2022
Randomized Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors (ECOG-ACRIN E2211)
Kunz PL, Graham NT, Catalano PJ, Nimeiri HS, Fisher GA, Longacre TA, Suarez CJ, Martin BA, Yao JC, Kulke MH, Hendifar AE, Shanks JC, Shah MH, Zalupski MM, Schmulbach EL, Reidy-Lagunes DL, Strosberg JR, O'Dwyer PJ, O'Dwyer P, Benson A. Randomized Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors (ECOG-ACRIN E2211). Journal Of Clinical Oncology 2022, 41: 1359-1369. PMID: 36260828, PMCID: PMC9995105, DOI: 10.1200/jco.22.01013.Peer-Reviewed Original ResearchConceptsAdvanced pancreatic neuroendocrine tumorsProgression-free survivalPancreatic neuroendocrine tumorsMedian progression-free survivalPrimary end pointNeuroendocrine tumorsResponse rateObjective responseOverall survivalRandomized studyIntermediate-grade pancreatic neuroendocrine tumorsLonger progression-free survivalEnd pointMGMT deficiencyMedian overall survivalPrimary analysis populationKey eligibility criteriaPhase II trialSmall prospective studiesHigh response rateMethylguanine methyltransferaseCapecitabine/Eligible patientsSecondary endpointsII trialA 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 analysis
2021
Comparison of Design, Eligibility, and Outcomes of Neuroendocrine Neoplasm Trials Initiated From 2000 to 2009 vs 2010 to 2020
Das S, Du L, Lee CL, Arhin ND, Chan JA, Kohn EC, Halperin DM, Berlin J, LaFerriere H, Singh S, Kunz PL, Dasari A. Comparison of Design, Eligibility, and Outcomes of Neuroendocrine Neoplasm Trials Initiated From 2000 to 2009 vs 2010 to 2020. JAMA Network Open 2021, 4: e2131744. PMID: 34705010, PMCID: PMC8552059, DOI: 10.1001/jamanetworkopen.2021.31744.Peer-Reviewed Original ResearchConceptsNeuroendocrine neoplasmsClinical trialsNational Cancer Institute Clinical TrialsEU Clinical Trials RegisterCoprimary end pointsObjective response rateProgression-free survivalClinical Trials RegisterKi-67 indexAllied Health LiteratureQuality improvement studyPhase IISpecific disease populationsWeb of ScienceDrug licensureTrials RegisterCochrane DatabaseTumor differentiationNovel agentsDisease populationInclusion criteriaMAIN OUTCOMECumulative IndexEnrollment periodResponse rateTemozolomide 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 response
2020
Patient Selection and Toxicities of PRRT for Metastatic Neuroendocrine Tumors and Research Opportunities
Shaheen S, Moradi F, Gamino G, Kunz PL. Patient Selection and Toxicities of PRRT for Metastatic Neuroendocrine Tumors and Research Opportunities. Current Treatment Options In Oncology 2020, 21: 25. PMID: 32172368, DOI: 10.1007/s11864-020-0711-9.Peer-Reviewed Original ResearchConceptsPeptide receptor radionuclide therapySomatostatin analoguesToxicity of PRRTOpinion statementNeuroendocrine tumorsMetastatic neuroendocrine tumorsLandscape of treatmentReceptor radionuclide therapyRecent treatment advancesTreatment of NETsPatient selectionNeuroendocrine tumorsTreatment advancesSomatostatin receptorsMinimal response rateRadionuclide therapyResponse rateHeterogenous groupTherapyTumor cellsBiological hallmarksTumorsTreatmentNETsIndolentNeoplasms
2018
Phase II study of epacadostat with pembrolizumab in metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma requiring paired biopsies.
Kardosh A, Tseng D, Sahaf B, Zomet A, Krupa J, Fisher G, Wang D, Mackall C, Kunz P. Phase II study of epacadostat with pembrolizumab in metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma requiring paired biopsies. Journal Of Clinical Oncology 2018, 36: tps191-tps191. DOI: 10.1200/jco.2018.36.4_suppl.tps191.Peer-Reviewed Original ResearchProgression-free survivalGastroesophageal junctionOverall survivalResponse rateGastric adenocarcinomaECOG performance status 0Phase II clinical trialPDL-1 expressionPerformance status 0Single-agent pembrolizumabMedian overall survivalPD-1 inhibitorsPhase II studyIncidence of adenocarcinomaGastroesophageal junction adenocarcinomaComprehensive immune profilingMajor health problemCombination immunotherapyEligible patientsKEYNOTE-059PFS ratesPrior therapyPrior trastuzumabStatus 0Advanced disease
2017
Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors
Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Öberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. New England Journal Of Medicine 2017, 376: 125-135. PMID: 28076709, PMCID: PMC5895095, DOI: 10.1056/nejmoa1607427.Peer-Reviewed Original ResearchConceptsMidgut neuroendocrine tumorsProgression-free survivalAdvanced midgut neuroendocrine tumorsOverall survivalNeuroendocrine tumorsControl groupInterim analysisResponse rateLu-DOTATATEHigh-dose octreotide LARLonger progression-free survivalEnd pointMetastatic midgut neuroendocrine tumorsFinal analysisData cutoff dateObjective response rateOverall survival benefitPrimary end pointSecondary end pointsSomatostatin analogue therapyPhase 3 trialSide effect profileRenal toxic effectsHigh response rateOctreotide LAR
2016
Oxaliplatin–Fluoropyrimidine Chemotherapy Plus Bevacizumab in Advanced Neuroendocrine Tumors
Kunz PL, Balise RR, Fehrenbacher L, Pan M, Venook AP, Fisher GA, Tempero MA, Ko AH, Korn WM, Hwang J, Bergsland EK. Oxaliplatin–Fluoropyrimidine Chemotherapy Plus Bevacizumab in Advanced Neuroendocrine Tumors. Pancreas 2016, 45: 1394-1400. PMID: 27171514, DOI: 10.1097/mpa.0000000000000659.Peer-Reviewed Original ResearchConceptsRadiographic response rateAdvanced neuroendocrine tumorsPrimary end pointProgression-free survivalNeuroendocrine tumorsPancreatic neuroendocrine tumorsNeuroendocrine carcinomaProspective phase II studyB studyEnd pointProlonged disease stabilityPhase II studyEffectiveness of bevacizumabDifferentiated neuroendocrine carcinomaPredictable toxicityRR-18Maintenance therapyDisease stabilityII studyRadiographic responsePatientsResponse rateNET subtypesBevacizumabMonths
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 cardia