2020
A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials
Amiri-Kordestani L, Xie D, Tolaney SM, Bloomquist E, Tang S, Ibrahim A, Goldberg KB, Theoret MR, Pazdur R, Sridhara R, Winer EP, Beaver JA. A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials. Annals Of Oncology 2020, 31: 1704-1708. PMID: 32866625, DOI: 10.1016/j.annonc.2020.08.2106.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalEarly breast cancerHER2-positive early breast cancerTH armOverall survivalAdjuvant paclitaxelTrastuzumab trialsReceptor statusLow-risk early breast cancerHuman epidermal growth factor receptor 2Positive early breast cancerPropensity scoreEpidermal growth factor receptor 2De-escalate therapyDisease-free survivalGrowth factor receptor 2Progesterone receptor statusSingle-arm studyEstrogen receptor statusSingle-arm trialPatient-level dataFactor receptor 2Drug Administration analysisCovariates of ageHistorical clinical trials
2017
Genomic Profiling in Node-Positive ER-Positive Early Breast Cancer: Can Tumor Biology Guide Locoregional Therapy?
Garrido-Castro AC, Winer EP. Genomic Profiling in Node-Positive ER-Positive Early Breast Cancer: Can Tumor Biology Guide Locoregional Therapy? Journal Of The National Cancer Institute 2017, 109: djw316. PMID: 28376163, DOI: 10.1093/jnci/djw316.Peer-Reviewed Original ResearchConceptsPositive early breast cancerEarly breast cancerLocoregional therapyBreast cancerGenomic profilingTherapyCancer
2016
A randomized trial (MA.17R) of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer.
Goss P, Ingle J, Pritchard K, Robert N, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff A, Winer E, Hudis C, Stopeck A, Beck J, Kaur J, Whelan K, Tu D, Parulekar W. A randomized trial (MA.17R) of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer. Journal Of Clinical Oncology 2016, 34: lba1-lba1. DOI: 10.1200/jco.2016.34.18_suppl.lba1.Peer-Reviewed Original ResearchEarly-stage breast cancerYears of tamoxifenAromatase inhibitor therapyDisease-free survivalBreast cancerAI treatmentPostmenopausal womenInhibitor therapyHormone receptor-positive early breast cancerReceptor-positive early breast cancerTwo-sided log-rank testDisease-free survival eventsPositive early breast cancerPrior adjuvant chemotherapyPlacebo-controlled trialYear overall survivalContralateral breast cancerEarly breast cancerAnnual incidence rateStage breast cancerLog-rank testStandard of careBreast cancer recurrenceAdjuvant chemotherapyAdjuvant letrozoleExtending 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 incidence
2014
Adjuvant Ovarian Suppression in Premenopausal Breast Cancer
Francis PA, Regan MM, Fleming GF, Láng I, Ciruelos E, Bellet M, Bonnefoi HR, Climent MA, Da Prada GA, Burstein HJ, Martino S, Davidson NE, Geyer CE, Walley BA, Coleman R, Kerbrat P, Buchholz S, Ingle JN, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Colleoni M, Viale G, Coates AS, Goldhirsch A, Gelber RD. Adjuvant Ovarian Suppression in Premenopausal Breast Cancer. New England Journal Of Medicine 2014, 372: 436-446. PMID: 25495490, PMCID: PMC4341825, DOI: 10.1056/nejmoa1412379.Peer-Reviewed Original ResearchConceptsTamoxifen plus ovarian suppressionOvarian suppressionRate of freedomBreast cancerTamoxifen groupPremenopausal womenPrimary analysisDisease-free survival ratesPositive early breast cancerAdjuvant ovarian suppressionNonreceipt of chemotherapyYears of tamoxifenDisease-free survivalPremenopausal breast cancerEarly breast cancerOvarian estrogen productionOverall study populationSuppression groupGreater treatment effectUse of exemestaneAdjuvant chemotherapyPrior chemotherapyMost recurrencesPrognostic factorsPrior receiptAdjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer
Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Láng I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA. Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer. New England Journal Of Medicine 2014, 371: 107-118. PMID: 24881463, PMCID: PMC4175521, DOI: 10.1056/nejmoa1404037.Peer-Reviewed Original ResearchMeSH KeywordsAdultAndrostadienesAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalEstradiolFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMastectomyMiddle AgedOsteoporosisPremenopauseQuality of LifeTamoxifenTriptorelin PamoateConceptsPositive early breast cancerEarly breast cancerOvarian suppressionBreast cancerPostmenopausal womenPremenopausal womenTamoxifen plus ovarian suppressionSuppression groupRate of freedomDisease-free survivalPhase 3 trialPremenopausal breast cancerOvarian estrogen productionPositive breast cancerAromatase inhibitor exemestaneAdjuvant exemestaneOvarian irradiationAdjuvant therapyAdjuvant treatmentAdverse eventsOverall survivalEstrogen productionAromatase inhibitorsGrade 3Primary analysis