2025
Immune-related adverse events are associated with better event-free survival in a phase I/II clinical trial of durvalumab concomitant with neoadjuvant chemotherapy in early-stage triple-negative breast cancer
Rios-Hoyo A, Dai J, Noel T, Blenman K, Park T, Pusztai L. Immune-related adverse events are associated with better event-free survival in a phase I/II clinical trial of durvalumab concomitant with neoadjuvant chemotherapy in early-stage triple-negative breast cancer. ESMO Open 2025, 10: 104494. PMID: 40107153, PMCID: PMC11964624, DOI: 10.1016/j.esmoop.2025.104494.Peer-Reviewed Original ResearchConceptsImmune-related adverse eventsTriple-negative breast cancerEvent-free survivalResidual cancer burdenDevelopment of immune-related adverse eventsOverall survivalAdverse eventsLandmark analysisAssociated with better event-free survivalBreast cancerEarly-stage triple-negative breast cancerFrequent immune-related adverse eventsMultiple immune-related adverse eventsEvent-free survival eventsRCB 0Immune checkpoint inhibitor therapyPhase I/II clinical trialsPathological complete responseSingle-arm clinical trialCheckpoint inhibitor therapyImmune checkpoint therapyMedian Follow-UpTime of surgeryYale Cancer CenterAdministered post-operatively
2023
Post-transplantation cyclophosphamide is associated with increased bacterial infections
Ustun C, Chen M, Kim S, Auletta J, Batista M, Battiwalla M, Cerny J, Gowda L, Hill J, Liu H, Munshi P, Nathan S, Seftel M, Wingard J, Chemaly R, Dandoy C, Perales M, Riches M, Papanicolaou G. Post-transplantation cyclophosphamide is associated with increased bacterial infections. Bone Marrow Transplantation 2023, 59: 76-84. PMID: 37903992, PMCID: PMC11164622, DOI: 10.1038/s41409-023-02131-z.Peer-Reviewed Original ResearchConceptsPost-transplant cyclophosphamideHematopoietic cell transplantationBacterial infectionsMost bacterial infectionsGVHD prophylaxisInfection cohortHost diseaseCalcineurin inhibitorsMyelodysplastic syndromeCell transplantationAcute leukemiaMore infectionsDay 180Greater incidencePatientsInfectionCohortProphylaxisCyclophosphamideTransplantationSyndromeGraftLeukemiaMortalityIncidenceHigh-grade B-cell lymphoma, not otherwise specified: a multi-institutional retrospective study
Zayac A, Landsburg D, Hughes M, Bock A, Nowakowski G, Ayers E, Girton M, Hu M, Beckman A, Li S, Medeiros L, Chang J, Stepanovic A, Kurt H, Sandoval-Sus J, Ansari-Lari M, Kothari S, Kress A, Xu M, Torka P, Sundaram S, Smith S, Naresh K, Karimi Y, Epperla N, Bond D, Farooq U, Saad M, Evens A, Pandya K, Naik S, Kamdar M, Haverkos B, Karmali R, Oh T, Vose J, Nutsch H, Rubinstein P, Chaudhry A, Olszewski A. High-grade B-cell lymphoma, not otherwise specified: a multi-institutional retrospective study. Blood Advances 2023, 7: 6381-6394. PMID: 37171397, PMCID: PMC10598493, DOI: 10.1182/bloodadvances.2023009731.Peer-Reviewed Original ResearchConceptsProgression-free survivalMulti-institutional retrospective studyHigh-grade B-cell lymphomaOverall survivalB-cell lymphomaComplete responseMYC rearrangementRetrospective studyBCL6 rearrangementsGerminal center B-cell immunophenotypeHigh serum lactate dehydrogenaseHigh-risk clinical factorsBetter progression-free survivalIntensive chemotherapy programsPoor performance statusStage IV diseaseFirst-line regimensMain prognostic factorsDose-intense chemotherapyHigh-grade morphologic featuresSerum lactate dehydrogenaseB-cell immunophenotypeDA-EPOCHR-CHOPMost patientsMitochondrial stress response gene Clpp deficiency impairs oocyte competence and deteriorate cyclophosphamide-induced ovarian damage in young mice
Li G, Gu J, Zhou X, Wu T, Li X, Hua R, Hai Z, Xiao Y, Su J, Yeung W, Liu K, Guo C, Wang T. Mitochondrial stress response gene Clpp deficiency impairs oocyte competence and deteriorate cyclophosphamide-induced ovarian damage in young mice. Frontiers In Endocrinology 2023, 14: 1122012. PMID: 37033217, PMCID: PMC10081448, DOI: 10.3389/fendo.2023.1122012.Peer-Reviewed Original ResearchConceptsCyclophosphamide-induced ovarian damageOvarian damageOocyte-specific deletionOocyte competencePremature ovarian insufficiencyImpaired oocyte competenceChemotherapeutic drug cyclophosphamideCaseinolytic peptidase PDecreased mitochondrial membrane potentialAneuploidy rateMII oocytesCTX treatmentElevated ROS levelsOvarian insufficiencyEarly folliculogenesisKnockout miceYoung miceMitochondrial membrane potentialMouse modelDrug cyclophosphamideTreat cancerMiceOocytesSpindle rateMembrane potentialRisk factors for serious infections in ANCA-associated vasculitis
Odler B, Riedl R, Gauckler P, Shin J, Leierer J, Merkel P, St. Clair W, Fervenza F, Geetha D, Monach P, Jayne D, Smith R, Rosenkranz A, Specks U, Stone J, Kronbichler A, Group R. Risk factors for serious infections in ANCA-associated vasculitis. Annals Of The Rheumatic Diseases 2023, 82: 681-687. PMID: 36702528, PMCID: PMC10176387, DOI: 10.1136/ard-2022-223401.Peer-Reviewed Original ResearchConceptsAntineutrophil cytoplasmic antibody-associated vasculitisRisk of severe infectionANCA-associated vasculitisSevere infectionsLaboratory data of patientsRisk factorsCD19+ cellsAntibody-associated vasculitisPneumocystis jirovecii</i>Associated with reduced riskAssociated with lower riskB cell subpopulationsRespiratory tract infectionsCox regression analysisSerum immunoglobulin M levelsData of patientsCox regression modelsImmunoglobulin M levelsRAVE trialTrimethoprim-sulfamethoxazoleTract infectionsCD3+T cellsRituximabTrial entryDecreased riskSecondary Neoplasms After Hematopoietic Cell Transplant for Sickle Cell Disease
Eapen M, Brazauskas R, Williams D, Walters M, St Martin A, Jacobs B, Antin J, Bona K, Chaudhury S, Coleman-Cowger V, DiFronzo N, Esrick E, Field J, Fitzhugh C, Kanter J, Kapoor N, Kohn D, Krishnamurti L, London W, Pulsipher M, Talib S, Thompson A, Waller E, Wun T, Horowitz M. Secondary Neoplasms After Hematopoietic Cell Transplant for Sickle Cell Disease. Journal Of Clinical Oncology 2023, 41: 2227-2237. PMID: 36623245, PMCID: PMC10448940, DOI: 10.1200/jco.22.01203.Peer-Reviewed Original ResearchConceptsLow-intensity regimensSickle cell diseaseSecondary neoplasmsRisk factorsCell diseaseLeukemia/myelodysplastic syndromeMixed donor chimerismReduced-intensity regimensFull donor chimerismHematopoietic cell transplantTotal body irradiationLow-dose radiationGray regression modelsMyeloid mutationsPrior inflammationCell transplantMyelodysplastic syndromeTolerance inductionIntense regimensPlausible etiologyHigh riskRegimensSolid tumorsNeoplasmsMyeloid malignanciesLearnings from clinical trials in patients with connective tissue disease-associated interstitial lung disease
Higuero Sevilla J, Memon A, Hinchcliff M. Learnings from clinical trials in patients with connective tissue disease-associated interstitial lung disease. Arthritis Research & Therapy 2023, 25: 118. PMID: 37422652, PMCID: PMC10329300, DOI: 10.1186/s13075-023-03090-y.Peer-Reviewed Original ResearchConceptsConnective tissue disease-associated interstitial lung diseaseInterstitial lung diseaseTreatment of patientsMycophenolate mofetilSSc-ILDLung diseaseClinical trialsScleroderma Lung Study IIPatient-reported outcome instrumentsIdiopathic inflammatory myositisClinical trial resultsInflammatory myositisIntravenous cyclophosphamideOral cyclophosphamideSubcutaneous tocilizumabGood tolerabilityLung functionSystemic sclerosisTreatment armamentariumRheumatoid arthritisPatient outcomesSimilar efficacyOutcome instrumentsPatientsUS Food
2022
Low-Intensity Adjuvant Chemotherapy for Breast Cancer in Older Women: Results From the Prospective Multicenter HOPE Trial
Sedrak M, Sun C, Ji J, Cohen H, Gross C, Tew W, Klepin H, Wildes T, Dotan E, Freedman R, O'Connor T, Chow S, Fenton M, Moy B, Chapman A, Dale W, Katheria V, Kuderer N, Lyman G, Magnuson A, Muss H. Low-Intensity Adjuvant Chemotherapy for Breast Cancer in Older Women: Results From the Prospective Multicenter HOPE Trial. Journal Of Clinical Oncology 2022, 41: 316-326. PMID: 36455189, PMCID: PMC9839299, DOI: 10.1200/jco.22.01440.Peer-Reviewed Original ResearchConceptsLow relative dose intensityRelative dose intensityAdjuvant chemotherapyHOPE trialDose intensityOlder patientsOlder womenBreast cancer benefitPrespecified secondary analysisCurative-intent treatmentInferior survival outcomesChemotherapy dose intensityKaplan-Meier methodLow performance statusMultivariable logistic regressionLog-rank testOverall survival probabilityToxic side effectsCancer benefitOverall survivalPerformance statusStandard chemotherapySupportive carePrimary outcomeSurvival outcomesPredictive 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 cyclePatient‐reported outcomes provide prognostic information for survival in patients with diffuse large B‐cell lymphoma: Analysis of 1239 patients from the GOYA study
Huang H, Datye A, Fan M, Knapp A, Nielsen T, Bottos A, Paulson J, Trask P, Efficace F. Patient‐reported outcomes provide prognostic information for survival in patients with diffuse large B‐cell lymphoma: Analysis of 1239 patients from the GOYA study. Cancer Medicine 2022, 11: 3312-3322. PMID: 35322932, PMCID: PMC9468432, DOI: 10.1002/cam4.4692.Peer-Reviewed Original ResearchConceptsDiffuse large B-cell lymphomaInternational Prognostic IndexProgression-free survivalLarge B-cell lymphomaB-cell lymphomaOverall survivalPrognostic valuePatient-reported outcomesPrognostic informationCox regression analysis of overall survivalClinical variablesAnalysis of overall survivalPhase III studyFifty-nine patientsCox regression analysisPatient risk stratificationPopulation of patientsEuropean Organization for Research and Treatment of Cancer Quality of LifeEuropean Organization for Research and TreatmentPlus chemotherapyIII studiesPrognostic indexTreatment of Cancer Quality of LifeGlobal health status/quality of lifeGlobal health status/qualityLong-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase III trial
Geyer C, Sikov W, Huober J, Rugo H, Wolmark N, O’Shaughnessy J, Maag D, Untch M, Golshan M, Lorenzo J, Metzger O, Dunbar M, Symmans W, Rastogi P, Sohn J, Young R, Wright G, Harkness C, McIntyre K, Yardley D, Loibl S. Long-term efficacy and safety of addition of carboplatin with or without veliparib to standard neoadjuvant chemotherapy in triple-negative breast cancer: 4-year follow-up data from BrighTNess, a randomized phase III trial. Annals Of Oncology 2022, 33: 384-394. PMID: 35093516, DOI: 10.1016/j.annonc.2022.01.009.Peer-Reviewed Original ResearchConceptsTriple-negative breast cancerEvent-free survivalAddition of carboplatinNeoadjuvant chemotherapyOverall survivalHazard ratioBreast cancerEarly-stage triple-negative breast cancerPathological complete response rateRandomized phase III trialComplete response rateCyclophosphamide neoadjuvant chemotherapyManageable acute toxicitiesManageable safety profileSafety of additionUntreated stage IIStandard neoadjuvant chemotherapyPhase III trialsCo-primary endpointsLong-term efficacyAcute myeloid leukemiaWeekly paclitaxelPrimary endpointSecondary endpointsIII trialsTRAIL Score: A Simple Model to Predict Immunochemotherapy Tolerability in Patients With Diffuse Large B-Cell Lymphoma
Harris W, Bataillard E, Choi Y, El-Galaly T, Cuchelkar V, Henneges C, Kwan A, Schneider D, Paulson J, Nielsen T. TRAIL Score: A Simple Model to Predict Immunochemotherapy Tolerability in Patients With Diffuse Large B-Cell Lymphoma. JCO Clinical Cancer Informatics 2022, 6: e2100121. PMID: 35044836, DOI: 10.1200/cci.21.00121.Peer-Reviewed Original ResearchConceptsDiffuse large B-cell lymphomaLarge B-cell lymphomaB-cell lymphomaR-CHOPFirst-line treatment of diffuse large B-cell lymphomaDiagnosed DLBCLTreatment of diffuse large B-cell lymphomaCourses of R-CHOPPresence of cardiovascular diseaseFirst-line treatmentProportion of patientsArea under the curveRoutine clinical settingCharlson Comorbidity IndexStandard of careHigh-risk categoryStandard chemoimmunotherapyChemotherapy toxicityCreatinine clearanceInferior outcomesBaseline characteristicsLogistic regression modelsComorbidity indexPatient frailtyEnd points
2021
Population pharmacokinetics of cyclophosphamide and 4-hydroxycyclophosphamide metabolite in patients with autoimmune glomerulonephritis
Iliopoulou VN, Charkoftaki G, Cooper JC, Dokoumetzidis A, Joy MS. Population pharmacokinetics of cyclophosphamide and 4-hydroxycyclophosphamide metabolite in patients with autoimmune glomerulonephritis. Journal Of Pharmacy And Pharmacology 2021, 73: 1683-1692. PMID: 34480477, DOI: 10.1093/jpp/rgab135.Peer-Reviewed Original ResearchConceptsPopulation pharmacokinetic modelPharmacokinetic modelAutoimmune glomerulonephritisCentral volumeSimultaneous population pharmacokinetic modelInitiation of therapyVisual predictive checkProportional error modelElimination rate constantDose regimensPopulation pharmacokineticsTotal clearancePatient variablesPlasma concentrationsCyclophosphamidePharmacokinetic evaluationPharmacokinetic parametersPatientsPlasma samplingPotential covariatesGlomerulonephritisSignificant covariatesPredictive checksFinal modelCovariatesPopulation Pharmacokinetics and Exposure‐Response Modeling of Daratumumab Subcutaneous Administration in Patients With Light‐Chain Amyloidosis
Luo M, Zhu P, Nnane I, Xiong Y, Merlini G, Comenzo R, Kastritis E, Wechalekar A, Weiss B, Tran N, Qin X, Vermeulen J, Sharma A, Sun Y, Zhou H. Population Pharmacokinetics and Exposure‐Response Modeling of Daratumumab Subcutaneous Administration in Patients With Light‐Chain Amyloidosis. The Journal Of Clinical Pharmacology 2021, 62: 656-669. PMID: 34708423, DOI: 10.1002/jcph.1994.Peer-Reviewed Original ResearchConceptsLight chain amyloidosisSafety end pointSystemic exposureExposure-response analysesEnd pointsPopulation pharmacokineticsAmyloid light-chain amyloidosisNo dose adjustmentEfficacy end pointSystemic amyloid light-chain amyloidosisExposure-responseTreatment of light-chain amyloidosisImpact of potential covariatesLogistic regression analysisNonlinear mixed-effects modelingConcentration-time dataDexamethasone regimenDose adjustmentHematologic responseDaratumumabImmunogenicity dataPopPK analysisPopPK modelPatterns of Initial Relapse from a Phase 3 Study of Response-Based Therapy for High-Risk Hodgkin Lymphoma (AHOD0831): A Report from the Children's Oncology Group
Parikh RR, Kelly KM, Hodgson DC, Hoppe BS, McCarten KM, Karolczuk K, Pei Q, Wu Y, Cho SY, Schwartz C, Cole PD, Roberts K. Patterns of Initial Relapse from a Phase 3 Study of Response-Based Therapy for High-Risk Hodgkin Lymphoma (AHOD0831): A Report from the Children's Oncology Group. International Journal Of Radiation Oncology • Biology • Physics 2021, 112: 890-900. PMID: 34767937, PMCID: PMC9038118, DOI: 10.1016/j.ijrobp.2021.10.152.Peer-Reviewed Original ResearchConceptsInvolved-field radiation therapySlow early responseClassical Hodgkin lymphomaBulky diseaseOncology GroupHodgkin's lymphomaRetrospective analysisChildren's Oncology Group protocolsHigh-risk Hodgkin lymphomaRadiation treatment volumesCycles of doxorubicinHigh-risk patientsPhase 3 studyTime of progressionChildren's Oncology GroupPatterns of failureInitial siteABVE-PCConsolidation RTEligible patientsField relapseInitial relapseMedian followRelapse siteStage IIIBPredictive Significance of Serum Interferon‐Inducible Protein Score for Response to Treatment in Systemic Sclerosis–Related Interstitial Lung Disease
Assassi S, Li N, Volkmann ER, Mayes MD, Rünger D, Ying J, Roth MD, Hinchcliff M, Khanna D, Frech T, Clements PJ, Furst DE, Goldin J, Bernstein EJ, Castelino FV, Domsic RT, Gordon JK, Hant FN, Shah AA, Shanmugam VK, Steen VD, Elashoff RM, Tashkin DP. Predictive Significance of Serum Interferon‐Inducible Protein Score for Response to Treatment in Systemic Sclerosis–Related Interstitial Lung Disease. Arthritis & Rheumatology 2021, 73: 1005-1013. PMID: 33350170, PMCID: PMC8169525, DOI: 10.1002/art.41627.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedbeta 2-MicroglobulinChemokine CCL19Chemokine CCL8Chemokine CXCL10Chemokine CXCL9CyclophosphamideFemaleHumansImmunosuppressive AgentsLung Diseases, InterstitialMaleMethotrexateMiddle AgedMycophenolic AcidObservational Studies as TopicPrognosisRandomized Controlled Trials as TopicReceptors, Tumor Necrosis Factor, Type IIScleroderma, SystemicVital CapacityConceptsInterstitial lung diseaseMycophenolate mofetilPredictive significanceCYC armILD courseMMF armSSc-ILDSystemic sclerosisLung diseaseHigh baseline C-reactive protein levelsTumor necrosis factor receptor type IIBaseline C-reactive protein levelsScleroderma Lung Study IIC-reactive protein levelsGood responseVital capacity percentChemotactic protein-2Receptor type IIActive immunosuppressionClinical predictorsCRP levelsObservational cohortProtein scoreActive treatmentTreatment armsIndividual-oocyte transcriptomic analysis shows that genotoxic chemotherapy depletes human primordial follicle reserve in vivo by triggering proapoptotic pathways without growth activation
Titus S, Szymanska K, Musul B, Turan V, Taylan E, Garcia- Milian R, Mehta S, Oktay K. Individual-oocyte transcriptomic analysis shows that genotoxic chemotherapy depletes human primordial follicle reserve in vivo by triggering proapoptotic pathways without growth activation. Scientific Reports 2021, 11: 407. PMID: 33431979, PMCID: PMC7801500, DOI: 10.1038/s41598-020-79643-x.Peer-Reviewed Original ResearchMeSH KeywordsAdultAnimalsAntineoplastic Combined Chemotherapy ProtocolsApoptosisCyclophosphamideDNA DamageFemaleGene Expression ProfilingHeterograftsHumansMiceMice, Inbred NODMice, SCIDOocytesOogenesisOvarian FollicleOvarian ReserveOvarySignal TransductionSingle-Cell AnalysisTranscriptomeYoung AdultConceptsPrimordial follicle oocytesFollicle lossGrowth activationHuman ovarian xenograft modelPI3K/PTEN/AktFollicle oocytesDNA damagePI3K/PTEN/Akt pathwayOvarian reserve depletionPrimordial follicle reservePTEN/AKT pathwayIngenuity Pathway AnalysisOvarian xenograft modelPTEN/AKTSevere DNA damageExpression of AktGonadotoxic chemotherapyAnti-apoptotic Bcl2Early menopauseFollicle reserveTranscriptomic analysisCyclophosphamide injectionHuman ovaryPhosphorylation statusRNA sequencing
2020
High dose cyclophosphamide for cytoreduction in patients with acute myeloid leukemia with hyperleukocytosis or leukostasis
Zhao J, Bewersdorf JP, Jaszczur S, Kowalski A, Perreault S, Schiffer M, Gore S, Podoltsev N, Prebet T, Shallis R, Zeidan AM. High dose cyclophosphamide for cytoreduction in patients with acute myeloid leukemia with hyperleukocytosis or leukostasis. Leukemia & Lymphoma 2020, 62: 1195-1202. PMID: 33325761, DOI: 10.1080/10428194.2020.1856835.Peer-Reviewed Original ResearchMeSH KeywordsCyclophosphamideCytoreduction Surgical ProceduresHumansLeukapheresisLeukemia, Myeloid, AcuteLeukocytosisLeukostasisConceptsWhite blood cell countHigh-dose cyclophosphamideAcute myeloid leukemiaMyeloid leukemiaDose cyclophosphamideBlast phase chronic myeloid leukemiaMedian white blood cell countPhase chronic myeloid leukemiaAdverse effectsSymptoms of leukostasisTumor lysis syndromeDay of admissionBlood cell countChronic myeloid leukemiaEvaluable patientsLeukostasis symptomsIntensive chemotherapyIntravascular coagulopathyLysis syndromePrimary endpointHemorrhagic cystitisEarly mortalityMedical emergencyCell countPatientsAssociation of Event-Free and Distant Recurrence–Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer
Consortium I, Yee D, DeMichele A, Yau C, Isaacs C, Symmans W, Albain K, Chen Y, Krings G, Wei S, Harada S, Datnow B, Fadare O, Klein M, Pambuccian S, Chen B, Adamson K, Sams S, Mhawech-Fauceglia P, Magliocco A, Feldman M, Rendi M, Sattar H, Zeck J, Ocal I, Tawfik O, LeBeau L, Sahoo S, Vinh T, Chien A, Forero-Torres A, Stringer-Reasor E, Wallace A, Pusztai L, Boughey J, Ellis E, Elias A, Lu J, Lang J, Han H, Clark A, Nanda R, Northfelt D, Khan Q, Viscusi R, Euhus D, Edmiston K, Chui S, Kemmer K, Park J, Liu M, Olopade O, Leyland-Jones B, Tripathy D, Moulder S, Rugo H, Schwab R, Lo S, Helsten T, Beckwith H, Haugen P, Hylton N, Veer L, Perlmutter J, Melisko M, Wilson A, Peterson G, Asare A, Buxton M, Paoloni M, Clennell J, Hirst G, Singhrao R, Steeg K, Matthews J, Asare S, Sanil A, Berry S, Esserman L, Berry D. Association of Event-Free and Distant Recurrence–Free Survival With Individual-Level Pathologic Complete Response in Neoadjuvant Treatment of Stages 2 and 3 Breast Cancer. JAMA Oncology 2020, 6: 1355-1362. PMID: 32701140, PMCID: PMC7378873, DOI: 10.1001/jamaoncol.2020.2535.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsBridged-Ring CompoundsCyclophosphamideDisease-Free SurvivalDoxorubicinFemaleHumansMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalProgression-Free SurvivalProportional Hazards ModelsReceptor, ErbB-2TaxoidsTrastuzumabTreatment OutcomeConceptsDistant recurrence-free survivalPathologic complete responseEvent-free survivalI-SPY2 trialRecurrence-free survivalLong-term outcomesBreast cancerComplete responseNeoadjuvant therapyPlatform trialsMolecular subtypesHigh-risk operable breast cancerThree-year event-free survivalHormone receptorsClinical stage 2Phase 3 confirmatory trialOperable breast cancerSubpopulation of womenNovel therapeutic combinationsStage 2Investigational regimensNeoadjuvant treatmentPrior surgeryTaxane treatmentStandard therapyAvoiding Peg-Filgrastim Prophylaxis During the Paclitaxel Portion of the Dose-Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen: A Prospective Study
Vaz-Luis I, Barroso-Sousa R, Di Meglio A, Hu J, Rees R, Sinclair N, Milisits L, Leone JP, Constantine M, Faggen M, Briccetti F, Block C, O'Neil K, Partridge A, Burstein H, Waks AG, Trippa L, Tolaney SM, Hassett M, Winer EP, Lin NU. Avoiding Peg-Filgrastim Prophylaxis During the Paclitaxel Portion of the Dose-Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen: A Prospective Study. Journal Of Clinical Oncology 2020, 38: 2390-2397. PMID: 32330102, PMCID: PMC7367545, DOI: 10.1200/jco.19.02484.Peer-Reviewed Original ResearchConceptsDose-dense paclitaxelPeg-filgrastimFebrile neutropeniaDay 1Adjuvant breast cancer chemotherapyCycle 1 day 1Patient experienced febrile neutropeniaCycles of paclitaxelDose-dense doxorubicinExperienced febrile neutropeniaPrimary end pointSingle-arm studyBreast cancer chemotherapyYears of ageDose delaysDoxorubicin-cyclophosphamidePaclitaxel cyclesPaclitaxel regimenPatients 18Investigator's discretionMedian ageTreatment delayProspective studyPrespecified algorithmBreast cancer
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