2022
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).
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
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