2024
Trends in breast cancer specific death by clinical stage at diagnoses between 2000-2017
Marczyk M, Kahn A, Silber A, Rosenblit M, Digiovanna M, Lustberg M, Pusztai L. Trends in breast cancer specific death by clinical stage at diagnoses between 2000-2017. Journal Of The National Cancer Institute 2024, djae241. PMID: 39348186, DOI: 10.1093/jnci/djae241.Peer-Reviewed Original ResearchBreast cancer-specific deathCancer-specific deathBreast cancerStage IAll-cause mortalityTemporal trendsStage I/II breast cancerHormone receptor-positiveNode-negative cancersPrimary tumor typeStage I/II diseaseMetastatic breast cancerStage II cancerBilateral cancerIV cancerFemale sexIV diseaseReceptor-positiveExcellent prognosisII cancerClinical stageTumor typesTreated patientsStage IIICancer
2023
Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases
Lin N, Murthy R, Abramson V, Anders C, Bachelot T, Bedard P, Borges V, Cameron D, Carey L, Chien A, Curigliano G, DiGiovanna M, Gelmon K, Hortobagyi G, Hurvitz S, Krop I, Loi S, Loibl S, Mueller V, Oliveira M, Paplomata E, Pegram M, Slamon D, Zelnak A, Ramos J, Feng W, Winer E. Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases. JAMA Oncology 2023, 9: 197-205. PMID: 36454580, PMCID: PMC9716438, DOI: 10.1001/jamaoncol.2022.5610.Peer-Reviewed Original ResearchConceptsErbB2-positive metastatic breast cancerMetastatic breast cancerPlacebo-combination groupPositive metastatic breast cancerNew brain lesionsBrain metastasesOverall survivalSubgroup analysisBrain lesionsBreast cancerIntracranial progression-free survivalPlacebo-controlled clinical trialIntracranial objective response rateStable brain metastasesMedian overall survivalObjective response rateProgression-free survivalExploratory subgroup analysisGreater clinical benefitCNS-PFSHER2CLIMB trialIntracranial outcomesFirst progressionMedian ageClinical benefit
2022
Aktualisierte Ergebnisse von Tucatinib versus Placebo in Kombination mit Trastuzumab und Capecitabin bei Patienten mit vorbehandeltem, metastasierten HER2-positiven Brustkrebs mit ZNS-Metastasen (HER2CLIMB)
Greil R, Lin N, Murthy R, Abramson V, Anders C, Bachelot T, Bedard P, Borges V, Cameron D, Carey L, Chien A, Curigliano G, DiGiovanna M, Gelmon K, Hortobagyi G, Hurvitz S, Krop I, Loi S, Loibl S, Mueller V, Oliveira M, Paplomata E, Pegram M, Slamon D, Zelnak A, Ramos J, Feng W, Winer E. Aktualisierte Ergebnisse von Tucatinib versus Placebo in Kombination mit Trastuzumab und Capecitabin bei Patienten mit vorbehandeltem, metastasierten HER2-positiven Brustkrebs mit ZNS-Metastasen (HER2CLIMB). Geburtshilfe Und Frauenheilkunde 2022, 82: e4-e5. DOI: 10.1055/s-0042-1746156.Peer-Reviewed Original Research
2021
How did the COVID crisis affect use of neoadjuvant therapy for patients with breast cancer?
Chagpar A, Lannin D, Mougalian S, Berger E, Gross C, Horowitz N, Sanft T, DiGiovanna M, Golshan M, Pusztai L. How did the COVID crisis affect use of neoadjuvant therapy for patients with breast cancer? Journal Of Clinical Oncology 2021, 39: e18708-e18708. DOI: 10.1200/jco.2021.39.15_suppl.e18708.Peer-Reviewed Original ResearchUse of NTNeoadjuvant therapyEarly pandemic periodBreast cancerNon-metastatic breast cancerPractice settingsEarly pandemicFlatiron Health databaseNeoadjuvant endocrine therapyTechnology-enabled abstractionSame period one yearSimilar clinicopathologic featuresLongitudinal electronic health recordsPeriod one yearElectronic health recordsTNBC subsetEndocrine therapyPatient ageTN patientsClinicopathologic featuresContemporary cohortClinical stageCancer clinicCancer managementHigh riskAdjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE
Mamounas EP, Untch M, Mano MS, Huang C, Geyer CE, von Minckwitz G, Wolmark N, Pivot X, Kuemmel S, DiGiovanna MP, Kaufman B, Kunz G, Conlin AK, Alcedo JC, Kuehn T, Wapnir I, Fontana A, Hackmann J, Polikoff J, Saghatchian M, Brufsky A, Yang Y, Zimovjanova M, Boulet T, Liu H, Tesarowski D, Lam LH, Song C, Smitt M, Loibl S. Adjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE. Annals Of Oncology 2021, 32: 1005-1014. PMID: 33932503, DOI: 10.1016/j.annonc.2021.04.011.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalAdjuvant T-DM1Residual invasive diseaseT-DM1 armNeoadjuvant chemotherapyEarly breast cancerHigh-risk tumorsRisk of recurrenceT-DM1Central nervous systemPeripheral neuropathyCNS recurrenceInvasive diseaseBreast cancerHER2-positive eBC patientsInvasive early breast cancerAnthracycline-based neoadjuvant chemotherapyHuman epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2Overall riskAdjuvant trastuzumab emtansineBaseline peripheral neuropathyLonger PN durationMore grade 3
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. Patients53. TUCATINIB VS PLACEBO ADDED TO TRASTUZUMAB AND CAPECITABINE FOR PATIENTS WITH PREVIOUSLY TREATED HER2+ METASTATIC BREAST CANCER (MBC) WITH BRAIN METASTASES (BM) (HER2CLIMB)
Lin N, Murthy R, Anders C, Borges V, Hurvitz S, Loi S, Abramson V, Bedard P, Oliveira M, Zelnack A, DiGiovanna M, Bachelot T, Chien A, O’Regan R, Wardley A, Mueller V, Carey L, McGoldrick S, An X, Winer E. 53. TUCATINIB VS PLACEBO ADDED TO TRASTUZUMAB AND CAPECITABINE FOR PATIENTS WITH PREVIOUSLY TREATED HER2+ METASTATIC BREAST CANCER (MBC) WITH BRAIN METASTASES (BM) (HER2CLIMB). Neuro-Oncology Advances 2020, 2: ii11-ii11. PMCID: PMC7401403, DOI: 10.1093/noajnl/vdaa073.041.Peer-Reviewed Original ResearchMetastatic breast cancerBrain metastasesCNS-PFSSecond progressionControl armEfficacy analysisBrain progressionExploratory efficacy analysesMedian CNS-PFSBaseline brain MRIMedian OSOverall deathRECIST 1.1Study therapyMedian timeInvestigator's evaluationIC diseaseLocal treatmentBreast cancerBrain MRIReduced riskCapecitabineTrastuzumabTucatinibHER2Tucatinib versus placebo added to trastuzumab and capecitabine for patients with previously treated HER2+ metastatic breast cancer with brain metastases (HER2CLIMB).
Lin N, Murthy R, Anders C, Borges V, Hurvitz S, Loi S, Abramson V, Bedard P, Oliveira M, Zelnak A, DiGiovanna M, Bachelot T, Chien A, O'Regan R, Wardley A, Müller V, Carey L, McGoldrick S, An G, Winer E. Tucatinib versus placebo added to trastuzumab and capecitabine for patients with previously treated HER2+ metastatic breast cancer with brain metastases (HER2CLIMB). Journal Of Clinical Oncology 2020, 38: 1005-1005. DOI: 10.1200/jco.2020.38.15_suppl.1005.Peer-Reviewed Original ResearchMetastatic breast cancerProgression-free survivalObjective response rateBrain metastasesOverall survivalCNS-PFSControl armSecond progressionEfficacy analysisBrain progressionLocal treatmentBreast cancerProlongation of PFSMedian progression-free survivalExploratory efficacy analysesMedian CNS-PFSMedian overall survivalBaseline brain MRIHER2 kinase inhibitorDeath overallRECIST 1.1Study therapyFree survivalInvestigator's evaluationIC disease
2018
Durvalumab (MEDI4736) concurrent with nab-paclitaxel and dose dense doxorubicin cyclophosphamide (ddAC) as neoadjuvant therapy for triple negative breast cancer (TNBC).
Pusztai L, Hofstatter E, Chung G, Horowitz N, Lannin D, Killelea B, Chagpar A, DiGiovanna M, Frederick C, Burello T, Harigopal M. Durvalumab (MEDI4736) concurrent with nab-paclitaxel and dose dense doxorubicin cyclophosphamide (ddAC) as neoadjuvant therapy for triple negative breast cancer (TNBC). Journal Of Clinical Oncology 2018, 36: 586-586. DOI: 10.1200/jco.2018.36.15_suppl.586.Peer-Reviewed Original Research
2017
Safety of MEDI4736 (anti-PD-L1 antibody) administered concomitant with weekly nab-paclitaxel and dose dense doxorubicin/cyclophosphamide (ddAC) as neoadjuvant chemotherapy for stage I-III triple negative breast cancer (TNBC): A Phase I/II trial.
Pusztai L, Silber A, Hofstatter E, Chung G, Horowitz N, Lannin D, Killelea B, Chagpar A, Szekely B, Frederick C, Rispoli L, DiGiovanna M. Safety of MEDI4736 (anti-PD-L1 antibody) administered concomitant with weekly nab-paclitaxel and dose dense doxorubicin/cyclophosphamide (ddAC) as neoadjuvant chemotherapy for stage I-III triple negative breast cancer (TNBC): A Phase I/II trial. Journal Of Clinical Oncology 2017, 35: 572-572. DOI: 10.1200/jco.2017.35.15_suppl.572.Peer-Reviewed Original ResearchImmune related adverse eventsTriple-negative breast cancerWeekly nab-paclitaxelWeeks of therapyNeoadjuvant chemotherapyDose levelsNab-paclitaxelPhase I/II trialPathologic complete response rateChest X-ray abnormalitiesDoxorubicin/cyclophosphamidePhase I toxicityComplete response rateImmune checkpoint inhibitorsPhase I portionRelated adverse eventsPhase II portionPhase I partX-ray abnormalitiesNegative breast cancerSequential taxaneAnthracycline chemotherapyCheckpoint inhibitorsII trialAdverse eventsPathologic complete response (pCR) rates after neoadjuvant pertuzumab (P) and trastuzumab (H) administered concomitantly with weekly paclitaxel (T) and 5-fluorouracil/epirubicin/cyclophosphamide (FEC) chemotherapy for clinical 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, Abu-Khalaf M, Sabbath K, Sanft T, Fischbach N, Brandt D, Hofstatter E, DiGiovanna M, Pusztai L. Pathologic complete response (pCR) rates after neoadjuvant pertuzumab (P) and trastuzumab (H) administered concomitantly with weekly paclitaxel (T) and 5-fluorouracil/epirubicin/cyclophosphamide (FEC) chemotherapy for clinical stage I-III HER2-positive breast cancer. Journal Of Clinical Oncology 2017, 35: 577-577. DOI: 10.1200/jco.2017.35.15_suppl.577.Peer-Reviewed Original ResearchPathologic complete response rateHER2-positive breast cancerDual HER2 blockadeComplete response ratePCR rateEstrogen receptorHER2 blockadeBreast cancerStage IResponse rateGrade 3/4 adverse eventsSymptomatic congestive heart failureClinical stage ICompletion of chemotherapyPhase II studyTaxane-based chemotherapyCongestive heart failureEfficacy of anthracyclinesPositive breast cancerNormal cardiac functionEntire treatment durationER- cancersER cohortNeoadjuvant pertuzumabWeekly paclitaxel
2016
A Novel Approach to the Medical Student Hematology Curriculum
Levinsohn E, DiGiovanna M, Encandela J, Takizawa P, Hafler J, Lee A. A Novel Approach to the Medical Student Hematology Curriculum. Blood 2016, 128: 3537. DOI: 10.1182/blood.v128.22.3537.3537.Peer-Reviewed Original ResearchHematology coursePreclinical curriculumNew curriculumStudent interestMedical schoolsTeam-based learning sessionsSuch curricular changesTraditional lecture formatCohorts of studentsCohesive learning experiencePercentage of studentsCase-based workshopsMedical student interestSource of feedbackSmall group workshopsIntroduction/BackgroundPrior curriculumStudent learningPreclinical educationLearning experienceStudent feedbackCourse designCurricular changesLecture formatStudent surveysOnset of side effects and adherence to endocrine therapy in the Breast Cancer Endocrine Therapy Adherence (BETA) pilot study.
Epstein L, Jhaveri A, Han G, Abu-Khalaf M, Hofstatter E, Sanft T, DiGiovanna M, Silber A, Adelson K, Chung G, Gross C, Pusztai L, Mougalian S. Onset of side effects and adherence to endocrine therapy in the Breast Cancer Endocrine Therapy Adherence (BETA) pilot study. Journal Of Clinical Oncology 2016, 34: e18136-e18136. DOI: 10.1200/jco.2016.34.15_suppl.e18136.Peer-Reviewed Original Research
2015
Review of trends in adjuvant chemotherapy regimens in breast cancer over 10 year period at Yale New Haven Hospital (YNHH).
Gnanajothy R, Chung G, DiGiovanna M, Abu-Khalaf M, Lannin D, Harris L. Review of trends in adjuvant chemotherapy regimens in breast cancer over 10 year period at Yale New Haven Hospital (YNHH). Journal Of Clinical Oncology 2015, 33: 144-144. DOI: 10.1200/jco.2015.33.28_suppl.144.Peer-Reviewed Original ResearchProspective study of the decision-making impact of the Breast Cancer Index in the selection of patients with ER+ breast cancer for extended endocrine therapy.
Sanft T, Aktas B, Schroeder B, Bossuyt V, DiGiovanna M, Abu-Khalaf M, Chung G, Silber A, Hofstatter E, Mougalian S, Epstein L, Hatzis C, Schnabel C, Pusztai L. Prospective study of the decision-making impact of the Breast Cancer Index in the selection of patients with ER+ breast cancer for extended endocrine therapy. Journal Of Clinical Oncology 2015, 33: 538-538. DOI: 10.1200/jco.2015.33.15_suppl.538.Peer-Reviewed Original ResearchMutation-based treatment recommendations from next generation sequencing data: A comparison of web tools.
Patel J, Reiner E, Bossuyt V, Epstein L, Platt J, DiGiovanna M, Chung G, Silber A, Sanft T, Hofstatter E, Mougalian S, Abu-Khalaf M, Gershkovich P, Hatzis C, Pusztai L. Mutation-based treatment recommendations from next generation sequencing data: A comparison of web tools. Journal Of Clinical Oncology 2015, 33: e12564-e12564. DOI: 10.1200/jco.2015.33.15_suppl.e12564.Peer-Reviewed Original Research
2014
Pilot study of sorafenib and biweekly capecitabine in patients with advanced breast and gastrointestinal tumors.
Jhaveri A, Abu-Khalaf M, DiGiovanna M, Pusztai L, Hofstatter E, Sanft T, Sowers N, Lurie B, Silber A, Brandt D, Hochster H, Lacy J, Stein S, Chung G. Pilot study of sorafenib and biweekly capecitabine in patients with advanced breast and gastrointestinal tumors. Journal Of Clinical Oncology 2014, 32: 2561-2561. DOI: 10.1200/jco.2014.32.15_suppl.2561.Peer-Reviewed Original Research
2013
Phase I study of the HDAC inhibitor vorinostat in combination with capecitabine in a biweekly schedule in advanced breast cancer.
James E, Chung G, Sowers N, Clark M, Lilian R, Abraham G, Chmael S, Cappiello M, DiGiovanna M, Hofstatter E, Sanft T, Israel G, Pusztai L, Harris L, Abu-Khalaf M. Phase I study of the HDAC inhibitor vorinostat in combination with capecitabine in a biweekly schedule in advanced breast cancer. Journal Of Clinical Oncology 2013, 31: 154-154. DOI: 10.1200/jco.2013.31.26_suppl.154.Peer-Reviewed Original ResearchDose-expansion phaseGrade 3 non-hematological toxicityGrade 4 febrile neutropeniaCycle-1 DLTGrade 3 fatigueGrade 3/4 toxicitiesGrade 4 neutropeniaGrade 4 thrombocytopeniaMedian age 51Non-hematological toxicitiesObjective response rateAdvanced breast cancerDose-escalation phaseModest clinical activityHDAC inhibitor vorinostatClinical trial informationHistone deacetylase inhibitorsFebrile neutropeniaStable diseaseObjective responsePrior linesHematological toxicityTreatment delayClinical activityBreast cancerThe impact of survivorship care plans on knowledge among breast cancer survivors.
Bulloch K, Irwin M, Chagpar A, Horowitz N, Killelea B, Pusztai L, Abu-Khalaf M, DiGiovanna M, Chung G, Hofstatter E, Levy A, Sanft T. The impact of survivorship care plans on knowledge among breast cancer survivors. Journal Of Clinical Oncology 2013, 31: 124-124. DOI: 10.1200/jco.2013.31.26_suppl.124.Peer-Reviewed Original ResearchSurvivorship care plansPotential side effectsSurveillance recommendationsSide effectsPatient knowledgeCancer survivorsCare plansLong-term side effectsCancer treatmentTreatment progressMedian patient ageBreast cancer survivorsCompletion of treatmentKnowledge of treatmentElectronic medical recordsOnly significant improvementPatient ageProspective studyTreatment detailsTumor stageCancer stageMedical recordsRisk factorsMedicine recommendationsStage IIIPhase I study of the HDAC inhibitor vorinostat in combination with capecitabine in a biweekly schedule in advanced breast cancer.
James E, Chung G, DiGiovanna M, Sanft T, Hofstatter E, Sowers N, Clark M, Lilian R, Chmael S, Cappiello M, Abraham G, Israel G, Pusztai L, Harris L, Abu-Khalaf M. Phase I study of the HDAC inhibitor vorinostat in combination with capecitabine in a biweekly schedule in advanced breast cancer. Journal Of Clinical Oncology 2013, 31: 2587-2587. DOI: 10.1200/jco.2013.31.15_suppl.2587.Peer-Reviewed Original ResearchDose-expansion phaseGrade 3 non-hematological toxicityTGFB pathwayGrade 4 febrile neutropeniaCycle-1 DLTGrade 3 fatigueGrade 3/4 toxicitiesGrade 4 neutropeniaGrade 4 thrombocytopeniaMedian age 51Non-hematological toxicitiesObjective response rateAdvanced breast cancerDose-escalation phaseModest clinical activityBiomarkers of responseHDAC inhibitor vorinostatClinical trial informationHistone deacetylase inhibitorsFebrile neutropeniaStable diseaseObjective responsePrior linesHematological toxicityTreatment delay