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
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
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 cardia