethyl in patients with carcinoid syndrome inadequately controlled by somatostatin analogs: Analysis of the completed TELESTAR extension period
Horsch D, Kulke M, Caplin M, Anthony L, Bergsland E, Oberg K, Warner R, Kunz P, Pulido E, Valle J, Dillon J, Lapuerta P, Banks P, Jackson S, Pavel M. Efficacy and safety of telotristat ethyl in patients with carcinoid syndrome inadequately controlled by somatostatin analogs: Analysis of the completed TELESTAR extension period. Endocrine Abstracts 2017 DOI: 10.1530/endoabs.52.p14.Peer-Reviewed Original ResearchCarcinoid Syndrome Complicating a Pancreatic Neuroendocrine Tumor
Gerson JN, Witteles RM, Chang DT, Beygui RE, Iagaru AH, Kunz PL. Carcinoid Syndrome Complicating a Pancreatic Neuroendocrine Tumor. Pancreas 2017, 46: 1381-1385. PMID: 29040196, DOI: 10.1097/mpa.0000000000000932.Peer-Reviewed Original ResearchConceptsPancreatic neuroendocrine tumorsNeuroendocrine tumorsCarcinoid syndromeRight upper quadrant abdominal painUpper quadrant abdominal painMetastatic pancreatic neuroendocrine tumorsRight-sided heart diseaseQuadrant abdominal painPulmonic valve replacementAbdominal painSystemic chemotherapyTreatable complicationHormone excessSerum serotoninValve replacementHeart diseaseHeterogeneous groupSyndromeElevated levelsTumorsDiseaseImportant entityDyspneaEmesisPainUnderstanding the Patient Experience with Carcinoid Syndrome: Exit Interviews from a Randomized, Placebo-controlled Study of Telotristat Ethyl
Anthony L, Ervin C, Lapuerta P, Kulke MH, Kunz P, Bergsland E, Hörsch D, Metz DC, Pasieka J, Pavlakis N, Pavel M, Caplin M, Öberg K, Ramage J, Evans E, Yang QM, Jackson S, Arnold K, Law L, DiBenedetti DB. Understanding the Patient Experience with Carcinoid Syndrome: Exit Interviews from a Randomized, Placebo-controlled Study of Telotristat Ethyl. Clinical Therapeutics 2017, 39: 2158-2168. PMID: 29074312, DOI: 10.1016/j.clinthera.2017.09.013.Peer-Reviewed Original ResearchConceptsTelotristat ethylBM frequencyCarcinoid syndromeBowel movementsPatient experienceDouble-blind treatment periodCarcinoid syndrome symptomsPrimary end pointSomatostatin analogue therapyPhase III studyClinical trial experienceTryptophan hydroxylase inhibitorEligible patientsStudy drugAnalogue therapyIII studyPatient interviewsResponder analysisTreatment periodPatient reportsSyndrome symptomsTreatment responsePrespecified criteriaHydroxylase inhibitorPatients440PD Efficacy and safety of telotristat ethyl in patients with carcinoid syndrome inadequately controlled by somatostatin analogs: Analysis of the completed TELESTAR extension period
Hörsch D, Kulke M, Caplin M, Anthony L, Bergsland E, Öberg K, Warner R, Kunz P, Pulido E, Valle J, Dillon J, Lapuerta P, Banks P, Jackson S, Pavel M. 440PD Efficacy and safety of telotristat ethyl in patients with carcinoid syndrome inadequately controlled by somatostatin analogs: Analysis of the completed TELESTAR extension period. Annals Of Oncology 2017, 28: v147. DOI: 10.1093/annonc/mdx368.012.Peer-Reviewed Original ResearchThe North American Neuroendocrine Tumor Society Consensus Guidelines for Surveillance and Medical Management of Midgut Neuroendocrine Tumors
Strosberg JR, Halfdanarson TR, Bellizzi AM, Chan JA, Dillon JS, Heaney AP, Kunz PL, O’Dorisio T, Salem R, Segelov E, Howe JR, Pommier RF, Brendtro K, Bashir MA, Singh S, Soulen MC, Tang L, Zacks JS, Yao JC, Bergsland EK. The North American Neuroendocrine Tumor Society Consensus Guidelines for Surveillance and Medical Management of Midgut Neuroendocrine Tumors. Pancreas 2017, 46: 707-714. PMID: 28609356, PMCID: PMC5642985, DOI: 10.1097/mpa.0000000000000850.Peer-Reviewed Original ResearchConceptsMidgut neuroendocrine tumorsNeuroendocrine tumorsNorth American Neuroendocrine Tumor Society Consensus GuidelinesNorth American Neuroendocrine Tumor SocietyNETTER-1 trialRADIANT-4 studyRefractory carcinoid syndromePhase 3 studyNonfunctioning neuroendocrine tumorEnteropancreatic neuroendocrine tumorsConsensus-based guidelinesCLARINET trialRADIANT-2Carcinoid syndromeTelotristat ethylMedical managementTherapeutic optionsConsensus guidelinesSurgical guidelinesLu-DOTATATEMultidisciplinary panelProximal colonGastrointestinal tractSmall intestinePatientsLanreotide 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 differenceSymptomsAssociation of weight change with telotristat ethyl in the treatment of carcinoid syndrome.
Weickert M, Kaltsas G, Hörsch D, Lapuerta P, Pavel M, Valle J, Caplin M, Bergsland E, Kunz P, Anthony L, Grande E, Oberg K, Warner R, Lombard-Bohas C, Welin S, Fleming R, Kittur A, Arnold K, Yang Q, Kulke M. Association of weight change with telotristat ethyl in the treatment of carcinoid syndrome. Journal Of Clinical Oncology 2017, 35: e15692-e15692. DOI: 10.1200/jco.2017.35.15_suppl.e15692.Peer-Reviewed Original ResearchMetastatic neuroendocrine tumorsCarcinoid syndromeWeek 12Neuroendocrine tumorsTelotristat ethylWeight gainWeight lossWeight changeDouble-blind treatment periodUncontrolled carcinoid syndromeBowel movement frequencyBody mass indexCochrane-Armitage testStatistical analysis planBM frequencyAdverse eventsAnalogue therapyDiarrhea severityPerformance statusMass indexBaseline ageTreatment periodPatientsReduced survivalIncidenceEfficacy 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
Efficacy and safety of telotristat etiprate in patients with carcinoid syndrome not adequately controlled by somatostatin analog therapy: Analysis of the ongoing TELESTAR extension period
Horsch D, Kulke M, Caplin M, Anthony L, Bergsland E, Oberg K, Welin S, Warner R, Lombard-Bohas C, Kunz P, Valle J, Fleming D, Lapuerta P, Banks P, Pavel M. Efficacy and safety of telotristat etiprate in patients with carcinoid syndrome not adequately controlled by somatostatin analog therapy: Analysis of the ongoing TELESTAR extension period. Endocrine Abstracts 2016 DOI: 10.1530/endoabs.46.oc3.Peer-Reviewed Original ResearchAssessing treatment benefit of telotristat etiprate in patients with carcinoid syndrome: Patient exit interviews
Anthony L, Horsch D, Ervin C, Kulke M, Pavel M, Bergsland E, Caplin M, Oberg K, Warner R, Kunz P, Metz D, Pasieka J, Pavlakis N, DiBenedetti D, Haydysch E, Yang Q, Jackson S, Arnold K, Law L, Lapuerta P. Assessing treatment benefit of telotristat etiprate in patients with carcinoid syndrome: Patient exit interviews. Endocrine Abstracts 2016 DOI: 10.1530/endoabs.46.p11.Peer-Reviewed Original ResearchTelotristat 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 signalsPlaceboPatients422PD Integrated placebo-controlled safety analysis from clinical studies of telotristat ethyl for the treatment of carcinoid syndrome
Kulke M, Hörsch D, Caplin M, Anthony L, Bergsland E, Oberg K, Welin S, Warner R, Bohas C, Kunz P, Grande E, Valle J, Lapuerta P, Banks P, Jackson S, Jiang W, Biran T, Pavel M. 422PD Integrated placebo-controlled safety analysis from clinical studies of telotristat ethyl for the treatment of carcinoid syndrome. Annals Of Oncology 2016, 27: vi138. DOI: 10.1093/annonc/mdw369.07.Peer-Reviewed Original Research438P 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 Research440P Longer term efficacy of lanreotide autogel/depot (LAN) for symptomatic treatment of carcinoid syndrome (CS) in neuroendocrine tumor (NET) patients from the ELECT open label study
Fisher G, Wolin E, Kunz P, Liyanage N, Mirakhur B, Lowenthal S, Pommier R, Shaheen M, Vinik A. 440P Longer term efficacy of lanreotide autogel/depot (LAN) for symptomatic treatment of carcinoid syndrome (CS) in neuroendocrine tumor (NET) patients from the ELECT open label study. Annals Of Oncology 2016, 27: vi144. DOI: 10.1093/annonc/mdw369.25.Peer-Reviewed Original ResearchLonger Term Efficacy of Lanreotide Autogel/Depot (LAN) for Symptomatic Treatment of Carcinoid Syndrome (CS) in Neuroendocrine Tumor (NET) Patients from the ELECT Open Label Study: 2016 ACG Presidential Poster Award
Fisher G, Wolin E, Kunz P, Liyanage N, Mirakhur B, Lowenthal S, Pommier R, Shaheen M, Vinik A. Longer Term Efficacy of Lanreotide Autogel/Depot (LAN) for Symptomatic Treatment of Carcinoid Syndrome (CS) in Neuroendocrine Tumor (NET) Patients from the ELECT Open Label Study: 2016 ACG Presidential Poster Award. The American Journal Of Gastroenterology 2016, 111: s457-s458. DOI: 10.14309/00000434-201610001-01052.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 ResearchEfficacy and safety of telotristat etiprate in patients with carcinoid syndrome not adequately controlled by somatostatin analog therapy: Analysis of the ongoing TELESTAR extension period
Hörsch D, Kulke M, Caplin M, Anthony L, Bergsland E, Öberg K, Welin S, Warner R, Lombard-Bohas C, Kunz P, Grande E, Valle J, Fleming D, Lapuerta P, Jackson S, Zambrowicz B, Sands A, Pavel M. Efficacy and safety of telotristat etiprate in patients with carcinoid syndrome not adequately controlled by somatostatin analog therapy: Analysis of the ongoing TELESTAR extension period. Zeitschrift Für Gastroenterologie 2016, 54 DOI: 10.1055/s-0036-1587175.Peer-Reviewed Original Research