2020
Brigatinib Versus Crizotinib in Advanced ALK Inhibitor–Naive ALK-Positive Non–Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial
Camidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, Lee KH, Delmonte A, Campelo M, Kim DW, Griesinger F, Felip E, Califano R, Spira A, Gettinger SN, Tiseo M, Lin HM, Gupta N, Hanley MJ, Ni Q, Zhang P, Popat S. Brigatinib Versus Crizotinib in Advanced ALK Inhibitor–Naive ALK-Positive Non–Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial. Journal Of Clinical Oncology 2020, 38: 3592-3603. PMID: 32780660, PMCID: PMC7605398, DOI: 10.1200/jco.20.00505.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerALK-positive non-small cell lung cancerProgression-free survivalBlinded independent review committeeCell lung cancerInterim analysisLung cancerAdvanced ALK-positive non-small cell lung cancerGlobal health status/QoL scoreNext-generation anaplastic lymphoma kinase (ALK) inhibitorPositive non-small cell lung cancerPredictors of PFSPromising first-line treatmentSecond prespecified interim analysisSuperior progression-free survivalPlasma concentration-time curveAnaplastic lymphoma kinase inhibitorsPrespecified interim analysisPrimary end pointSecond interim analysisFirst-line treatmentFirst interim analysisHealth-related qualityIndependent review committeePatient-reported outcomes
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
2012
Results of a global phase II study with crizotinib in advanced ALK -positive non-small cell lung cancer (NSCLC).
Kim D, Ahn M, Shi Y, De Pas T, Yang P, Riely G, Crinò L, Evans T, Liu X, Han J, Salgia R, Moro-Sibilot D, Ou S, Gettinger S, Wu Y, Lanzalone S, Polli A, Iyer S, Shaw A. Results of a global phase II study with crizotinib in advanced ALK -positive non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2012, 30: 7533-7533. DOI: 10.1200/jco.2012.30.15_suppl.7533.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced ALK-positive non-small cell lung cancerALK-positive non-small cell lung cancerPatient-reported symptomsTumor responseFrequent treatment-related AEsECOG PS 0Efficacy of crizotinibPrior chemotherapy regimensTreatment-related AEsTreatment-related SAEsDisease control rateMedian treatment durationPhase II studyFavorable tolerability profileMajority of patientsCell lung cancerEnd of treatmentEORTC QLQ-C30Standard of careALK gene rearrangementHigh response rateFebrile neutropeniaLC-13Median PFS