2022
PRESTO 2: An International Survey to Evaluate Patients’ Injection Experiences with the Latest Devices/Formulations of Long-Acting Somatostatin Analog Therapies for Neuroendocrine Tumors or Acromegaly
O’Toole D, Kunz P, Webb S, Goldstein G, Khawaja S, McDonnell M, Boiziau S, Gueguen D, Houchard A, Ribeiro-Oliveira A, Prebtani A. PRESTO 2: An International Survey to Evaluate Patients’ Injection Experiences with the Latest Devices/Formulations of Long-Acting Somatostatin Analog Therapies for Neuroendocrine Tumors or Acromegaly. Advances In Therapy 2022, 40: 671-690. PMID: 36502449, PMCID: PMC9741754, DOI: 10.1007/s12325-022-02360-6.Peer-Reviewed Original ResearchConceptsInjection site painNeuroendocrine tumorsInjection experienceRecent injectionLanreotide autogel/depotMultivariate logistic regression modelOdds of painSomatostatin analogue therapyProportion of patientsInjection site reactionsLogistic regression modelsSSA useAnalogue therapySecondary endpointsDisease subgroupsPainPatientsAcromegalyInjection modalitiesMonthsInjectionTumors
2020
Cost-Effectiveness of Initial Versus Delayed Lanreotide for Treatment of Metastatic Enteropancreatic Neuroendocrine Tumors.
Barnes JI, Lin JK, Gupta D, Owens DK, Goldhaber-Fiebert JD, Kunz PL. Cost-Effectiveness of Initial Versus Delayed Lanreotide for Treatment of Metastatic Enteropancreatic Neuroendocrine Tumors. Journal Of The National Comprehensive Cancer Network 2020, 18: 1200-1209. PMID: 32886901, DOI: 10.6004/jnccn.2020.7563.Peer-Reviewed Original ResearchConceptsIncremental cost-effectiveness ratioMetastatic enteropancreatic neuroendocrine tumorsEnteropancreatic neuroendocrine tumorsNeuroendocrine tumorsInitial therapyActive surveillanceNCCN Clinical Practice GuidelinesProlonged progression-free survivalProgression-free survivalClinical practice guidelinesActive surveillance strategyLifetime time horizonCost-effectiveness ratioHealthcare sector perspectiveProbabilistic sensitivity analysesCLARINET trialPostprogression treatmentPlacebo armAdrenal tumorsTumor trialsTreatment optionsPractice guidelinesLanreotideSurveillance strategiesQALY
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
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 signalsPlaceboPatientsRole of Somatostatin Analogues in the Treatment of Neuroendocrine Tumors
Narayanan S, Kunz PL. Role of Somatostatin Analogues in the Treatment of Neuroendocrine Tumors. Hematology/Oncology Clinics Of North America 2016, 30: 163-177. PMID: 26614375, DOI: 10.1016/j.hoc.2015.09.008.Peer-Reviewed Original ResearchConceptsSomatostatin analoguesNeuroendocrine tumorsRole of SSAsTreatment of NETsPeptide receptor radionuclide therapyMetastatic neuroendocrine tumorsHormone-related symptomsReceptor radionuclide therapyRare epithelial neoplasmLocal therapySymptom managementTumor controlNeuroendocrine differentiationEffective therapyEpithelial neoplasmsDisease CenterPromising treatmentRadionuclide therapyTumor growthTherapyTreatmentTumorsSurgeryNeoplasmsLung
2015
New and Emerging Treatment Options for Gastroenteropancreatic Neuroendocrine Tumors.
Phan AT, Kunz PL, Reidy-Lagunes DL. New and Emerging Treatment Options for Gastroenteropancreatic Neuroendocrine Tumors. Clinical Advances In Hematology And Oncology 2015, 13: 1-18; quiz 1 p following 18. PMID: 26430956.Peer-Reviewed Original ResearchConceptsGastroenteropancreatic neuroendocrine tumorsGEP-NETsSomatostatin analoguesTreatment optionsNeuroendocrine tumorsPancreatic NETsLanreotide depot/autogelClassical carcinoid syndromeExtent of metastasisFirst-line treatmentHepatic arterial embolizationMetastatic carcinoid tumorsValvular heart diseasePrimary tumor siteComplex of symptomsAgents everolimusUnresectable diseaseCarcinoid syndromeCytoreductive surgeryArterial embolizationLiver metastasesPalliative treatmentCarcinoid tumorsClinical symptomsAblative therapyRole 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 ResearchConceptsNeuroendocrine tumorsSomatostatin analoguesTumor controlTreatment of NETsSystemic tumor controlHormone-related symptomsManagement of patientsRare epithelial neoplasmAdvanced diseaseHormone excessSymptom managementNeuroendocrine differentiationEpithelial neoplasmsGastrointestinal tractPatientsTumorsTreatmentDiarrheaNeoplasmsLungSerotoninSyndromeSymptomsManagementMainstay
2014
Phase II clinical trial of pasireotide long-acting repeatable in patients with metastatic neuroendocrine tumors
Cives M, Kunz P, Morse B, Coppola D, Schell M, Campos T, Nguyen P, Nandoskar P, Khandelwal V, Strosberg J. Phase II clinical trial of pasireotide long-acting repeatable in patients with metastatic neuroendocrine tumors. Endocrine Related Cancer 2014, 22: 1-9. PMID: 25376618, PMCID: PMC4643672, DOI: 10.1530/erc-14-0360.Peer-Reviewed Original ResearchConceptsProgression-free survivalOverall radiographic response rateOverall survivalPasireotide LARSomatostatin analoguesFirst-line systemic agentMedian progression-free survivalPhase II clinical trialGrade 3 hyperglycemiaMetastatic grade 1Neuroendocrine tumor growthPrevious systemic therapyRadiographic response rateRates of hyperglycemiaGrade 3/4 toxicitiesMedian overall survivalMetastatic neuroendocrine tumorsPhase II studySolid Tumors criteriaTreatment-naïve patientsHepatic tumor burdenResponse Evaluation CriteriaNovel somatostatin analogReceptor subtype 1LAR treatment