2024
Phase Ib portion of the ACTION-1 phase Ib/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Safety and efficacy findings.
Halperin D, Morris M, Ulaner G, Strosberg J, Mehr S, Li D, Soares H, Anthony L, Kotiah S, Jacene H, Tesselaar M, Kunz P, Ferreira D, Li J, Ma K, Rearden J, Moran S, Hope T, Singh S. Phase Ib portion of the ACTION-1 phase Ib/3 trial of RYZ101 in gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Safety and efficacy findings. Journal Of Clinical Oncology 2024, 42: 3091-3091. DOI: 10.1200/jco.2024.42.16_suppl.3091.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPhase Ib portionDose-limiting toxicitySerious adverse eventsGEP-NETsSomatostatin analoguesAdverse eventsFrequent treatment-emergent adverse eventsEfficacy dataData review committeePlanned dose levelsProgression-free survivalDuration of responseGastroenteropancreatic neuroendocrine tumorsLonger-term safetyAlpha-emitting radiopharmaceuticalStandard of careDose holdRECIST v1.1Stable diseasePartial responseStarting doseTumor responseDose modificationNeuroendocrine tumors
2023
Novel use of alternate (Alt) response (Rp) criteria (Cr) for early prediction of outcomes in pancreatic (P) neuroendocrine tumors (NETs): Utilizing banked imaging data from the ECOG-ACRIN E2211 study.
Vijayvergia N, Handorf E, Kunz P, Alkim E, Burke L, Catalano P, Graham N, Levin L, Li W, Meeker C, Rubin D, Narasimhan Sridharan A, O'Dwyer P, Wong T, Anaokar J. Novel use of alternate (Alt) response (Rp) criteria (Cr) for early prediction of outcomes in pancreatic (P) neuroendocrine tumors (NETs): Utilizing banked imaging data from the ECOG-ACRIN E2211 study. Journal Of Clinical Oncology 2023, 41: 4133-4133. DOI: 10.1200/jco.2023.41.16_suppl.4133.Peer-Reviewed Original ResearchProgression-free survivalImproved progression-free survivalNeuroendocrine tumorsStable diseaseProgressive diseaseRadiomic featuresCT/MRI scansPancreatic neuroendocrine tumorsPortal venous phaseShort-term imagingSmaller threshold changesInter-reader agreementTumor sizeC-statisticFirst disease assessmentPotential adjunctTreatment decisionsVenous phasePD casesTime-varying outcomeMRI scansClinical practicePredictive valueTumor densityInter-reader variability
2019
Evaluating the Role of Theranostics in Grade 3 Neuroendocrine Neoplasms
Waseem N, Aparici CM, Kunz PL. Evaluating the Role of Theranostics in Grade 3 Neuroendocrine Neoplasms. Journal Of Nuclear Medicine 2019, 60: 882-891. PMID: 30850504, DOI: 10.2967/jnumed.118.217851.Peer-Reviewed Original ResearchConceptsPeptide receptor radionuclide therapyG3 neuroendocrine neoplasmsNeuroendocrine neoplasmsOverall survivalRole of PRRTUse of PRRTPhase III clinical trialsGrade 3 neuroendocrine neoplasmsLeast stable diseaseMidgut neuroendocrine neoplasmsProgression-free survivalLonger overall survivalReceptor radionuclide therapyShorter overall survivalHigh Ki-67Gastroenteropancreatic neuroendocrine neoplasmsNew histologic classificationSomatostatin receptor expressionF-FDG PETDrug Administration approvalLow proliferation indexRole of theranosticsRadiologic responseStable diseasePartial responseTemozolomide 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
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
2013
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 DV, 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. Phase II Study Evaluating 2 Dosing Schedules of Oral Foretinib (GSK1363089), cMET/VEGFR2 Inhibitor, in Patients with Metastatic Gastric Cancer. PLOS ONE 2013, 8: e54014. PMID: 23516391, PMCID: PMC3597709, DOI: 10.1371/journal.pone.0054014.Peer-Reviewed Original ResearchConceptsObjective response rateMetastatic gastric cancerStable diseaseMET amplificationPhospho-METGastric adenocarcinomaIntermittent dosingGastric cancerTreatment-related adverse eventsPhase II studyMetastatic gastric adenocarcinomaRates of hypertensionElevated aspartate aminotransferaseOral multikinase inhibitorEndothelial cell growth factorVascular endothelial cell growth factorCell growth factorEvaluable patientsForetinib treatmentPrior therapyAdverse eventsII studyUnselected patientsDosing schedulesMedian age
2009
Assessment of two dosing schedules of GSK1363089 (GSK089), a dual MET/VEGFR2 inhibitor, in metastatic gastric cancer (GC): Interim results of a multicenter phase II study
Jhawer M, Kindler H, Wainberg Z, Ford J, Kunz P, Tang L, McCallum S, Kallender H, Shah M. Assessment of two dosing schedules of GSK1363089 (GSK089), a dual MET/VEGFR2 inhibitor, in metastatic gastric cancer (GC): Interim results of a multicenter phase II study. Journal Of Clinical Oncology 2009, 27: 4502-4502. DOI: 10.1200/jco.2009.27.15_suppl.4502.Peer-Reviewed Original ResearchMetastatic gastric cancerPhase II studyGastric cancerStable diseaseAdverse eventsCMET amplificationEvaluable ptsII studyDosing schedulesGrade 5 adverse eventsMulticenter phase II studyAdequate organ functionECOG PS 0Prior chemotherapy regimensTreatment tumor biopsiesAntitumor activityDaily dosing schedulePrimary study endpointMinimal antitumor activityAttractive therapeutic targetCMET pathwayLFT abnormalitiesMeasurable diseaseTreatment biopsiesChemotherapy regimens