2023
Overall survival analysis from the ADAURA trial of adjuvant osimertinib in patients with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC).
Herbst R, Tsuboi M, John T, Kato T, Majem M, Grohé C, Wang J, Goldman J, Lu S, Su W, de Marinis F, Shepherd F, Lee K, Le N, Dechaphunkul A, Kowalski D, Poole L, Stachowiak M, Rukazenkov Y, Wu Y. Overall survival analysis from the ADAURA trial of adjuvant osimertinib in patients with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2023, 41: lba3-lba3. DOI: 10.1200/jco.2023.41.17_suppl.lba3.Peer-Reviewed Original ResearchNon-small cell lung cancerStage IB-IIIA non-small cell lung cancerAdjuvant osimertinibOverall survival analysisOS HRAdjuvant chemotherapyOS benefitOS ratesII-IIIASurvival analysisDisease-free survival benefitFinal overall survival analysisGlobal phase III studyEGFR T790M resistance mutationII-IIIA diseaseStage IB-IIIAT790M resistance mutationTolerable safety profilePhase III studyCell lung cancerComplete tumor resectionEGFR-TKI sensitizingM resistance mutationExtended treatment durationADAURA studyAdjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non–Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial
Herbst R, Wu Y, John T, Grohe C, Majem M, Wang J, Kato T, Goldman J, Laktionov K, Kim S, Yu C, Vu H, Lu S, Lee K, Mukhametshina G, Akewanlop C, de Marinis F, Bonanno L, Domine M, Shepherd F, Urban D, Huang X, Bolanos A, Stachowiak M, Tsuboi M. Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non–Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial. Journal Of Clinical Oncology 2023, 41: 1830-1840. PMID: 36720083, PMCID: PMC10082285, DOI: 10.1200/jco.22.02186.Peer-Reviewed Original ResearchConceptsII-IIIA diseaseStage IB-IIIAAdjuvant osimertinibDFS HRDFS ratesDistant recurrenceEnd pointSafety profileLung cancerSignificant disease-free survival benefitPrimary analysisDisease-free survival benefitLong-term safety profileSmall cell lung cancerStratified log-rank testExploratory end pointsPrimary end pointSecondary end pointsConsistent safety profilePatterns of recurrenceCell lung cancerComplete tumor resectionLog-rank testADAURA trialData cutoff
2020
Osimertinib as adjuvant therapy in patients (pts) with stage IB–IIIA EGFR mutation positive (EGFRm) NSCLC after complete tumor resection: ADAURA.
Herbst R, Tsuboi M, John T, Grohé C, Majem M, Goldman J, Kim S, Marmol D, Rukazenkov Y, Wu Y. Osimertinib as adjuvant therapy in patients (pts) with stage IB–IIIA EGFR mutation positive (EGFRm) NSCLC after complete tumor resection: ADAURA. Journal Of Clinical Oncology 2020, 38: lba5-lba5. DOI: 10.1200/jco.2020.38.18_suppl.lba5.Peer-Reviewed Original ResearchDisease-free survivalComplete tumor resectionDFS hazard ratioAdjuvant chemotherapyData cutoffHazard ratioOverall survivalTumor resectionAdjuvant osimertinibDFS ratesEGFRm NSCLCEGFR-TKISafety profileEGFR mutation-positive NSCLCEffective new treatment strategyResected stage IISafety of osimertinibEarly-stage diseaseMutation-positive NSCLCNew treatment strategiesUnplanned interim analysisEligible ptsIIIA NSCLCNSCLC presentPS 0/1
2019
1450P Frequency of epidermal growth factor receptor (EGFR) mutations in stage IB–IIIA EGFR mutation positive non-small cell lung cancer (NSCLC) after complete tumour resection
Tsuboi M, Herbst R, John T, Grohe C, Majem M, Goldman J, Kim S, Yu C, Miziara J, Novello S, Urban D, Akewanlop C, Öztürk A, Quang B, Kowalski D, Marmol D, Marotti M, Laus G, Wu Y. 1450P Frequency of epidermal growth factor receptor (EGFR) mutations in stage IB–IIIA EGFR mutation positive non-small cell lung cancer (NSCLC) after complete tumour resection. Annals Of Oncology 2019, 30: v589. DOI: 10.1093/annonc/mdz258.010.Peer-Reviewed Original ResearchNon-small cell lung cancerBristol-Myers SquibbComplete tumor resectionEGFR mutationsBoehringer IngelheimMerck SharpAdjuvant therapyComplete resectionTumor resectionStage IB-IIIA non-small cell lung cancerEGFRm non-small cell lung cancerMutation-positive non-small cell lung cancerEarly-stage non-small cell lung cancerEGFR mutation-positive non-small cell lung cancerEli LillyOral EGFR tyrosine kinase inhibitorPositive non-small cell lung cancerT790MEpidermal growth factor receptor (EGFR) mutationsEGFR T790M mutationEGFR tyrosine kinase inhibitorsGenentech/RocheNon-squamous histologySafety of osimertinibPlacebo-controlled study