2024
Prediction of Benefit From Adjuvant Pertuzumab by 80-Gene Signature in the APHINITY (BIG 4-11) Trial
Krop I, Mittempergher L, Paulson J, Andre F, Bonnefoi H, Loi S, Loibl S, Gelber R, Caballero C, Bhaskaran R, Dreezen C, Menicucci A, Bernards R, van ’t Veer L, Piccart M. Prediction of Benefit From Adjuvant Pertuzumab by 80-Gene Signature in the APHINITY (BIG 4-11) Trial. JCO Precision Oncology 2024, 8: e2200667. PMID: 38237097, DOI: 10.1200/po.22.00667.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalHER2 typeLuminal typeInvasive disease-free survival eventsHazard ratioEarly-stage breast cancerLuminal-type tumorsMolecular subtype signaturesAnti-HER2 therapyHER2-positive tumorsDisease-free survivalStandard adjuvant chemotherapyBasal-type tumorsBasal typePredictive of benefitAdjuvant pertuzumabAPHINITY trialHER2-typeHER2-positiveInferior prognosisAdjuvant chemotherapyTumor subtypesNo significant differenceAnti-HER2Breast tumors
2021
Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial)
Ruddy KJ, Zheng Y, Tayob N, Hu J, Dang CT, Yardley DA, Isakoff SJ, Valero VV, Faggen MG, Mulvey TM, Bose R, Sella T, Weckstein DJ, Wolff AC, Reeder-Hayes KE, Rugo HS, Ramaswamy B, Zuckerman DS, Hart LL, Gadi VK, Constantine M, Cheng KL, Briccetti FM, Schneider BP, Merrill Garrett A, Kelly Marcom P, Albain KS, DeFusco PA, Tung NM, Ardman BM, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu MC, Rosenberg S, DeMeo MK, Burstein HJ, Winer EP, Krop IE, Partridge AH, Tolaney SM. Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial). Breast Cancer Research And Treatment 2021, 189: 103-110. PMID: 34120223, DOI: 10.1007/s10549-021-06267-8.Peer-Reviewed Original ResearchConceptsChemotherapy-related amenorrheaEarly-stage breast cancerRisk of infertilityAdo-trastuzumab emtansineT-DM1Gonadotropin-releasing hormone agonistAdjuvant T-DM1T-DM1 3.6Amenorrhea ratesPermanent menopauseStandard HER2Chemotherapy regimensPrimary endpointProtocol therapyMedian ageOvarian toxicityPremature menopauseHormone agonistBreast cancerMenstrual dataMonthsAmenorrheaEmtansineMenopauseTrastuzumabImpact of HER2 heterogeneity on treatment response of early-stage HER2-positive breast cancer: phase II neoadjuvant clinical trial of T-DM1 combined with pertuzumab
Filho OM, Viale G, Stein S, Trippa L, Yardley DA, Mayer IA, Abramson VG, Arteaga CL, Spring LM, Waks AG, Wrabel E, DeMeo MK, Bardia A, Dell'Orto P, Russo L, King TA, Polyak K, Michor F, Winer EP, Krop IE. Impact of HER2 heterogeneity on treatment response of early-stage HER2-positive breast cancer: phase II neoadjuvant clinical trial of T-DM1 combined with pertuzumab. Cancer Discovery 2021, 11: candisc.1557.2020. PMID: 33941592, PMCID: PMC8598376, DOI: 10.1158/2159-8290.cd-20-1557.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerHER2 heterogeneityBreast cancerEarly-stage HER2-positive breast cancerHER2-positive early-stage breast cancerTherapeutic resistancePathologic complete response rateEarly-stage breast cancerNeoadjuvant clinical trialsComplete response rateSubset of patientsHER2 therapyPretreatment biopsiesEvaluable casesCure rateT-DM1Trastuzumab emtansineClinical trialsTreatment strategiesTreatment responseTreatment selectionResponse rateRelated commentaryTherapyIssue feature
2020
Sensitive Detection of Minimal Residual Disease in Patients Treated for Early-Stage Breast Cancer
Parsons HA, Rhoades J, Reed SC, Gydush G, Ram P, Exman P, Xiong K, Lo CC, Li T, Fleharty M, Kirkner GJ, Rotem D, Cohen O, Yu F, Fitarelli-Kiehl M, Leong KW, Hughes ME, Rosenberg SM, Collins LC, Miller KD, Blumenstiel B, Trippa L, Cibulskis C, Neuberg DS, DeFelice M, Freeman SS, Lennon NJ, Wagle N, Ha G, Stover DG, Choudhury AD, Getz G, Winer EP, Meyerson M, Lin NU, Krop I, Love JC, Makrigiorgos GM, Partridge AH, Mayer EL, Golub TR, Adalsteinsson VA. Sensitive Detection of Minimal Residual Disease in Patients Treated for Early-Stage Breast Cancer. Clinical Cancer Research 2020, 26: 2556-2564. PMID: 32170028, PMCID: PMC7654718, DOI: 10.1158/1078-0432.ccr-19-3005.Peer-Reviewed Original ResearchConceptsMinimal residual diseaseMetastatic breast cancerDigital droplet PCRBreast cancerTumor mutationsResidual diseaseMRD detectionEarly-stage breast cancerCurative-intent treatmentCohort of patientsEarly-stage diseaseMedian lead timeClinical data collectionWhole-exome sequencingMRD testFirst positive sampleDistant recurrenceMost patientsMetastatic diagnosisStage 0PatientsPlasma samplingClinical sensitivityPatient-specific mutationsCfDNA samples
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 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
2016
Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: American Society of Clinical Oncology Endorsement of Cancer Care Ontario Guideline Recommendations
Henry NL, Somerfield MR, Abramson VG, Allison KH, Anders CK, Chingos DT, Hurria A, Openshaw TH, Krop IE. Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: American Society of Clinical Oncology Endorsement of Cancer Care Ontario Guideline Recommendations. Journal Of Clinical Oncology 2016, 34: 2303-2311. PMID: 27001586, DOI: 10.1200/jco.2015.65.8609.Peer-Reviewed Original ResearchConceptsOncotype DX recurrence scoreDX recurrence scoreDistant relapse riskNode-negative tumorsRisk stratification toolRecurrence scoreEstrogen receptorRole of patientsASCO panelAdjuvant therapyStratification toolRelapse riskBreast cancerDisease factorsHuman epidermal growth factor receptor 2 (HER2) statusEpidermal growth factor receptor 2 statusSmall node-negative tumorsLymph node-negative tumorsEarly-stage breast cancerAdjuvant therapy recommendationsClinical Oncology EndorsementHER2-positive diseaseLymphovascular invasion positivityMicrometastatic nodal diseaseSystemic therapy decisions
2015
Chemotherapy-related amenorrhea after adjuvant paclitaxel–trastuzumab (APT trial)
Ruddy KJ, Guo H, Barry W, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer BA, Hudis C, Krop IE, Burstein HJ, Winer EP, Partridge AH, Tolaney SM. Chemotherapy-related amenorrhea after adjuvant paclitaxel–trastuzumab (APT trial). Breast Cancer Research And Treatment 2015, 151: 589-596. PMID: 25981899, PMCID: PMC5057177, DOI: 10.1007/s10549-015-3426-z.Peer-Reviewed Original ResearchConceptsChemotherapy-related amenorrheaChemotherapy initiationMenopausal symptomsBreast cancerAdjuvant breast cancer therapyEarly-stage breast cancerNode-negative HER2Weeks of paclitaxelStage breast cancerLast menstrual periodBreast cancer therapyAdjuvant paclitaxelAmenorrhea ratesAPT trialEligible patientsEvaluable populationPremenopausal womenAdjuvant studiesTrastuzumab monotherapyMedian timeMenstrual periodCancer regimensAmenorrheaTrastuzumabMonthsFeasibility and Cardiac Safety of Trastuzumab Emtansine After Anthracycline-Based Chemotherapy As (neo)Adjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early-Stage Breast Cancer
Krop IE, Suter TM, Dang CT, Dirix L, Romieu G, Zamagni C, Citron ML, Campone M, Xu N, Smitt M, Gianni L. Feasibility and Cardiac Safety of Trastuzumab Emtansine After Anthracycline-Based Chemotherapy As (neo)Adjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early-Stage Breast Cancer. Journal Of Clinical Oncology 2015, 33: 1136-1142. PMID: 25713436, PMCID: PMC5657012, DOI: 10.1200/jco.2014.58.7782.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAnthracyclinesAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantCombined Modality TherapyCyclophosphamideDoxorubicinDrug Administration ScheduleEpirubicinFeasibility StudiesFluorouracilHeadacheHeart FailureHumansMaytansineMiddle AgedNauseaNeoplasm StagingReceptor, ErbB-2TrastuzumabTreatment OutcomeYoung AdultConceptsEarly-stage breast cancerHER2-positive early-stage breast cancerHuman epidermal growth factor receptorT-DM1Breast cancerEpidermal growth factor receptorGrowth factor receptorCardiac eventsCardiac safetyTrastuzumab emtansineSymptomatic congestive heart failureAsymptomatic LVEF declineCytotoxic agent DM1Planned radiation doseAnthracycline-based chemotherapyCoprimary end pointsPhase III trialsCongestive heart failureFactor receptorMetastatic breast cancerVentricular ejection fractionT-DM1 treatmentStage breast cancerLVEF declineAdverse events
2011
P1-06-23: Changes in Gene Expression after One Dose of Trastuzumab (T) in HER2+ Breast Cancer Cell Lines Predict Novel Pathways of Response in HER2 Positive Early Stage Breast Cancer.
Sprecher E, Lezon-Geyda K, Sarkar S, Bossuyt V, Narayaan M, Kumar A, Krop I, Winer E, Tuck D, Kleinstein S, Harris L. P1-06-23: Changes in Gene Expression after One Dose of Trastuzumab (T) in HER2+ Breast Cancer Cell Lines Predict Novel Pathways of Response in HER2 Positive Early Stage Breast Cancer. Cancer Research 2011, 71: p1-06-23-p1-06-23. DOI: 10.1158/0008-5472.sabcs11-p1-06-23.Peer-Reviewed Original ResearchPathologic complete responseBreast cancer patientsBreast cancer cell linesSensitive cell linesCancer cell linesCancer patientsSingle doseBreast cancerHER2-positive early-stage breast cancerPositive early-stage breast cancerCell linesBreast tumorsEarly breast cancer patientsEarly-stage breast cancerDose of trastuzumabEarly-stage HER2Early breast cancerResistant breast tumorsStage breast cancerTumor core biopsiesPathway analysisMechanism of actionResistant HER2RECIST criteriaClinical response
2009
Personalizing treatment in early-stage breast cancer: The role of standard clinical factors and genomic information in adjuvant chemotherapy decision making
Gold J, Najita J, Lester S, Richardson A, Morganstern D, Chen W, Partridge A, Krop I, Winer E, Burstein H. Personalizing treatment in early-stage breast cancer: The role of standard clinical factors and genomic information in adjuvant chemotherapy decision making. Journal Of Clinical Oncology 2009, 27: 572-572. DOI: 10.1200/jco.2009.27.15_suppl.572.Peer-Reviewed Original ResearchEarly-stage breast cancerOncotype DX recurrence scoreRecurrence scoreDX recurrence scoreAdjuvant chemotherapyClinical factorsTumor gradeChemotherapy decisionsBreast cancerMultivariable logistic regression modelStandard clinicopathologic dataProgesterone receptor expressionReceipt of chemotherapyAdjuvant chemotherapy decisionsLow recurrence scoreHigh recurrence scoreStage breast cancerSingle academic institutionLikelihood of benefitStandard clinical factorsElectronic medical recordsLogistic regression modelsChemotherapy recommendationsMenopausal statusChemotherapy administration