2023
Osimertinib in Resected EGFR-Mutated NSCLC. Reply.
Tsuboi M, Herbst R, Wu Y. Osimertinib in Resected EGFR-Mutated NSCLC. Reply. New England Journal Of Medicine 2023, 389: 1342. PMID: 37792623, DOI: 10.1056/nejmc2309385.Peer-Reviewed Original ResearchThree-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC: Updated Analysis From the Phase 3 ADAURA Trial
John T, Grohé C, Goldman J, Shepherd F, de Marinis F, Kato T, Wang Q, Su W, Choi J, Sriuranpong V, Melotti B, Fidler M, Chen J, Albayaty M, Stachowiak M, Taggart S, Wu Y, Tsuboi M, Herbst R, Majem M. Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC: Updated Analysis From the Phase 3 ADAURA Trial. Journal Of Thoracic Oncology 2023, 18: 1209-1221. PMID: 37236398, DOI: 10.1016/j.jtho.2023.05.015.Peer-Reviewed Original ResearchMeSH KeywordsAniline CompoundsCarcinoma, Non-Small-Cell LungErbB ReceptorsHumansLung NeoplasmsMutationProtein Kinase InhibitorsQuality of LifeConceptsThree-year safetyAdverse eventsAdjuvant osimertinibStage IBWeek 12Treatment completionCommon adverse eventsMost adverse eventsResected stage IBSignificant efficacy benefitDisease-free survivalNew safety signalsSF-36 surveyHealth-related qualityInterstitial lung diseaseMental component summaryTotal exposure durationADAURA trialWeek 24Component summaryEfficacy benefitsOsimertinib treatmentSF-36Lung diseaseSafety signals
2022
Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial
Majem M, Goldman JW, John T, Grohe C, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Li S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Atagi S, Zeng L, Kulkarni D, Medic N, Tsuboi M, Herbst RS, Wu YL. Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial. Clinical Cancer Research 2022, 28: 2286-2296. PMID: 35012927, PMCID: PMC9359973, DOI: 10.1158/1078-0432.ccr-21-3530.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerWeek 96Short Form-36 Health SurveyDisease-free survival benefitSF-36 score changesMental component summary scoresPrior adjuvant chemotherapyComponent summary scoresHealth-related qualityCell lung cancerADAURA trialOral osimertinibAdjuvant chemotherapyAdjuvant treatmentSurvival benefitLung cancerHealth SurveySummary scoresScore changeOverall populationPlaceboLife outcomesOsimertinibDiscontinuationPatients
2021
Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC
Wu YL, John T, Grohe C, Majem M, Goldman JW, Kim SW, Kato T, Laktionov K, Vu HV, Wang Z, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Atasoy A, Herbst RS, Tsuboi M. Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC. Journal Of Thoracic Oncology 2021, 17: 423-433. PMID: 34740861, DOI: 10.1016/j.jtho.2021.10.014.Peer-Reviewed Original ResearchMeSH KeywordsAcrylamidesAniline CompoundsCarcinoma, Non-Small-Cell LungChemotherapy, AdjuvantErbB ReceptorsHumansLung NeoplasmsMutationConceptsAdjuvant chemotherapy useDisease-free survivalAdjuvant chemotherapyChemotherapy useStage IBDisease stageEGFRm NSCLCStage IIPostoperative chemotherapy usePrevious adjuvant chemotherapyADAURA studyAdjuvant osimertinibIIIA NSCLCAdjuvant therapyDFS benefitMedian durationPrespecified analysisPatient ageRecurrence rateEffective treatmentNSCLCChemotherapyPatientsMeaningful improvementsOsimertinibA plain language summary of results from the ADAURA study: osimertinib after surgery for patients who have early-stage EGFR-mutated non-small cell lung cancer
Wu YL, Tsuboi M, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS. A plain language summary of results from the ADAURA study: osimertinib after surgery for patients who have early-stage EGFR-mutated non-small cell lung cancer. Future Oncology 2021, 17: 4827-4835. PMID: 34723634, DOI: 10.2217/fon-2021-0752.Peer-Reviewed Original ResearchMeSH KeywordsAcrylamidesAniline CompoundsCarcinoma, Non-Small-Cell LungErbB ReceptorsHumansLanguageLung NeoplasmsMutationConceptsNon-small cell lung cancerCell lung cancerClinical studiesADAURA studyLung cancerPost-surgery chemotherapyTypes of NSCLCRisk of tumorsPrevious clinical studiesCentral nervous systemEpidermal growth factor receptorEarly-stage EGFRGrowth factor receptorNCT numberActivity of EGFROsimertinib treatmentNSCLC tumorsSpinal cordTumor removalNSCLCSide effectsNervous systemOsimertinibPatientsSurgeryOsimertinib in EGFR-Mutated Lung Cancer. Reply.
Herbst RS, Wu YL, Tsuboi M. Osimertinib in EGFR-Mutated Lung Cancer. Reply. New England Journal Of Medicine 2021, 384: 675-676. PMID: 33596365, DOI: 10.1056/nejmc2033951.Peer-Reviewed Original ResearchTargeted therapies for resectable lung adenocarcinoma: ADAURA opens for thoracic oncologic surgeons
Jones DR, Wu YL, Tsuboi M, Herbst RS. Targeted therapies for resectable lung adenocarcinoma: ADAURA opens for thoracic oncologic surgeons. Journal Of Thoracic And Cardiovascular Surgery 2021, 162: 288-292. PMID: 33691940, PMCID: PMC8519337, DOI: 10.1016/j.jtcvs.2021.02.008.Peer-Reviewed Original Research
2020
Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer
Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS. Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer. New England Journal Of Medicine 2020, 383: 1711-1723. PMID: 32955177, DOI: 10.1056/nejmoa2027071.Peer-Reviewed Original ResearchMeSH KeywordsAcrylamidesAdultAgedAged, 80 and overAniline CompoundsAntineoplastic AgentsCarcinoma, Non-Small-Cell LungChemotherapy, AdjuvantDisease-Free SurvivalDouble-Blind MethodErbB ReceptorsFemaleHumansLung NeoplasmsLymphatic MetastasisMaleMiddle AgedMutationNeoplasm Recurrence, LocalNeoplasm StagingPneumonectomyProtein Kinase InhibitorsConceptsDisease-free survivalMutation-positive NSCLCIIIA diseasePlacebo groupOsimertinib groupStage IBLung cancerUntreated epidermal growth factor receptorNon-small cell lung cancerOverall populationStage IIEnd pointCentral nervous system diseaseSafety of osimertinibPrimary end pointSecondary end pointsPhase 3 trialOverall survival dataCell lung cancerNew safety concernsNervous system diseasesEpidermal growth factor receptorGrowth factor receptorAdjuvant therapyOverall survival
2018
ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection
Wu YL, Herbst R, Mann H, Rukazenkov Y, Marotti M, Tsuboi M. ADAURA: Phase III, Double-blind, Randomized Study of Osimertinib Versus Placebo in EGFR Mutation-positive Early-stage NSCLC After Complete Surgical Resection. Clinical Lung Cancer 2018, 19: e533-e536. PMID: 29789220, DOI: 10.1016/j.cllc.2018.04.004.Peer-Reviewed Original ResearchConceptsCell lung cancerDisease recurrenceLung cancerMutation statusSurvival rateEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsComplete surgical tumor resectionDisease-free survival ratesT790M mutation statusReceptor tyrosine kinase inhibitorsMaximum treatment durationStage IB-IIIAPlacebo-controlled studyDisease-free survivalEarly-stage NSCLCComplete surgical resectionOverall survival rateHealth-related qualityHealth resource useSurgical tumor resectionEGFR mutation statusTyrosine kinase inhibitorsCentral confirmationVersus Placebo