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
2014
Phase II clinical trial of pasireotide LAR in patients with metastatic neuroendocrine tumors.
Strosberg J, Jump H, Valone T, Weber J, Khandelwal V, Kunz P. Phase II clinical trial of pasireotide LAR in patients with metastatic neuroendocrine tumors. Journal Of Clinical Oncology 2014, 32: 241-241. DOI: 10.1200/jco.2014.32.3_suppl.241.Peer-Reviewed Original ResearchPasireotide LARSomatostatin analoguesMedian PFSLong-term insulin therapySomatostatin receptor subtypes 1Phase II clinical trialBest radiographic responseGrade 3 hyperglycemiaPrior systemic therapyRates of hyperglycemiaYear OS ratesTreatment-naïve patientsMetastatic neuroendocrine tumorsPhase II trialIntermediate-grade tumorsNovel somatostatin analogReceptor subtype 1LAR treatmentQ4 weeksStable diseaseII trialNaïve patientsPrimary endpointRefractory patientsInsulin therapy
2011
Single-Fraction Stereotactic Body Radiation Therapy and Sequential Gemcitabine for the Treatment of Locally Advanced Pancreatic Cancer
Schellenberg D, Kim J, Christman-Skieller C, Chun CL, Columbo LA, Ford JM, Fisher GA, Kunz PL, Van Dam J, Quon A, Desser TS, Norton J, Hsu A, Maxim PG, Xing L, Goodman KA, Chang DT, Koong AC. Single-Fraction Stereotactic Body Radiation Therapy and Sequential Gemcitabine for the Treatment of Locally Advanced Pancreatic Cancer. International Journal Of Radiation Oncology • Biology • Physics 2011, 81: 181-188. PMID: 21549517, DOI: 10.1016/j.ijrobp.2010.05.006.Peer-Reviewed Original ResearchConceptsSingle-fraction stereotactic body radiotherapyAdvanced pancreatic cancerSequential gemcitabinePancreatic cancerGrade 3Local controlIntensity-modulated radiotherapy techniqueStereotactic body radiation therapyGreater nonhematologic toxicityLate grade 3Nonmetastatic pancreatic adenocarcinomaAcute grade 3Cycles of chemotherapyFraction Stereotactic Body Radiation TherapyExcellent local controlPhase II trialStereotactic body radiotherapyBody radiation therapyInternal target volumeInstitutional review boardNonhematologic toxicityAlive patientsII trialLocal progressionDuodenal perforation
2008
Phase II Trial of Single Fraction Stereotactic Body Radiotherapy Delivered by Trilogy Linear Accelerator for the Treatment of Locally Advanced Adenocarcinoma of the Pancreas
Schellenberg D, Kim J, Columbo L, Lee C, Fisher G, Kunz P, Maxim P, Goodman K, Chang D, Koong A. Phase II Trial of Single Fraction Stereotactic Body Radiotherapy Delivered by Trilogy Linear Accelerator for the Treatment of Locally Advanced Adenocarcinoma of the Pancreas. International Journal Of Radiation Oncology • Biology • Physics 2008, 72: s127. DOI: 10.1016/j.ijrobp.2008.06.428.Peer-Reviewed Original Research