2022
Randomized Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors (ECOG-ACRIN E2211)
Kunz PL, Graham NT, Catalano PJ, Nimeiri HS, Fisher GA, Longacre TA, Suarez CJ, Martin BA, Yao JC, Kulke MH, Hendifar AE, Shanks JC, Shah MH, Zalupski MM, Schmulbach EL, Reidy-Lagunes DL, Strosberg JR, O'Dwyer PJ, O'Dwyer P, Benson A. Randomized Study of Temozolomide or Temozolomide and Capecitabine in Patients With Advanced Pancreatic Neuroendocrine Tumors (ECOG-ACRIN E2211). Journal Of Clinical Oncology 2022, 41: 1359-1369. PMID: 36260828, PMCID: PMC9995105, DOI: 10.1200/jco.22.01013.Peer-Reviewed Original ResearchConceptsAdvanced pancreatic neuroendocrine tumorsProgression-free survivalPancreatic neuroendocrine tumorsMedian progression-free survivalPrimary end pointNeuroendocrine tumorsResponse rateObjective responseOverall survivalRandomized studyIntermediate-grade pancreatic neuroendocrine tumorsLonger progression-free survivalEnd pointMGMT deficiencyMedian overall survivalPrimary analysis populationKey eligibility criteriaPhase II trialSmall prospective studiesHigh response rateMethylguanine methyltransferaseCapecitabine/Eligible patientsSecondary endpointsII trialA 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 analysisEverolimus with or without bevacizumab in advanced pNET: CALGB 80701 (Alliance).
Kulke MH, Ou FS, Niedzwiecki D, Huebner L, Kunz P, Kennecke HF, Wolin EM, Chan JA, O'Reilly EM, Meyerhardt JA, Venook A. Everolimus with or without bevacizumab in advanced pNET: CALGB 80701 (Alliance). Endocrine Related Cancer 2022, 29: 335-344. PMID: 35324465, PMCID: PMC9257687, DOI: 10.1530/erc-21-0239.Peer-Reviewed Original ResearchConceptsAdvanced pancreatic neuroendocrine tumorsProgression-free survivalPancreatic neuroendocrine tumorsVEGF pathway inhibitorsCombination armPrimary endpointMedian overall survival durationTreatment-related adverse eventsImproved progression-free survivalRandomized phase II studySuperior progression-free survivalPathway inhibitorOverall survival durationPhase II studyTreatment-related toxicityCombination of everolimusMTOR inhibitor everolimusHigh response rateAdverse eventsII studyInvestigator reviewCombination therapyStandard doseInhibitor everolimusNeuroendocrine tumors
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