2024
Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan
Heist R, Sands J, Bardia A, Shimizu T, Lisberg A, Krop I, Yamamoto N, Kogawa T, Al-Hashimi S, Fung S, Galor A, Pisetzky F, Basak P, Lau C, Meric-Bernstam F. Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan. Cancer Treatment Reviews 2024, 125: 102720. PMID: 38502995, DOI: 10.1016/j.ctrv.2024.102720.Peer-Reviewed Original ResearchNon-small cell lung cancerTriple-negative breast cancerTrophoblast cell surface antigen 2Antibody drug conjugatesAdverse eventsHR+/HER2- BCDelivery of cytotoxic agents to tumor cellsBreast cancerCytotoxic agents to tumor cellsTopoisomerase I inhibitor payloadAgents to tumor cellsInterstitial lung disease/pneumonitisInfusion-related reactionsSolid tumor indicationsPhase I studyCell lung cancerNovel antibody drug conjugatesSystemic therapySafety profileSolid tumorsTumor indicationsTumor cellsLung cancerClinical managementClinical trials
2023
Axillary Nodal Response to Neoadjuvant T-DM1 Combined with Pertuzumab in a Prospective Phase II Multi-Institution Clinical Trial.
Weiss A, Jin Q, Waks A, Yardley D, Spring L, Wrabel E, Tayob N, Viale G, Krop I, King T, Metzger-Filho O. Axillary Nodal Response to Neoadjuvant T-DM1 Combined with Pertuzumab in a Prospective Phase II Multi-Institution Clinical Trial. Journal Of The American College Of Surgeons 2023, 238: 303-311. PMID: 38047578, DOI: 10.1097/xcs.0000000000000916.Peer-Reviewed Original ResearchHER2-positive breast cancerMulti-institution clinical trialBreast pCRBreast cancerDual HER2RCB-IIClinical trialsHigher pathologic complete response rateNodal responsePhase II single-arm trialPathologic complete response rateAxillary surgical stagingPathologic nodal responseResidual breast diseaseComplete response ratePre-operative treatmentSingle-arm trialPathologic nodal diseaseNeoadjuvant trialsYpN0 rateNodal diseaseSurgical stagingPathologic responseSystemic therapyFuture trialsImpact of Neoadjuvant Paclitaxel/Trastuzumab/Pertuzumab on Breast Tumor Downsizing for Patients with HER2+ Breast Cancer: Single-Arm Prospective Clinical Trial.
Weiss A, Li T, Desai N, Tung N, Poorvu P, Partridge A, Nakhlis F, Dominici L, Sinclair N, Spring L, Faggen M, Constantine M, Krop I, DeMeo M, Wrabel E, Alberti J, Chikarmane S, Tayob N, King T, Tolaney S, Winer E, Mittendorf E, Waks A. Impact of Neoadjuvant Paclitaxel/Trastuzumab/Pertuzumab on Breast Tumor Downsizing for Patients with HER2+ Breast Cancer: Single-Arm Prospective Clinical Trial. Journal Of The American College Of Surgeons 2023, 237: 247-256. PMID: 37194964, DOI: 10.1097/xcs.0000000000000761.Peer-Reviewed Original ResearchConceptsBreast conservation therapyTrastuzumab/pertuzumabBreast cancerTumor downsizingSystemic therapyBCT ratesSingle-arm prospective clinical trialBreast pathologic complete responseSingle-arm prospective trialBreast cancer warrants further investigationBCT-eligible patientsBreast size ratioCancer warrants further investigationEarly-stage HER2Neoadjuvant systemic therapyPathologic complete responseProspective clinical trialsWarrants further investigationBCT eligibilityMulticentric tumorsNeoadjuvant regimensProspective trialComplete responseLocal therapyConservation therapy
2022
Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline Update
Giordano SH, Franzoi MAB, Temin S, Anders CK, Chandarlapaty S, Crews JR, Kirshner JJ, Krop IE, Lin NU, Morikawa A, Patt DA, Perlmutter J, Ramakrishna N, Davidson NE. Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline Update. Journal Of Clinical Oncology 2022, 40: 2612-2635. PMID: 35640077, DOI: 10.1200/jco.22.00519.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerBreast cancerSystemic therapyTrastuzumab deruxtecanGuideline recommendationsAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical congestive heart failureEvidence-based guideline recommendationsStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionReceptor-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorASCO Guideline UpdateThird-line settingSecond-line treatmentFirst-line therapyFirst-line treatmentTime of progressionAbsence of progressionCongestive heart failureManagement of Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Guideline Update
Ramakrishna N, Anders CK, Lin NU, Morikawa A, Temin S, Chandarlapaty S, Crews JR, Davidson NE, Franzoi MAB, Kirshner JJ, Krop IE, Patt DA, Perlmutter J, Giordano SH. Management of Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Guideline Update. Journal Of Clinical Oncology 2022, 40: 2636-2655. PMID: 35640075, DOI: 10.1200/jco.22.00520.Peer-Reviewed Original ResearchConceptsWhole brain radiotherapyAdvanced breast cancerBrain metastasesSystemic therapyBreast cancerLocal therapyGuideline recommendationsAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerPositive advanced breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorAppropriate local therapyASCO Guideline UpdateBest supportive careProgression-free survivalSize of metastasesGrowth factor receptor 2Presence of symptomsRoutine magnetic resonanceFactor receptor 2Outcomes of interestMagnetic resonance imagingEpidermal growth factor receptor
2019
Local–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial)
Bellon JR, Guo H, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis M, Wolff AC, Carey LA, Overmoyer BA, Partridge AH, Hudis CA, Krop I, Burstein HJ, Winer EP, Tolaney SM. Local–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial). Breast Cancer Research And Treatment 2019, 176: 303-310. PMID: 31004299, DOI: 10.1007/s10549-019-05238-4.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerLocal-regional recurrenceDisease-free survivalEffective anti-HER2 therapyLRR-free survivalAnti-HER2 therapyBreast-conserving surgeryBreast cancerRadiation therapySystemic therapyHormone receptor-positive tumorsProspective multi-institutional studyHER2-negative diseaseHER2-positive diseaseNegative axillary nodesEffective systemic therapyProspective multicenter trialEarly-stage patientsKaplan-Meier methodReceptor-positive tumorsHER2-positive tumorsMulti-institutional studyFuture investigational effortsAdjuvant trastuzumabProtocol therapy
2018
Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Clinical Practice Guideline Update
Giordano SH, Temin S, Chandarlapaty S, Crews JR, Esteva FJ, Kirshner JJ, Krop IE, Levinson J, Lin NU, Modi S, Patt DA, Perlmutter J, Ramakrishna N, Winer EP, Davidson NE. Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Clinical Practice Guideline Update. Journal Of Clinical Oncology 2018, 36: jco.2018.79.269. PMID: 29939838, DOI: 10.1200/jco.2018.79.2697.Peer-Reviewed Original ResearchConceptsAdvanced breast cancerBreast cancerSystemic therapyTrastuzumab emtansineEstrogen receptor-positive/progesterone receptor-positive breast cancerAdvanced human epidermal growth factor receptorASCO Clinical Practice Guideline UpdateHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical congestive heart failureClinical Practice Guideline UpdateEvidence-based guideline recommendationsStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionReceptor-positive breast cancerHuman epidermal growth factor receptor 2Epidermal growth factor receptor 2Human epidermal growth factor receptorThird-line settingSecond-line treatmentFirst-line therapyFirst-line treatmentProgression-free survivalTime of progressionRecommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Clinical Practice Guideline Update
Ramakrishna N, Temin S, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Giordano SH, Kirshner JJ, Krop IE, Levinson J, Modi S, Patt DA, Perlmutter J, Winer EP, Lin NU. Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Clinical Practice Guideline Update. Journal Of Clinical Oncology 2018, 36: jco.2018.79.271. PMID: 29939840, DOI: 10.1200/jco.2018.79.2713.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptorAdvanced breast cancerBrain metastasesBreast cancerEpidermal growth factor receptorGrowth factor receptorSystemic therapyLocal therapyAdvanced human epidermal growth factor receptorASCO Clinical Practice Guideline UpdateHER2-positive advanced breast cancerClinical Practice Guideline UpdateAppropriate local therapyBest supportive careWhole brain radiotherapyProgression-free survivalSize of metastasesFactor receptorExpert panelPresence of symptomsRoutine magnetic resonanceOutcomes of interestStrong quality evidenceMagnetic resonance imagingAdvocacy experts
2017
Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Focused Update Guideline Summary
Krop I, Ismaila N, Stearns V. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Focused Update Guideline Summary. JCO Oncology Practice 2017, 13: jop.2017.024646. PMID: 28696818, DOI: 10.1200/jop.2017.024646.Peer-Reviewed Original ResearchUse of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update
Krop I, Ismaila N, Andre F, Bast RC, Barlow W, Collyar DE, Hammond ME, Kuderer NM, Liu MC, Mennel RG, Van Poznak C, Wolff AC, Stearns V. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update. Journal Of Clinical Oncology 2017, 35: jco.2017.74.047. PMID: 28692382, PMCID: PMC5846188, DOI: 10.1200/jco.2017.74.0472.Peer-Reviewed Original ResearchConceptsAdjuvant systemic therapyNode-positive breast cancerAdjuvant systemic chemotherapyHigh clinical riskBreast cancerSystemic therapyClinical riskSystemic chemotherapySuch patientsClinical utilityEarly-stage invasive breast cancerClinical Oncology Clinical Practice GuidelineNode-negative breast cancerOncology Clinical Practice GuidelineHuman epidermal growth factor receptor 2Early-stage breast cancerEpidermal growth factor receptor 2Triple-negative breast cancerGood-prognosis populationUse of MammaPrintInvolved lymph nodesGrowth factor receptor 2Invasive breast cancerClinical practice guidelinesClinical risk categories
2015
Personalization of loco-regional care for primary breast cancer patients (part 1)
Toi M, Winer EP, Benson JR, Inamoto T, Forbes JF, von Minckwitz G, Robertson J, Grobmyer SR, Jatoi I, Sasano H, Kunkler I, Ho AY, Yamauchi C, Chow L, Huang CS, Han W, Noguchi S, Pegram MD, Yamauchi H, Lee ES, Larionov AA, Bevilacqua J, Yoshimura M, Sugie T, Yamauchi A, Krop IE, Noh DY, Klimberg VS. Personalization of loco-regional care for primary breast cancer patients (part 1). Future Oncology 2015, 11: 1297-1300. PMID: 25952777, DOI: 10.2217/fon.15.65.Peer-Reviewed Original ResearchConceptsPrimary systemic therapySystemic therapyConsensus conferenceCompletion axillary lymph node dissectionAxillary lymph node dissectionPrimary breast cancer patientsLoco-regional managementPost-Z0011 eraPreoperative hormonal therapyPrimary surgical patientsLymph node dissectionBreast cancer carePathological tumor stageBreast cancer patientsLoco-regional treatmentPrimary treatment planBreast cancer susceptibilityAxillary irradiationAxillary managementAxillary treatmentNodal depositsAxillary stagingHormonal therapyNode dissectionSentinel lymphPersonalization of loco-regional care for primary breast cancer patients (part 2)
Toi M, Winer EP, Benson JR, Inamoto T, Forbes JF, von Minckwitz G, Robertson J, Grobmyer SR, Jatoi I, Sasano H, Kunkler I, Ho AY, Yamauchi C, Chow L, Huang CS, Han W, Noguchi S, Pegram MD, Yamauchi H, Lee ES, Larionov AA, Bevilacqua J, Yoshimura M, Sugie T, Yamauchi A, Krop IE, Noh DY, Klimberg VS. Personalization of loco-regional care for primary breast cancer patients (part 2). Future Oncology 2015, 11: 1301-1305. PMID: 25952778, DOI: 10.2217/fon.15.66.Peer-Reviewed Original ResearchConceptsPrimary systemic therapyPreoperative hormonal therapySystemic therapyHormonal therapyBreast cancerGenetic predispositionConsensus conferencePrimary breast cancer patientsAdverse pathological factorsDownstaging of tumorsLoco-regional managementNode-positive patientsRegional nodal irradiationBreast cancer careContralateral prophylactic mastectomyPathological tumor stageBreast cancer patientsLoco-regional treatmentSporadic breast cancerBreast cancer susceptibilityAxillary treatmentNodal irradiationAxillary stagingPremenopausal womenClinical response
2014
NI-23BRAIN BREAST METASTASES RESPOND TO ANTI-ANGIOGENIC THERAPY BY MODES OF VASCULAR NORMALIZATION
Emblem K, Pinho M, Chandra V, Gerstner E, Stufflebeam S, Sorenson G, Harris G, Freedman R, Sohl J, Younger J, Krop I, Winer E, Lin N. NI-23BRAIN BREAST METASTASES RESPOND TO ANTI-ANGIOGENIC THERAPY BY MODES OF VASCULAR NORMALIZATION. Neuro-Oncology 2014, 16: v143-v143. PMCID: PMC4218348, DOI: 10.1093/neuonc/nou264.22.Peer-Reviewed Original ResearchAnti-angiogenic therapyBreast cancerBrain metastasesVascular normalizationTumor perfusionBrain tumorsDay 1Largest contrast-enhancing lesionPerfusion MRIParenchymal brain metastasesMonths of therapyPhase II studyHormone receptor statusMetastatic breast cancerSubset of patientsContrast-enhancing lesionsPrimary brain tumorsAnti-angiogenic effectsOxygen saturation levelsPrior therapyBreast metastasisII studySystemic therapyImproved survivalReceptor statusSystemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline
Giordano SH, Temin S, Kirshner JJ, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Gonzalez-Angulo AM, Krop I, Levinson J, Lin NU, Modi S, Patt DA, Perez EA, Perlmutter J, Ramakrishna N, Winer EP. Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. Journal Of Clinical Oncology 2014, 32: 2078-2099. PMID: 24799465, PMCID: PMC6076031, DOI: 10.1200/jco.2013.54.0948.Peer-Reviewed Original ResearchMeSH KeywordsAdo-Trastuzumab EmtansineAnastrozoleAntibodies, Monoclonal, HumanizedAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsClinical Trials as TopicComorbidityDocetaxelDrug Administration ScheduleEvidence-Based MedicineFemaleHealth Status DisparitiesHealthcare DisparitiesHumansLapatinibLetrozoleMaytansineMolecular Targeted TherapyNitrilesQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSocieties, MedicalTaxoidsTrastuzumabTreatment OutcomeTriazolesUnited StatesConceptsAdvanced breast cancerHuman epidermal growth factor receptorSecond-line treatmentProgression-free survivalFirst-line treatmentBreast cancerPFS benefitT-DM1Epidermal growth factor receptorEndocrine therapyGrowth factor receptorSystemic therapyEstrogen receptor-positive/progesterone receptor-positive breast cancerAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerProgesterone receptor-positive breast cancerClinical Oncology Clinical Practice GuidelineClinical congestive heart failureStandard first-line therapyPositive advanced breast cancerLeft ventricular ejection fractionOncology Clinical Practice GuidelineReceptor-positive breast cancerThird-line settingFirst-line therapyRecommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: American Society of Clinical Oncology Clinical Practice Guideline
Ramakrishna N, Temin S, Chandarlapaty S, Crews JR, Davidson NE, Esteva FJ, Giordano SH, Gonzalez-Angulo AM, Kirshner JJ, Krop I, Levinson J, Modi S, Patt DA, Perez EA, Perlmutter J, Winer EP, Lin NU. Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: American Society of Clinical Oncology Clinical Practice Guideline. Journal Of Clinical Oncology 2014, 32: 2100-2108. PMID: 24799487, PMCID: PMC6366342, DOI: 10.1200/jco.2013.54.0955.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBrain NeoplasmsBreast NeoplasmsComorbidityConsensusCranial IrradiationDisease ManagementEvidence-Based MedicineFemaleHealth Status DisparitiesHealthcare DisparitiesHumansRadiosurgeryReceptor, ErbB-2Societies, MedicalTreatment OutcomeUnited StatesConceptsMagnetic resonance imagingHuman epidermal growth factor receptorAdvanced breast cancerBrain metastasesBreast cancerEpidermal growth factor receptorGrowth factor receptorSystemic therapyLocal therapyAdvanced human epidermal growth factor receptorHER2-positive advanced breast cancerClinical Oncology Clinical Practice GuidelineExpert consensus-based recommendationsOncology Clinical Practice GuidelineConsensus-based processRoutine magnetic resonance imagingAppropriate local therapyBest supportive careWhole brain radiotherapySize of metastasesFactor receptorClinical practice guidelinesPresence of symptomsConsensus-based recommendationsAmerican Society
2012
Results from a phase Ib study of trastuzumab emtansine (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab.
Modi S, Elias A, LoRusso P, Samant M, Guardino E, Althaus B, Krop I. Results from a phase Ib study of trastuzumab emtansine (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab. Journal Of Clinical Oncology 2012, 30: 528-528. DOI: 10.1200/jco.2012.30.15_suppl.528.Peer-Reviewed Original ResearchHER2-positive metastatic breast cancerMetastatic breast cancerT-DM1Prior systemic therapyPhase Ib studyPhase II studyDose-escalation studySingle-agent activityDuration of responseDose escalation schemeFuture clinical trialsDLT criteriaII studyMedian ageSystemic therapyExtension trialPreclinical dataTrastuzumab emtansineClinical trialsMedian numberToxicity CriteriaBreast cancerIb studyPhase IbQ3w
2006
Early Breast Cancer (Stage I and Stage II): Tailored Systemic Therapy for Endocrine-Responsive Breast Cancer
Krop I, Winer E. Early Breast Cancer (Stage I and Stage II): Tailored Systemic Therapy for Endocrine-Responsive Breast Cancer. 2006, 327-348. DOI: 10.1007/978-3-540-28266-2_17.Peer-Reviewed Original Research