2022
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
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 randomized study of temozolomide or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors: Final analysis of efficacy and evaluation of MGMT (ECOG-ACRIN E2211).
Kunz P, Graham N, Catalano P, Nimeiri H, Fisher G, Longacre T, Suarez C, Rubin D, Yao J, Kulke M, Hendifar A, Shanks J, Shah M, Zalupski M, Schmulbach E, Reidy D, Strosberg J, Wong T, O'Dwyer P, Benson A. A randomized study of temozolomide or temozolomide and capecitabine in patients with advanced pancreatic neuroendocrine tumors: Final analysis of efficacy and evaluation of MGMT (ECOG-ACRIN E2211). Journal Of Clinical Oncology 2022, 40: 4004-4004. DOI: 10.1200/jco.2022.40.16_suppl.4004.Peer-Reviewed Original ResearchProgression-free survivalPancreatic neuroendocrine tumorsMedian progression-free survivalAdvanced pancreatic neuroendocrine tumorsCombination of capecitabineNeuroendocrine tumorsResponse rateEligible patientsPrimary endpointOverall survivalIntermediate-grade pancreatic neuroendocrine tumorsTwo-sided log-rank testLonger progression-free survivalEfficacy analysis populationObjective tumor responsePhase II trialLog-rank testHigh response rateSecondary endpointsII trialProspective studyAnalysis populationTreatment optionsTumor responseInterim analysisEverolimus with or without bevacizumab in advanced pNET: CALGB 80701 (Alliance).
Kulke MH, Ou FS, Niedzwiecki D, Huebner L, Kunz P, Kennecke HF, Wolin EM, Chan JA, O'Reilly EM, Meyerhardt JA, Venook A. Everolimus with or without bevacizumab in advanced pNET: CALGB 80701 (Alliance). Endocrine Related Cancer 2022, 29: 335-344. PMID: 35324465, PMCID: PMC9257687, DOI: 10.1530/erc-21-0239.Peer-Reviewed Original ResearchConceptsAdvanced pancreatic neuroendocrine tumorsProgression-free survivalPancreatic neuroendocrine tumorsVEGF pathway inhibitorsCombination armPrimary endpointMedian overall survival durationTreatment-related adverse eventsImproved progression-free survivalRandomized phase II studySuperior progression-free survivalPathway inhibitorOverall survival durationPhase II studyTreatment-related toxicityCombination of everolimusMTOR inhibitor everolimusHigh response rateAdverse eventsII studyInvestigator reviewCombination therapyStandard doseInhibitor everolimusNeuroendocrine tumors
2021
Temozolomide in Grade 3 Gastroenteropancreatic Neuroendocrine Neoplasms: A Multicenter Retrospective Review
Chan DL, Bergsland EK, Chan JA, Gadgil R, Halfdanarson TR, Hornbacker K, Kelly V, Kunz PL, McGarrah PW, Raj NP, Reidy DL, Thawer A, Whitman J, Wu L, Becker C, Singh S. Temozolomide in Grade 3 Gastroenteropancreatic Neuroendocrine Neoplasms: A Multicenter Retrospective Review. The Oncologist 2021, 26: 950-955. PMID: 34342086, PMCID: PMC8571741, DOI: 10.1002/onco.13923.Peer-Reviewed Original ResearchConceptsG3 neuroendocrine neoplasmsFirst-line settingPercent of patientsMulticenter retrospective reviewTreatment failureGastroenteropancreatic neuroendocrine neoplasmsNeuroendocrine neoplasmsRetrospective reviewOptimal treatmentResponse rateGastrointestinal neuroendocrine neoplasmsLocal pathology reportsDiscontinuation of therapyMedian TTFFirst-line treatmentOverall response rateConfirmatory prospective studiesViable treatment optionPancreatic neuroendocrine neoplasmsRadiologic responseTemozolomide regimenPrimary endpointAdverse eventsMedian durationRadiographic responseFinal overall survival in the phase 3 NETTER-1 study of lutetium-177-DOTATATE in patients with midgut neuroendocrine tumors.
Strosberg J, Caplin M, Kunz P, Ruszniewski P, Bodei L, Hendifar A, Mittra E, Wolin E, Yao J, Pavel M, Grande E, Van Cutsem E, Seregni E, Duarte H, Gericke G, Bartalotta A, Demange A, Mutevelic S, Krenning E, group O. Final overall survival in the phase 3 NETTER-1 study of lutetium-177-DOTATATE in patients with midgut neuroendocrine tumors. Journal Of Clinical Oncology 2021, 39: 4112-4112. DOI: 10.1200/jco.2021.39.15_suppl.4112.Peer-Reviewed Original ResearchProgression-free survivalMedian overall survivalFinal overall survivalNETTER-1 studyNETTER-1 trialNew safety signalsOverall survivalMidgut neuroendocrine tumorsControl armMyelodysplastic syndromeNeuroendocrine tumorsLu-DOTATATEPrimary endpointLast patientSafety signalsFurther anti-cancer treatmentBest supportive careKey secondary endpointOpen-label trialLutetium-177 DOTATATEAnti-cancer treatmentEligible patientsNETTER-1RECIST 1.1Secondary endpoints
2020
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
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
2019
Prognostic value of somatostatin receptor expressing tumor volume calculated from 68Ga-DOTATATE PET/CT in patients with well-differentiated neuroendocrine tumors
Toriihara A, Baratto L, Nobashi T, Park S, Hatami N, Davidzon G, Kunz PL, Iagaru A. Prognostic value of somatostatin receptor expressing tumor volume calculated from 68Ga-DOTATATE PET/CT in patients with well-differentiated neuroendocrine tumors. European Journal Of Nuclear Medicine And Molecular Imaging 2019, 46: 2244-2251. PMID: 31350603, DOI: 10.1007/s00259-019-04455-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overDisease ProgressionDisease-Free SurvivalFemaleHumansImage Processing, Computer-AssistedKaplan-Meier EstimateLiver NeoplasmsMaleMiddle AgedMultivariate AnalysisNeoplasm MetastasisNeuroendocrine TumorsOrganometallic CompoundsPositron Emission Tomography Computed TomographyPrognosisProgression-Free SurvivalProportional Hazards ModelsProspective StudiesReceptors, SomatostatinRetrospective StudiesConceptsProgression-free survivalProportional hazards modelPET/CTPrognostic valueTumor volumeNeuroendocrine tumorsTumor gradeSomatostatin receptorsKaplan-Meier survival analysisCox proportional hazards modelPositron emission tomography/Volume of interestMaximum standardized uptake valueMethodsNinety-two patientsWHO tumor gradeLog-rank testSomatostatin receptor expressionEmission tomography/Standardized uptake valueSignificant differencesVolumetric parametersPrimary endpointIndependent predictorsResultsUnivariate analysisTomography/Temozolomide in grade III neuroendocrine neoplasms (G3 NENs): A multicenter retrospective review.
Chan D, Bergsland E, Chan J, Gadgil R, Halfdanarson T, Hornbacker K, Kelly V, Kunz P, McGarrah P, Raj N, Reidy D, Thawer A, Whitman J, Wu L, Singh S. Temozolomide in grade III neuroendocrine neoplasms (G3 NENs): A multicenter retrospective review. Journal Of Clinical Oncology 2019, 37: 321-321. DOI: 10.1200/jco.2019.37.4_suppl.321.Peer-Reviewed Original ResearchTreatment failureG3 NENRetrospective reviewDose reduction/discontinuationBest radiological responseLocal pathology reportsMulticentre retrospective reviewOptimal systemic treatmentProspective confirmatory trialMedian TTFMulticenter retrospective reviewReduction/discontinuationBetter response rateViable treatment optionGastroenteropancreatic NENRadiologic responseStable diseasePrimary endpointRECIST criteriaAdverse eventsOverall survivalPartial responseProgressive diseaseRadiological responseSystemic treatment
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
2015
Phase II pilot study of single-agent etirinotecan pegol (NKTR-102) in bevacizumab-resistant high grade glioma
Nagpal S, Recht CK, Bertrand S, Thomas RP, Ajlan A, Pena J, Gershon M, Coffey G, Kunz PL, Li G, Recht LD. Phase II pilot study of single-agent etirinotecan pegol (NKTR-102) in bevacizumab-resistant high grade glioma. Journal Of Neuro-Oncology 2015, 123: 277-282. PMID: 25935109, PMCID: PMC4452613, DOI: 10.1007/s11060-015-1795-0.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngiogenesis InhibitorsAntineoplastic AgentsBevacizumabBrain NeoplasmsDrug Resistance, NeoplasmFemaleFollow-Up StudiesGliomaHeterocyclic Compounds, 4 or More RingsHumansMaleMiddle AgedNeoplasm GradingNeoplasm Recurrence, LocalPilot ProjectsPolyethylene GlycolsPrognosisProspective StudiesSurvival RateYoung AdultConceptsHigh-grade gliomasEtirinotecan pegolOverall survivalRANO criteriaPhase II pilot studyGrade 3 toxicityMedian overall survivalOpen-label trialFurther clinical investigationMedian KPSChemotherapy cyclesHematologic toxicityPrimary endpointSecondary endpointsPartial responseMedian agePatient agePoor prognosisHGG patientsTumor exposureClinical dataAnaplastic astrocytomaBevacizumabClinical investigationGrade gliomas
2014
A phase II study of capecitabine, carboplatin, and bevacizumab for metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma.
Kunz P, Nandoskar P, Koontz M, Ji H, Ford J, Balise R, Kamaya A, Rubin D, Fisher G. A phase II study of capecitabine, carboplatin, and bevacizumab for metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma. Journal Of Clinical Oncology 2014, 32: 115-115. DOI: 10.1200/jco.2014.32.3_suppl.115.Peer-Reviewed Original ResearchProgression-free survivalGastroesophageal junctionStable diseaseOverall survivalPartial responseGastric adenocarcinomaPrimary endpointProgressive diseaseDay 1Response rateMedian progression-free survivalCombination of capecitabineFirst tumor assessmentBest supportive careMedian overall survivalPhase II studyPromising response ratesAddition of bevacizumabIncidence of adenocarcinomaMajor health problemQuality of lifeSecondary endpointsBaseline characteristicsFree survivalGastric cardiaPhase II clinical trial of pasireotide LAR in patients with metastatic neuroendocrine tumors.
Strosberg J, Jump H, Valone T, Weber J, Khandelwal V, Kunz P. Phase II clinical trial of pasireotide LAR in patients with metastatic neuroendocrine tumors. Journal Of Clinical Oncology 2014, 32: 241-241. DOI: 10.1200/jco.2014.32.3_suppl.241.Peer-Reviewed Original ResearchPasireotide LARSomatostatin analoguesMedian PFSLong-term insulin therapySomatostatin receptor subtypes 1Phase II clinical trialBest radiographic responseGrade 3 hyperglycemiaPrior systemic therapyRates of hyperglycemiaYear OS ratesTreatment-naïve patientsMetastatic neuroendocrine tumorsPhase II trialIntermediate-grade tumorsNovel somatostatin analogReceptor subtype 1LAR treatmentQ4 weeksStable diseaseII trialNaïve patientsPrimary endpointRefractory patientsInsulin therapy