2024
Neoadjuvant Chemotherapy and Immunotherapy for Estrogen Receptor–Positive Human Epidermal Growth Factor 2–Negative Breast Cancer
Ríos-Hoyo A, Cobain E, Huppert L, Beitsch P, Buchholz T, Esserman L, van 't Veer L, Rugo H, Pusztai L. Neoadjuvant Chemotherapy and Immunotherapy for Estrogen Receptor–Positive Human Epidermal Growth Factor 2–Negative Breast Cancer. Journal Of Clinical Oncology 2024, 42: 2632-2636. PMID: 38593393, DOI: 10.1200/jco.23.02614.Peer-Reviewed Original Research
2023
LBA3 Phase III study of neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for early-stage triple-negative breast cancer (TNBC): KEYNOTE-522 Korean subgroup analysis
Park Y, Im S, Ahn J, Kim M, Cortés J, Dent R, Pusztai L, McArthur H, Kummel S, Denkert C, O'Shaughnessy J, Mouret-Reynier M, Ferreira M, Cortes M, Boileau J, Hui R, Zhu Y, Pan W, Karantza V, Schmid P. LBA3 Phase III study of neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for early-stage triple-negative breast cancer (TNBC): KEYNOTE-522 Korean subgroup analysis. Annals Of Oncology 2023, 34: s1467-s1468. DOI: 10.1016/j.annonc.2023.10.132.Peer-Reviewed Original ResearchLBA18 Pembrolizumab or placebo plus chemotherapy followed by pembrolizumab or placebo for early-stage TNBC: Updated EFS results from the phase III KEYNOTE-522 study
Schmid P, Cortés J, Dent R, Pusztai L, McArthur H, Kummel S, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Foukakis T, Reynier M, Ferreira M, Im S, Cardoso F, Ding Y, Pan W, Tryfonidis K, O'Shaughnessy J. LBA18 Pembrolizumab or placebo plus chemotherapy followed by pembrolizumab or placebo for early-stage TNBC: Updated EFS results from the phase III KEYNOTE-522 study. Annals Of Oncology 2023, 34: s1257. DOI: 10.1016/j.annonc.2023.10.008.Peer-Reviewed Original ResearchLBA20 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 Research356P Prognostic value of the residual cancer burden after neoadjuvant chemotherapy for invasive lobular breast cancer: An international pooled cohort study
Gottipati S, Earl H, Yau C, Cameron D, Abraham J, Hayward L, Reyal F, Osdoit M, Sonke G, Wesseling J, Boughey J, Goetz M, DeMichele A, Pusztai L, Sharma P, Jimenez M, Cobo S, Del Monte-Millan M, Symmans F, Mukhtar R. 356P Prognostic value of the residual cancer burden after neoadjuvant chemotherapy for invasive lobular breast cancer: An international pooled cohort study. Annals Of Oncology 2023, 34: s325-s326. DOI: 10.1016/j.annonc.2023.09.535.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 differencesChemotherapyOncotype DX results increase concordance in adjuvant chemotherapy recommendations for early-stage breast cancer
Licata L, Viale G, Giuliano M, Curigliano G, Chavez-MacGregor M, Foldi J, Oke O, Collins J, Del Mastro L, Puglisi F, Montemurro F, Vernieri C, Gerratana L, Giordano S, Rognone A, Sica L, Gentilini O, Cascinu S, Pusztai L, Giordano A, Criscitiello C, Bianchini G. Oncotype DX results increase concordance in adjuvant chemotherapy recommendations for early-stage breast cancer. Npj Breast Cancer 2023, 9: 51. PMID: 37291235, PMCID: PMC10250312, DOI: 10.1038/s41523-023-00559-6.Peer-Reviewed Original ResearchEarly-stage breast cancerAdjuvant chemotherapy recommendationsChemotherapy recommendationsOncotype DX resultsClinicopathologic featuresRecurrence scorePhysician uncertaintyBreast cancerDiscordant recommendationsAdjuvant chemotherapy resultsAddition of chemotherapyChemotherapy resultsOncotype DXInstitutional databasePhysician judgmentBreast oncologistsClinical practiceOncologistsCancerAssay resultsRS resultsChange recommendationsPredictive informationChemotherapyRecommendationsP125 Neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy followed by adjuvant pembrolizumab vs placebo for early TNBC: surgical outcomes from the phase 3 KEYNOTE-522 study
Kümmel S, Schmid P, Harbeck N, Takahashi M, Untch M, Boileau J, Cortes J, McArthur H, Dent R, O’Shaughnessy J, Pusztai L, Foukakis T, Park Y, Hui R, Cardoso F, Denkert C, Zhu Y, Pan W, Karantza V, Fasching P. P125 Neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy followed by adjuvant pembrolizumab vs placebo for early TNBC: surgical outcomes from the phase 3 KEYNOTE-522 study. The Breast 2023, 68: s63-s64. DOI: 10.1016/s0960-9776(23)00242-4.Peer-Reviewed Original ResearchEvaluation of the Sensitivity to Endocrine Therapy Index and 21-Gene Breast Recurrence Score in the SWOG S8814 Trial
Speers C, Symmans W, Barlow W, Trevarton A, The S, Du L, Rae J, Shak S, Baehner R, Sharma P, Pusztai L, Hortobagyi G, Hayes D, Albain K, Godwin A, Thompson A. Evaluation of the Sensitivity to Endocrine Therapy Index and 21-Gene Breast Recurrence Score in the SWOG S8814 Trial. Journal Of Clinical Oncology 2023, 41: 1841-1848. PMID: 36649570, PMCID: PMC10082279, DOI: 10.1200/jco.22.01499.Peer-Reviewed Original ResearchConceptsBreast Recurrence ScoreAnthracycline-based chemotherapyDisease-free survivalRecurrence scoreEndocrine therapyTherapy indexAdjuvant anthracycline-based chemotherapyNode-positive breast cancerAdjuvant endocrine therapyPrimary end pointSubset of patientsPostmenopausal patientsChemotherapy benefitTreatment armsPrognostic indexPrognostic informationBreast cancerPrognostic assessmentPrognostic performancePatientsEnd pointTumor samplesChemotherapyClinical validationProportional hazards assumptionTumor-Derived Extracellular Vesicles as Complementary Prognostic Factors to Circulating Tumor Cells in Metastatic Breast Cancer
Nanou A, Miao J, Coumans F, Dolce E, Darga E, Barlow W, Smerage J, Paoletti C, Godwin A, Pusztai L, Sharma P, Thompson A, Hortobagyi G, Terstappen L, Hayes D. Tumor-Derived Extracellular Vesicles as Complementary Prognostic Factors to Circulating Tumor Cells in Metastatic Breast Cancer. JCO Precision Oncology 2023, 7: e2200372. PMID: 36634296, PMCID: PMC9928629, DOI: 10.1200/po.22.00372.Peer-Reviewed Original ResearchConceptsCycles of chemotherapyMetastatic breast cancerTumor-derived extracellular vesiclesOverall survivalBreast cancerTumor cellsExtracellular vesiclesComplementary prognostic factorComplementary prognostic valuePoor overall survivalAdditional prognostic biomarkerLonger OSPrognostic factorsPrognostic significanceCTC countPrognostic valuePrognostic biomarkerChemotherapyCancerPatientsCTCsCellsBiomarkers
2022
Molecular differences between younger versus older ER-positive and HER2-negative breast cancers
Qing T, Karn T, Rozenblit M, Foldi J, Marczyk M, Shan N, Blenman K, Holtrich U, Kalinsky K, Meric-Bernstam F, Pusztai L. Molecular differences between younger versus older ER-positive and HER2-negative breast cancers. Npj Breast Cancer 2022, 8: 119. PMID: 36344517, PMCID: PMC9640562, DOI: 10.1038/s41523-022-00492-0.Peer-Reviewed Original ResearchBreast cancerYounger patientsHER2-negative breast cancerNode-positive breast cancerNode-negative diseaseSame clinical featuresHigh mutation burdenLower mRNA expressionAdjuvant chemotherapyMicroarray cohortTAILORx trialOvarian suppressionOlder patientsPatient ageClinical featuresProliferation-related gene expressionScore 0Mutation burdenCopy number gainsOlder womenGATA3 mutationsAge groupsGene signatureMRNA expressionChemotherapyA preliminary, prospective study of peripheral neuropathy and cognitive function in patients with breast cancer during taxane therapy
Ibrahim EY, Munshani S, Domenicano I, Rodwin R, Nowak RJ, Pusztai L, Lustberg M, Ehrlich BE. A preliminary, prospective study of peripheral neuropathy and cognitive function in patients with breast cancer during taxane therapy. PLOS ONE 2022, 17: e0275648. PMID: 36206298, PMCID: PMC9543876, DOI: 10.1371/journal.pone.0275648.Peer-Reviewed Original ResearchConceptsNeurological side effectsSide effectsBreast cancerTaxane exposureProgressive neurological changesTaxane-based chemotherapyNon-interventional studyWeeks of treatmentEnd of treatmentIrreversible side effectsCourse of treatmentQuality of lifeTaxane therapyPeripheral neuropathyProspective studyPeripheral bloodBlood levelsCancer survivalNeuronal viabilityNeurological changesEffective treatmentChemotherapyCognitive impairmentPatientsPotential protein biomarkers135MO HRQoL with neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy, followed by adjuvant pembrolizumab vs placebo for early-stage TNBC: Results from KEYNOTE-522
Dent R, Cortés J, Pusztai L, McArthur H, Kuemmel S, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Haiderali A, Jia L, Nguyen A, Pan W, O'Shaughnessy J, Schmid P. 135MO HRQoL with neoadjuvant pembrolizumab + chemotherapy vs placebo + chemotherapy, followed by adjuvant pembrolizumab vs placebo for early-stage TNBC: Results from KEYNOTE-522. Annals Of Oncology 2022, 33: s600-s601. DOI: 10.1016/j.annonc.2022.07.170.Peer-Reviewed Original ResearchPrediction of pathologic complete response to neoadjuvant chemotherapy in breast cancer (SWOG S0800) using image analysis-based tumor infiltrating lymphocyte measurements.
Blenman K, Fanucci K, Bai Y, Pelekanou V, Nahleh Z, Shafi S, Burela S, Barlow W, Sharma P, Thompson A, Godwin A, Rimm D, Hortobagyi G, Pusztai L. Prediction of pathologic complete response to neoadjuvant chemotherapy in breast cancer (SWOG S0800) using image analysis-based tumor infiltrating lymphocyte measurements. Journal Of Clinical Oncology 2022, 40: 594-594. DOI: 10.1200/jco.2022.40.16_suppl.594.Peer-Reviewed Original ResearchPathologic complete responseBreast cancerNeoadjuvant chemotherapyComplete responseTIL scoreResidual diseaseResponse predictive markersBetter EFSBevacizumab benefitLymphocyte measurementsTIL assessmentFree survivalPredictive markerTIL quantificationInternational guidelinesPretreatment samplesLogistic regressionCancerOutcome discriminationChemotherapyScoresContinuous scoresTumorsClinical adoptionStrong positive correlationPembrolizumab vs placebo + chemotherapy as neoadjuvant treatment, followed by pembrolizumab vs placebo as adjuvant treatment for early triple-negative breast cancer (TNBC): Phase 3 KEYNOTE-522 study
Kümmel S, Cortés J, Dent R, Pusztai L, McArthur H, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Ding Y, Tryfonidis K, Aktan G, Karantza V, O’Shaughnessy J, Schmid P. Pembrolizumab vs placebo + chemotherapy as neoadjuvant treatment, followed by pembrolizumab vs placebo as adjuvant treatment for early triple-negative breast cancer (TNBC): Phase 3 KEYNOTE-522 study. European Journal Of Surgical Oncology 2022, 48: e30-e31. DOI: 10.1016/j.ejso.2021.12.430.Peer-Reviewed Original Research
2021
VP7-2021: KEYNOTE-522: Phase III study of neoadjuvant pembrolizumab + chemotherapy vs. placebo + chemotherapy, followed by adjuvant pembrolizumab vs. placebo for early-stage TNBC
Schmid P, Cortes J, Dent R, Pusztai L, McArthur H, Kümmel S, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Ding Y, Tryfonidis K, Aktan G, Karantza V, O’Shaughnessy J. VP7-2021: KEYNOTE-522: Phase III study of neoadjuvant pembrolizumab + chemotherapy vs. placebo + chemotherapy, followed by adjuvant pembrolizumab vs. placebo for early-stage TNBC. Annals Of Oncology 2021, 32: 1198-1200. DOI: 10.1016/j.annonc.2021.06.014.Peer-Reviewed Original Research
2020
1O KEYNOTE-522 Asian subgroup: Phase III study of neoadjuvant pembrolizumab (pembro) vs placebo (pbo) + chemotherapy (chemo) followed by adjuvant pembro vs pbo for early triple-negative breast cancer (TNBC)
Dent R, Cortes J, Pusztai L, McArthur H, Kuemmel S, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching P, Cardoso F, Jia L, Jensen E, Karantza V, Aktan G, O'Shaughnessy J, Schmid P. 1O KEYNOTE-522 Asian subgroup: Phase III study of neoadjuvant pembrolizumab (pembro) vs placebo (pbo) + chemotherapy (chemo) followed by adjuvant pembro vs pbo for early triple-negative breast cancer (TNBC). Annals Of Oncology 2020, 31: s1241-s1242. DOI: 10.1016/j.annonc.2020.10.021.Peer-Reviewed Original ResearchPD-L1 Protein Expression on Both Tumor Cells and Macrophages are Associated with Response to Neoadjuvant Durvalumab with Chemotherapy in Triple-negative Breast Cancer
Ahmed FS, Gaule P, McGuire J, Patel K, Blenman K, Pusztai L, Rimm DL. PD-L1 Protein Expression on Both Tumor Cells and Macrophages are Associated with Response to Neoadjuvant Durvalumab with Chemotherapy in Triple-negative Breast Cancer. Clinical Cancer Research 2020, 26: 5456-5461. PMID: 32709714, PMCID: PMC7572612, DOI: 10.1158/1078-0432.ccr-20-1303.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntigens, CDAntigens, Differentiation, MyelomonocyticAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenBiomarkers, TumorCell ProliferationFemaleGene Expression Regulation, NeoplasticHumansLymphocytes, Tumor-InfiltratingMacrophagesMiddle AgedNeoadjuvant TherapyProgrammed Cell Death 1 ReceptorTriple Negative Breast NeoplasmsConceptsTriple-negative breast cancerPD-L1 expressionNeoadjuvant durvalumabTumor cellsImmune cellsBreast cancerPretreatment core-needle biopsiesPhase I/II clinical trialsPD-L1 protein expressionIMpassion 130 trialCore needle biopsyAmount of CD68Neoadjuvant settingMetastatic settingPD-L1Clinical trialsNeedle biopsyInsufficient tissuePatientsCD68Stromal compartmentQuantitative immunofluorescenceChemotherapyFinal analysisProtein expression134TiP 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 ResearchGene Expression Profiling as an Emerging Diagnostic Tool to Personalize Chemotherapy Selection for Early Stage Breast Cancer
Liedtke C, Pusztai L. Gene Expression Profiling as an Emerging Diagnostic Tool to Personalize Chemotherapy Selection for Early Stage Breast Cancer. 2020, 77-96. DOI: 10.1201/9780429137723-6.Peer-Reviewed Original ResearchBreast cancerEarly-stage breast cancerCombination chemotherapy regimensSubstantial tumor responseAdvanced breast cancerNeoadjuvant chemotherapy regimenStage breast cancerAdjuvant chemotherapyChemotherapy regimenNeoadjuvant therapyChemotherapy regimensPreoperative chemotherapyChemotherapy selectionOverall survivalInoperable cancerTumor responseStage ICancer tissuesCancerGene expression profilingChemotherapyDiagnostic toolCurrent standardSemiquantitative mannerExpression profiling