2022
Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials
Pagani O, Walley B, Fleming G, Colleoni M, Láng I, Gomez H, Tondini C, Burstein H, Goetz M, Ciruelos E, Stearns V, Bonnefoi H, Martino S, Geyer C, Chini C, Puglisi F, Spazzapan S, Ruhstaller T, Winer E, Ruepp B, Loi S, Coates A, Gelber R, Goldhirsch A, Regan M, Francis P, Group F. Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials. Journal Of Clinical Oncology 2022, 41: 1376-1382. PMID: 36521078, PMCID: PMC10419413, DOI: 10.1200/jco.22.01064.Peer-Reviewed Original ResearchConceptsDistant recurrence-free intervalOvarian function suppressionDisease-free survivalPrimary end pointOverall survivalAdjuvant exemestaneEnd pointBreast cancerReceptor-positive early breast cancerHuman epidermal growth factor receptorClinical trial updateYears of exemestaneOverall survival benefitHigh-risk patientsPremenopausal breast cancerRecurrence-free intervalEarly breast cancerGrade 3 tumorsRisk of recurrenceEpidermal growth factor receptorGrowth factor receptorSOFT trialTreat populationOvarian suppressionPremenopausal women
2021
Genomic features of rapid versus late relapse in triple negative breast cancer
Zhang Y, Asad S, Weber Z, Tallman D, Nock W, Wyse M, Bey JF, Dean KL, Adams EJ, Stockard S, Singh J, Winer EP, Lin NU, Jiang YZ, Ma D, Wang P, Shi L, Huang W, Shao ZM, Cherian M, Lustberg MB, Ramaswamy B, Sardesai S, VanDeusen J, Williams N, Wesolowski R, Obeng-Gyasi S, Sizemore GM, Sizemore ST, Verschraegen C, Stover DG. Genomic features of rapid versus late relapse in triple negative breast cancer. BMC Cancer 2021, 21: 568. PMID: 34006255, PMCID: PMC8130400, DOI: 10.1186/s12885-021-08320-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultBiomarkers, TumorChemotherapy, AdjuvantDatasets as TopicDisease-Free SurvivalDNA Copy Number VariationsFemaleFollow-Up StudiesGene Expression ProfilingGene Expression Regulation, NeoplasticHumansLogistic ModelsMastectomyMiddle AgedModels, GeneticMutationNeoadjuvant TherapyNeoplasm Recurrence, LocalPrognosisRisk AssessmentTime FactorsTriple Negative Breast NeoplasmsConceptsLate relapseRapid relapseImmune signaturesBreast cancerAnti-tumor CD8 T cellsBackgroundTriple-negative breast cancerTriple-negative breast cancerCD8 T cellsTumor mutation burdenIndependent validation cohortNegative breast cancerFisher's exact testPearson's chi-squared testChi-squared testLogistic regression modelsLuminal signaturePrimary TNBCTNBC subsetImmune subsetsClinical featuresValidation cohortWhole-genome copy numberPrimary tumorM1 macrophagesT cells
2020
A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer
Krop I, Abramson V, Colleoni M, Traina T, Holmes F, Garcia-Estevez L, Hart L, Awada A, Zamagni C, Morris PG, Schwartzberg L, Chan S, Gucalp A, Biganzoli L, Steinberg J, Sica L, Trudeau M, Markova D, Tarazi J, Zhu Z, O'Brien T, Kelly C, Winer E, Yardley D. A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor–Positive Breast Cancer. Clinical Cancer Research 2020, 26: 6149-6157. PMID: 32988969, DOI: 10.1158/1078-0432.ccr-20-1693.Peer-Reviewed Original ResearchConceptsProgression-free survivalHormone receptor-positive breast cancerReceptor-positive breast cancerPhase II trialEndocrine therapyBreast cancerII trialAR mRNACohort 1Higher AR mRNA levelsLower ESR1 mRNA levelsET-naïve patientsGrade adverse eventsPrior endocrine therapyMetastatic breast cancerAndrogen receptor inhibitorMRNA levelsAR mRNA levelsESR1 mRNA levelsEnzalutamide armITT populationTreat populationAdvanced diseasePrimary endpointAdverse eventsEffect of Exercise or Metformin on Biomarkers of Inflammation in Breast and Colorectal Cancer: A Randomized Trial
Brown JC, Zhang S, Ligibel JA, Irwin ML, Jones LW, Campbell N, Pollak MN, Sorrentino A, Cartmel B, Harrigan M, Tolaney SM, Winer EP, Ng K, Abrams TA, Sanft T, Douglas PS, Hu FB, Fuchs CS, Meyerhardt JA. Effect of Exercise or Metformin on Biomarkers of Inflammation in Breast and Colorectal Cancer: A Randomized Trial. Cancer Prevention Research 2020, 13: 1055-1062. PMID: 32859615, PMCID: PMC7718298, DOI: 10.1158/1940-6207.capr-20-0188.Peer-Reviewed Original ResearchConceptsHs-CRPColorectal cancerPhysical activityHigh-sensitivity C-reactive proteinLow baseline physical activitySurvivors of breastTrial product estimandBaseline physical activityBiomarkers of inflammationC-reactive proteinMeasures of inflammationImproved clinical outcomesEffects of exerciseType 2 diabetesCombination of exerciseStandard therapyClinical outcomesCancer recurrenceObservational studyTreatment groupsInflammation outcomesMetforminIL6Factorial trialInflammationTumor Mutational Burden and PTEN Alterations as Molecular Correlates of Response to PD-1/L1 Blockade in Metastatic Triple-Negative Breast Cancer
Barroso-Sousa R, Keenan TE, Pernas S, Exman P, Jain E, Garrido-Castro AC, Hughes M, Bychkovsky B, Umeton R, Files JL, Lindeman NI, MacConaill LE, Hodi FS, Krop IE, Dillon D, Winer EP, Wagle N, Lin NU, Mittendorf EA, Van Allen EM, Tolaney SM. Tumor Mutational Burden and PTEN Alterations as Molecular Correlates of Response to PD-1/L1 Blockade in Metastatic Triple-Negative Breast Cancer. Clinical Cancer Research 2020, 26: 2565-2572. PMID: 32019858, PMCID: PMC7269810, DOI: 10.1158/1078-0432.ccr-19-3507.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerHigh tumor mutational burdenProgression-free survivalTumor mutational burdenObjective response rateImmune checkpoint inhibitorsAnti-PD-1/L1 therapyTriple-negative breast cancerOverall survivalL1 therapyPD-L1Breast cancerMutational burdenLow objective response rateLonger progression-free survivalShorter progression-free survivalDana-Farber Cancer InstituteTumor genomic featuresShorter overall survivalMutations/megabaseCheckpoint inhibitorsVisceral metastasesL1 blockadePerformance statusPrior linesSensitive 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
2019
Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial
Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Henschel V, Molinero L, Chui SY, Maiya V, Husain A, Winer EP, Loi S, Emens LA, Investigators I. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology 2019, 21: 44-59. PMID: 31786121, DOI: 10.1016/s1470-2045(19)30689-8.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDouble-Blind MethodFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm InvasivenessNeoplasm MetastasisPaclitaxelPrognosisReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSurvival RateTriple Negative Breast NeoplasmsYoung AdultConceptsMetastatic triple-negative breast cancerInterim overall survival analysisTriple-negative breast cancerOverall survival analysisTreatment-related deathsMedian overall survivalNab-paclitaxelPhase 3 trialOverall survivalTreat populationBreast cancerSurvival analysisAtezolizumab groupPlacebo groupInterim analysisTreatment groupsEastern Cooperative Oncology Group performance statusDay 1Interactive voice-web response systemInvestigator-assessed progression-free survivalMeaningful overall survival benefitNew treatment-related deathsProgression-free survival resultsSolid Tumors version 1.1Tumor-infiltrating immune cellsReply to A.K. Goel et al.
Tolaney SM, Winer EP. Reply to A.K. Goel et al. Journal Of Clinical Oncology 2019, 37: 2954-2955. PMID: 31518173, DOI: 10.1200/jco.19.01822.Peer-Reviewed Original ResearchEvaluating the addition of bevacizumab to endocrine therapy as first-line treatment for hormone receptor–positive metastatic breast cancer: a pooled analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials
Martín M, Loibl S, Hyslop T, De la Haba-Rodríguez J, Aktas B, Cirrincione CT, Mehta K, Barry WT, Morales S, Carey LA, Garcia-Saenz JA, Partridge A, Martinez-Jañez N, Hahn O, Winer E, Guerrero-Zotano A, Hudis C, Casas M, Rodriguez-Martin C, Furlanetto J, Carrasco E, Dickler MN, Group G, GBG, Oncology A. Evaluating the addition of bevacizumab to endocrine therapy as first-line treatment for hormone receptor–positive metastatic breast cancer: a pooled analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials. European Journal Of Cancer 2019, 117: 91-98. PMID: 31276981, PMCID: PMC6718694, DOI: 10.1016/j.ejca.2019.06.002.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBone NeoplasmsBreast NeoplasmsEvaluation Studies as TopicFemaleFollow-Up StudiesFulvestrantHumansLetrozoleMiddle AgedNeoplasm Recurrence, LocalPrognosisReceptors, EstrogenReceptors, ProgesteroneSoft Tissue NeoplasmsSurvival RateTamoxifenConceptsProgression-free survivalClinical benefit rateObjective response rateEndocrine therapyMetastatic breast cancerOverall survivalGrade IIIBreast cancerHormone receptor-positive metastatic breast cancerMedian progression-free survivalAddition of BevSignificant additional toxicityStandard endocrine therapyDe novo diseaseAddition of bevacizumabFirst-line treatmentPredictors of efficacyNovo diseaseRecurrent diseaseLiver eventsEndocrine sensitivityBenefit rateAdditional toxicityPatientsResponse rateRibociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial
Goel S, Pernas S, Tan-Wasielewski Z, Barry WT, Bardia A, Rees R, Andrews C, Tahara RK, Trippa L, Mayer EL, Winer EP, Spring LM, Tolaney SM. Ribociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial. Clinical Breast Cancer 2019, 19: 399-404. PMID: 31235441, DOI: 10.1016/j.clbc.2019.05.010.Peer-Reviewed Original ResearchConceptsHER2-positive breast cancerAdvanced HER2-positive breast cancerProgression-free survivalBreast cancerAdverse eventsObjective responseGrade 3 adverse eventsGrade 4/5 adverse eventsHormone receptor-positive diseaseMedian progression-free survivalAnti-HER2 combinationClinical benefit rateHER2-negative diseasePhase 1b/2 studyPhase 1b/2 trialPrior therapy linesReceptor-positive diseaseAnti-HER2 therapyNew safety concernsCyclin-dependent kinase 4Stable diseaseExpansion cohortMetastatic settingPrior linesQTc prolongationSeven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer
Tolaney SM, Guo H, Pernas S, Barry WT, Dillon DA, Ritterhouse L, Schneider BP, Shen F, Fuhrman K, Baltay M, Dang CT, Yardley DA, Moy B, Marcom PK, Albain KS, Rugo HS, Ellis MJ, Shapira I, Wolff AC, Carey LA, Overmoyer B, Partridge AH, Hudis CA, Krop IE, Burstein HJ, Winer EP. Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer. Journal Of Clinical Oncology 2019, 37: jco.19.00066. PMID: 30939096, PMCID: PMC7587424, DOI: 10.1200/jco.19.00066.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBreast NeoplasmsBreast Neoplasms, MaleChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesGene Expression Regulation, NeoplasticGenetic Predisposition to DiseaseGenotypeHumansLymph NodesMaleMiddle AgedPaclitaxelPeripheral Nervous System DiseasesPoisson DistributionPolymorphism, Single NucleotideReceptor, ErbB-2RecurrenceRiskTrastuzumabTreatment OutcomeConceptsDisease-free survivalRecurrence-free intervalSmall HER2-positive tumorsAdjuvant paclitaxelHER2-positive tumorsLong-term outcomesTrastuzumab trialsBreast cancerOverall survivalSmall human epidermal growth factor receptor 2Breast cancer-specific survivalPaclitaxel-induced peripheral neuropathyExcellent long-term outcomesHuman epidermal growth factor receptor 2HER2-positive breast cancerEpidermal growth factor receptor 2Human epidermal growth factor receptorPAM50 intrinsic subtypesCancer-specific survivalPhase II studyPrimary end pointGrowth factor receptor 2Positive breast cancerTreatment of patientsSeven-year followThe immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial
Barroso-Sousa R, Barry WT, Guo H, Dillon D, Tan YB, Fuhrman K, Osmani W, Getz A, Baltay M, Dang C, Yardley D, Moy B, Marcom PK, Mittendorf EA, Krop IE, Winer EP, Tolaney SM. The immune profile of small HER2-positive breast cancers: a secondary analysis from the APT trial. Annals Of Oncology 2019, 30: 575-581. PMID: 30753274, PMCID: PMC8033534, DOI: 10.1093/annonc/mdz047.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenBiomarkers, TumorBreastBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMastectomyMiddle AgedPaclitaxelReceptor, ErbB-2TrastuzumabTumor BurdenTumor MicroenvironmentConceptsHER2-positive breast cancerSmall HER2-positive breast cancersImmune gene signaturesBreast cancerImmune profileAPT trialPD-L1Immune markersImmune microenvironmentSmall HER2-positive tumorsStromal PD-L1 expressionNode-negative breast cancerCell signatureGene signatureHuman epidermal growth factor receptorStromal PD-L1PD-L1 expressionHistological grade 2Luminal B tumorsB cell signaturesBreast cancer trialsHER2-positive tumorsImmune cell signaturesBasal-like tumorsHistological grade 1
2018
Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O’Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Annals Of Oncology 2018, 29: 1541-1547. PMID: 29718092, DOI: 10.1093/annonc/mdy155.Peer-Reviewed Original ResearchMeSH KeywordsAgedAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsDouble-Blind MethodFemaleFollow-Up StudiesHumansLetrozoleLiver NeoplasmsLung NeoplasmsLymphatic MetastasisNeoplasm Recurrence, LocalPrognosisPurinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSurvival RateConceptsProgression-free survivalFirst-line ribociclibOverall response rateMONALEESA-2 studySecondary end pointsAdvanced breast cancerBreast cancerEnd pointOverall survivalHER2-negative advanced breast cancerKey secondary end pointMedian progression-free survivalHuman epidermal growth factor receptorExploratory biomarker analysisExploratory end pointsImproved efficacy outcomesManageable toxicity profilePrimary end pointSecond interim analysisMetastatic breast cancerPhase III trialsESR1 mRNA levelsEpidermal growth factor receptorTP53 mutation statusBiomarker analysisTailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer
Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Láng I, Gómez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM. Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. New England Journal Of Medicine 2018, 379: 122-137. PMID: 29863451, PMCID: PMC6193457, DOI: 10.1056/nejmoa1803164.Peer-Reviewed Original ResearchConceptsTamoxifen plus ovarian suppressionTamoxifen-alone groupOvarian suppressionPremenopausal womenBreast cancerAdverse eventsOverall survivalDisease-free survival ratesOvarian Function TrialYears of tamoxifenAdjuvant endocrine therapyHigher adverse eventsReceipt of chemotherapyPremenopausal breast cancerLow recurrence rateAromatase inhibitor exemestaneUse of exemestaneSuppression groupExemestane TrialDistant recurrenceEndocrine therapyRecurrence rateGrade 3ExemestaneTamoxifen
2017
Ki67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results From the American College of Surgeons Oncology Group Z1031 Trial (Alliance)
Ellis MJ, Suman VJ, Hoog J, Goncalves R, Sanati S, Creighton CJ, DeSchryver K, Crouch E, Brink A, Watson M, Luo J, Tao Y, Barnes M, Dowsett M, Budd GT, Winer E, Silverman P, Esserman L, Carey L, X. C, Unzeitig G, Pluard T, Whitworth P, Babiera G, Guenther JM, Dayao Z, Ota D, Leitch M, Olson JA, Allred DC, Hunt K. Ki67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results From the American College of Surgeons Oncology Group Z1031 Trial (Alliance). Journal Of Clinical Oncology 2017, 35: jco.2016.69.440. PMID: 28045625, PMCID: PMC5455353, DOI: 10.1200/jco.2016.69.4406.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnastrozoleAndrostadienesAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsClinical Decision-MakingFemaleFollow-Up StudiesHumansKi-67 AntigenLetrozoleMiddle AgedMitotic IndexNeoadjuvant TherapyNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingNitrilesPredictive Value of TestsPrognosisProportional Hazards ModelsReceptors, EstrogenReceptors, ProgesteroneSurvival RateTranscriptomeTriazolesConceptsPreoperative endocrine prognostic indexBreast cancerNeoadjuvant chemotherapyAmerican CollegeEstrogen receptor-positive primary breast cancerNeoadjuvant aromatase inhibitor therapyPathologic complete response rateER-positive breast cancerAromatase inhibitor therapyComplete response rateER-positive tumorsPrimary breast cancerRisk of relapseAromatase inhibitor treatmentKi67 proliferation indexEndocrine monotherapyNeoadjuvant AIsAI therapyPCR ratePostmenopausal womenInhibitor therapyCox modelingOptimal therapyPrognostic indexRelapse risk
2016
Risk of acute myeloid leukemia and myelodysplastic syndrome among older women receiving anthracycline-based adjuvant chemotherapy for breast cancer on Modern Cooperative Group Trials (Alliance A151511)
Freedman RA, Seisler DK, Foster JC, Sloan JA, Lafky JM, Kimmick GG, Hurria A, Cohen HJ, Winer EP, Hudis CA, Partridge AH, Carey LA, Jatoi A, Klepin HD, Citron M, Berry DA, Shulman LN, Buzdar AU, Suman VJ, Muss HB. Risk of acute myeloid leukemia and myelodysplastic syndrome among older women receiving anthracycline-based adjuvant chemotherapy for breast cancer on Modern Cooperative Group Trials (Alliance A151511). Breast Cancer Research And Treatment 2016, 161: 363-373. PMID: 27866278, PMCID: PMC5226883, DOI: 10.1007/s10549-016-4051-1.Peer-Reviewed Original ResearchConceptsAML/MDSAcute myeloid leukemiaOlder patientsAdjuvant chemotherapyMyeloid leukemiaBreast cancerAnthracycline-based adjuvant chemotherapyMultivariable Cox regressionCooperative group trialsEffect of cyclophosphamideRace/ethnicityAnthracycline usePerformance statusCox regressionMyelodysplastic syndromeClinical trialsGroup trialsOlder womenOncology trialsPatientsStudy registrationOlder ageAnthracyclinesCancerAgeExtending Aromatase-Inhibitor Adjuvant Therapy to 10 Years
Goss PE, Ingle JN, Pritchard KI, Robert NJ, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff AC, Winer E, Hudis C, Stopeck A, Beck JT, Kaur JS, Whelan K, Tu D, Parulekar WR. Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years. New England Journal Of Medicine 2016, 375: 209-219. PMID: 27264120, PMCID: PMC5024713, DOI: 10.1056/nejmoa1604700.Peer-Reviewed Original ResearchConceptsContralateral breast cancerDisease-free survivalAromatase inhibitorsBreast cancerOverall survivalDisease-free survival ratesPositive early breast cancerAdjuvant aromatase inhibitorsNew-onset osteoporosisPlacebo-controlled trialPrimary end pointEarly breast cancerAnnual incidence rateTreatment of choiceBreast cancer recurrenceExtension of treatmentQuality of lifeBone painLetrozole groupAdjuvant therapyPlacebo groupPostmenopausal womenDisease recurrenceIncidence rateLower incidencePictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial
Krop IE, Mayer IA, Ganju V, Dickler M, Johnston S, Morales S, Yardley DA, Melichar B, Forero-Torres A, Lee SC, de Boer R, Petrakova K, Vallentin S, Perez EA, Piccart M, Ellis M, Winer E, Gendreau S, Derynck M, Lackner M, Levy G, Qiu J, He J, Schmid P. Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial. The Lancet Oncology 2016, 17: 811-821. PMID: 27155741, PMCID: PMC5524539, DOI: 10.1016/s1470-2045(16)00106-6.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overBiomarkers, TumorBreast NeoplasmsDouble-Blind MethodDrug Resistance, NeoplasmEstradiolEstrogen Receptor AntagonistsFemaleFollow-Up StudiesFulvestrantHumansMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPrognosisReceptor, ErbB-2Receptors, EstrogenSalvage TherapySurvival RateConceptsProgression-free survivalSerious adverse eventsTreatment-related serious adverse eventsWorse adverse eventsPlacebo groupAdverse eventsNon-measurable diseaseAromatase inhibitor treatmentPIK3CA mutationsBreast cancerDay 1Grade 3Inhibitor treatmentDay 15Cycle 1Median progression-free survivalHER2-negative breast cancerEndocrine-resistant breast cancerPIK3CA-mutated tumorsPhase 2 studyPhase 2 trialMetastatic breast cancerWeeks of treatmentAromatase inhibitor resistanceF Hoffmann-La RocheRandomized trial of a physical activity intervention in women with metastatic breast cancer
Ligibel JA, Giobbie-Hurder A, Shockro L, Campbell N, Partridge AH, Tolaney SM, Lin NU, Winer EP. Randomized trial of a physical activity intervention in women with metastatic breast cancer. Cancer 2016, 122: 1169-1177. PMID: 26872302, DOI: 10.1002/cncr.29899.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBreast NeoplasmsChemotherapy, AdjuvantChi-Square DistributionCombined Modality TherapyDisease-Free SurvivalExercise TherapyFemaleFollow-Up StudiesHumansMastectomy, SegmentalMiddle AgedNeoplasm InvasivenessNeoplasm StagingPhysical FitnessQuality of LifeRadiotherapy, AdjuvantReference ValuesSurvival AnalysisTreatment OutcomeUnited StatesConceptsMetastatic breast cancerEarly-stage breast cancerExercise interventionBreast cancerPhysical functioningLife Questionnaire-Core 30 questionnaireModerate-intensity aerobic exercisePhysical Activity Recall interviewModerate-intensity exercise interventionAdvanced breast cancerPhysical activity interventionsTime of enrollmentWait-list control groupQuality of lifeMetastatic diseaseCancer QualityMedian ageIntervention armMedian timeActivity interventionsAerobic exerciseWeekly exerciseTreadmill testFunctional capacityNonsignificant increase
2015
Body Mass Index, PAM50 Subtype, and Outcomes in Node-Positive Breast Cancer: CALGB 9741 (Alliance)
Ligibel JA, Cirrincione CT, Liu M, Citron M, Ingle JN, Gradishar W, Martino S, Sikov W, Michaelson R, Mardis E, Perou CM, Ellis M, Winer E, Hudis CA, Berry D, Barry WT. Body Mass Index, PAM50 Subtype, and Outcomes in Node-Positive Breast Cancer: CALGB 9741 (Alliance). Journal Of The National Cancer Institute 2015, 107: djv179. PMID: 26113580, PMCID: PMC4651106, DOI: 10.1093/jnci/djv179.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBody Mass IndexBreast NeoplasmsCyclophosphamideDisease-Free SurvivalDoxorubicinDrug Administration ScheduleFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLymph NodesLymphatic MetastasisMiddle AgedNeoplasm Recurrence, LocalPaclitaxelReceptors, EstrogenTreatment OutcomeConceptsBody mass indexBaseline body mass indexNode-positive breast cancerBreast cancerCALGB 9741Prognostic factorsMass indexMedian baseline body mass indexSignificant prognostic factorsIndependent prognostic factorBreast cancer outcomesGroup of patientsSequence of chemotherapyEstrogen receptor statusProportional hazards regressionActual body weightDose densityDosed chemotherapyMenopausal statusOverall survivalReceptor statusRandomized trialsHazards regressionPoor prognosisTumor size