2024
Navigating practical challenges in immunotherapy for metastatic triple negative breast cancer
Licata L, Dieci M, De Angelis C, Marchiò C, Miglietta F, Cortesi L, Fabi A, Schmid P, Cortes J, Pusztai L, Bianchini G, Curigliano G. Navigating practical challenges in immunotherapy for metastatic triple negative breast cancer. Cancer Treatment Reviews 2024, 128: 102762. PMID: 38776613, DOI: 10.1016/j.ctrv.2024.102762.Peer-Reviewed Original ResearchTriple-negative breast cancerBreast cancerMetastatic triple negative breast cancerManagement of breast cancer patientsTriple negative breast cancerApproval of immunotherapyImmune checkpoint inhibitorsNegative breast cancerBreast cancer patientsEveryday clinical practiceCheckpoint inhibitorsTumor typesCancer patientsClinical trialsCancer therapyImmunotherapyCancerClinical practicePositive resultsCliniciansTumorTherapyPatientsTrialsInhibitors
2023
LBA20 A randomized, double-blind trial of nivolumab (NIVO) vs placebo (PBO) with neoadjuvant chemotherapy (NACT) followed by adjuvant endocrine therapy (ET) ± NIVO in patients (pts) with high-risk, ER+ HER2− primary breast cancer (BC)
Loi S, Curigliano G, Salgado R, Diaz R, Delaloge S, Rojas C, Kok M, Manich C, Harbeck N, Mittendorf E, Yardley D, Pusztai L, Zaizar A, Ungureanu A, Ades F, Chandra R, Nathani R, Pacius M, Wu J, McArthur H. LBA20 A randomized, double-blind trial of nivolumab (NIVO) vs placebo (PBO) with neoadjuvant chemotherapy (NACT) followed by adjuvant endocrine therapy (ET) ± NIVO in patients (pts) with high-risk, ER+ HER2− primary breast cancer (BC). Annals Of Oncology 2023, 34: s1259-s1260. DOI: 10.1016/j.annonc.2023.10.010.Peer-Reviewed Original ResearchTreatment efficacy score: a better surrogate for arm-level survival differences in neoadjuvant breast cancer trials?
Chehayeb R, Kahn A, Pusztai L. Treatment efficacy score: a better surrogate for arm-level survival differences in neoadjuvant breast cancer trials? Future Oncology 2023, 19: 1945-1951. PMID: 37767612, DOI: 10.2217/fon-2022-1203.Peer-Reviewed Original ResearchExcellent long-term survivalNeoadjuvant breast cancer trialsResidual cancer burden scorePathologic complete responseBreast cancer trialsLong-term survivalNeoadjuvant chemotherapyPathologic responseComplete responseSurvival improvementBurden scoreResidual diseaseTrial armsSurvival differencesCancer trialsBreast cancerTreatment efficacyStage IIGood surrogateEfficacy scoresTrialsSurvivalScoresRate differencesChemotherapyPitfalls in machine learning‐based assessment of tumor‐infiltrating lymphocytes in breast cancer: A report of the International Immuno‐Oncology Biomarker Working Group on Breast Cancer
Thagaard J, Broeckx G, Page D, Jahangir C, Verbandt S, Kos Z, Gupta R, Khiroya R, Abduljabbar K, Haab G, Acs B, Akturk G, Almeida J, Alvarado‐Cabrero I, Amgad M, Azmoudeh‐Ardalan F, Badve S, Baharun N, Balslev E, Bellolio E, Bheemaraju V, Blenman K, Fujimoto L, Bouchmaa N, Burgues O, Chardas A, Cheang M, Ciompi F, Cooper L, Coosemans A, Corredor G, Dahl A, Portela F, Deman F, Demaria S, Hansen J, Dudgeon S, Ebstrup T, Elghazawy M, Fernandez‐Martín C, Fox S, Gallagher W, Giltnane J, Gnjatic S, Gonzalez‐Ericsson P, Grigoriadis A, Halama N, Hanna M, Harbhajanka A, Hart S, Hartman J, Hauberg S, Hewitt S, Hida A, Horlings H, Husain Z, Hytopoulos E, Irshad S, Janssen E, Kahila M, Kataoka T, Kawaguchi K, Kharidehal D, Khramtsov A, Kiraz U, Kirtani P, Kodach L, Korski K, Kovács A, Laenkholm A, Lang‐Schwarz C, Larsimont D, Lennerz J, Lerousseau M, Li X, Ly A, Madabhushi A, Maley S, Narasimhamurthy V, Marks D, McDonald E, Mehrotra R, Michiels S, Minhas F, Mittal S, Moore D, Mushtaq S, Nighat H, Papathomas T, Penault‐Llorca F, Perera R, Pinard C, Pinto‐Cardenas J, Pruneri G, Pusztai L, Rahman A, Rajpoot N, Rapoport B, Rau T, Reis‐Filho J, Ribeiro J, Rimm D, Roslind A, Vincent‐Salomon A, Salto‐Tellez M, Saltz J, Sayed S, Scott E, Siziopikou K, Sotiriou C, Stenzinger A, Sughayer M, Sur D, Fineberg S, Symmans F, Tanaka S, Taxter T, Tejpar S, Teuwen J, Thompson E, Tramm T, Tran W, van der Laak J, van Diest P, Verghese G, Viale G, Vieth M, Wahab N, Walter T, Waumans Y, Wen H, Yang W, Yuan Y, Zin R, Adams S, Bartlett J, Loibl S, Denkert C, Savas P, Loi S, Salgado R, Stovgaard E. Pitfalls in machine learning‐based assessment of tumor‐infiltrating lymphocytes in breast cancer: A report of the International Immuno‐Oncology Biomarker Working Group on Breast Cancer. The Journal Of Pathology 2023, 260: 498-513. PMID: 37608772, PMCID: PMC10518802, DOI: 10.1002/path.6155.Peer-Reviewed Original ResearchConceptsTumor-infiltrating lymphocytesTriple-negative breast cancerBreast cancerTIL assessmentHER2-positive breast cancerRoutine clinical managementTIL evaluationTumor-immune interactionsClinical managementDiscordant assessmentsClinical significancePrognostic biomarkerTIL quantificationCancerDaily practicePatientsTrialsTissue patternsAssessmentLymphocytesBiomarkersP111 A phase 3, open-label trial of neoadjuvant trastuzumab deruxtecan (T-DXd) monotherapy or T-DXd followed by THP vs ddAC-THP in high-risk HER2-positive early-stage breast cancer (DESTINY-Breast11)
Harbeck N, Boileau J, Modi S, Kelly C, Ohno S, Wu J, Konpa A, Herbolsheimer P, Safdar S, Zhang Y, Pusztai L. P111 A phase 3, open-label trial of neoadjuvant trastuzumab deruxtecan (T-DXd) monotherapy or T-DXd followed by THP vs ddAC-THP in high-risk HER2-positive early-stage breast cancer (DESTINY-Breast11). The Breast 2023, 68: s57. DOI: 10.1016/s0960-9776(23)00228-x.Peer-Reviewed Original Research
2022
139MO Identification of biologically-driven HER2-positive breast cancer subgroups associated with prognosis after adjuvant trastuzumab in the ALTTO trial
Rediti M, Venet D, Garcia A, Agbor-tarh D, Maetens M, Vincent D, Majjaj S, El-Abed S, Liu M, Di Cosimo S, Piccart M, Pusztai L, Loi S, Salgado R, Viale G, Rothé F, Sotiriou C. 139MO Identification of biologically-driven HER2-positive breast cancer subgroups associated with prognosis after adjuvant trastuzumab in the ALTTO trial. Annals Of Oncology 2022, 33: s602-s603. DOI: 10.1016/j.annonc.2022.07.174.Peer-Reviewed Original ResearchPathologic complete response (pCR) rates for HR+/HER2- breast cancer by molecular subtype in the I-SPY2 Trial.
Huppert L, Rugo H, Pusztai L, Mukhtar R, Chien A, Yau C, Wolf D, Berry D, van 't Veer L, Yee D, DeMichele A, Esserman L, Consortium I. Pathologic complete response (pCR) rates for HR+/HER2- breast cancer by molecular subtype in the I-SPY2 Trial. Journal Of Clinical Oncology 2022, 40: 504-504. DOI: 10.1200/jco.2022.40.16_suppl.504.Peer-Reviewed Original ResearchI-SPY2 trialInvestigational agentsMolecular subtypesNodal statusPathologic complete response rateMultiple investigational agentsComplete response ratePhase 3 trialHER2- breast cancerLuminal statusNeoadjuvant therapyPrimary endpointImmune signaturesPCR rateTreatment armsHeterogenous diseaseBC therapySubtype 5Breast cancerImmune biologyResponse ratePembrolizumabHormone receptorsDiseaseTrials
2020
Text Messaging to Increase Compliance with Adjuvant Endocrine Therapy in Breast Cancer
Pusztai L, Taylor R, Mougalian SS. Text Messaging to Increase Compliance with Adjuvant Endocrine Therapy in Breast Cancer. Cancer Cell 2020, 38: 323-325. PMID: 32931742, DOI: 10.1016/j.ccell.2020.08.006.Peer-Reviewed Original Research134TiP A phase III trial of nivolumab with neoadjuvant chemotherapy and adjuvant endocrine therapy in ER+/HER2− primary breast cancer: CheckMate 7FL
Curigliano G, McArthur H, Harbeck N, Pusztai L, Delaloge S, Letrent K, Chen T, Li B, Tatsuoka K, Zardavas D, Loi S. 134TiP A phase III trial of nivolumab with neoadjuvant chemotherapy and adjuvant endocrine therapy in ER+/HER2− primary breast cancer: CheckMate 7FL. Annals Of Oncology 2020, 31: s60-s61. DOI: 10.1016/j.annonc.2020.03.236.Peer-Reviewed Original Research
2019
Reanalysis of the NCCN PD-L1 companion diagnostic assay study for lung cancer in the context of PD-L1 expression findings in triple-negative breast cancer
Rimm DL, Han G, Taube JM, Yi ES, Bridge JA, Flieder DB, Homer R, Roden AC, Hirsch FR, Wistuba II, Pusztai L. Reanalysis of the NCCN PD-L1 companion diagnostic assay study for lung cancer in the context of PD-L1 expression findings in triple-negative breast cancer. Breast Cancer Research 2019, 21: 72. PMID: 31196152, PMCID: PMC6567382, DOI: 10.1186/s13058-019-1156-6.Peer-Reviewed Original ResearchConceptsPD-L1 expressionImmune cell PD-L1 expressionLung cancerImmune cellsTriple-negative breast cancerEasy scoring methodCompanion diagnostic testsPD-L1Immune therapyBreast cancerImmunohistochemical testsBetter outcomesLarger studyTumor cellsDiagnostic testsCancerExpression findingsCellsExpressionPoor agreementScoring methodTherapyTrialsCorrections to “Pathway level alterations rather than mutations in single genes predict response to HER2-targeted therapies in the neo-ALTTO trial”
Shi W, Jiang T, Nuciforo P, Hatzis C, Holmes E, Harbeck N, Sotiriou C, Peña L, Loi S, Rosa DD, Chia S, Wardley A, Ueno T, Rossari J, Eidtmann H, Armour A, Piccart-Gebhart M, Rimm DL, Baselga J, Pusztai L. Corrections to “Pathway level alterations rather than mutations in single genes predict response to HER2-targeted therapies in the neo-ALTTO trial”. Annals Of Oncology 2019, 30: 1018. PMID: 30624555, PMCID: PMC6594454, DOI: 10.1093/annonc/mdy530.Peer-Reviewed Original ResearchP359 Phase III randomized, placebo-controlled clinical trial evaluating the use of adjuvant endocrine therapy±everolimusin patients with high-risk, hormone receptor (HR) positive, HER2-negative breast cancer (BC): SWOG/NRG/Alliance S1207 (NCT01674140)
Chavez-Macgregor M, Barlow W, Pusztai L, Rastogi P, Ganz P, Mamounas E, Bandos H, Miao J, Gralow J, Hortobagyi G, investigators S. P359 Phase III randomized, placebo-controlled clinical trial evaluating the use of adjuvant endocrine therapy±everolimusin patients with high-risk, hormone receptor (HR) positive, HER2-negative breast cancer (BC): SWOG/NRG/Alliance S1207 (NCT01674140). The Breast 2019, 44: s139. DOI: 10.1016/s0960-9776(19)30460-6.Peer-Reviewed Original Research
2018
correction to: Pathway level alterations rather than mutations in single genes predict response to HER2-targeted therapies in the neo-ALTTO trial
Shi W, Jiang T, Nuciforo P, Hatzis C, Holmes E, Harbeck N, Sotiriou C, Peña L, Loi S, Rosa DD, Chia S, Wardley A, Ueno T, Rossari J, Eidtmann H, Armour A, Piccart-Gebhart M, Rimm DL, Baselga J, Pusztai L. correction to: Pathway level alterations rather than mutations in single genes predict response to HER2-targeted therapies in the neo-ALTTO trial. Annals Of Oncology 2018, 29: 2152. PMID: 29701764, PMCID: PMC6225898, DOI: 10.1093/annonc/mdx805.Peer-Reviewed Original ResearchImmune profiling of pre- and post-treatment breast cancer tissues from the S0800 randomized neoadjuvant trial of weekly nab-paclitaxel with or without bevacizumab and dose dense doxorubicin and cyclophosphamide.
Li X, Warren S, Pelekanou V, Wali V, Cesano A, Liu M, Danaher P, Elliott N, Nahleh Z, Hayes D, Hortobagyi G, Barlow W, Hatzis C, Pusztai L. Immune profiling of pre- and post-treatment breast cancer tissues from the S0800 randomized neoadjuvant trial of weekly nab-paclitaxel with or without bevacizumab and dose dense doxorubicin and cyclophosphamide. Journal Of Clinical Oncology 2018, 36: 578-578. DOI: 10.1200/jco.2018.36.15_suppl.578.Peer-Reviewed Original Research
2017
New Therapeutic Strategies for Triple-Negative Breast Cancer.
Székely B, Silber AL, Pusztai L. New Therapeutic Strategies for Triple-Negative Breast Cancer. Oncology 2017, 31: 130-7. PMID: 28205193.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerResidual cancerBreast cancerEarly-stage triple-negative breast cancerUnselected triple negative breast cancerIntroduction of taxanesOngoing adjuvant trialsImmune checkpoint inhibitorsSurvival of patientsImportant clinical trialsImportant therapeutic advanceBRCA-mutant cancersNew therapeutic strategiesAntibody-drug conjugatesAdjuvant trialsNeoadjuvant chemotherapyAdjuvant therapyCheckpoint inhibitorsIdentifies patientsTherapeutic advancesClinical trialsHigh riskTherapeutic strategiesCancerTrials
2016
Testing Violations of the Exponential Assumption in Cancer Clinical Trials with Survival Endpoints
Han G, Schell MJ, Zhang H, Zelterman D, Pusztai L, Adelson K, Hatzis C. Testing Violations of the Exponential Assumption in Cancer Clinical Trials with Survival Endpoints. Biometrics 2016, 73: 687-695. PMID: 27669414, PMCID: PMC6093291, DOI: 10.1111/biom.12590.Peer-Reviewed Original ResearchRelationship between Complete Pathologic Response to Neoadjuvant Chemotherapy and Survival in Triple-Negative Breast Cancer
Hatzis C, Symmans WF, Zhang Y, Gould RE, Moulder SL, Hunt KK, Abu-Khalaf M, Hofstatter EW, Lannin D, Chagpar AB, Pusztai L. Relationship between Complete Pathologic Response to Neoadjuvant Chemotherapy and Survival in Triple-Negative Breast Cancer. Clinical Cancer Research 2016, 22: 26-33. PMID: 26286912, DOI: 10.1158/1078-0432.ccr-14-3304.Peer-Reviewed Original ResearchConceptsPathologic complete responseRecurrence-free survivalTriple-negative breast cancerSurvival benefitNeoadjuvant trialsNeoadjuvant chemotherapyTrial populationBaseline prognosisBreast cancerOverall survival benefitComplete pathologic responseSignificant survival benefitPostneoadjuvant therapyPCR rateComplete responseImproved survivalPathologic responseSurvival improvementTreatment armsPatient survivalResidual diseaseControl armPrognostic variablesPatientsTrials
2015
Can routine cavity shave margins (CSM) improve local control in breast cancer? Initial results of the SHAVE trial, a prospective randomized controlled trial of routine CSM vs. standard partial mastectomy (SPM).
Chagpar A, Killelea B, Tsangaris T, Butler M, Stavris K, Yao X, Li F, Bossuyt V, Pusztai L, Horowitz N. Can routine cavity shave margins (CSM) improve local control in breast cancer? Initial results of the SHAVE trial, a prospective randomized controlled trial of routine CSM vs. standard partial mastectomy (SPM). Journal Of Clinical Oncology 2015, 33: 1012-1012. DOI: 10.1200/jco.2015.33.15_suppl.1012.Peer-Reviewed Original Research
2013
Genome-wide gene expression profiling to predict resistance to anthracyclines in breast cancer patients
Haibe-Kains B, Desmedt C, Di Leo A, Azambuja E, Larsimont D, Selleslags J, Delaloge S, Duhem C, Kains JP, Carly B, Maerevoet M, Vindevoghel A, Rouas G, Lallemand F, Durbecq V, Cardoso F, Salgado R, Rovere R, Bontempi G, Michiels S, Buyse M, Nogaret JM, Qi Y, Symmans F, Pusztai L, D'Hondt V, Piccart-Gebhart M, Sotiriou C. Genome-wide gene expression profiling to predict resistance to anthracyclines in breast cancer patients. Data In Brief 2013, 1: 7-10. PMID: 26484051, PMCID: PMC4608867, DOI: 10.1016/j.gdata.2013.09.001.Peer-Reviewed Original ResearchBreast cancer patientsResponse/resistanceAnthracycline monotherapyNeoadjuvant trialsGene expression signaturesNegative tumorsCancer patientsBreast cancerClinical dataEstrogen receptorClinical OncologyPredictive valuePatientsAnthracyclinesGene expressionII alphaExpression signaturesGenome-wide gene expressionMonotherapyExpressionTumorsCancerOncologyTrialsBiomarkersConcordance Between CYP2D6 Genotypes Obtained From Tumor-Derived and Germline DNA
Rae JM, Regan MM, Thibert JN, Gersch C, Thomas D, Leyland-Jones B, Viale G, Pusztai L, Hayes DF, Skaar T, Van Poznak C. Concordance Between CYP2D6 Genotypes Obtained From Tumor-Derived and Germline DNA. Journal Of The National Cancer Institute 2013, 105: 1332-1334. PMID: 23958736, PMCID: PMC3888280, DOI: 10.1093/jnci/djt204.Peer-Reviewed Original ResearchConceptsCYP2D6 genotypeCYP2D6 metabolic phenotypeBreast cancer patientsMetabolic phenotypeAnti-estrogen tamoxifenCancer clinical trialsCancer patientsClinical trialsTumor alterationsGermline DNAConflicting resultsPatientsTumorsTissue sourcesGenotype association studiesConcordanceGenotypesPhenotypeAssociation studiesFFPETTamoxifenEndoxifenWBCCYP2D6Trials