2024
Safety and time to response of [177Lu]Lu-DOTATATE in patients with newly diagnosed advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Sub-analysis of the phase 3 randomized NETTER-2 study.
Kunz P, Ferone D, Halperin D, Myrehaug S, Herrmann K, Pavel M, Chasen B, Capdevila J, Tafuto S, Oh D, Yoo C, Falk S, Halfdanarson T, Folitar I, Zhang Y, de Herder W, Singh S. Safety and time to response of [177Lu]Lu-DOTATATE in patients with newly diagnosed advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Sub-analysis of the phase 3 randomized NETTER-2 study. Journal Of Clinical Oncology 2024, 42: 4131-4131. DOI: 10.1200/jco.2024.42.16_suppl.4131.Peer-Reviewed Original ResearchTime to responseObjective response rateGastroenteropancreatic neuroendocrine tumorsLu-DOTATATEGEP-NETsAdverse eventsHematologic toxicityNeuroendocrine tumorsSafety profileSub-analysisMedian time to responseCases of myelodysplastic syndromeOctreotide long-actingHematologic adverse eventsProgression-free survivalTime to first occurrenceRandomized treatment periodFatal adverse eventsInfection rateDose interruptionCTCAE gradeRadioligand therapyMyelodysplastic syndromeEligible ptsLaboratory abnormalities
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 ResearchConceptsNeutropenic 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