2024
[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 carePhase 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
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.
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 progression
2009
Adjuvant chemoradiotherapy with carboplatin and a fluoropyrimidine for resectable gastric and gastroesophageal junction cancer: A retrospective review of the Stanford experience
de Bruin M, Kunz P, Sharma V, Norton J, Bastidas J, Chang D, Koong A, Koong A, Balise R, Ford J, Fisher G. Adjuvant chemoradiotherapy with carboplatin and a fluoropyrimidine for resectable gastric and gastroesophageal junction cancer: A retrospective review of the Stanford experience. Journal Of Clinical Oncology 2009, 27: e15674-e15674. DOI: 10.1200/jco.2009.27.15_suppl.e15674.Peer-Reviewed Original ResearchStanford Cancer CenterGEJ cancerAdjuvant chemoradiotherapyRetrospective reviewCycles of carboplatinPercentage of patientsGastroesophageal junction cancerGastroesophageal junction adenocarcinomaStandard of careExternal beam radiotherapyInfusional 5FUModified regimenPo bidPositive gastricResectable gastricAdjuvant treatmentCurative intentCurative resectionGastrointestinal toxicityMean followStage IBStage IIIAStage IIIBJunction cancerOverall survival