2021
Brigatinib Versus Crizotinib in ALK Inhibitor–Naive Advanced ALK-Positive NSCLC: Final Results of Phase 3 ALTA-1L Trial
Camidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, Lee KH, Delmonte A, Garcia Campelo MR, Kim DW, Griesinger F, Felip E, Califano R, Spira AI, Gettinger SN, Tiseo M, Lin HM, Liu Y, Vranceanu F, Niu H, Zhang P, Popat S. Brigatinib Versus Crizotinib in ALK Inhibitor–Naive Advanced ALK-Positive NSCLC: Final Results of Phase 3 ALTA-1L Trial. Journal Of Thoracic Oncology 2021, 16: 2091-2108. PMID: 34537440, DOI: 10.1016/j.jtho.2021.07.035.Peer-Reviewed Original ResearchConceptsBlinded independent review committeeIndependent review committeeBrain metastasesSurvival benefitSuperior efficacyTP53 mutationsAdvanced ALK-positive NSCLCBaseline brain metastasesSecondary ALK mutationsMedian overall survivalOverall survival benefitPrimary end pointNew safety signalsPhase 3 studyALK-positive NSCLCLung cancer trialsPlasma cell-free DNAPoor prognostic biomarkerReview CommitteeEML4-ALK variantsCell-free DNAAdvanced ALKOverall survivalPoor PFSPositive NSCLC
2013
Subgroup analysis of crizotinib versus either pemetrexed (PEM) or docetaxel (DOC) in the phase III study (PROFILE 1007) of advanced ALK -positive non-small cell lung cancer (NSCLC).
Solomon B, Gettinger S, Riely G, Gadgeel S, Nokihara H, Han J, Hida T, Satouchi M, Baldini E, Siena S, Yamamoto N, Horn L, Tassell V, Polli A, Camidge D. Subgroup analysis of crizotinib versus either pemetrexed (PEM) or docetaxel (DOC) in the phase III study (PROFILE 1007) of advanced ALK -positive non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: 8105-8105. DOI: 10.1200/jco.2013.31.15_suppl.8105.Peer-Reviewed Original ResearchNon-small cell lung cancerMedian PFSPFS ratesSubgroup analysisSuperior efficacyAdvanced ALK-positive non-small cell lung cancerALK-positive non-small cell lung cancerManageable side-effect profilePrior platinum-based regimenStage IIIB/IVCausality adverse eventsMedian treatment durationPlatinum-based regimenSafety of crizotinibIIIB/IVPhase III studySide effect profileCell lung cancerIndependent radiologic reviewPEM patientsPo bidPROFILE 1007Crizotinib treatmentCare chemotherapyData cutoff