2022
A phase II study of sapanisertib (TAK-228) a mTORC1/2 inhibitor in rapalog-resistant advanced pancreatic neuroendocrine tumors (PNET): ECOG-ACRIN EA2161
Rajdev L, Lee JW, Libutti SK, Benson AB, Fisher GA, Kunz PL, Hendifar AE, Catalano P, O’Dwyer P. A phase II study of sapanisertib (TAK-228) a mTORC1/2 inhibitor in rapalog-resistant advanced pancreatic neuroendocrine tumors (PNET): ECOG-ACRIN EA2161. Investigational New Drugs 2022, 40: 1306-1314. PMID: 36264382, PMCID: PMC9795724, DOI: 10.1007/s10637-022-01311-w.Peer-Reviewed Original ResearchConceptsPancreatic neuroendocrine tumorsNeuroendocrine tumorsTreatment-related grade 3 adverse eventsGrade 3 adverse eventsAdvanced pancreatic neuroendocrine tumorsTwo-stage phase II trialObjective tumor responsePhase II studyPhase II trialContinuous dosing scheduleStage 1Lack of responseEligible patientsMedian OSMedian PFSII trialAdverse eventsII studyObjective responseDosing schedulesTumor responseClinical activityPatientsMTOR pathwayMTORC1/2 inhibitorsRandomized 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 analysis
2021
Final overall survival in the phase 3 NETTER-1 study of lutetium-177-DOTATATE in patients with midgut neuroendocrine tumors.
Strosberg J, Caplin M, Kunz P, Ruszniewski P, Bodei L, Hendifar A, Mittra E, Wolin E, Yao J, Pavel M, Grande E, Van Cutsem E, Seregni E, Duarte H, Gericke G, Bartalotta A, Demange A, Mutevelic S, Krenning E, group O. Final overall survival in the phase 3 NETTER-1 study of lutetium-177-DOTATATE in patients with midgut neuroendocrine tumors. Journal Of Clinical Oncology 2021, 39: 4112-4112. DOI: 10.1200/jco.2021.39.15_suppl.4112.Peer-Reviewed Original ResearchProgression-free survivalMedian overall survivalFinal overall survivalNETTER-1 studyNETTER-1 trialNew safety signalsOverall survivalMidgut neuroendocrine tumorsControl armMyelodysplastic syndromeNeuroendocrine tumorsLu-DOTATATEPrimary endpointLast patientSafety signalsFurther anti-cancer treatmentBest supportive careKey secondary endpointOpen-label trialLutetium-177 DOTATATEAnti-cancer treatmentEligible patientsNETTER-1RECIST 1.1Secondary endpoints
2018
Phase II study of epacadostat with pembrolizumab in metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma requiring paired biopsies.
Kardosh A, Tseng D, Sahaf B, Zomet A, Krupa J, Fisher G, Wang D, Mackall C, Kunz P. Phase II study of epacadostat with pembrolizumab in metastatic or unresectable gastroesophageal junction and gastric adenocarcinoma requiring paired biopsies. Journal Of Clinical Oncology 2018, 36: tps191-tps191. DOI: 10.1200/jco.2018.36.4_suppl.tps191.Peer-Reviewed Original ResearchProgression-free survivalGastroesophageal junctionOverall survivalResponse rateGastric adenocarcinomaECOG performance status 0Phase II clinical trialPDL-1 expressionPerformance status 0Single-agent pembrolizumabMedian overall survivalPD-1 inhibitorsPhase II studyIncidence of adenocarcinomaGastroesophageal junction adenocarcinomaComprehensive immune profilingMajor health problemCombination immunotherapyEligible patientsKEYNOTE-059PFS ratesPrior therapyPrior trastuzumabStatus 0Advanced disease
2017
Understanding the Patient Experience with Carcinoid Syndrome: Exit Interviews from a Randomized, Placebo-controlled Study of Telotristat Ethyl
Anthony L, Ervin C, Lapuerta P, Kulke MH, Kunz P, Bergsland E, Hörsch D, Metz DC, Pasieka J, Pavlakis N, Pavel M, Caplin M, Öberg K, Ramage J, Evans E, Yang QM, Jackson S, Arnold K, Law L, DiBenedetti DB. Understanding the Patient Experience with Carcinoid Syndrome: Exit Interviews from a Randomized, Placebo-controlled Study of Telotristat Ethyl. Clinical Therapeutics 2017, 39: 2158-2168. PMID: 29074312, DOI: 10.1016/j.clinthera.2017.09.013.Peer-Reviewed Original ResearchConceptsTelotristat ethylBM frequencyCarcinoid syndromeBowel movementsPatient experienceDouble-blind treatment periodCarcinoid syndrome symptomsPrimary end pointSomatostatin analogue therapyPhase III studyClinical trial experienceTryptophan hydroxylase inhibitorEligible patientsStudy drugAnalogue therapyIII studyPatient interviewsResponder analysisTreatment periodPatient reportsSyndrome symptomsTreatment responsePrespecified criteriaHydroxylase inhibitorPatients
2014
A novel biomarker panel examining response to adjuvant pancreatic cancer therapy in RTOG 9704.
Heestand G, Murphy J, Moughan J, Regine W, Luo J, Graber M, Kunz P, Fisher G, Guha C, Lin B, Mowat R, Gaur R, Buyyounouski M, Chen Y, Chang D, Koong A. A novel biomarker panel examining response to adjuvant pancreatic cancer therapy in RTOG 9704. Journal Of Clinical Oncology 2014, 32: 176-176. DOI: 10.1200/jco.2014.32.3_suppl.176.Peer-Reviewed Original ResearchDisease-free survivalMatrix metalloproteinase-7RTOG 9704MMP-7 serum levelsProximity ligation assaySerum samplesBaseline serum specimensBaseline serum samplesResected stage ILevels of CEAPancreatic cancer patientsPancreatic cancer therapyNovel biomarker panelNational Cancer InstituteGEM armImproved OSEligible patientsOS benefitAdjuvant therapyGemcitabine chemotherapySerum levelsCA 19Cancer patientsClinical endpointsPancreatic cancer