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 modalitiesMonthsInjectionTumorsPMON57 Impact of Injection Modalities on Real-World Injection Experience in Patients with Acromegaly or Neuroendocrine Tumors (NETs) Treated With Somatostatin Analog (SSA) Therapy: Data from the PRESTO 2 Survey
Ribeiro-Oliveira A, O’toole D, Kunz P, Houchard A, Boiziau S, Prebtani A, Webb S. PMON57 Impact of Injection Modalities on Real-World Injection Experience in Patients with Acromegaly or Neuroendocrine Tumors (NETs) Treated With Somatostatin Analog (SSA) Therapy: Data from the PRESTO 2 Survey. Journal Of The Endocrine Society 2022, 6: a557-a557. PMCID: PMC9625390, DOI: 10.1210/jendso/bvac150.1157.Peer-Reviewed Original ResearchInjection site painNeuroendocrine tumorsInjection experiencePrimary endpointLast doseLast injectionLanreotide autogel/depotFirst-line medical treatmentInjection modalitiesMultivariate logistic regression analysisOdds of painProportion of patientsSomatostatin analogue therapyInjection site reactionsLogistic regression analysisSecondary endpointsAnalogue therapySSA therapyDisease groupPainMedical treatmentPatientsAcromegalyInjection siteEndpointA phase II study of sapanisertib (TAK-228) a mTORC1/2 inhibitor in rapalog-resistant advanced pancreatic neuroendocrine tumors (PNET): ECOG-ACRIN EA2161
Rajdev L, Lee JW, Libutti SK, Benson AB, Fisher GA, Kunz PL, Hendifar AE, Catalano P, O’Dwyer P. A phase II study of sapanisertib (TAK-228) a mTORC1/2 inhibitor in rapalog-resistant advanced pancreatic neuroendocrine tumors (PNET): ECOG-ACRIN EA2161. Investigational New Drugs 2022, 40: 1306-1314. PMID: 36264382, PMCID: PMC9795724, DOI: 10.1007/s10637-022-01311-w.Peer-Reviewed Original ResearchConceptsPancreatic neuroendocrine tumorsNeuroendocrine tumorsTreatment-related grade 3 adverse eventsGrade 3 adverse eventsAdvanced pancreatic neuroendocrine tumorsTwo-stage phase II trialObjective tumor responsePhase II studyPhase II trialContinuous dosing scheduleStage 1Lack of responseEligible patientsMedian OSMedian PFSII trialAdverse eventsII studyObjective responseDosing schedulesTumor responseClinical activityPatientsMTOR pathwayMTORC1/2 inhibitorsCorrection: Phase II Study Evaluating 2 Dosing Schedules of Oral Foretinib (GSK1363089), cMET/VEGFR2 Inhibitor, in Patients with Metastatic Gastric Cancer
Shah MA, Wainberg ZA, Catenacci DVT, Hochster HS, Ford J, Kunz P, Lee FC, Kallender H, Cecchi F, Rabe DC, Keer H, Martin AM, Liu Y, Gagnon R, Bonate P, Liu L, Gilmer T, Bottaro DP. Correction: Phase II Study Evaluating 2 Dosing Schedules of Oral Foretinib (GSK1363089), cMET/VEGFR2 Inhibitor, in Patients with Metastatic Gastric Cancer. PLOS ONE 2022, 17: e0276211. PMID: 36215283, PMCID: PMC9550092, DOI: 10.1371/journal.pone.0276211.Peer-Reviewed Original Research92: [177Lu]Lu-Dota-Tate as First-Line Therapy for Patients with Grade 2 and 3 Advanced Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETS): The NETTER-2 Study
Myrehaug S, Singh S, Pavel M, Kunz P, de Herder W, Herrmann K, D’Amelio A, Santoro P, Folitar I, Ferone D. 92: [177Lu]Lu-Dota-Tate as First-Line Therapy for Patients with Grade 2 and 3 Advanced Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETS): The NETTER-2 Study. Radiotherapy And Oncology 2022, 174: s40-s41. DOI: 10.1016/s0167-8140(22)04371-7.Peer-Reviewed Original ResearchReal-world injection experience and use of independent injection among patients using lanreotide autogel/depot (LAN) prefilled syringe or octreotide long-acting release (OCT) to treat acromegaly or neuroendocrine tumors (NETs): international PRESTO 2 survey
Webb S, O'Toole D, Kunz P, Houchard A, Boiziau S, Ribeiro-Oliveira A, Prebtani A. Real-world injection experience and use of independent injection among patients using lanreotide autogel/depot (LAN) prefilled syringe or octreotide long-acting release (OCT) to treat acromegaly or neuroendocrine tumors (NETs): international PRESTO 2 survey. Endocrine Abstracts 2022 DOI: 10.1530/endoabs.81.oc4.5.Peer-Reviewed Original Research
2021
Correction: Phase II Study Evaluating 2 Dosing Schedules of Oral Foretinib (GSK1363089), cMET/VEGFR2 Inhibitor, in Patients with Metastatic Gastric Cancer
Shah MA, Wainberg ZA, Catenacci DVT, Hochster HS, Ford J, Kunz P, Lee FC, Kallender H, Cecchi F, Rabe DC, Keer H, Martin AM, Liu Y, Gagnon R, Bonate P, Liu L, Gilmer T, Bottaro DP. Correction: Phase II Study Evaluating 2 Dosing Schedules of Oral Foretinib (GSK1363089), cMET/VEGFR2 Inhibitor, in Patients with Metastatic Gastric Cancer. PLOS ONE 2021, 16: e0261994. PMID: 34941969, PMCID: PMC8699912, DOI: 10.1371/journal.pone.0261994.Peer-Reviewed Original ResearchMaking Sense of a Complex Disease: A Practical Approach to Managing Neuroendocrine Tumors
Zhang JY, Kunz PL. Making Sense of a Complex Disease: A Practical Approach to Managing Neuroendocrine Tumors. JCO Oncology Practice 2021, 18: 258-264. PMID: 34652954, DOI: 10.1200/op.21.00240.Peer-Reviewed Original ResearchConceptsNeuroendocrine tumorsFunctional statusPrimary sitePrevalence of NETsMetastatic neuroendocrine tumorsExtent of diseaseOngoing clinical trialsSomatostatin receptor statusIndividualized treatment planHeterogeneous clinical entityPace of diseaseConsideration of patientsPerformance statusSystemic therapyReceptor statusTumor characteristicsClinical entityTherapeutic optionsPathologic classificationClinical trialsTherapeutic decisionsDiagnostic modalitiesTreatment planDiseasePatients1102P The phase III NETTER-1 study of 177Lu-DOTATATE in patients with midgut neuroendocrine tumours: Further survival analyses
Ruszniewski P, Caplin M, Kunz P, Bodei L, Hendifar A, Mittra E, Wolin E, Yao J, Pavel M, Grande E, Van Cutsem E, Seregni E, Duarte H, Demange A, Mutevelic S, Krenning E, Strosberg J. 1102P The phase III NETTER-1 study of 177Lu-DOTATATE in patients with midgut neuroendocrine tumours: Further survival analyses. Annals Of Oncology 2021, 32: s911-s912. DOI: 10.1016/j.annonc.2021.08.184.Peer-Reviewed Original ResearchO-2 Overall survival and long-term safety data from the NETTER-1 trial: 177-Lu-Dotatate vs. high-dose octreotide in patients with progressive midgut NETs
Strosberg J, Caplin M, Kunz P, Ruszniewski P, Bodei L, Hendifar A, Mittra E, Wolin E, Yao J, Pavel M, Pulido E, Van Cutsem E, Seregni E, Duarte H, Gericke G, Bartalotta A, Demange A, Mutevelic S, Krenning E. O-2 Overall survival and long-term safety data from the NETTER-1 trial: 177-Lu-Dotatate vs. high-dose octreotide in patients with progressive midgut NETs. Annals Of Oncology 2021, 32: s217-s218. DOI: 10.1016/j.annonc.2021.05.006.Peer-Reviewed Original Research
2020
Commonwealth Neuroendocrine Tumour Research Collaboration and the North American Neuroendocrine Tumor Society Guidelines for the Diagnosis and Management of Patients With Lung Neuroendocrine Tumors: An International Collaborative Endorsement and Update of the 2015 European Neuroendocrine Tumor Society Expert Consensus Guidelines
Singh S, Bergsland EK, Card CM, Hope TA, Kunz PL, Laidley DT, Lawrence B, Leyden S, Metz DC, Michael M, Modahl LE, Myrehaug S, Padda SK, Pommier RF, Ramirez RA, Soulen M, Strosberg J, Sung A, Thawer A, Wei B, Xu B, Segelov E. Commonwealth Neuroendocrine Tumour Research Collaboration and the North American Neuroendocrine Tumor Society Guidelines for the Diagnosis and Management of Patients With Lung Neuroendocrine Tumors: An International Collaborative Endorsement and Update of the 2015 European Neuroendocrine Tumor Society Expert Consensus Guidelines. Journal Of Thoracic Oncology 2020, 15: 1577-1598. PMID: 32663527, DOI: 10.1016/j.jtho.2020.06.021.Peer-Reviewed Original ResearchConceptsLung neuroendocrine tumorsManagement of patientsNeuroendocrine tumorsConsensus guidelinesNorth American Neuroendocrine Tumor SocietyRecent evidenceEuropean Neuroendocrine Tumor SocietyGlobal consensus guidelinesMetastatic neuroendocrine tumorsExpert consensus guidelinesEvidence-based statementsNew consensus statementPerson-centred careSociety guidelinesUncommon cancerCurrent guidelinesConsensus statementPractice guidelinesInclusion criteriaBest practice guidelinesConsensus articlePatientsSystematic reviewPractice changeTumorsPAM staining intensity of primary neuroendocrine neoplasms is a potential prognostic biomarker
Horton TM, Sundaram V, Lee CH, Hornbacker K, Van Vleck A, Benjamin KN, Zemek A, Longacre TA, Kunz PL, Annes JP. PAM staining intensity of primary neuroendocrine neoplasms is a potential prognostic biomarker. Scientific Reports 2020, 10: 10943. PMID: 32616904, PMCID: PMC7331689, DOI: 10.1038/s41598-020-68071-6.Peer-Reviewed Original ResearchConceptsPrimary neuroendocrine neoplasmsNeuroendocrine neoplasmsPAM immunoreactivityPAM stainingStage-independent predictorUnpredictable clinical behaviorRisk of deathIndividual patient prognosisRare epithelial tumorsHigh-grade tumorsPotential prognostic biomarkerMedian timeSmall bowelAvailable biomarkersTumor sizeDisease stageClinical associationsGrade tumorsClinical behaviorPatient prognosisPrognostic biomarkerEpithelial tumorsTherapy selectionSurvival implicationsPatientsEvaluation of the incidence of acute nausea and vomiting after administration of an amino acid solution containing only arginine and lysine with lutetium Lu-177 dotatate.
Alonzo N, Seyer M, Kim E, Keshavarzi R, Yee K, Kunz P. Evaluation of the incidence of acute nausea and vomiting after administration of an amino acid solution containing only arginine and lysine with lutetium Lu-177 dotatate. Journal Of Clinical Oncology 2020, 38: 12113-12113. DOI: 10.1200/jco.2020.38.15_suppl.12113.Peer-Reviewed Original ResearchLu-177 DOTATATEAA infusionAmino acid solutionRates of nauseaPercentage of patientsRetrospective chart reviewGastroenteropancreatic neuroendocrine tumorsAcute nauseaSecondary endpointsAdult patientsChart reviewNeuroendocrine tumorsNormal salinePatientsInfusion timeAA solutionIncidenceDOTATATEInfusionHistorical incidenceAmino acids 10NauseaVomitingAdministrationEssential AATime 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
2019
Comparison of definitive chemoradiation with 5-fluorouracil versus capecitabine in anal cancer
Pumpalova Y, Kozak MM, von Eyben R, Kunz P, Fisher G, Chang DT, Haraldsdottir S. Comparison of definitive chemoradiation with 5-fluorouracil versus capecitabine in anal cancer. Journal Of Gastrointestinal Oncology 2019, 10: 605-615. PMID: 31392040, PMCID: PMC6657317, DOI: 10.21037/jgo.2019.02.17.Peer-Reviewed Original ResearchAnal cancer patientsIncidence of recurrenceAnal cancerDefinitive chemoradiationOverall survivalCancer patientsLonger recurrence-free intervalCancer-specific survivalDisease-specific survivalRecurrence-free intervalSignificant lower incidenceLoco-regional relapseLog-rank testMann-Whitney U testAnal painMore colostomiesLocoregional recurrencePatient characteristicsRectal cancerOverall incidenceGray's testLower incidenceCommon gradePatientsRecurrence
2018
Long-Term Survivors of Pancreatic Cancer
Kardosh A, Lichtensztajn DY, Gubens MA, Kunz PL, Fisher GA, Clarke CA. Long-Term Survivors of Pancreatic Cancer. Pancreas 2018, 47: 958-966. PMID: 30074526, PMCID: PMC6095724, DOI: 10.1097/mpa.0000000000001133.Peer-Reviewed Original ResearchConceptsLong-term survivalPancreatic cancerPancreatic adenocarcinomaCalifornia Cancer RegistryLong-term survivorsPancreatic cancer mortalityAsian/Pacific IslandersNational Cancer InstituteNon-Hispanic whitesAdjuvant chemotherapyUnresectable patientsBaseline characteristicsSurgical resectionTerm survivorsCancer RegistryPoor prognosisSurgical interventionCancer CenterCancer mortalityDegree of differentiationCancer InstituteSurvival rateYounger ageLogistic regressionPatientsNCCN Guidelines Insights: Neuroendocrine and Adrenal Tumors, Version 2.2018.
Shah MH, Goldner WS, Halfdanarson TR, Bergsland E, Berlin JD, Halperin D, Chan J, Kulke MH, Benson AB, Blaszkowsky LS, Eads J, Engstrom PF, Fanta P, Giordano T, He J, Heslin MJ, Kalemkerian GP, Kandeel F, Khan SA, Kidwai WZ, Kunz PL, Kuvshinoff BW, Lieu C, Pillarisetty VG, Saltz L, Sosa JA, Strosberg JR, Sussman CA, Trikalinos NA, Uboha NA, Whisenant J, Wong T, Yao JC, Burns JL, Ogba N, Zuccarino-Catania G. NCCN Guidelines Insights: Neuroendocrine and Adrenal Tumors, Version 2.2018. Journal Of The National Comprehensive Cancer Network 2018, 16: 693-702. PMID: 29891520, DOI: 10.6004/jnccn.2018.0056.Peer-Reviewed Original ResearchConceptsPrimary neuroendocrine tumorNeuroendocrine tumorsAdrenal tumorsManagement of NETsLocoregional advanced diseaseNCCN Guidelines InsightsAdrenal gland tumorsAdvanced diseaseNCCN guidelinesAdult patientsDistant metastasisGastrointestinal tractGland tumorsTumorsNeuroendocrineManagement optionsGuidelinesPatientsPheochromocytomaMetastasisParagangliomaDiseaseTractA randomized study of temozolomide or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors: A trial of the ECOG-ACRIN Cancer Research Group (E2211).
Kunz P, Catalano P, Nimeiri H, Fisher G, Longacre T, Suarez C, Yao J, Kulke M, Hendifar A, Shanks J, Shah M, Zalupski M, Schmulbach E, Reidy D, Strosberg J, O'Dwyer P, Benson A. A randomized study of temozolomide or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors: A trial of the ECOG-ACRIN Cancer Research Group (E2211). Journal Of Clinical Oncology 2018, 36: 4004-4004. DOI: 10.1200/jco.2018.36.15_suppl.4004.Peer-Reviewed Original ResearchA 20-year comparison of definitive chemoradiation with 5-FU versus capecitabine in anal cancer patients treated at a single institution.
Pumpalova Y, Kozak M, von Eyben R, Kunz P, Fisher G, Chang D, Haraldsdottir S. A 20-year comparison of definitive chemoradiation with 5-FU versus capecitabine in anal cancer patients treated at a single institution. Journal Of Clinical Oncology 2018, 36: e15573-e15573. DOI: 10.1200/jco.2018.36.15_suppl.e15573.Peer-Reviewed Original ResearchChanges 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 frequencyTumors