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 ResearchMeSH KeywordsCarcinoma, Non-Small-Cell LungHumansLung NeoplasmsNeoplasm Recurrence, LocalQuality of LifeSmall Cell Lung CarcinomaConceptsNon-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 signalsQuality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I
Unger J, Qian L, Redman M, Tavernier S, Minasian L, Sigal E, Papadimitrakopoulou V, Leblanc M, Cleeland C, Dzingle S, Summers T, Chao H, Madhusudhana S, Villaruz L, Crawford J, Gray J, Kelly K, Gandara D, Bazhenova L, Herbst R, Gettinger S, Moinpour C. Quality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I. Journal Of The National Cancer Institute 2023, 115: 437-446. PMID: 36625510, PMCID: PMC10086628, DOI: 10.1093/jnci/djad003.Peer-Reviewed Original ResearchConceptsQuality of lifeComposite risk modelAppetite lossSeverity scoreWeek 13Advanced squamous cell lung cancerWeek 7Baseline patient-reported outcomesRandomized phase III trialSquamous cell lung cancerPhase III trialsRisk of progressionShortness of breathCell lung cancerPatient-reported outcomesRisk of deathMultivariable linear regressionEffect of treatmentEvaluable patientsPrimary endpointIII trialsOverall survivalMedian ageAdvanced cancerPrognostic relevance
2022
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of lung cancer and mesothelioma
Govindan R, Aggarwal C, Antonia SJ, Davies M, Dubinett SM, Ferris A, Forde PM, Garon EB, Goldberg SB, Hassan R, Hellmann MD, Hirsch FR, Johnson ML, Malik S, Morgensztern D, Neal JW, Patel JD, Rimm DL, Sagorsky S, Schwartz LH, Sepesi B, Herbst RS. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of lung cancer and mesothelioma. Journal For ImmunoTherapy Of Cancer 2022, 10: e003956. PMID: 35640927, PMCID: PMC9157337, DOI: 10.1136/jitc-2021-003956.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerSmall cell lung cancerClinical practice guidelinesLung cancerQuality of lifePractice guidelinesTreatment of NSCLCImmune-related adverse eventsCancer clinical practice guidelinesLung cancer careImmune checkpoint inhibitorsUse of immunotherapyFirst-line therapySubset of patientsCell lung cancerCancer care providersImmunotherapy of cancerConsensus-based recommendationsAdjuvant settingAdvanced diseaseCheckpoint inhibitorsAdverse eventsDurable responsesThoracic malignanciesAutoimmune disordersHealth-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
2016
Scientific Advances in Lung Cancer 2015
Tsao AS, Scagliotti GV, Bunn PA, Carbone DP, Warren GW, Bai C, de Koning HJ, Yousaf-Khan AU, McWilliams A, Tsao MS, Adusumilli PS, Rami-Porta R, Asamura H, Van Schil PE, Darling GE, Ramalingam SS, Gomez DR, Rosenzweig KE, Zimmermann S, Peters S, Ou S, Reungwetwattana T, Jänne PA, Mok TS, Wakelee HA, Pirker R, Mazières J, Brahmer JR, Zhou Y, Herbst RS, Papadimitrakopoulou VA, Redman MW, Wynes MW, Gandara DR, Kelly RJ, Hirsch FR, Pass HI. Scientific Advances in Lung Cancer 2015. Journal Of Thoracic Oncology 2016, 11: 613-638. PMID: 27013409, DOI: 10.1016/j.jtho.2016.03.012.Peer-Reviewed Original ResearchConceptsLung cancerMajor global health problemSpecific oncogenic driversLung cancer therapyGlobal health problemLung cancer researchOncogene-driven tumorsQuality of lifeImportant therapeutic breakthroughsAdvanced diseaseImmunotherapy fieldPrecision cancer medicineNew patientsNew agentsTherapeutic breakthroughHealth problemsOncogenic driversCancerTherapyCancer medicinePast yearSignificant scientific advancementsCancer 2015Cancer therapyRegulatory approval
2007
Phase I participants’ views of quality of life and trial participation burdens
Cohen MZ, Slomka J, Pentz RD, Flamm AL, Gold D, Herbst RS, Abbruzzese JL. Phase I participants’ views of quality of life and trial participation burdens. Supportive Care In Cancer 2007, 15: 885-890. PMID: 17252219, DOI: 10.1007/s00520-007-0216-0.Peer-Reviewed Original ResearchConceptsTrial participationCurrent QoLPrevious cancer treatmentPhase I trialPhase I cancer trialsI cancer trialsSymptoms of diseaseStudy drugI trialCancer trialsPhysical complicationsTrial participantsSide effectsQoLCancer treatmentPhase ITrialsPotential participantsBurdenPerception of qualityProcedural burdenRespondent burdenParticipantsTreatmentBaseline ability
2005
Clinically Meaningful Improvement in Symptoms and Quality of Life for Patients With Non-Small-Cell Lung Cancer Receiving Gefitinib in a Randomized Controlled Trial
Cella D, Herbst RS, Lynch TJ, Prager D, Belani CP, Schiller JH, Heyes A, Ochs JS, Wolf MK, Kay AC, Kris MG, Natale RB. Clinically Meaningful Improvement in Symptoms and Quality of Life for Patients With Non-Small-Cell Lung Cancer Receiving Gefitinib in a Randomized Controlled Trial. Journal Of Clinical Oncology 2005, 23: 2946-2954. PMID: 15699477, DOI: 10.1200/jco.2005.05.153.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugDouble-Blind MethodEndpoint DeterminationFemaleGefitinibHealth StatusHumansLung NeoplasmsMaleMiddle AgedQuality of LifeQuinazolinesSensitivity and SpecificitySurvival AnalysisConceptsLung Cancer SubscaleSymptom improvementTumor responseQuality of lifeCancer Therapy-Lung (FACT-L) questionnairePivotal phase II trialMedian overall survival timeCoprimary end pointsPrior chemotherapy regimensProtocol-specified analysisSymptom improvement ratePhase II trialBetter overall survivalCell lung cancerOverall survival timeGefitinib 250Radiographic regressionChemotherapy regimensStable diseaseII trialMost patientsOverall survivalRadiographic responseSymptomatic patientsNSCLC patients
2003
Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors.
LoRusso PM, Herbst RS, Rischin D, Ranson M, Calvert H, Raymond E, Kieback D, Kaye S, Gianni L, Harris A, Bjork T, Maddox AM, Rothenberg ML, Small EJ, Rubin EH, Feyereislova A, Heyes A, Averbuch SD, Ochs J, Baselga J. Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors. Clinical Cancer Research 2003, 9: 2040-8. PMID: 12796366.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerPhase I clinical trialCell lung cancerDisease-related symptomsQuality of lifeAdvanced cancerLung cancerClinical changesClinical trialsOvarian cancerEpidermal growth factor receptor tyrosine kinase inhibitor ZD1839Tumor typesEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsTyrosine kinase inhibitor ZD1839Receptor tyrosine kinase inhibitorsCancer Therapy questionnaireLung Cancer SubscaleMultiple-dose safetyPhase I trialUnited States trialsTyrosine kinase inhibitorsFact QuestionnairePrior therapyTOI scores
1997
CHEMOTHERAPY FOR ADVANCED NON–SMALL CELL LUNG CANCER
Herbst RS, Dang NH, Skarin AT. CHEMOTHERAPY FOR ADVANCED NON–SMALL CELL LUNG CANCER. Hematology/Oncology Clinics Of North America 1997, 11: 473-517. PMID: 9209907, DOI: 10.1016/s0889-8588(05)70445-7.Peer-Reviewed Original Research