2023
Vitamin D Insufficiency as a Risk Factor for Paclitaxel-Induced Peripheral Neuropathy in SWOG S0221.
Chen C, Zirpoli G, Barlow W, Budd G, McKiver B, Pusztai L, Hortobagyi G, Albain K, Damaj M, Godwin A, Thompson A, Henry N, Ambrosone C, Stringer K, Hertz D. Vitamin D Insufficiency as a Risk Factor for Paclitaxel-Induced Peripheral Neuropathy in SWOG S0221. Journal Of The National Comprehensive Cancer Network 2023, 21: 1172-1180.e3. PMID: 37935109, PMCID: PMC10976748, DOI: 10.6004/jnccn.2023.7062.Peer-Reviewed Original ResearchConceptsChemotherapy-induced peripheral neuropathyVitamin D insufficiencyD insufficiencyVitamin DPaclitaxel scheduleMechanical hypersensitivityPeripheral neuropathyRisk factorsDeficient dietPaclitaxel-Induced Peripheral NeuropathyEarly-stage breast cancerPaclitaxel-containing chemotherapyVitamin D supplementationSufficient vitamin DVitamin D deficiencyBody mass indexMultiple logistic regressionSelf-reported raceD supplementationD deficiencySensitized miceProspective trialFemale patientsMass indexPredictive biomarkersImpact of Anti-HER2 Therapy Alone and With Weekly Paclitaxel on the Ovarian Reserve of Young Women With HER2-Positive Breast Cancer.
Lambertini M, Ceppi M, Anderson R, Cameron D, Bruzzone M, Franzoi M, Massarotti C, El-Abed S, Wang Y, Lecocq C, Nuciforo P, Rolyance R, Pusztai L, Sohn J, Latocca M, Arecco L, Pistilli B, Ruddy K, Ballestrero A, Del Mastro L, Peccatori F, Partridge A, Saura C, Untch M, Piccart M, Di Cosimo S, de Azambuja E, Demeestere I. Impact of Anti-HER2 Therapy Alone and With Weekly Paclitaxel on the Ovarian Reserve of Young Women With HER2-Positive Breast Cancer. Journal Of The National Comprehensive Cancer Network 2023, 21: 33-41.e16. PMID: 36634607, DOI: 10.6004/jnccn.2022.7065.Peer-Reviewed Original ResearchConceptsAnti-HER2 therapyAMH levelsOvarian reserveWeekly paclitaxelAntimüllerian hormoneBreast cancerWeek 2HER2-positive early breast cancerHER2-positive breast cancerSubsequent ovarian functionAnti-HER2 agentsAnti-HER2 treatmentMedian AMH levelsEarly breast cancerTime of surgeryFrozen serum samplesBiomarker analysisNeoALTTO trialPotential gonadotoxicityPremenopausal womenMedian ageAMH valuesOvarian functionAMH declineGonadotoxicity
2022
Predictive Markers of Response to Neoadjuvant Durvalumab with Nab-Paclitaxel and Dose-Dense Doxorubicin/Cyclophosphamide in Basal-Like Triple-Negative Breast Cancer.
Blenman KRM, Marczyk M, Karn T, Qing T, Li X, Gunasekharan V, Yaghoobi V, Bai Y, Ibrahim EY, Park T, Silber A, Wolf DM, Reisenbichler E, Denkert C, Sinn BV, Rozenblit M, Foldi J, Rimm DL, Loibl S, Pusztai L. Predictive Markers of Response to Neoadjuvant Durvalumab with Nab-Paclitaxel and Dose-Dense Doxorubicin/Cyclophosphamide in Basal-Like Triple-Negative Breast Cancer. Clinical Cancer Research 2022, 28: 2587-2597. PMID: 35377948, PMCID: PMC9464605, DOI: 10.1158/1078-0432.ccr-21-3215.Peer-Reviewed Original ResearchConceptsBasal-like triple-negative breast cancerPathologic complete responseResidual diseaseNeoadjuvant durvalumabDNA damage repairSomatic mutationsBreast cancerWnt/β-cateninHigh expressionTriple-negative breast cancerBasal-Like TripleDoxorubicin/cyclophosphamideDNA repairTumor mutation burdenRNA sequencingEpithelial-mesenchymal transitionFive-gene signatureB-cell markersCancer driversEnrichment analysisNegative breast cancerDamage repairGene expressionJAK-STATCell cycle
2021
Durvalumab with olaparib and paclitaxel for high-risk HER2-negative stage II/III breast cancer: Results from the adaptively randomized I-SPY2 trial
Pusztai L, Yau C, Wolf DM, Han HS, Du L, Wallace AM, String-Reasor E, Boughey JC, Chien AJ, Elias AD, Beckwith H, Nanda R, Albain KS, Clark AS, Kemmer K, Kalinsky K, Isaacs C, Thomas A, Shatsky R, Helsten TL, Forero-Torres A, Liu MC, Brown-Swigart L, Petricoin EF, Wulfkuhle JD, Asare SM, Wilson A, Singhrao R, Sit L, Hirst GL, Berry S, Sanil A, Asare AL, Matthews JB, Perlmutter J, Melisko M, Rugo HS, Schwab RB, Symmans WF, Yee D, Van't Veer LJ, Hylton NM, DeMichele AM, Berry DA, Esserman LJ. Durvalumab with olaparib and paclitaxel for high-risk HER2-negative stage II/III breast cancer: Results from the adaptively randomized I-SPY2 trial. Cancer Cell 2021, 39: 989-998.e5. PMID: 34143979, PMCID: PMC11064785, DOI: 10.1016/j.ccell.2021.05.009.Peer-Reviewed Original ResearchConceptsHER2-negative breast cancerTriple-negative breast cancerI-SPY2 trialBreast cancerNeoadjuvant chemotherapyStage II/III HER2-negative breast cancerStage II/III breast cancerGrade 3 adverse eventsPathologic complete response ratePD-L1 inhibitor durvalumabMast cell signaturePaclitaxel neoadjuvant chemotherapyComplete response rateHER2-negative patientsStandard neoadjuvant chemotherapyHER2-negative cancersPARP inhibitor olaparibAdverse eventsGene expression signaturesCare controlSuperior efficacyImmune responseResponse rateCancerInhibitor olaparib
2020
Cost-Effectiveness of Neoadjuvant-Adjuvant Treatment Strategies for Women With ERBB2 (HER2)–Positive Breast Cancer
Kunst N, Wang SY, Hood A, Mougalian SS, DiGiovanna MP, Adelson K, Pusztai L. Cost-Effectiveness of Neoadjuvant-Adjuvant Treatment Strategies for Women With ERBB2 (HER2)–Positive Breast Cancer. JAMA Network Open 2020, 3: e2027074. PMID: 33226431, PMCID: PMC7684449, DOI: 10.1001/jamanetworkopen.2020.27074.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAdultAgedAnthracyclinesAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Agents, PhytogenicBreast NeoplasmsCase-Control StudiesCost-Benefit AnalysisCross-Linking ReagentsDrug Therapy, CombinationFemaleHumansImmunosuppressive AgentsMiddle AgedNeoadjuvant TherapyPaclitaxelQuality-Adjusted Life YearsReceptor, ErbB-2TrastuzumabTubulin ModulatorsUnited StatesConceptsErbB2-positive breast cancerAdjuvant treatment strategiesAdjuvant T-DM1Pathologic complete responseT-DM1Treatment strategiesBreast cancerKATHERINE trialResidual diseaseNeoadjuvant regimenHigher health benefitsHealth care payer perspectiveAdjuvant trastuzumab emtansineAnthracycline/cyclophosphamideDifferent adjuvant therapiesFlatiron Health databaseIncremental cost-effectiveness ratioNeoadjuvant treatment optionsHealth benefitsPositive breast cancerCare payer perspectiveCost-effectiveness ratioBase-case analysisDecision analytic modelH. PatientsPembrolizumab for Early Triple-Negative Breast Cancer
Schmid P, Cortes J, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J. Pembrolizumab for Early Triple-Negative Breast Cancer. New England Journal Of Medicine 2020, 382: 810-821. PMID: 32101663, DOI: 10.1056/nejmoa1910549.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCyclophosphamideDoxorubicinEpirubicinFemaleHumansIntention to Treat AnalysisKaplan-Meier EstimateMiddle AgedNeoadjuvant TherapyNeoplasm StagingPaclitaxelTriple Negative Breast NeoplasmsConceptsEarly triple-negative breast cancerTriple-negative breast cancerPathological complete responseCycles of pembrolizumabPercentage of patientsDefinitive surgeryComplete responseBreast cancerNeoadjuvant chemotherapyTreatment-related adverse eventsUntreated stage IIPrimary end pointAcceptable safety profileEvent-free survivalPhase 3 trialSecond primary tumorsFirst interim analysisAdjuvant pembrolizumabTreat populationDistant recurrenceNeoadjuvant therapyPromising antitumor activityAdverse eventsSafety profilePrimary tumor
2018
Single-arm, neoadjuvant, phase II trial of pertuzumab and trastuzumab administered concomitantly with weekly paclitaxel followed by 5-fluoruracil, epirubicin, and cyclophosphamide (FEC) for stage I–III HER2-positive breast cancer
Foldi J, Mougalian S, Silber A, Lannin D, Killelea B, Chagpar A, Horowitz N, Frederick C, Rispoli L, Burrello T, Abu-Khalaf M, Sabbath K, Sanft T, Brandt DS, Hofstatter EW, Hatzis C, DiGiovanna MP, Pusztai L. Single-arm, neoadjuvant, phase II trial of pertuzumab and trastuzumab administered concomitantly with weekly paclitaxel followed by 5-fluoruracil, epirubicin, and cyclophosphamide (FEC) for stage I–III HER2-positive breast cancer. Breast Cancer Research And Treatment 2018, 169: 333-340. PMID: 29396664, DOI: 10.1007/s10549-017-4653-2.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerPhase II trialII trialNeoadjuvant chemotherapyPCR rateHormone receptorsBreast cancerGrade 3/4 adverse eventsPathologic complete response rateCyclophosphamide neoadjuvant chemotherapyComplete response rateSymptomatic heart failureAsymptomatic decreaseNeoadjuvant settingWeekly paclitaxelAdverse eventsHeart failureTherapeutic plateauCardiac functionInterim analysisStage IResponse ratePurposeThe purposePatientsNegative cases
2017
Cardiac biomarkers for early detection and prediction of trastuzumab and/or lapatinib-induced cardiotoxicity in patients with HER2-positive early-stage breast cancer: a NeoALTTO sub-study (BIG 1-06)
Ponde N, Bradbury I, Lambertini M, Ewer M, Campbell C, Ameels H, Zardavas D, Di Cosimo S, Baselga J, Huober J, Izquierdo M, Fumagalli D, Bozovic-Spasojevic I, Maetens M, Harbeck N, Pusztai L, Berghorn M, Im YH, Borrego MR, Chen DR, Rodeheffer R, Piccart M, Suter T, de Azambuja E. Cardiac biomarkers for early detection and prediction of trastuzumab and/or lapatinib-induced cardiotoxicity in patients with HER2-positive early-stage breast cancer: a NeoALTTO sub-study (BIG 1-06). Breast Cancer Research And Treatment 2017, 168: 631-638. PMID: 29280043, PMCID: PMC5843537, DOI: 10.1007/s10549-017-4628-3.Peer-Reviewed Original ResearchConceptsAnti-HER2 therapyNT-proBNPBiomarker elevationCardiac toxicityEarly predictorHER2-positive early-stage breast cancerEarly-stage breast cancerAnthracycline-naïve patientsEarly cardiac toxicityLevels of TnTNT-proBNP elevationBrain natriuretic peptideBreast cancer patientsNeoALTTO trialWeekly paclitaxelCardiac dysfunctionTreatment armsCardiac damageNatriuretic peptideCancer patientsCardiac biomarkersBreast cancerPatientsTroponin TAmino-terminal fragmentLong-Term Prognostic Risk After Neoadjuvant Chemotherapy Associated With Residual Cancer Burden and Breast Cancer Subtype
Symmans WF, Wei C, Gould R, Yu X, Zhang Y, Liu M, Walls A, Bousamra A, Ramineni M, Sinn B, Hunt K, Buchholz TA, Valero V, Buzdar AU, Yang W, Brewster AM, Moulder S, Pusztai L, Hatzis C, Hortobagyi GN. Long-Term Prognostic Risk After Neoadjuvant Chemotherapy Associated With Residual Cancer Burden and Breast Cancer Subtype. Journal Of Clinical Oncology 2017, 35: jco.2015.63.101. PMID: 28135148, PMCID: PMC5455352, DOI: 10.1200/jco.2015.63.1010.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDisease-Free SurvivalDoxorubicinEpirubicinFemaleFluorouracilHumansMiddle AgedNeoadjuvant TherapyNeoplasm, ResidualPaclitaxelPhenotypePrognosisProspective StudiesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRisk AssessmentSurvival RateTime FactorsTrastuzumabTumor BurdenConceptsResidual cancer burdenPhenotypic subsetsNeoadjuvant chemotherapyValidation cohortPrognostic riskCancer burdenRCB classBreast cancerRCB indexRelapse-free survival estimatesRelapse-free survival rateHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Hormone receptorsOriginal development cohortGrowth factor receptor 2Clinical-pathologic variablesKaplan-Meier analysisLong-term prognosisLog-rank testIndependent validation cohortBreast cancer subtypesLong-term survivalFactor receptor 2Concurrent trastuzumab
2016
SWOG S0800 (NCI CDR0000636131): addition of bevacizumab to neoadjuvant nab-paclitaxel with dose-dense doxorubicin and cyclophosphamide improves pathologic complete response (pCR) rates in inflammatory or locally advanced breast cancer
Nahleh ZA, Barlow WE, Hayes DF, Schott AF, Gralow JR, Sikov WM, Perez EA, Chennuru S, Mirshahidi HR, Corso SW, Lew DL, Pusztai L, Livingston RB, Hortobagyi GN. SWOG S0800 (NCI CDR0000636131): addition of bevacizumab to neoadjuvant nab-paclitaxel with dose-dense doxorubicin and cyclophosphamide improves pathologic complete response (pCR) rates in inflammatory or locally advanced breast cancer. Breast Cancer Research And Treatment 2016, 158: 485-495. PMID: 27393622, PMCID: PMC4963434, DOI: 10.1007/s10549-016-3889-6.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerEvent-free survivalAddition of bevacizumabInflammatory breast cancerAdvanced breast cancerDose-dense doxorubicinNab-paclitaxelPathologic complete responseBreast cancerPCR rateOverall survivalOpen-label phase II clinical trialHormone receptor-positive diseaseImproved event-free survivalPathologic complete response ratePhase II clinical trialNeoadjuvant chemotherapy armNeoadjuvant nab-paclitaxelRole of bevacizumabWeekly nab-paclitaxelComplete response rateReceptor-positive diseaseHormone receptor statusSequence of administrationChemotherapy armAdaptive Randomization of Veliparib–Carboplatin Treatment in Breast Cancer
Rugo HS, Olopade OI, DeMichele A, Yau C, van 't Veer LJ, Buxton MB, Hogarth M, Hylton NM, Paoloni M, Perlmutter J, Symmans WF, Yee D, Chien AJ, Wallace AM, Kaplan HG, Boughey JC, Haddad TC, Albain KS, Liu MC, Isaacs C, Khan QJ, Lang JE, Viscusi RK, Pusztai L, Moulder SL, Chui SY, Kemmer KA, Elias AD, Edmiston KK, Euhus DM, Haley BB, Nanda R, Northfelt DW, Tripathy D, Wood WC, Ewing C, Schwab R, Lyandres J, Davis SE, Hirst GL, Sanil A, Berry DA, Esserman LJ. Adaptive Randomization of Veliparib–Carboplatin Treatment in Breast Cancer. New England Journal Of Medicine 2016, 375: 23-34. PMID: 27406347, PMCID: PMC5259561, DOI: 10.1056/nejmoa1513749.Peer-Reviewed Original ResearchConceptsPathological complete responseHuman epidermal growth factor receptor 2Triple-negative breast cancerStandard therapyComplete responseBreast cancerBiomarker subtypesExperimental regimensEpidermal growth factor receptor 2I-SPY 2Triple-negative populationCompletion of chemotherapyPrimary end pointPhase 3 trialStandard neoadjuvant chemotherapyGrowth factor receptor 2HER2-negative tumorsAdaptive randomizationBiomarker signaturesTumor volume changesFactor receptor 2Phase 2Carboplatin groupNeoadjuvant trialsNeoadjuvant chemotherapyAdaptive Randomization of Neratinib in Early Breast Cancer
Park JW, Liu MC, Yee D, Yau C, van 't Veer LJ, Symmans WF, Paoloni M, Perlmutter J, Hylton NM, Hogarth M, DeMichele A, Buxton MB, Chien AJ, Wallace AM, Boughey JC, Haddad TC, Chui SY, Kemmer KA, Kaplan HG, Isaacs C, Nanda R, Tripathy D, Albain KS, Edmiston KK, Elias AD, Northfelt DW, Pusztai L, Moulder SL, Lang JE, Viscusi RK, Euhus DM, Haley BB, Khan QJ, Wood WC, Melisko M, Schwab R, Helsten T, Lyandres J, Davis SE, Hirst GL, Sanil A, Esserman LJ, Berry DA. Adaptive Randomization of Neratinib in Early Breast Cancer. New England Journal Of Medicine 2016, 375: 11-22. PMID: 27406346, PMCID: PMC5259558, DOI: 10.1056/nejmoa1513750.Peer-Reviewed Original ResearchConceptsPathological complete responseComplete responseBreast cancerNeoadjuvant therapyStandard chemotherapyHuman epidermal growth factor receptor 2 (HER2) statusEpidermal growth factor receptor 2 statusBiomarker signaturesSerial magnetic resonance imagingI-SPY 2 TRIALTyrosine kinase inhibitor neratinibClinical stage IIPrimary end pointHormone receptor statusPhase 2 trialPhase 3 trialStandard neoadjuvant chemotherapyEarly breast cancerMultiple new agentsAdaptive randomizationNegative breast cancerConfirmatory phase 3 trialPhase 3 testingExperimental groupMagnetic resonance imaging
2014
Open-label randomized clinical trial of standard neoadjuvant chemotherapy with paclitaxel followed by FEC versus the combination of paclitaxel and everolimus followed by FEC in women with triple receptor-negative breast cancer †
Gonzalez-Angulo AM, Akcakanat A, Liu S, Green MC, Murray JL, Chen H, Palla SL, Koenig KB, Brewster AM, Valero V, Ibrahim NK, Moulder-Thompson S, Litton JK, Tarco E, Moore J, Flores P, Crawford D, Dryden MJ, Symmans WF, Sahin A, Giordano SH, Pusztai L, Do K, Mills GB, Hortobagyi GN, Meric-Bernstam F. Open-label randomized clinical trial of standard neoadjuvant chemotherapy with paclitaxel followed by FEC versus the combination of paclitaxel and everolimus followed by FEC in women with triple receptor-negative breast cancer †. Annals Of Oncology 2014, 25: 1122-1127. PMID: 24669015, PMCID: PMC4037860, DOI: 10.1093/annonc/mdu124.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerPathological complete responseStandard neoadjuvant chemotherapyNeoadjuvant chemotherapyReverse phase protein arrayBreast cancerPrimary triple-negative breast cancerMTOR pathwayReceptor-negative breast cancerTriple receptor-negative breast cancerAddition of everolimusGrade 3 pneumonitisGrade 3/4 stomatitisPI3K/AKT/mTOR pathwayRash/desquamationClinical response rateGrade 3/4 toxicitiesPhase II studyClinical end pointsCombination of paclitaxelAKT/mTOR pathwayDirect antiproliferative activityBreast cancer cellsDownregulation of mTORII study
2013
Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Ixabepilone or Paclitaxel in Early Stage Breast Cancer and Evaluation of βIII‐Tubulin Expression as a Predictive Marker
Saura C, Tseng L, Chan S, Chacko RT, Campone M, Manikhas A, Nag SM, Leichman CG, Dasappa L, Fasching PA, de Mendoza F, Symmans WF, Liu D, Mukhopadhyay P, Horak C, Xing G, Pusztai L. Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Ixabepilone or Paclitaxel in Early Stage Breast Cancer and Evaluation of βIII‐Tubulin Expression as a Predictive Marker. The Oncologist 2013, 18: 787-794. PMID: 23853246, PMCID: PMC3720631, DOI: 10.1634/theoncologist.2013-0075.Peer-Reviewed Original ResearchConceptsEarly-stage breast cancerStage breast cancerPathologic complete responseΒIII-tubulin expressionBreast cancerTreatment armsWeekly paclitaxelPositive patientsPredictive markerNeoadjuvant doxorubicin/cyclophosphamideRandomized phase II trialΒIII-tubulinCommon nonhematologic toxicitiesDoxorubicin/cyclophosphamideInvasive breast adenocarcinomaPhase II trialCore needle biopsyCycles of ACHigh response rateSignificant differencesNeoadjuvant cyclophosphamideNonhematologic toxicityNeoadjuvant treatmentII trialNegative patientsBiomarker Analysis of Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Ixabepilone or Paclitaxel in Early-Stage Breast Cancer
Horak CE, Pusztai L, Xing G, Trifan OC, Saura C, Tseng LM, Chan S, Welcher R, Liu D. Biomarker Analysis of Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Ixabepilone or Paclitaxel in Early-Stage Breast Cancer. Clinical Cancer Research 2013, 19: 1587-1595. PMID: 23340299, DOI: 10.1158/1078-0432.ccr-12-1359.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsATP Binding Cassette Transporter, Subfamily BATP Binding Cassette Transporter, Subfamily B, Member 1Biomarkers, TumorBreast NeoplasmsCyclophosphamideDoxorubicinEpothilonesFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticHumansMicrofilament ProteinsMicrotubule-Associated ProteinsNeoadjuvant TherapyNeoplasm ProteinsNuclear ProteinsPaclitaxelPrognosisTubulinConceptsMDR1 protein expressionNeoadjuvant doxorubicin/cyclophosphamideEarly-stage breast cancerDoxorubicin/cyclophosphamidePositive patientsProtein expressionTreatment armsBreast cancerPathologic complete response rateEfficacy of ixabepiloneInvasive breast adenocarcinomaComplete response ratePhase II trialCore needle biopsyRates of pCRΒIII-tubulin proteinNeoadjuvant settingII trialNegative patientsGene expressionPrimary cancerPredictive biomarkersPredictive markerRisk ratioNeedle biopsy
2012
Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial
Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gómez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang TW, Horváth Z, Coccia-Portugal M, Domont J, Tseng LM, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M, Team O. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. The Lancet 2012, 379: 633-640. PMID: 22257673, PMCID: PMC5705192, DOI: 10.1016/s0140-6736(11)61847-3.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDiarrheaDrug Administration ScheduleFemaleHumansInfusions, IntravenousLapatinibLiverMiddle AgedNeoadjuvant TherapyPaclitaxelQuinazolinesReceptor, ErbB-2TrastuzumabTreatment OutcomeConceptsPathological complete responseBreast cancerHER2-positive early breast cancerHER2-positive primary breast cancerAnti-HER2 monoclonal antibody trastuzumabHER2-positive breast cancerHER2-overexpressing breast cancerTyrosine kinase inhibitor lapatinibGrade 3 diarrheaLiver enzyme alterationsAnti-HER2 agentsAnti-HER2 therapyPhase 3 studyPhase 3 trialEarly breast cancerPrimary breast cancerSingle-agent therapySynergistic antitumour activityMajor cardiac dysfunctionKinase inhibitor lapatinibMonoclonal antibody trastuzumabAdjuvant chemotherapyNeoadjuvant phaseNeoadjuvant settingOral lapatinib
2010
Evaluation of a 30-Gene Paclitaxel, Fluorouracil, Doxorubicin, and Cyclophosphamide Chemotherapy Response Predictor in a Multicenter Randomized Trial in Breast Cancer
Tabchy A, Valero V, Vidaurre T, Lluch A, Gomez H, Martin M, Qi Y, Barajas-Figueroa LJ, Souchon E, Coutant C, Doimi FD, Ibrahim NK, Gong Y, Hortobagyi GN, Hess KR, Symmans WF, Pusztai L. Evaluation of a 30-Gene Paclitaxel, Fluorouracil, Doxorubicin, and Cyclophosphamide Chemotherapy Response Predictor in a Multicenter Randomized Trial in Breast Cancer. Clinical Cancer Research 2010, 16: 5351-5361. PMID: 20829329, PMCID: PMC4181852, DOI: 10.1158/1078-0432.ccr-10-1265.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, PharmacologicalBiomarkers, TumorBreast NeoplasmsCarcinoma, Ductal, BreastCyclophosphamideDoxorubicinFemaleFluorouracilGene Expression Regulation, NeoplasticHumansMiddle AgedPaclitaxelPredictive Value of TestsPrognosisTreatment OutcomeConceptsPositive predictive valuePathologic complete responseFAC armPCR rateBreast cancerPredictive valueGene expression profilingDifferent molecular subsetsFine-needle aspiration biopsyMulticenter Randomized TrialInternational clinical trialsGenomic predictorsNegative predictive valueTreatment response predictionWeekly paclitaxelNeoadjuvant chemotherapyCyclophosphamide chemotherapyFAC chemotherapyPreoperative chemotherapyComplete responseRandomized trialsTreatment armsPredictive markerClinical trialsMolecular subsetsAssessment of an RNA interference screen-derived mitotic and ceramide pathway metagene as a predictor of response to neoadjuvant paclitaxel for primary triple-negative breast cancer: a retrospective analysis of five clinical trials
Juul N, Szallasi Z, Eklund AC, Li Q, Burrell RA, Gerlinger M, Valero V, Andreopoulou E, Esteva FJ, Symmans WF, Desmedt C, Haibe-Kains B, Sotiriou C, Pusztai L, Swanton C. Assessment of an RNA interference screen-derived mitotic and ceramide pathway metagene as a predictor of response to neoadjuvant paclitaxel for primary triple-negative breast cancer: a retrospective analysis of five clinical trials. The Lancet Oncology 2010, 11: 358-365. PMID: 20189874, DOI: 10.1016/s1470-2045(10)70018-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsArea Under CurveBreast NeoplasmsCeramidesDrug Screening Assays, AntitumorFemaleHumansLogistic ModelsMetagenomicsMiddle AgedMitosisModels, GeneticMultivariate AnalysisNeoadjuvant TherapyPaclitaxelPredictive Value of TestsRetrospective StudiesRNA InterferenceConceptsTriple-negative breast cancerPathological complete responseMultivariate logistic regressionBreast cancerClinical trialsPrimary triple-negative breast cancerEpidermal growth factor receptor 2Logistic regressionBreast Cancer Research FoundationAddition of taxanesPaclitaxel-containing chemotherapyClinical trial cohortProportion of patientsCohort of patientsGrowth factor receptor 2Paclitaxel combination chemotherapyUK Medical Research CouncilAlternative treatment regimensPredictors of responseCancer Research UKBreast cancer cell linesTriple-negative breast cancer cell linesFactor receptor 2Cancer Research FoundationCell linesProspective Comparison of Clinical and Genomic Multivariate Predictors of Response to Neoadjuvant Chemotherapy in Breast Cancer
Lee JK, Coutant C, Kim YC, Qi Y, Theodorescu D, Symmans WF, Baggerly K, Rouzier R, Pusztai L. Prospective Comparison of Clinical and Genomic Multivariate Predictors of Response to Neoadjuvant Chemotherapy in Breast Cancer. Clinical Cancer Research 2010, 16: 711-718. PMID: 20068086, PMCID: PMC2807997, DOI: 10.1158/1078-0432.ccr-09-2247.Peer-Reviewed Original ResearchAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, PharmacologicalBreast NeoplasmsCarcinomaCyclophosphamideDoxorubicinFemaleFluorouracilGene Expression ProfilingGene Expression Regulation, NeoplasticHumansMiddle AgedNeoadjuvant TherapyOligonucleotide Array Sequence AnalysisPaclitaxelPrognosisSensitivity and Specificity
2009
Evaluation of Microtubule-Associated Protein-Tau Expression As a Prognostic and Predictive Marker in the NSABP-B 28 Randomized Clinical Trial
Pusztai L, Jeong JH, Gong Y, Ross JS, Kim C, Paik S, Rouzier R, Andre F, Hortobagyi GN, Wolmark N, Symmans WF. Evaluation of Microtubule-Associated Protein-Tau Expression As a Prognostic and Predictive Marker in the NSABP-B 28 Randomized Clinical Trial. Journal Of Clinical Oncology 2009, 27: 4287-4292. PMID: 19667268, PMCID: PMC2744271, DOI: 10.1200/jco.2008.21.6887.Peer-Reviewed Original ResearchMeSH KeywordsAnthracyclinesAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantCyclophosphamideDoxorubicinEstrogen Receptor alphaFemaleFollow-Up StudiesHumansImmunohistochemistryKaplan-Meier EstimateMaleMicrotubule-Associated ProteinsMiddle AgedMultivariate AnalysisPaclitaxelPredictive Value of TestsPrognosisProportional Hazards ModelsRandomized Controlled Trials as TopicReceptor, ErbB-2Tau ProteinsConceptsDisease-free survivalOverall survivalTau protein expressionTau expressionEndocrine therapyPaclitaxel chemotherapyClinical trialsHuman epidermal growth factor receptor 2 (HER2) expressionEpidermal growth factor receptor 2 expressionBetter disease-free survivalWorse disease-free survivalD. Anderson Cancer CenterPrimary breast cancer specimensCourses of doxorubicinHER2-positive statusHormone receptor positiveNational Surgical BreastAdjuvant endocrine therapyPercent of patientsProtein expressionGreater tumor sizeER-positive statusEstrogen receptor-positive statusLow histologic gradeAnderson Cancer Center