2024
1148MO A multivariate efficacy analysis of [177Lu]Lu-DOTA-TATE in the NETTER 2 study
Pavel M, Ferone D, Halperin D, Myrehaug S, Herrmann K, Kunz P, Chasen B, Castillon J, Tafuto S, Oh D, Yoo C, Falk S, Halfdanarson T, Folitar I, Zhang Y, de Herder W, Singh S. 1148MO A multivariate efficacy analysis of [177Lu]Lu-DOTA-TATE in the NETTER 2 study. Annals Of Oncology 2024, 35: s753. DOI: 10.1016/j.annonc.2024.08.1207.Peer-Reviewed Original Research[177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high‑dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2–3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study
Singh S, Halperin D, Myrehaug S, Herrmann K, Pavel M, Kunz P, Chasen B, Tafuto S, Lastoria S, Capdevila J, García-Burillo A, Oh D, Yoo C, Halfdanarson T, Falk S, Folitar I, Zhang Y, Aimone P, de Herder W, Ferone D, Investigators A. [177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high‑dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2–3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study. The Lancet 2024, 403: 2807-2817. PMID: 38851203, DOI: 10.1016/s0140-6736(24)00701-3.Peer-Reviewed Original ResearchGastroenteropancreatic neuroendocrine tumorsProgression-free survivalAdvanced gastroenteropancreatic neuroendocrine tumorsLong-acting octreotideLu-DOTATATENeuroendocrine tumorsGrade 2Open-labelControl groupTreated patientsWell-differentiatedStandard first-line treatment optionMedian progression-free survivalProgression-free survival eventsTreatment periodFirst-line treatment optionProgression-free survival analysisNeuroendocrine tumor gradingSomatostatin receptor-positiveFirst-line therapyInteractive response technologyHigh-dose octreotidePhase 3 studyPhase 3 trialStandard of care211MO First-line efficacy of [177Lu]Lu-DOTA-TATE in patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors by tumor grade and primary origin: Subgroup analysis of the phase III NETTER-2 study
Singh S, Halperin D, Myrehaug S, Herrmann K, Pavel M, Kunz P, Chasen B, Capdevila J, Tafuto S, Oh D, Yoo C, Falk S, Halfdanarson T, Folitar I, Zhang Y, de Herder W, Ferone D. 211MO First-line efficacy of [177Lu]Lu-DOTA-TATE in patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors by tumor grade and primary origin: Subgroup analysis of the phase III NETTER-2 study. Annals Of Oncology 2024, 35: s92-s93. DOI: 10.1016/j.annonc.2024.05.219.Peer-Reviewed Original ResearchSafety and time to response of [177Lu]Lu-DOTATATE in patients with newly diagnosed advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Sub-analysis of the phase 3 randomized NETTER-2 study.
Kunz P, Ferone D, Halperin D, Myrehaug S, Herrmann K, Pavel M, Chasen B, Capdevila J, Tafuto S, Oh D, Yoo C, Falk S, Halfdanarson T, Folitar I, Zhang Y, de Herder W, Singh S. Safety and time to response of [177Lu]Lu-DOTATATE in patients with newly diagnosed advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Sub-analysis of the phase 3 randomized NETTER-2 study. Journal Of Clinical Oncology 2024, 42: 4131-4131. DOI: 10.1200/jco.2024.42.16_suppl.4131.Peer-Reviewed Original ResearchTime to responseObjective response rateGastroenteropancreatic neuroendocrine tumorsLu-DOTATATEGEP-NETsAdverse eventsHematologic toxicityNeuroendocrine tumorsSafety profileSub-analysisMedian time to responseCases of myelodysplastic syndromeOctreotide long-actingHematologic adverse eventsProgression-free survivalTime to first occurrenceRandomized treatment periodFatal adverse eventsInfection rateDose interruptionCTCAE gradeRadioligand therapyMyelodysplastic syndromeEligible ptsLaboratory abnormalitiesPhase 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[177Lu]Lu-DOTA-TATE in newly diagnosed patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Primary analysis of the phase 3 randomized NETTER-2 study
Ferone D, Halperin D, Myrehaug S, Herrmann K, Pavel M, Kunz P, Chasen B, Capdevila J, Tafuto S, Oh D, Yoo C, Falk S, Halfdanarson T, Folitar I, Zhang Y, Santoro P, Aimone P, de H, Singh S. [177Lu]Lu-DOTA-TATE in newly diagnosed patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Primary analysis of the phase 3 randomized NETTER-2 study. Endocrine Abstracts 2024 DOI: 10.1530/endoabs.99.oc7.2.Peer-Reviewed Original ResearchCorrection to: 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. Correction to: 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 2024, 41: 2531-2533. PMID: 38480663, DOI: 10.1007/s12325-024-02829-6.Peer-Reviewed Original Research[177Lu]Lu-DOTA-TATE in newly diagnosed patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Primary analysis of the phase 3 randomized NETTER-2 study.
Singh S, Halperin D, Myrehaug S, Herrmann K, Pavel M, Kunz P, Chasen B, Capdevila J, Tafuto S, Oh D, Yoo C, Falk S, Halfdanarson T, Folitar I, Zhang Y, Santoro P, Aimone P, de Herder W, Ferone D. [177Lu]Lu-DOTA-TATE in newly diagnosed patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Primary analysis of the phase 3 randomized NETTER-2 study. Journal Of Clinical Oncology 2024, 42: lba588-lba588. DOI: 10.1200/jco.2024.42.3_suppl.lba588.Peer-Reviewed Original ResearchProgression-free survivalObjective response rateOctreotide long-acting releaseLong-acting releaseGastroenteropancreatic neuroendocrine tumorsRadioligand therapyGEP-NETsLu-DOTATATENeuroendocrine tumorsControl armEfficacy of radioligand therapyMedian progression-free survivalProlonged progression-free survivalCases of myelodysplastic syndromeAdvanced GEP-NETsMedian cumulative doseStratified hazard ratioStratified odds ratiosMonths prior to enrollmentLu-DOTATATE treatmentUnmet medical needG3 tumorsMyelodysplastic syndromePrognostic subgroupsEligible pts
2023
ACTION-1: A randomized Phase Ib/3 trial of RYZ101 compared with SoC in SSTR+ well-differentiated GEP-NET with progression following Lu-177 SSA
Hope T, Halperin D, Strosberg J, Jacene H, E.T. T, Kunz P, Ferreira D, Li J, Ma K, Rearden J, Moran S, Singh S. ACTION-1: A randomized Phase Ib/3 trial of RYZ101 compared with SoC in SSTR+ well-differentiated GEP-NET with progression following Lu-177 SSA. Endocrine Abstracts 2023 DOI: 10.1530/endoabs.98.t1.Peer-Reviewed Original Research1198P 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
Strosberg J, Ulaner G, Halperin D, Mehr S, Li D, Soares H, Anthony L, Kotiah S, Jacene H, Kunz P, Ferreira D, Li J, Ma K, Rearden J, Moran S, Hope T, Singh S, Morris M. 1198P 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. Annals Of Oncology 2023, 34: s707. DOI: 10.1016/j.annonc.2023.09.731.Peer-Reviewed Original ResearchACTION-1 phase Ib/3 trial of RYZ101 in somatostatin receptor subtype 2–expressing (SSTR2+) gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Initial safety analysis.
Morris M, Ulaner G, Halperin D, Strosberg J, Mehr S, Li D, Soares H, Anthony L, Kotiah S, Jacene H, Pavel M, Kunz P, Ferreira D, Li J, Ma K, Rearden J, Moran S, Hope T, Singh S. ACTION-1 phase Ib/3 trial of RYZ101 in somatostatin receptor subtype 2–expressing (SSTR2+) gastroenteropancreatic neuroendocrine tumors (GEP-NET) progressing after 177Lu somatostatin analogue (SSA) therapy: Initial safety analysis. Journal Of Clinical Oncology 2023, 41: 4132-4132. DOI: 10.1200/jco.2023.41.16_suppl.4132.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAdverse eventsGEP-NETsTarget dose-limiting toxicity (DLT) rateDose de-escalation studyTreatment-related serious AEsDose-limiting toxicity rateData review committeeDe-escalation studiesECOG PS 0Phase 3 doseSomatostatin analogue therapySerious adverse eventsGastroenteropancreatic neuroendocrine tumorsStandard of careSomatostatin receptor subtypesInitial safety analysisSerious AEsAnalogue therapyPS 0Dose escalationKBq/Neuroendocrine tumorsToxicity ratesDisease progressionConsensus report of the 2021 National Cancer Institute neuroendocrine tumor clinical trials planning meeting
Singh S, Hope T, Bergsland E, Bodei L, Bushnell D, Chan J, Chasen B, Chauhan A, Das S, Dasari A, Del Rivero J, El-Haddad G, Goodman K, Halperin D, Lewis M, Lindwasser O, Myrehaug S, Raj N, Reidy-Lagunes D, Soares H, Strosberg J, Kohn E, Kunz P, Bergsland E, Beveridge T, Bodei L, Borek A, Brockman M, Bushnell D, Capala J, Chan J, Chasen B, Chauhan A, Das S, Dasari N, Davies-Venn C, Del Rivero J, Demaria S, Donoghue M, Eads J, El-Haddad G, Fielman N, Fishbein L, Gericke G, Goodman K, Halperin D, Hendifar A, Hicks R, Hobbs R, Hobday T, Hope T, Iyer R, Jaffe D, Kennedy A, Kohn E, Kulke M, Kunos C, Kunz P, Lewis M, Lin F, Lindwasser W, Mailman J, McDonald M, McEwan S, Myrehaug S, Nakasato A, Nothwehr S, Ou F, Padda S, Pavel M, Pilowa A, Raj N, Ramnaraign B, Reidy-Lagunes D, Rubinstein L, Saletan S, Shah M, Singh S, Soares H, Soulen M, Strosberg J, Untch B, Wahba M, Wong R, Yao J. Consensus report of the 2021 National Cancer Institute neuroendocrine tumor clinical trials planning meeting. Journal Of The National Cancer Institute 2023, 115: 1001-1010. PMID: 37255328, PMCID: PMC10483264, DOI: 10.1093/jnci/djad096.Peer-Reviewed Original ResearchConceptsPeptide receptor radionuclide therapyClinical trialsNeuroendocrine tumorsNeuroendocrine neoplasmsClinical trial recommendationsLiver-dominant diseaseReceptor radionuclide therapyTumor clinical trialsUse of dosimetryImmunotherapy combinationsTherapeutic optionsTreatment optionsGastroenteropancreatic NETsTrial recommendationsConsensus reportNew agentsInhibitor combinationsRadionuclide therapyPatient advocatesMultidisciplinary expertsOptimal sequencingTrialsTreatmentTherapyDiseaseA review of diversity, equity, and inclusion (DEI) efforts by medical oncology journals.
Abuali I, Parikh A, Kunz P. A review of diversity, equity, and inclusion (DEI) efforts by medical oncology journals. Journal Of Clinical Oncology 2023, 41: 11023-11023. DOI: 10.1200/jco.2023.41.16_suppl.11023.Peer-Reviewed Original ResearchNovel 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 variabilityAge- and sex-based differences in the genomic profiles of patients with gastrointestinal (GI) and pancreatic neuroendocrine neoplasms (NENs).
Liu L, Li S, Gandhi N, Farrell A, Lou E, Soares H, Nazha B, Swensen J, Oberley M, Nabhan C, Abraham J, Korn W, Kunz P, Vijayvergia N. Age- and sex-based differences in the genomic profiles of patients with gastrointestinal (GI) and pancreatic neuroendocrine neoplasms (NENs). Journal Of Clinical Oncology 2023, 41: 655-655. DOI: 10.1200/jco.2023.41.4_suppl.655.Peer-Reviewed Original ResearchNeuroendocrine neoplasmsPancreatic neuroendocrine neoplasmsP-NENsGI-NENGI-NENsImmune profileKRAS mutationsImmune checkpoint gene expressionHigh tumor mutation burdenCaris Life SciencesDMMR/MSIDistinct immune profilesTumor mutation burdenYears of ageMechanisms of ageWhole-exome sequencingMann-Whitney USex-based differencesSite of originDistinct molecular profilesICGs expressionAge-associated effectsOverall survivalPatient demographicsImmune landscapeA 46-Year-Old Woman With Chronic Dyspnea and Diarrhea
Kshattry S, White M, Tchack J, Laskin W, Kunz P. A 46-Year-Old Woman With Chronic Dyspnea and Diarrhea. CHEST Journal 2023, 163: e23-e29. PMID: 36628681, DOI: 10.1016/j.chest.2022.08.2214.Peer-Reviewed Original ResearchConceptsPack-year historyCurrent tobacco usePertinent medical historyReview of systemsNew edemaAbdominal painChest painChronic dyspneaHealthy womenHot flashesRecent travelMedical historyDegree relativesFamily historyTobacco useOlder womenColon cancerHeart palpitationsMedical careWeight lossDyspneaPainDiarrheaWomenEpisodes
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 modalitiesMonthsInjectionTumorsWhere Are All the Women in Industry Advisory Boards?
Shroff R, Goodman K, Mehnert J, Vose J, Moran S, Yessaian J, Baldo L, Alexander B, Highsmith Q, Mills J, Kunz P. Where Are All the Women in Industry Advisory Boards? Journal Of Clinical Oncology 2022, 41: 1659-1663. PMID: 36331246, DOI: 10.1200/jco.21.02219.Peer-Reviewed Original ResearchExploratory genomic analysis of high-grade neuroendocrine neoplasms across diverse primary sites.
Sun TY, Zhao L, Van Hummelen P, Martin B, Hornbacker K, Lee H, Xia LC, Padda SK, Ji HP, Kunz P. Exploratory genomic analysis of high-grade neuroendocrine neoplasms across diverse primary sites. Endocrine Related Cancer 2022, 29: 665-679. PMID: 36165930, PMCID: PMC10043760, DOI: 10.1530/erc-22-0015.Peer-Reviewed Original ResearchConceptsHigh-grade neuroendocrine neoplasmsDiverse primary sitesG3 NENNeuroendocrine neoplasmsPrimary siteHigh tumor mutation burdenExploratory genomic analysisTumor mutation burdenPoor survival outcomesMutations/MbDifferent primary sitesOrgan of originRare cancer typesSurvival outcomesWorse prognosisRare tumorCell cycling pathwaysMutation burdenTherapeutic implicationsClinical standpointSomatic copy number alterationsCopy number alterationsCancer typesNeoplasmsUpregulation of oncogenesPMON57 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 siteEndpoint