2020
Overall Survival of CDK4/6-Inhibitor–Based Treatments in Clinically Relevant Subgroups of Metastatic Breast Cancer: Systematic Review and Meta-Analysis
Schettini F, Giudici F, Giuliano M, Cristofanilli M, Arpino G, Del Mastro L, Puglisi F, De Placido S, Paris I, De Placido P, Venturini S, De Laurentis M, Conte P, Juric D, Llombart-Cussac A, Pusztai L, Prat A, Jerusalem G, Di Leo A, Generali D. Overall Survival of CDK4/6-Inhibitor–Based Treatments in Clinically Relevant Subgroups of Metastatic Breast Cancer: Systematic Review and Meta-Analysis. Journal Of The National Cancer Institute 2020, 112: 1089-1097. PMID: 32407488, PMCID: PMC7669227, DOI: 10.1093/jnci/djaa071.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6FemaleHumansLetrozoleNeoplasm MetastasisPiperazinesProtein Kinase InhibitorsPyridinesRandomized Controlled Trials as TopicConceptsSecond-line therapyMetastatic breast cancerEndocrine therapyCDK4/6 inhibitorsVisceral involvementBreast cancerPostmenopausal metastatic breast cancerAvailable phase IIChemotherapy-naïve patientsClear OS benefitSpecific clinical subgroupsProgression-free survivalOverall survival dataBreast cancer prognosisStudy-level factorsCyclin-dependent kinase 4Random-effects modelSystematic literature searchEndocrine monotherapyOS benefitOS independentOverall survivalUpfront therapyMenopausal statusMetastatic sites
2018
Tumor infiltrating lymphocytes and PD-L1 expression in pre- and post-treatment breast cancers in the SWOG S0800 Phase II neoadjuvant chemotherapy trial
Pelekanou V, Barlow WE, Nahleh Z, Wasserman B, Lo YC, von Wahlde MK, Hayes D, Hortobagyi GN, Gralow J, Tripathy D, Porter P, Szekely B, Hatzis C, Rimm DL, Pusztai L. Tumor infiltrating lymphocytes and PD-L1 expression in pre- and post-treatment breast cancers in the SWOG S0800 Phase II neoadjuvant chemotherapy trial. Molecular Cancer Therapeutics 2018, 17: molcanther.1005.2017. PMID: 29588392, PMCID: PMC6548451, DOI: 10.1158/1535-7163.mct-17-1005.Peer-Reviewed Original ResearchConceptsPD-L1 expressionPathologic complete responseTIL countPosttreatment tissuePD-L1Estrogen receptorImmune checkpoint inhibitor therapyPD-L1 positivity rateTumor-infiltrating lymphocyte countsDoxorubicin/cyclophosphamideCheckpoint inhibitor therapyPD-L1 levelsMol Cancer TherNab-paclitaxelLymphocyte countResidual cancerComplete responseER statusImmune changesInhibitor therapyCox regressionPatient populationControl armClinical trialsPositivity rate
2007
Pharmacogenomic Predictor Discovery in Phase II Clinical Trials for Breast Cancer
Pusztai L, Anderson K, Hess KR. Pharmacogenomic Predictor Discovery in Phase II Clinical Trials for Breast Cancer. Clinical Cancer Research 2007, 13: 6080-6086. PMID: 17947471, DOI: 10.1158/1078-0432.ccr-07-0809.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials, Phase II as TopicGene Expression ProfilingGene Expression Regulation, NeoplasticHumansIn Situ Hybridization, FluorescenceOligonucleotide Array Sequence AnalysisPharmacogeneticsProbabilityRNA, MessengerTissue DistributionTrastuzumabConceptsPhase II studyPhase II trialII trialII studyBreast cancerTwo-stage phase II trialPhase II clinical trialPhase II trial designPredictors of responseMarker-positive patientsPhase II designUnselected patientsPatient populationClinical trialsTrastuzumab responseInsufficient responseTrial designResponse markersSame drugResponse rateMarker testingPotential predictorsMarker assessmentTrialsPatientsLimitations of pharmacogenomic predictor discovery in Phase II clinical trials
Pusztai L. Limitations of pharmacogenomic predictor discovery in Phase II clinical trials. Pharmacogenomics 2007, 8: 1443-1448. PMID: 17979517, DOI: 10.2217/14622416.8.10.1443.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials, Phase II as TopicDrug TherapyGenetic MarkersHumansPharmacogeneticsReproducibility of Results
2005
Epidermal growth factor receptor expression correlates with poor survival in patients who have breast carcinoma treated with doxorubicin‐based neoadjuvant chemotherapy
Buchholz TA, Tu X, Ang KK, Esteva FJ, Kuerer HM, Pusztai L, Cristofanilli M, Singletary SE, Hortobagyi GN, Sahin AA. Epidermal growth factor receptor expression correlates with poor survival in patients who have breast carcinoma treated with doxorubicin‐based neoadjuvant chemotherapy. Cancer 2005, 104: 676-681. PMID: 15981280, DOI: 10.1002/cncr.21217.Peer-Reviewed Original ResearchMeSH KeywordsAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicCyclophosphamideDisease-Free SurvivalDoxorubicinErbB ReceptorsFemaleFluorouracilHumansImmunohistochemistryNeoadjuvant TherapyPrognosisRandomized Controlled Trials as TopicSurvival AnalysisConceptsEpidermal growth factor receptorBreast carcinomaEGFR expressionAnthracycline chemotherapyLymph nodesEpidermal growth factor receptor expression correlatesSurvival ratePathologic complete response ratePretreatment tumor tissue samplesDisease-free survival ratesCox regression analysis modelComplete response rateEGFR-negative tumorsEGFR-positive diseasePositive lymph nodesAdvanced breast carcinomaMore lymph nodesOutcomes of patientsOverall survival rateProgesterone receptor statusEGFR-positive tumorsTumor tissue samplesKnowledge of outcomesGrowth factor receptorCyclophosphamide chemotherapy