2023
Multicenter Phase 2 Trial of the PARP Inhibitor Olaparib in Recurrent IDH1 and IDH2-Mutant Glioma
Fanucci K, Pilat M, Shyr D, Shyr Y, Boerner S, Li J, Durecki D, Drappatz J, Puduvalli V, Lieberman F, Gonzalez J, Giglio P, Ivy S, Bindra R, Omuro A, LoRusso P. Multicenter Phase 2 Trial of the PARP Inhibitor Olaparib in Recurrent IDH1 and IDH2-Mutant Glioma. Cancer Research Communications 2023, 3: 192-201. PMID: 36968138, PMCID: PMC10035510, DOI: 10.1158/2767-9764.crc-22-0436.Peer-Reviewed Original ResearchConceptsProgression-free survivalMedian progression-free survivalProlonged stable diseaseStable diseasePhase II trialGrade 4 tumorsII trialOlaparib monotherapyGrade 2Multicenter phase 2 trialSingle-arm phase II trialWorld Health Organization classificationMedian overall survivalNeuro-Oncology criteriaPhase 2 trialOverall response rateFuture patient stratificationMutant gliomasPARP inhibitor olaparibEvaluable patientsPrimary endpointOverall survivalProgressive diseaseSelect patientsClinical benefit
2022
Multicenter phase 2 trial of the PARP inhibitor (PARPi) olaparib in recurrent IDH1 and IDH2-mutant contrast-enhancing glioma.
Fanucci K, Pilat M, Shah R, Boerner S, Li J, Durecki D, Drappatz J, Collichio F, Puduvalli V, Lieberman F, Gonzalez J, Giglio P, Bao X, Ivy S, Bindra R, Omuro A, LoRusso P. Multicenter phase 2 trial of the PARP inhibitor (PARPi) olaparib in recurrent IDH1 and IDH2-mutant contrast-enhancing glioma. Journal Of Clinical Oncology 2022, 40: 2035-2035. DOI: 10.1200/jco.2022.40.16_suppl.2035.Peer-Reviewed Original ResearchProgression-free survivalMedian progression-free survivalStable diseaseDuration of responseOverall response ratePARP inhibitorsOverall survivalStandard therapyOlaparib monotherapyMulticenter phase 2 trialCDKN2A deletionClinical predictive markersGrade 3 lymphopeniaProlonged stable diseasePhase 2 trialGrade 4 tumorsFuture patient stratificationRecent preclinical studiesHigh-grade gliomasNovel drug combinationsContrast-enhancing gliomasEligible ptsEvaluable ptsRecent histologyPrimary endpointPhase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter
Lim M, Weller M, Idbaih A, Steinbach J, Finocchiaro G, Raval RR, Ansstas G, Baehring J, Taylor JW, Honnorat J, Petrecca K, De Vos F, Wick A, Sumrall A, Sahebjam S, Mellinghoff IK, Kinoshita M, Roberts M, Slepetis R, Warad D, Leung D, Lee M, Reardon DA, Omuro A. Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. Neuro-Oncology 2022, 24: 1935-1949. PMID: 35511454, PMCID: PMC9629431, DOI: 10.1093/neuonc/noac116.Peer-Reviewed Original ResearchConceptsProgression-free survivalOverall survivalMGMT promoterBaseline corticosteroidsTreatment-related adverse event ratesImmune checkpoint inhibitor nivolumabNew safety signalsPhase III trialsAdverse event ratesCheckpoint inhibitor nivolumabCare radiotherapyInhibitor nivolumabPrimary endpointIII trialsSame regimenExperience recurrenceNivolumabSafety signalsPlaceboPatientsRadiotherapyTemozolomideEvent ratesMonthsPhase IIIRadiotherapy combined with nivolumab or temozolomide for newly diagnosed glioblastoma with unmethylated MGMT promoter: An international randomized phase III trial
Omuro A, Brandes AA, Carpentier AF, Idbaih A, Reardon DA, Cloughesy T, Sumrall A, Baehring J, van den Bent M, Bähr O, Lombardi G, Mulholland P, Tabatabai G, Lassen U, Sepulveda JM, Khasraw M, Vauleon E, Muragaki Y, Di Giacomo AM, Butowski N, Roth P, Qian X, Fu AZ, Liu Y, Potter V, Chalamandaris AG, Tatsuoka K, Lim M, Weller M. Radiotherapy combined with nivolumab or temozolomide for newly diagnosed glioblastoma with unmethylated MGMT promoter: An international randomized phase III trial. Neuro-Oncology 2022, 25: 123-134. PMID: 35419607, PMCID: PMC9825306, DOI: 10.1093/neuonc/noac099.Peer-Reviewed Original ResearchConceptsOverall survivalUnmethylated MGMT promoterMedian OSPrimary endpointInternational randomized phase III trialTreatment-related adverse event ratesMedian progression-free survivalRandomized phase III trialMGMT promoterEfficacy of nivolumabLonger median OSMedian overall survivalNew safety signalsProgression-free survivalAddition of temozolomideAdverse event ratesPhase III trialsUse of temozolomideStandard of careStudy treatment armsImproved OSIII trialsTreatment armsStandard radiotherapyNivolumabNivolumab plus radiotherapy with or without temozolomide in newly diagnosed glioblastoma: Results from exploratory phase I cohorts of CheckMate 143
Omuro A, Reardon DA, Sampson JH, Baehring J, Sahebjam S, Cloughesy TF, Chalamandaris AG, Potter V, Butowski N, Lim M. Nivolumab plus radiotherapy with or without temozolomide in newly diagnosed glioblastoma: Results from exploratory phase I cohorts of CheckMate 143. Neuro-Oncology Advances 2022, 4: vdac025. PMID: 35402913, PMCID: PMC8989388, DOI: 10.1093/noajnl/vdac025.Peer-Reviewed Original ResearchSafety/tolerabilityNew safety signalsOverall survivalCheckMate 143Median OSSafety signalsGrade 3/4 treatment-related adverse eventsTreatment-related adverse eventsEfficacy of nivolumabImmune checkpoint inhibitionMedian overall survivalPhase 1 cohortFirst-line treatmentPart APrimary endpointSecondary endpointsAdverse eventsCheckpoint inhibitionPatientsI cohortNivolumabTemozolomideRadiotherapyMonthsPart B
2021
CTIM-25. A RANDOMIZED PHASE 3 STUDY OF NIVOLUMAB OR PLACEBO COMBINED WITH RADIOTHERAPY PLUS TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA WITH METHYLATED MGMT PROMOTER: CHECKMATE 548
Weller M, Lim M, Idbaih A, Steinbach J, Finocchiaro G, Raval R, Ashby L, Ansstas G, Baehring J, Taylor J, Honnorat J, Petrecca K, de Vos F, Wick A, Sumrall A, Roberts M, Slepetis R, Warad D, Lee M, Reardon D, Omuro A. CTIM-25. A RANDOMIZED PHASE 3 STUDY OF NIVOLUMAB OR PLACEBO COMBINED WITH RADIOTHERAPY PLUS TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA WITH METHYLATED MGMT PROMOTER: CHECKMATE 548. Neuro-Oncology 2021, 23: vi55-vi56. PMCID: PMC8598415, DOI: 10.1093/neuonc/noab196.217.Peer-Reviewed Original ResearchProgression-free survivalMedian overall survivalPhase 3 studyOverall survivalMGMT promoterBaseline corticosteroidsMedian progression-free survivalTreatment-related adverse eventsRandomized phase 3 studyTumor PD-L1 expressionBlinded independent central reviewDual primary endpointsRole of immunotherapyNew safety signalsPD-L1 expressionPositive prognostic factorIndependent central reviewPredictors of benefitCare radiotherapyTreatment landscapeAdverse eventsPrognostic factorsCentral reviewNivolumabNovel therapies
2020
CTNI-50. NEUROCOGNITIVE FUNCTION (NCF) OF THE PHOTON COHORT IN NRG-BN001
Wefel J, DeMora L, Gondi V, Tsien C, Chenevert T, Gilbert M, Omuro A, Cao Y, Srinivasan A, Rogers L, Shi W, Nedzi L, Chan M, Suh J, Battiste J, Mishra M, Shivnani A, Movsas B, Mehta M. CTNI-50. NEUROCOGNITIVE FUNCTION (NCF) OF THE PHOTON COHORT IN NRG-BN001. Neuro-Oncology 2020, 22: ii53-ii54. PMCID: PMC7651205, DOI: 10.1093/neuonc/noaa215.216.Peer-Reviewed Original ResearchNeurocognitive functionNCF testsSD-RTCycle 3Ongoing randomized phase II trialRandomized phase II trialNon-significant timeSecondary endpoint analysisPhase II trialMixed effects longitudinal modelsTreatment effect interactionEvaluable patientsNCF outcomesPhoton cohortsEligible patientsII trialOverall survivalPatient refusalRadiation therapyGroup 2Common reasonGroup 1Arm differencesPatientsEffects longitudinal modelsEffect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma
Reardon DA, Brandes AA, Omuro A, Mulholland P, Lim M, Wick A, Baehring J, Ahluwalia MS, Roth P, Bähr O, Phuphanich S, Sepulveda JM, De Souza P, Sahebjam S, Carleton M, Tatsuoka K, Taitt C, Zwirtes R, Sampson J, Weller M. Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma. JAMA Oncology 2020, 6: 1003-1010. PMID: 32437507, PMCID: PMC7243167, DOI: 10.1001/jamaoncol.2020.1024.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngiogenesis InhibitorsAntineoplastic Agents, ImmunologicalBevacizumabBrain NeoplasmsDNA Modification MethylasesDNA Repair EnzymesFemaleGlioblastomaHumansImmune Checkpoint InhibitorsMaleMiddle AgedNeoplasm Recurrence, LocalNivolumabProgrammed Cell Death 1 ReceptorTemozolomideTreatment OutcomeTumor Suppressor ProteinsYoung AdultConceptsTreatment-related adverse eventsPhase 3 clinical trialsPrimary end pointOverall survivalRecurrent glioblastomaClinical trialsMedian OSGrade 3/4 treatment-related adverse eventsRandomized phase 3 clinical trialSingle-agent PD-1 blockadeEnd pointEffects of nivolumabUnacceptable toxic effectsMedian overall survivalObjective response ratePD-1 blockadeOverall patient populationImmune checkpoint blockadeData cutoffAdverse eventsCheckpoint blockadeFirst recurrenceInhibitor therapyClinical outcomesSafety profile
2019
ATIM-47. NIVOLUMAB VS BEVACIZUMAB IN PATIENTS WITH RECURRENT GLIOBLASTOMA: EXPLORATORY ANALYSIS OF MGMT METHYLATION STATUS AND BASELINE CORTICOSTEROID USE
Weller M, Reardon D, Brandes A, Sampson J, Mulholland P, Wick A, Baehring J, Ahluwalia M, Roth P, Bähr O, Phuphanich S, Sepulveda J, de Souza P, Sahebjam S, Potter V, Tatsuoka K, Taitt C, Zwirtes R, Omuro A, Lim M. ATIM-47. NIVOLUMAB VS BEVACIZUMAB IN PATIENTS WITH RECURRENT GLIOBLASTOMA: EXPLORATORY ANALYSIS OF MGMT METHYLATION STATUS AND BASELINE CORTICOSTEROID USE. Neuro-Oncology 2019, 21: vi12-vi12. PMCID: PMC6847600, DOI: 10.1093/neuonc/noz175.045.Peer-Reviewed Original ResearchMedian overall survivalBaseline corticosteroid useCorticosteroid useBaseline corticosteroidsMGMT methylation statusRecurrent glioblastomaUnmethylated tumorsMultivariable Cox proportional hazards model analysisCox proportional hazards model analysisLonger median overall survivalProportional hazards model analysisBevacizumab-treated patientsLimited survival benefitNivolumab-treated patientsSubgroup of patientsExploratory subgroup analysisHazards model analysisMethyltransferase promoter methylation statusDNA methyltransferase promoter methylation statusMethylation statusMGMT promoter statusTemozolomide chemoradiotherapyFirst recurrencePrimary endpointOverall survivalResidual Tumor Volume, Cell Volume Fraction, and Tumor Cell Kill During Fractionated Chemoradiation Therapy of Human Glioblastoma using Quantitative Sodium MR Imaging
Thulborn KR, Lu A, Atkinson IC, Pauliah M, Beal K, Chan TA, Omuro A, Yamada J, Bradbury MS. Residual Tumor Volume, Cell Volume Fraction, and Tumor Cell Kill During Fractionated Chemoradiation Therapy of Human Glioblastoma using Quantitative Sodium MR Imaging. Clinical Cancer Research 2019, 25: 1226-1232. PMID: 30487127, PMCID: PMC7462306, DOI: 10.1158/1078-0432.ccr-18-2079.Peer-Reviewed Original ResearchConceptsResidual tumor volumeTumor cell killTissue sodium concentrationChemoradiation therapyOverall survivalHuman glioblastomaTumor volumeQuantitative sodium MR imagingCell killQuantitative sodium MRITumor cellsVariable tumor responseSodium MRITwo-compartment modelTumor resectionTumor responseDisease progressionSodium MR imagingTumor marginsMR imagingTherapyGlioblastomaTreatment volumeCancer cellsSodium concentrationTumor mutational load predicts survival after immunotherapy across multiple cancer types
Samstein RM, Lee CH, Shoushtari AN, Hellmann MD, Shen R, Janjigian YY, Barron DA, Zehir A, Jordan EJ, Omuro A, Kaley TJ, Kendall SM, Motzer RJ, Hakimi AA, Voss MH, Russo P, Rosenberg J, Iyer G, Bochner BH, Bajorin DF, Al-Ahmadie HA, Chaft JE, Rudin CM, Riely GJ, Baxi S, Ho AL, Wong RJ, Pfister DG, Wolchok JD, Barker CA, Gutin PH, Brennan CW, Tabar V, Mellinghoff IK, DeAngelis LM, Ariyan CE, Lee N, Tap WD, Gounder MM, D’Angelo S, Saltz L, Stadler ZK, Scher HI, Baselga J, Razavi P, Klebanoff CA, Yaeger R, Segal NH, Ku GY, DeMatteo RP, Ladanyi M, Rizvi NA, Berger MF, Riaz N, Solit DB, Chan TA, Morris LGT. Tumor mutational load predicts survival after immunotherapy across multiple cancer types. Nature Genetics 2019, 51: 202-206. PMID: 30643254, PMCID: PMC6365097, DOI: 10.1038/s41588-018-0312-8.Peer-Reviewed Original ResearchConceptsTumor mutational burdenHigh tumor mutational burdenImproved survivalCancer typesImmune checkpoint inhibitor treatmentAdvanced cancer patientsBetter overall survivalCheckpoint inhibitor treatmentMultiple cancer typesClinical responseOverall survivalCancer patientsPredictive biomarkersCancer histologyMetastatic cancerMutational burdenPatientsInhibitor treatmentNext-generation sequencingSurvivalICIMutational loadUniversal definitionAssociationImmunotherapy
2018
Multicenter Phase IB Trial of Carboxyamidotriazole Orotate and Temozolomide for Recurrent and Newly Diagnosed Glioblastoma and Other Anaplastic Gliomas.
Omuro A, Beal K, McNeill K, Young RJ, Thomas A, Lin X, Terziev R, Kaley TJ, DeAngelis LM, Daras M, Gavrilovic IT, Mellinghoff I, Diamond EL, McKeown A, Manne M, Caterfino A, Patel K, Bavisotto L, Gorman G, Lamson M, Gutin P, Tabar V, Chakravarty D, Chan TA, Brennan CW, Garrett-Mayer E, Karmali RA, Pentsova E. Multicenter Phase IB Trial of Carboxyamidotriazole Orotate and Temozolomide for Recurrent and Newly Diagnosed Glioblastoma and Other Anaplastic Gliomas. Journal Of Clinical Oncology 2018, 36: 1702-1709. PMID: 29683790, PMCID: PMC5993168, DOI: 10.1200/jco.2017.76.9992.Peer-Reviewed Original ResearchConceptsAnaplastic gliomasCohort 2Cohort 1Median progression-free survivalFavorable brain penetrationMedian overall survivalPhase Ib studyPhase Ib trialPhase II doseProgression-free survivalRecurrent anaplastic gliomasDependent calcium channelsNovel oral inhibitorSignal of activityMismatch repair genesIb trialTreat populationMethylguanine-DNA methyltransferaseOverall survivalComplete responseFlat doseOral inhibitorBrain penetrationResults FortyTherapeutic concentrations
2017
Overall survival in patients with glioblastoma before and after bevacizumab approval
Johnson DR, Omuro AMP, Ravelo A, Sommer N, Guerin A, Ionescu-Ittu R, Shi S, Macalalad A, Uhm JH. Overall survival in patients with glioblastoma before and after bevacizumab approval. Current Medical Research And Opinion 2017, 34: 813-820. PMID: 29025274, DOI: 10.1080/03007995.2017.1392294.Peer-Reviewed Original ResearchConceptsOverall survivalTreatment of patientsBevacizumab approvalProgressive glioblastomaGBM diagnosisUS population-based cancer registry dataPopulation-based cancer registry dataCox proportional hazards regressionLarge population-based studyOS of patientsApproval of bevacizumabGross total resectionKaplan-Meier analysisPopulation-based studyProportional hazards regressionLimited therapeutic optionsCancer registry dataAdjusted hazardAdult patientsMedian ageTotal resectionStudy cohortAggressive diseaseHazards regressionTherapeutic optionsMulticenter, Phase 1, Dose Escalation Study of Hypofractionated Stereotactic Radiation Therapy With Bevacizumab for Recurrent Glioblastoma and Anaplastic Astrocytoma
Clarke J, Neil E, Terziev R, Gutin P, Barani I, Kaley T, Lassman AB, Chan TA, Yamada J, DeAngelis L, Ballangrud A, Young R, Panageas KS, Beal K, Omuro A. Multicenter, Phase 1, Dose Escalation Study of Hypofractionated Stereotactic Radiation Therapy With Bevacizumab for Recurrent Glioblastoma and Anaplastic Astrocytoma. International Journal Of Radiation Oncology • Biology • Physics 2017, 99: 797-804. PMID: 28870792, PMCID: PMC5654655, DOI: 10.1016/j.ijrobp.2017.06.2466.Peer-Reviewed Original ResearchMeSH KeywordsAgedAngiogenesis InhibitorsAstrocytomaBevacizumabBrainBrain NeoplasmsFemaleGlioblastomaHumansIntention to Treat AnalysisKarnofsky Performance StatusMaleMaximum Tolerated DoseMiddle AgedNeoplasm Recurrence, LocalOrgans at RiskProspective StudiesRadiation Dose HypofractionationRadiosurgeryRe-IrradiationTumor BurdenConceptsRecurrent high-grade gliomaDose-limiting toxicityHigh-grade gliomasStereotactic reirradiationHypofractionated Stereotactic Radiation TherapyCorpus callosum involvementDose level cohortsGrade 3 fatigueMedian overall survivalKarnofsky performance statusDose-escalation studyTreatment-related effectsBiological equivalent doseStereotactic radiation therapyWarrants further investigationAbsence of brainstemDose-escalation trial designBevacizumab dosesCallosum involvementConcomitant bevacizumabSymptomatic radionecrosisEscalation studyOverall survivalPerformance statusResected specimensNCCTG N1174: Phase I/comparative randomized phase (Ph) II trial of TRC105 plus bevacizumab versus bevacizumab in recurrent glioblastoma (GBM) (Alliance).
Galanis E, Anderson S, Butowski N, Hormigo A, Schiff D, Tran D, Omuro A, Jaeckle K, Kumar S, Kaufmann T, Buckner J, Twohy E, Giannini C, Wen P. NCCTG N1174: Phase I/comparative randomized phase (Ph) II trial of TRC105 plus bevacizumab versus bevacizumab in recurrent glioblastoma (GBM) (Alliance). Journal Of Clinical Oncology 2017, 35: 2023-2023. DOI: 10.1200/jco.2017.35.15_suppl.2023.Peer-Reviewed Original ResearchProgression-free survivalII trialMedian progression-free survivalRandomized phase II trialPhase II trialGlioma stem cellsOverall survivalOverall incidenceRecurrent glioblastomaMultiple time pointsVEGF inhibitionGrade 3GBM patientsPositive subsetSingle agentI cohortResponse rateHumanized antibodyFlow cytometryEndothelial cellsTime pointsTGFβ receptorsGlioblastomaBevacizumabCD105OS10.3 Randomized Phase 3 Study Evaluating the Efficacy and Safety of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: CheckMate 143
Reardon D, Omuro A, Brandes A, Rieger J, Wick A, Sepulveda J, Phuphanich S, de Souza P, Ahluwalia M, Lim M, Vlahovic G, Sampson J. OS10.3 Randomized Phase 3 Study Evaluating the Efficacy and Safety of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: CheckMate 143. Neuro-Oncology 2017, 19: iii21-iii21. PMCID: PMC5463583, DOI: 10.1093/neuonc/nox036.071.Peer-Reviewed Original ResearchObjective response rateTreatment-related AEsProgression-free survivalOverall survivalRecurrent glioblastomaSerious AEsMeasurable diseaseOS ratesInvestigator-assessed progression-free survivalCommon treatment-related AEsHuman IgG4 monoclonal antibodyOnly serious AESafety of nivolumabMedian overall survivalNeuro-Oncology criteriaSecond-line settingDeath-1 receptorSingle-agent therapyAvailable treatment optionsMalignant neoplasm progressionIgG4 monoclonal antibodyMultiple cancer typesCheckMate 143Evaluable ptsImproved OS
2016
Patterns of response and relapse in primary CNS lymphomas after first-line chemotherapy: imaging analysis of the ANOCEF-GOELAMS prospective randomized trial
Tabouret E, Houillier C, Martin-Duverneuil N, Blonski M, Soussain C, Ghesquières H, Houot R, Larrieu D, Soubeyran P, Gressin R, Gyan E, Chinot O, Taillandier L, Choquet S, Alentorn A, Leclercq D, Omuro A, Tanguy ML, Hoang-Xuan K. Patterns of response and relapse in primary CNS lymphomas after first-line chemotherapy: imaging analysis of the ANOCEF-GOELAMS prospective randomized trial. Neuro-Oncology 2016, 19: 422-429. PMID: 27994065, PMCID: PMC5464299, DOI: 10.1093/neuonc/now238.Peer-Reviewed Original ResearchConceptsPrimary CNS lymphomaProgression-free survivalOverall survivalCNS lymphomaPrognostic valueMRI characteristicsRandomized phase II trialEarly MRI evaluationFirst-line chemotherapyPatterns of relapsePhase II trialBaseline tumor sizeEnd of treatmentOverall tumor burdenPotential prognostic valueComplete response achievementHypersignal lesionsInfratentorial localizationProlonged OSII trialObjective responsePoor OSProspective trialMRI abnormalitiesTumor burdenA Comprehensive Assessment of Toxicities in Patients with Central Nervous System Lymphoma Undergoing Autologous Stem Cell Transplantation Using Thiotepa, Busulfan, and Cyclophosphamide Conditioning
Scordo M, Bhatt V, Hsu M, Omuro AM, Matasar MJ, DeAngelis LM, Dahi PB, Moskowitz CH, Giralt SA, Sauter CS. A Comprehensive Assessment of Toxicities in Patients with Central Nervous System Lymphoma Undergoing Autologous Stem Cell Transplantation Using Thiotepa, Busulfan, and Cyclophosphamide Conditioning. Transplantation And Cellular Therapy 2016, 23: 38-43. PMID: 27713090, PMCID: PMC5518313, DOI: 10.1016/j.bbmt.2016.09.024.Peer-Reviewed Original ResearchConceptsAutologous stem cell transplantationPrimary central nervous system lymphomaSecondary central nervous system lymphomaCentral nervous system lymphomaProgression-free survivalNervous system lymphomaTransplantation-related mortalityStem cell transplantationOverall survivalSystem lymphomaCyclophosphamide conditioningNonhematologic toxicityCell transplantationTreatment strategiesTime of ASCTFavorable progression-free survivalHigh-dose therapyBusulfan areaBusulfan dosingAdult patientsPatient characteristicsMedian numberToxicity burdenPatientsConsiderable toxicity
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 4.0Multicenter phase 2 study of patupilone for recurrent or progressive brain metastases from non–small cell lung cancer
Nayak L, DeAngelis LM, Robins HI, Govindan R, Gadgeel S, Kelly K, Rigas JR, Peereboom DM, Rosenfeld SS, Muzikansky A, Zheng M, Urban P, Abrey LE, Omuro A, Wen PY. Multicenter phase 2 study of patupilone for recurrent or progressive brain metastases from non–small cell lung cancer. Cancer 2015, 121: 4165-4172. PMID: 26308485, PMCID: PMC5941922, DOI: 10.1002/cncr.29636.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerProgressive brain metastasesBrain metastasesCell lung cancerAdverse eventsStudy drugLung cancerGrade 3/4 adverse eventsMulticenter phase 2 studyNSCLC brain metastasesSteady-state distribution volumePhase 1/2 studyRecurrent brain metastasesPhase 2 studyProgression-free survivalFirst prospective studyConcentration-time curvePrimary endpointAdult patientsOverall survivalPulmonary embolismMedian agePeripheral neuropathyMedian timeProspective study