2024
Strength of evidence underlying the CMS-FDA parallel review of comprehensive genomic profiling tests in the cancer setting
Stackland S, Schnabel D, Dinan M, Presley C, Gross C. Strength of evidence underlying the CMS-FDA parallel review of comprehensive genomic profiling tests in the cancer setting. Journal Of The National Cancer Institute 2024, 117: 144-151. PMID: 39288939, PMCID: PMC11717411, DOI: 10.1093/jnci/djae196.Peer-Reviewed Original ResearchComprehensive genomic profilingComprehensive genomic profiling testCenter for Medical Technology PolicyClinical careClinical outcomesDiagnostic testsAssessed clinical outcomesOutcomes of patientsStrength of evidenceCourse of clinical careEfficacy of diagnostic testsNovel diagnostic testsPeer-reviewed literatureGenomic profiling testsFoundationOne CDxGenomic testingSolid tumorsStudy designGenomic alterationsGenomic profilingF1CDxCancer settingClinical utilityCancer typesCompare groupsMolecular profiling of metastatic breast cancer and target-based therapeutic matching in an Asian tertiary phase I oncology unit
Walsh R, Ong R, Cheo S, Low P, Jayagopal A, Lee M, Ngoi N, Ow S, Wong A, Lim S, Lim Y, Heong V, Sundar R, Soo R, Chee C, Yong W, Goh B, Lee S, Tan D, Lim J. Molecular profiling of metastatic breast cancer and target-based therapeutic matching in an Asian tertiary phase I oncology unit. Frontiers In Oncology 2024, 14: 1342346. PMID: 38812774, PMCID: PMC11133600, DOI: 10.3389/fonc.2024.1342346.Peer-Reviewed Original ResearchProlonged median progression-free survivalTumor mutational burdenObjective response rateMetastatic breast cancerHazard ratioNext-generation sequencingPhase I unitMedian OSMolecular profilingOverall survivalAssociated with prolonged median PFSBreast cancerMedian progression-free survivalTreatment outcomesTrials of targeted therapiesProgression-free survivalData cut-offBroad-panel next-generation sequencingTumor molecular profilingTreatment eventsFoundationOne CDxMBC patientsMutational burdenAssociated with improvementsTertiary centre
2023
Variable Landscape of PD-L1 Expression in Breast Carcinoma as Detected by the DAKO 22C3 Immunohistochemistry Assay
Danziger N, Sokol E, Graf R, Hiemenz M, Maule J, Parimi V, Palmieri C, Pusztai L, Ross J, Huang R. Variable Landscape of PD-L1 Expression in Breast Carcinoma as Detected by the DAKO 22C3 Immunohistochemistry Assay. The Oncologist 2023, 28: 319-326. PMID: 36866462, PMCID: PMC10078903, DOI: 10.1093/oncolo/oyad025.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerPD-L1 expressionNegative triple negative breast cancerTNBC tissue samplesPD-L1 positivityPD-L1Dako 22C3Breast cancerDeath ligand 1 (PD-L1) immunohistochemistry (IHC) assaysPD-L1 groupNon-TNBC patientsTissue samplesComprehensive genomic profilingBreast cancer subtypesFoundationOne CDxImmunotherapy efficacyMetastatic sitesTNBC casesBC patientsBreast carcinomaPositive statusImmunohistochemistry assaysOptimum cutoffCancer subtypesGenomic profilingSpectrum and implications of activating BRAF alterations in advanced prostate cancer (aPC).
Chehrazi-Raffle A, Tukachinsky H, Schrock A, Hwang J, Zengin Z, Meza L, Chawla N, Ebrahimi H, Govindarajan A, Castro D, Rock A, Tripathi A, Dorff T, Pal S, Oxnard G, Agarwal N, Antonarakis E. Spectrum and implications of activating BRAF alterations in advanced prostate cancer (aPC). Journal Of Clinical Oncology 2023, 41: 220-220. DOI: 10.1200/jco.2023.41.6_suppl.220.Peer-Reviewed Original ResearchAdvanced prostate cancerComprehensive genomic profilingGenomic alterationsBRAF alterationsTissue biopsiesCancer typesFurther clinical investigationTMPRSS2-ERG fusionFoundationOne CDxMedian ageCommon genomic alterationsAPC patientsProstate cancerMolecular subtypesClinical investigationHigh incidenceActionable targetsBRAF rearrangementsCancer-related genesHotspot missense mutationsGenomic profilingBRAFCDK12 mutationsGenetic activationBiopsy
2020
Association of tumor mutational burden (TMB) and clinical outcomes with pembrolizumab (pembro) versus chemotherapy (chemo) in patients with metastatic triple-negative breast cancer (mTNBC) from KEYNOTE-119.
Winer E, Lipatov O, Im S, Goncalves A, Muñoz-Couselo E, Lee K, Schmid P, Testa L, Witzel I, Ohtani S, Lunceford J, Karantza V, Mejia J, Cristescu R, Aurora-Garg D, Jelinic P, Huang L, Cortes J. Association of tumor mutational burden (TMB) and clinical outcomes with pembrolizumab (pembro) versus chemotherapy (chemo) in patients with metastatic triple-negative breast cancer (mTNBC) from KEYNOTE-119. Journal Of Clinical Oncology 2020, 38: 1013-1013. DOI: 10.1200/jco.2020.38.15_suppl.1013.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTumor mutational burdenMut/MbClinical outcomesTriple-negative breast cancerChemo-treated patientsPrior systemic treatmentThird-line settingOverall study populationNumber of patientsTwo-sided p valuePD-L1 enrichmentReceiver operator characteristic analysisEstimates of efficacyOperator characteristic analysisP-valueFoundationOne CDxBaseline characteristicsMetastatic diseaseSystemic treatmentPotential positive associationTreatment armsClinical benefitCox regressionBreast cancer
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