2022
Phase 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 IIINivolumab 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
2020
Radiotherapy (RT) Dose-intensification (DI) Using Intensity-modulated RT (IMRT) versus Standard-dose (SD) RT with Temozolomide (TMZ) in Newly Diagnosed Glioblastoma (GBM): Preliminary Results of NRG Oncology BN001
Gondi V, Pugh S, Tsien C, Chenevert T, Gilbert M, Omuro A, Mcdonough J, Aldape K, Srinivasan A, Rogers C, Shi W, Suh J, Algan O, Nedzi L, Chan M, Bahary J, Mehta M. Radiotherapy (RT) Dose-intensification (DI) Using Intensity-modulated RT (IMRT) versus Standard-dose (SD) RT with Temozolomide (TMZ) in Newly Diagnosed Glioblastoma (GBM): Preliminary Results of NRG Oncology BN001. International Journal Of Radiation Oncology • Biology • Physics 2020, 108: s22-s23. DOI: 10.1016/j.ijrobp.2020.07.2109.Peer-Reviewed Original Research
2011
Multicenter phase II trial of temozolomide (TMZ) and rituximab (RIT) for recurrent primary CNS lymphoma (PCNSL): North American Brain Tumor Consortium (NABTC) study 05-01.
Nayak L, Abrey L, Drappatz J, Gilbert M, Reardon D, Lamborn K, Wen P, Prados M, DeAngelis L, Omuro A. Multicenter phase II trial of temozolomide (TMZ) and rituximab (RIT) for recurrent primary CNS lymphoma (PCNSL): North American Brain Tumor Consortium (NABTC) study 05-01. Journal Of Clinical Oncology 2011, 29: 2039-2039. DOI: 10.1200/jco.2011.29.15_suppl.2039.Peer-Reviewed Original ResearchFLAIR, T1 contrast enhancement, MR perfusion, and FDG PET following hypofractionated stereotactic radiotherapy (HFSRT), bevacizumab (BEV), and temozolomide (TMZ) for glioblastoma (GBM).
Grommes C, Karimi S, Beal K, Chan T, Abrey L, Gutin P, Omuro A. FLAIR, T1 contrast enhancement, MR perfusion, and FDG PET following hypofractionated stereotactic radiotherapy (HFSRT), bevacizumab (BEV), and temozolomide (TMZ) for glioblastoma (GBM). Journal Of Clinical Oncology 2011, 29: 2048-2048. DOI: 10.1200/jco.2011.29.15_suppl.2048.Peer-Reviewed Original Research
2010
Phase II trial of continuous low-dose temozolomide (TMZ) for recurrent malignant glioma (MG) with and without prior exposure to bevacizumab (BEV).
Khasraw M, Abrey L, Lassman A, Hormigo A, Nolan C, Gavrilovic I, Mellinghoff I, Reiner A, DeAngelis L, Omuro A. Phase II trial of continuous low-dose temozolomide (TMZ) for recurrent malignant glioma (MG) with and without prior exposure to bevacizumab (BEV). Journal Of Clinical Oncology 2010, 28: 2065-2065. DOI: 10.1200/jco.2010.28.15_suppl.2065.Peer-Reviewed Original ResearchA phase I safety and pharmacokinetic study of XL765 (SAR245409), a novel PI3K/TORC1/TORC2 inhibitor, in combination with temozolomide (TMZ) in patients (pts) with newly diagnosed malignant glioma.
Nghiemphu P, Omuro A, Cloughesy T, Mellinghoff I, Norden A, Nguyen L, Rajangam K, Wen P. A phase I safety and pharmacokinetic study of XL765 (SAR245409), a novel PI3K/TORC1/TORC2 inhibitor, in combination with temozolomide (TMZ) in patients (pts) with newly diagnosed malignant glioma. Journal Of Clinical Oncology 2010, 28: 3085-3085. DOI: 10.1200/jco.2010.28.15_suppl.3085.Peer-Reviewed Original ResearchMulticenter randomized phase II trial of methotrexate (MTX) and temozolomide (TMZ) versus MTX, procarbazine (PCB), vincristine (VINC), and cytarabine (Ara-C) for primary CNS lymphoma (PCNSL) in elderly patients.
Omuro A, Taillandier L, Chinot O, Ghesquieres H, Soussain C, Delwail V, Choquet S, Tanguy M, Lamy T, Hoang-Xuan K. Multicenter randomized phase II trial of methotrexate (MTX) and temozolomide (TMZ) versus MTX, procarbazine (PCB), vincristine (VINC), and cytarabine (Ara-C) for primary CNS lymphoma (PCNSL) in elderly patients. Journal Of Clinical Oncology 2010, 28: tps144-tps144. DOI: 10.1200/jco.2010.28.15_suppl.tps144.Peer-Reviewed Original ResearchNitrosourea-based chemotherapy for low grade gliomas failing initial treatment with temozolomide
Kaloshi G, Sierra del Rio M, Ducray F, Psimaras D, Idbaih A, Laigle-Donadey F, Taillibert S, Houillier C, Dehais C, Omuro A, Sanson M, Delattre JY, Hoang-Xuan K. Nitrosourea-based chemotherapy for low grade gliomas failing initial treatment with temozolomide. Journal Of Neuro-Oncology 2010, 100: 439-441. PMID: 20464625, DOI: 10.1007/s11060-010-0197-6.Peer-Reviewed Original ResearchConceptsLow-grade gliomasGrade gliomasProgressive low-grade gliomaTerms of PFSContrast enhancementEfficacy of nitrosoureasBetter PFSMedian PFSMedian OSObjective responseSalvage treatmentUpfront therapyMedian ageBetter prognosisInitial treatmentConventional radiotherapyChromosome 1p/19q codeletionNon-enhancing tumorResponse ratePatientsTemozolomidePure oligodendrogliomasPFSGliomasDisappointing results
2007
Dynamic history of low‐grade gliomas before and after temozolomide treatment
Ricard D, Kaloshi G, Amiel‐Benouaich A, Lejeune J, Marie Y, Mandonnet E, Kujas M, Mokhtari K, Taillibert S, Laigle‐Donadey F, Carpentier AF, Omuro A, Capelle L, Duffau H, Cornu P, Guillevin R, Sanson M, Hoang‐Xuan K, Delattre J. Dynamic history of low‐grade gliomas before and after temozolomide treatment. Annals Of Neurology 2007, 61: 484-490. PMID: 17469128, DOI: 10.1002/ana.21125.Peer-Reviewed Original ResearchConceptsMean tumor diameterLow-grade gliomasMajority of tumorsTemozolomide treatmentImpact of temozolomideSerial magnetic resonance imagesUntreated low-grade gliomaGenetic alterationsNeoadjuvant temozolomideTumor diameterContinuous administrationP53 overexpressionOptimal durationTumor progressionTumorsTemozolomidePatientsGliomasMagnetic resonance imagesNatural progressionTreatmentProgressive growthLower ratesResonance imagesP53
2006
Vinorelbine combined with a protracted course of temozolomide for recurrent brain Metastases: a phase I trial
Omuro AM, Raizer JJ, Demopoulos A, Malkin MG, Abrey LE. Vinorelbine combined with a protracted course of temozolomide for recurrent brain Metastases: a phase I trial. Journal Of Neuro-Oncology 2006, 78: 277-280. PMID: 16614943, DOI: 10.1007/s11060-005-9095-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Agents, AlkylatingAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsBreast NeoplasmsCarcinoma, Non-Small-Cell LungDacarbazineDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansLung NeoplasmsLymphopeniaMaleMaximum Tolerated DoseMiddle AgedNeutropeniaTemozolomideThrombocytopeniaTreatment OutcomeVinblastineVinorelbineConceptsCourses of temozolomideRecurrent brain metastasesBrain metastasesDose of vinorelbineProgressive brain metastasesPhase II trialPhase I trialEfficacy of temozolomideVinorelbine doseII trialStarting doseMedian survivalRadiographic responseI trialMedian ageModest efficacyNew regimenPatient 2Lung cancerPrimary tumorGrade 3PatientsVinorelbineTemozolomideDose
2005
Salvage temozolomide for prior temozolomide responders
Franceschi E, Omuro AM, Lassman AB, Demopoulos A, Nolan C, Abrey LE. Salvage temozolomide for prior temozolomide responders. Cancer 2005, 104: 2473-2476. PMID: 16270316, DOI: 10.1002/cncr.21564.Peer-Reviewed Original ResearchConceptsDisease recurrenceRecurrent/progressive gliomaInitial disease recurrencePotential hematologic complicationsSubsequent salvage therapyFirst-line therapyProgression-free survivalTime of diagnosisLow-grade oligodendrogliomasWarrants further investigationSalvage therapyStable diseaseHematologic complicationsObjective responseRadiographic responseMedian ageRetrospective reviewDisease progressionTMZ treatmentAnaplastic astrocytomaPatientsProgressive gliomasRecurrenceTemozolomideSame agents