2023
Understanding health-related quality of life measures used in early-stage non-small cell lung cancer clinical trials: A review
Majem M, Basch E, Cella D, Garon E, Herbst R, Leighl N. Understanding health-related quality of life measures used in early-stage non-small cell lung cancer clinical trials: A review. Lung Cancer 2023, 187: 107419. PMID: 38070301, DOI: 10.1016/j.lungcan.2023.107419.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerEarly-stage diseaseHealth-related qualityClinical trialsEarly-stage non-small cell lung cancerTreatment-related adverse effectsAppropriate HRQoL instrumentNSCLC clinical trialsCell lung cancerLong-term treatmentLung cancer clinical trialsCancer clinical researchCancer clinical trialsAdjuvant treatmentAdvanced diseaseHRQOL assessmentTreatment landscapeDisease recurrenceHRQoL instrumentsLung cancerDisease progressionLife measuresHRQoLNarrative reviewHealthcare professionalsThree-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 ResearchConceptsThree-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
2019
Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1–Expressing NSCLC
Barlesi F, Garon E, Kim D, Felip E, Han J, Kim J, Ahn M, Fidler M, Gubens M, de Castro G, Surmont V, Li Q, Deitz A, Lubiniecki G, Herbst R. Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1–Expressing NSCLC. Journal Of Thoracic Oncology 2019, 14: 793-801. PMID: 30711649, DOI: 10.1016/j.jtho.2019.01.016.Peer-Reviewed Original ResearchConceptsGlobal health statusDeath ligand 1Composite endpointPhase II/III studyGHS/QoL scoresLife Questionnaire Core 30Programmed Death Ligand 1Symptom domainsNSCLC patient populationPembrolizumab-treated patientsWeek 12 changesHealth-related qualityLigand 1Quality of lifeGHS/KEYNOTE-010Advanced NSCLCChest painIII studyOverall survivalCancer QualityEuroQol-5D.Life scoresMean baselinePatient population
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
2016
1219P Assessment of health-related quality of life (HRQoL) in KEYNOTE-010: A phase 2/3 study of pembrolizumab vs docetaxel in patients with previously treated advanced NSCLC
Barlesi F, Garon E, Kim D, Felip E, Han J, Kim J, Ahn M, Fidler M, Gubens M, Castro G, Surmont V, Li Q, Deitz A, Lubiniecki G, Herbst R. 1219P Assessment of health-related quality of life (HRQoL) in KEYNOTE-010: A phase 2/3 study of pembrolizumab vs docetaxel in patients with previously treated advanced NSCLC. Annals Of Oncology 2016, 27: vi422. DOI: 10.1093/annonc/mdw383.19.Peer-Reviewed Original Research