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
2012
Phase I trial of ixabepilone administered as three oral doses each separated by 6 hours every 3 weeks in patients with advanced solid tumors
Kunz PL, He AR, Colevas AD, Pishvaian MJ, Hwang JJ, Clemens PL, Messina M, Kaleta R, Abrahao F, Sikic BI, Marshall JL. Phase I trial of ixabepilone administered as three oral doses each separated by 6 hours every 3 weeks in patients with advanced solid tumors. Investigational New Drugs 2012, 30: 2364-2370. PMID: 22331549, PMCID: PMC3703248, DOI: 10.1007/s10637-012-9800-3.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedDrug Administration ScheduleEpothilonesFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasmsTreatment OutcomeTubulin ModulatorsConceptsNeutropenic sepsisGrade 4 febrile neutropeniaDoses of ixabepiloneAdvanced solid tumorsExcellent performance statusPhase I trialSerial plasma samplesPlasma drug concentrationsRefractory advanced cancersHigh inter-individual variabilityFebrile neutropeniaPerformance statusI trialMedian ageAdvanced cancerInter-individual variabilityOral dosesSafety profileCohort 2Cohort 1Cohort 3PK variabilityOral formulationIxabepilonePatients
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