2020
A phase II study of dose-dense temozolomide and lapatinib for recurrent low-grade and anaplastic supratentorial, infratentorial, and spinal cord ependymoma
Gilbert MR, Yuan Y, Wu J, Mendoza T, Vera E, Omuro A, Lieberman F, Robins HI, Gerstner ER, Wu J, Wen PY, Mikkelsen T, Aldape K, Armstrong TS. A phase II study of dose-dense temozolomide and lapatinib for recurrent low-grade and anaplastic supratentorial, infratentorial, and spinal cord ependymoma. Neuro-Oncology 2020, 23: 468-477. PMID: 33085768, PMCID: PMC7992893, DOI: 10.1093/neuonc/noaa240.Peer-Reviewed Original ResearchConceptsProgression-free survivalDose-dense temozolomideMedian progression-free survivalAdult patientsObjective responseSymptom burdenClinical trialsRecurrent ependymomaMD Anderson Symptom Inventory-Brain TumorProspective phase II clinical trialMedian Karnofsky performance statusPhase II clinical trialDemonstrated clinical activityModerate-severe painPatients age 18Phase II studyKarnofsky performance statusProspective clinical trialsSpinal cord tumorsStandard medical treatmentPrimary outcome measureSpinal cord ependymomasDisease-related symptomsExpression of ErbB2Daily lapatinib
2017
OS07.3 Nivolumab in Combination With Radiotherapy With or Without Temozolomide in Patients With Newly Diagnosed Glioblastoma: Updated Results From CheckMate 143
Omuro A, Vlahovic G, Baehring J, Butowski N, Reardon D, Cloughesy T, Sahebjam S, Lim M, Zwirtes R, Sampson J. OS07.3 Nivolumab in Combination With Radiotherapy With or Without Temozolomide in Patients With Newly Diagnosed Glioblastoma: Updated Results From CheckMate 143. Neuro-Oncology 2017, 19: iii13-iii13. PMCID: PMC5463686, DOI: 10.1093/neuonc/nox036.044.Peer-Reviewed Original ResearchTreatment-related AEsAdverse eventsCheckMate 143Standard radiotherapyDisease progressionFirst prospective clinical trialHerpes simplex virus encephalitisTreatment-related adverse eventsTolerability of nivolumabTreatment-related deathsImmune checkpoint inhibitorsSimplex virus encephalitisDeath-1 receptorNew safety signalsPhase 2/3 studyProspective clinical trialsImmune cell infiltrationNovel therapeutic optionsMonoclonal antibody inhibitorMultiple cancer typesConcurrent temozolomideUnmethylated MGMTAdjuvant temozolomideCheckpoint inhibitorsRadiographic progression
2016
ATIM-16. NIVOLUMAB COMBINED WITH RADIOTHERAPY WITH OR WITHOUT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA: RESULTS FROM PHASE 1 SAFETY COHORTS IN CHECKMATE 143
Omuro A, Vlahovic G, Baehring J, Butowski N, Reardon D, Cloughesy T, Sahebjam S, Lim M, Strauss L, Latek R, Zwirtes R, Paliwal P, Harbison C, Sampson J. ATIM-16. NIVOLUMAB COMBINED WITH RADIOTHERAPY WITH OR WITHOUT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA: RESULTS FROM PHASE 1 SAFETY COHORTS IN CHECKMATE 143. Neuro-Oncology 2016, 18: vi21-vi21. DOI: 10.1093/neuonc/now212.081.Peer-Reviewed Original ResearchAdverse eventsCheckMate 143Frequent treatment-related adverse eventsTreatment-related serious adverse eventsFirst prospective clinical trialProgression/unacceptable toxicityTreatment-related adverse eventsCombination of nivolumabTolerability of nivolumabSerious adverse eventsDeath-1 receptorProspective clinical trialsNew safety concernsMonoclonal antibody inhibitorMultiple cancer typesMeasurable diseaseNivolumab CombinedSafety cohortToxic deathsTumor flareRadiographic progressionTreatment discontinuationMost patientsUnacceptable toxicityPoor prognosis
2015
A Detailed Evaluation of Transplant-Related Toxicities and Outcome for Patients with CNS Lymphoma (CNSL) Consolidated with High-Dose Therapy and Autologous Stem Cell Transplantation (HDT-ASCT) Using Thiotepa, Busulfan (Bu), Cyclophosphamide (TBC) Conditioning
Scordo M, Bhatt V, Hsu M, Omuro A, Matasar M, DeAngelis L, Dahi P, Moskowitz C, Giralt S, Sauter C. A Detailed Evaluation of Transplant-Related Toxicities and Outcome for Patients with CNS Lymphoma (CNSL) Consolidated with High-Dose Therapy and Autologous Stem Cell Transplantation (HDT-ASCT) Using Thiotepa, Busulfan (Bu), Cyclophosphamide (TBC) Conditioning. Blood 2015, 126: 4354. DOI: 10.1182/blood.v126.23.4354.4354.Peer-Reviewed Original ResearchNon-hematologic toxicitiesProgression-free survivalKaplan-Meier curvesSignificant grade 3HDT-ASCTMore grade 3Whole brain radiotherapyKarnofsky performance statusOverall survivalCNS lymphomaGrade 3Prior regimensHematopoietic cell transplant comorbidity indexAutologous stem cell transplantationHigh-dose therapyTransplant-related mortalityKaplan-Meier methodProspective clinical trialsRetrospective chart reviewStem cell transplantationGroups of ptsInitiation of conditioningYears of ageBU pharmacokineticsCTCAE 4.0
2014
AT-07A PHASE II STUDY OF LAPATINIB AND DOSE-DENSE TEMOZOLOMIDE (TMZ) FOR ADULTS WITH RECURRENT EPENDYMOMA: PATIENT REPORTED OUTCOMES (PRO) FROM A CERN CLINICAL TRIAL
Armstrong T, Vera-Bolanos E, Gilbert M, Yuan Y, Wani K, Wu J, Omuro A, Lieberman F, Robins H, Gerstner E, Wu J, Wen P, Mikkelsen T, Aldape K, Mendoza T. AT-07A PHASE II STUDY OF LAPATINIB AND DOSE-DENSE TEMOZOLOMIDE (TMZ) FOR ADULTS WITH RECURRENT EPENDYMOMA: PATIENT REPORTED OUTCOMES (PRO) FROM A CERN CLINICAL TRIAL. Neuro-Oncology 2014, 16: v9-v9. PMCID: PMC4217844, DOI: 10.1093/neuonc/nou237.7.Peer-Reviewed Original ResearchDose-dense temozolomideProgression-free survivalSymptom burdenClinical trialsDisease progressionRecurrent ependymomaFirst prospective clinical trialMedian progression-free survivalPatient Reported Outcome MeasuresPhase II studyOverall symptom burdenProspective clinical trialsPrimary CNS tumorCycle 6Majority of symptomsDry mouthFree survivalPrimary endpointRecurrent diseaseSymptom benefitCNS tumorII studyTreatment courseSymptom interferenceVision changesAT-23A PHASE II STUDY OF LAPATINIB AND DOSE-DENSE TEMOZOLOMIDE (TMZ) FOR ADULTS WITH RECURRENT EPENDYMOMA: A CERN CLINICAL TRIAL
Gilbert M, Yuan Y, Wani K, Wu J, Omuro A, Lieberman F, Robins H, Gerstner E, Wu J, Wen P, Mikkelsen T, Armstrong T, Aldape K. AT-23A PHASE II STUDY OF LAPATINIB AND DOSE-DENSE TEMOZOLOMIDE (TMZ) FOR ADULTS WITH RECURRENT EPENDYMOMA: A CERN CLINICAL TRIAL. Neuro-Oncology 2014, 16: v13-v13. PMCID: PMC4217801, DOI: 10.1093/neuonc/nou237.23.Peer-Reviewed Original ResearchDose-dense temozolomideClinical trialsPredictive markerFirst prospective clinical trialPhase II studyPrimary CNS tumorsProspective clinical trialsPossible predictive markerPotential predictive markerPatient reported outcomesSubsequent clinical trialsMGMT promoter statusMedian KPSMedian progressionPrimary endpointRecurrent diseaseII studyOverall survivalSymptom burdenMedian ageInitial treatmentCNS tumorsExtensive resectionStandard treatmentPRO collection