2024
Multi-stakeholder, intentional outreach for improving representative recruitment in Pragmatica–Lung (SWOG S2302).
Carrizosa D, Miao J, Reckamp K, Dragnev K, Hesketh P, Iams W, Henick B, Czerlanis C, DeSanto F, Sundstrom J, Johnson J, Gansauer L, Groller T, Redman M, Herbst R, Gray J. Multi-stakeholder, intentional outreach for improving representative recruitment in Pragmatica–Lung (SWOG S2302). Journal Of Clinical Oncology 2024, 42: 11019-11019. DOI: 10.1200/jco.2024.42.16_suppl.11019.Peer-Reviewed Original ResearchRecruitment planTrial designClinical trial enrollmentAdvanced/metastatic NSCLCAccrual rateStandard therapyPatient education materialsImprove community awarenessPatient accrual rateSWOGClinical trialsTrial enrollmentVA sitesApproaches to trial designPatient advocatesPatientsDecrease barriersMinority accrualRecruitment strategiesAdvocacy partnersLatinx patientsCommunity awarenessTrialsEducational materialsEnrollment informationA process to reanalyze clinical DNA sequencing data for biomarker matching in the Lung-MAP Master Protocol
Neal J, Minichiello K, Brennick R, Huang R, Hiemenz M, Amler C, Patel J, Herbst R, Reckamp K, Borghaei H, Highleyman L, Redman M, Pasquina L, Kozono D. A process to reanalyze clinical DNA sequencing data for biomarker matching in the Lung-MAP Master Protocol. The Oncologist 2024, 29: e843-e847. PMID: 38597608, PMCID: PMC11144964, DOI: 10.1093/oncolo/oyae062.Peer-Reviewed Original ResearchLung mappingClinical trialsStandard-of-care testingTumor genomic profilingClinical trial assayMaster protocolDNA sequence dataRaw genomic dataMedian timeBioinformatics pipelineSequence dataGenomic dataBiomarker testingGenomic profilingCancer clinical trialsMolecular resultsTissue samplesPatientsSubstudy
2023
LBA63 SAPPHIRE: Phase III study of sitravatinib plus nivolumab versus docetaxel in patients with previously treated advanced non-squamous non-small cell lung cancer (NSCLC)
Borghaei H, Johnson M, Garon E, He K, Planchard D, Reck M, Popat S, Herbst R, Leal T, Dumoulin D, de Marinis F, Reynolds C, Theelen W, Percent I, Calderon V, Flandin A, Shazer R, Yan X, Harrigan R, Peters S. LBA63 SAPPHIRE: Phase III study of sitravatinib plus nivolumab versus docetaxel in patients with previously treated advanced non-squamous non-small cell lung cancer (NSCLC). Annals Of Oncology 2023, 34: s1308. DOI: 10.1016/j.annonc.2023.10.064.Peer-Reviewed Original ResearchRepresentativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP)
Vaidya R, Unger J, Qian L, Minichiello K, Herbst R, Gandara D, Neal J, Leal T, Patel J, Dragnev K, Waqar S, Edelman M, Sigal E, Adam S, Malik S, Blanke C, LeBlanc M, Kelly K, Gray J, Redman M. Representativeness of Patients Enrolled in the Lung Cancer Master Protocol (Lung-MAP). JCO Precision Oncology 2023, 7: e2300218. PMID: 37677122, PMCID: PMC10581630, DOI: 10.1200/po.23.00218.Peer-Reviewed Original ResearchConceptsCharacteristics of patientsLung-MAPMaster protocolsNSCLC populationCell lung cancer trialsSEER registry dataPatients 65 yearsPrecision medicine clinical trialsPatient exclusion criteriaLung cancer trialsRepresentativeness of patientsMedicine clinical trialsNSCLC trialsOlder patientsMedicaid/More patientsSubgroup analysisCancer trialsClinical trialsVulnerable patientsRegistry dataExclusion criteriaPatientsNSCLC studiesSociodemographic characteristicsOsimertinib as adjuvant therapy in patients with resected EGFRm stage IB-IIIA NSCLC: updated results from ADAURA
Grohé C, Tsuboi M, Wu Y, John T, Majem M, Wang J, Kato T, Goldman J, Kim S, Yu C, Vu H, Mukhametshina G, Akewanlop C, de Marinis F, Shepherd F, Urban D, Stachowiak M, Balanos A, Huang X, Herbst R, Kern J. Osimertinib as adjuvant therapy in patients with resected EGFRm stage IB-IIIA NSCLC: updated results from ADAURA. Pneumologie 2023, 77: s17-s17. DOI: 10.1055/s-0043-1760904.Peer-Reviewed Original Research
2022
584 Evaluation of a composite immunotherapy signature in non-small cell lung cancer patients treated with atezolizumab
Tolba K, Gandara D, Montesion M, Nabet B, Srivastava M, Albacker L, Redman M, Kozono D, Cummings C, Herbst R, Shames D, Fabrizio D. 584 Evaluation of a composite immunotherapy signature in non-small cell lung cancer patients treated with atezolizumab. 2022, a611-a611. DOI: 10.1136/jitc-2022-sitc2022.0584.Peer-Reviewed Original Research296P Osimertinib as adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) stage IB-IIIA non-small cell lung cancer (NSCLC): Updated results from ADAURA
Wu Y, Tsuboi M, Grohe C, John T, Tarruella M, Wang J, Kato T, Goldman J, Kim S, Yu C, Vu H, Mukhametshina G, Akewanlop C, de Marinis F, Shepherd F, Urban D, Stachowiak M, Bolanos A, Huang X, Herbst R. 296P Osimertinib as adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) stage IB-IIIA non-small cell lung cancer (NSCLC): Updated results from ADAURA. Annals Of Oncology 2022, 33: s1548-s1549. DOI: 10.1016/j.annonc.2022.10.324.Peer-Reviewed Original ResearchLBA5 Long-term tolerability of adjuvant osimertinib in patients with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC) from ADAURA
John T, Grohe C, Goldman J, De Marinis F, Kato T, Wang Q, Choi J, Melotti B, Fidler M, Sainsbury L, Stachowiak M, Taggart S, Wu Y, Tsuboi M, Herbst R, Tarruella M. LBA5 Long-term tolerability of adjuvant osimertinib in patients with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC) from ADAURA. Annals Of Oncology 2022, 33: s1548. DOI: 10.1016/j.annonc.2022.10.323.Peer-Reviewed Original ResearchCancer of the Lung
Morgensztern D, Boffa D, Chen A, Dhanasopon A, Goldberg S, Decker R, Devarakonda S, Ko J, Soto L, Waqar S, Wistuba I, Herbst R. Cancer of the Lung. 2022, 1-29. DOI: 10.1002/9781119000822.hfcm085.pub2.Peer-Reviewed Original ResearchBFAST but be smart: bTMB remains an exploratory biomarker in NSCLC
Kim SY, Herbst RS. BFAST but be smart: bTMB remains an exploratory biomarker in NSCLC. Nature Reviews Clinical Oncology 2022, 20: 3-4. PMID: 36271141, DOI: 10.1038/s41571-022-00698-y.Peer-Reviewed Original ResearchConceptsCell lung cancerTumor mutational burdenLung cancerMutational burdenBlood-based tumor mutational burdenAdvanced-stage solid tumorsFirst phase III trialHigh tumor mutational burdenImmune checkpoint inhibitorsPhase III trialsIII trialsPredictive biomarkersExploratory biomarkersCompanion biomarkersSolid tumorsBiomarkersCancerBurdenPembrolizumabNSCLCPatientsTumorsTrialsP2.12-03 External Validation of a Novel CT-Based Prognostic Radiomic Signature in Patients with Metastatic NSCLC in SWOG S0819 Phase III Randomized Trial
Dercle L, Gomez D, Zhao B, Kelly K, Herbst R, Redman M, Gandara D, Schwartz L. P2.12-03 External Validation of a Novel CT-Based Prognostic Radiomic Signature in Patients with Metastatic NSCLC in SWOG S0819 Phase III Randomized Trial. Journal Of Thoracic Oncology 2022, 17: s152. DOI: 10.1016/j.jtho.2022.07.251.Peer-Reviewed Original ResearchLBA47 Osimertinib as adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) stage IB-IIIA non-small cell lung cancer (NSCLC): Updated results from ADAURA
Tsuboi M, Wu Y, Grohe C, John T, Tarruella M, Wang J, Kato T, Goldman J, Kim S, Yu C, Vu H, Mukhametshina G, Akewanlop C, de Marinis F, Shepherd F, Urban D, Stachowiak M, Bolanos A, Huang X, Herbst R. LBA47 Osimertinib as adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) stage IB-IIIA non-small cell lung cancer (NSCLC): Updated results from ADAURA. Annals Of Oncology 2022, 33: s1413-s1414. DOI: 10.1016/j.annonc.2022.08.047.Peer-Reviewed Original ResearchDiscovery of Biomarkers of Resistance to Immune Checkpoint Blockade in NSCLC Using High-Plex Digital Spatial Profiling
Moutafi M, Martinez-Morilla S, Divakar P, Vathiotis I, Gavrielatou N, Aung TN, Yaghoobi V, Fernandez AI, Zugazagoitia J, Herbst R, Schalper KA, Rimm DL. Discovery of Biomarkers of Resistance to Immune Checkpoint Blockade in NSCLC Using High-Plex Digital Spatial Profiling. Journal Of Thoracic Oncology 2022, 17: 991-1001. PMID: 35490853, PMCID: PMC9356986, DOI: 10.1016/j.jtho.2022.04.009.Peer-Reviewed Original ResearchConceptsImmune checkpoint inhibitorsICI resistanceDigital spatial profilingICI therapyOverall survivalPretreatment samplesQuantitative immunofluorescenceImmune checkpoint blockadeRole of neutrophilsShorter overall survivalCandidate biomarker proteinsCandidate protein biomarkersCohort validationOperable NSCLCUntreated NSCLCCheckpoint inhibitorsCheckpoint blockadeCD66b expressionAdditional patientsClinical efficacyPoor outcomeDiscovery of biomarkersUnivariate analysisNSCLCPatientsANtiangiogenic Second-line Lung cancer Meta-Analysis on individual patient data in non-small cell lung cancer: ANSELMA
Remon J, Lacas B, Herbst R, Reck M, Garon EB, Scagliotti GV, Ramlau R, Hanna N, Vansteenkiste J, Yoh K, Groen HJM, Heymach JV, Mandrekar SJ, Okamoto I, Neal JW, Heist RS, Planchard D, Pignon JP, Besse B, group A, Besse B, Lacas B, Pignon J, Remon J, Berghmans T, Dahlberg S, Felip E, Berghmans T, Besse B, Dahlberg S, Felip E, Garon E, Groen H, Hanna N, Heist R, Herbst R, Heymach J, Lacas B, Adjei A, Heist R, Mandrekar S, Neal J, Okamoto I, Pignon J, Ramlau R, Remon J, Reck M, Scagliotti G, Vansteenkiste J, Yoh K. ANtiangiogenic Second-line Lung cancer Meta-Analysis on individual patient data in non-small cell lung cancer: ANSELMA. European Journal Of Cancer 2022, 166: 112-125. PMID: 35286903, DOI: 10.1016/j.ejca.2022.02.002.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerProgression-free survivalAdvanced non-small cell lung cancerFirst-line therapyCell lung cancerIndividual patient dataHazard ratioYounger patientsLung cancerPulmonary thromboembolic eventsPatient dataSecond-line treatmentFirst-line treatmentRisk of hypertensionFixed-effects modelOS benefitPFS benefitThromboembolic eventsOverall survivalSubgroup analysisAntiangiogenicsMeta-AnalysisPatientsMedical needChemotherapyHealth-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 ResearchConceptsAdjuvant 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 ResearchConceptsNon-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 systemOsimertinibPatientsSurgeryLBA42 COAST: An open-label, randomised, phase II platform study of durvalumab alone or in combination with novel agents in patients with locally advanced, unresectable, stage III NSCLC
Martinez-Marti A, Majem M, Barlesi F, Costa E, Chu Q, Monnet I, Sanchez A, Dahkil S, Camidge D, He P, Soo-Hoo Y, Cooper Z, Kumar R, Bothos J, Aggarwal C, Herbst R. LBA42 COAST: An open-label, randomised, phase II platform study of durvalumab alone or in combination with novel agents in patients with locally advanced, unresectable, stage III NSCLC. Annals Of Oncology 2021, 32: s1320. DOI: 10.1016/j.annonc.2021.08.2121.Peer-Reviewed Original ResearchUpdated Overall Survival Analysis From IMpower110: Atezolizumab Versus Platinum-Based Chemotherapy in Treatment-Naive Programmed Death-Ligand 1–Selected NSCLC
Jassem J, de Marinis F, Giaccone G, Vergnenegre A, Barrios CH, Morise M, Felip E, Oprean C, Kim YC, Andric Z, Mocci S, Enquist I, Komatsubara K, McCleland M, Kuriki H, Villalobos M, Phan S, Spigel DR, Herbst RS. Updated Overall Survival Analysis From IMpower110: Atezolizumab Versus Platinum-Based Chemotherapy in Treatment-Naive Programmed Death-Ligand 1–Selected NSCLC. Journal Of Thoracic Oncology 2021, 16: 1872-1882. PMID: 34265434, DOI: 10.1016/j.jtho.2021.06.019.Peer-Reviewed Original ResearchConceptsPD-L1 expressionWT patientsExpression subgroupsWT groupExpression groupHigh PD-L1 expression groupLow PD-L1 expression groupHigh PD-L1 expressionSignificant overall survival benefitNew safety signalsOverall survival benefitPrimary end pointPhase 3 trialPlatinum-based chemotherapyOverall survival analysisAtezolizumab armChemotherapy armOS benefitMetastatic NSCLCSurvival benefitOS improvementSafety signalsAtezolizumabSafety dataPatientsOA06.03 Patient-Reported Outcomes from ADAURA: Osimertinib as Adjuvant Therapy in Patients with Resected EGFR Mutated (EGFRm) NSCLC
Majem M, Goldman J, John T, Grohe C, Laktionov K, Kim S, Kato T, Vu H, Lu S, Lee K, Akewanlop C, Yu C, De Marinis F, Bonanno L, Domine M, Shepherd F, Zeng L, Kulkarni D, Medic N, Tsuboi M, Herbst R, Wu Y. OA06.03 Patient-Reported Outcomes from ADAURA: Osimertinib as Adjuvant Therapy in Patients with Resected EGFR Mutated (EGFRm) NSCLC. Journal Of Thoracic Oncology 2021, 16: s112-s113. DOI: 10.1016/j.jtho.2021.01.291.Peer-Reviewed Original Research