2022
Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT)
Sella T, Zheng Y, Tayob N, Ruddy K, Freedman R, Dang C, Yardley D, Isakoff S, Valero V, DeMeo M, Burstein H, Winer E, Wolff A, Krop I, Partridge A, Tolaney S. Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT). Npj Breast Cancer 2022, 8: 127. PMID: 36450763, PMCID: PMC9712612, DOI: 10.1038/s41523-022-00495-x.Peer-Reviewed Original ResearchHER2-positive breast cancerPatient-reported toxicityPatient-reported outcomesT-DM1Treatment discontinuationTrastuzumab emtansineBreast cancerStage I HER2-positive breast cancerAdjuvant trastuzumab emtansineExcellent disease outcomesLess activity impairmentPaclitaxel/trastuzumabSocial/familyPositive breast cancerSuperior QoLOlder patientsTreatment toleranceTreatment armsTreatment regimensEligible participantsGlobal QoLTherapy optionsActivity impairmentMultivariable modelDisease outcome
2020
Association of tumor mutational burden (TMB) and clinical outcomes with pembrolizumab (pembro) versus chemotherapy (chemo) in patients with metastatic triple-negative breast cancer (mTNBC) from KEYNOTE-119.
Winer E, Lipatov O, Im S, Goncalves A, Muñoz-Couselo E, Lee K, Schmid P, Testa L, Witzel I, Ohtani S, Lunceford J, Karantza V, Mejia J, Cristescu R, Aurora-Garg D, Jelinic P, Huang L, Cortes J. Association of tumor mutational burden (TMB) and clinical outcomes with pembrolizumab (pembro) versus chemotherapy (chemo) in patients with metastatic triple-negative breast cancer (mTNBC) from KEYNOTE-119. Journal Of Clinical Oncology 2020, 38: 1013-1013. DOI: 10.1200/jco.2020.38.15_suppl.1013.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerTumor mutational burdenMut/MbClinical outcomesTriple-negative breast cancerChemo-treated patientsPrior systemic treatmentThird-line settingOverall study populationNumber of patientsTwo-sided p valuePD-L1 enrichmentReceiver operator characteristic analysisEstimates of efficacyOperator characteristic analysisP-valueFoundationOne CDxBaseline characteristicsMetastatic diseaseSystemic treatmentPotential positive associationTreatment armsClinical benefitCox regressionBreast cancer
2019
CALGB (Alliance) 40603: Long-term outcomes (LTOs) after neoadjuvant chemotherapy (NACT) +/- carboplatin (Cb) and bevacizumab (Bev) in triple-negative breast cancer (TNBC).
Sikov W, Polley M, Twohy E, Perou C, Singh B, Berry D, Tolaney S, Somlo G, Port E, Ma C, Kuzma C, Mamounas E, Golshan M, Bellon J, Collyar D, Hahn O, Hudis C, Winer E, Partridge A, Carey L. CALGB (Alliance) 40603: Long-term outcomes (LTOs) after neoadjuvant chemotherapy (NACT) +/- carboplatin (Cb) and bevacizumab (Bev) in triple-negative breast cancer (TNBC). Journal Of Clinical Oncology 2019, 37: 591-591. DOI: 10.1200/jco.2019.37.15_suppl.591.Peer-Reviewed Original ResearchTriple-negative breast cancerLong-term outcomesNeoadjuvant chemotherapyPoor outcomeResidual diseaseUntreated triple-negative breast cancerBetter long-term outcomesClinical stage IIDose-dense ACPretreatment clinical stageWeeks of paclitaxelPathologic complete responseResidual cancer burdenStandard neoadjuvant chemotherapyClinical trial informationBreast/axillaBetter EFSPrimary endpointStandard chemotherapyComplete responseTreatment armsCancer burdenChemotherapy dosesClinical stageTrial arms
2017
Evaluating the addition of bevacizumab (Bev) to endocrine therapy as first-line treatment for hormone-receptor positive (HR+)/HER2-negative advanced breast cancer (ABC): Pooled-analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials.
Martin M, Loibl S, Hyslop T, de la Haba-Rodriguez J, Aktas B, Cirrincione C, Carrasco E, Mehta K, Barry W, Morales S, Carey L, Garcia Saenz J, Partridge A, Martinez N, Hahn O, Winer E, Guerrero A, Hudis C, Casas M, Dickler M. Evaluating the addition of bevacizumab (Bev) to endocrine therapy as first-line treatment for hormone-receptor positive (HR+)/HER2-negative advanced breast cancer (ABC): Pooled-analysis from the LEA (GEICAM/2006-11_GBG51) and CALGB 40503 (Alliance) trials. Journal Of Clinical Oncology 2017, 35: 1012-1012. DOI: 10.1200/jco.2017.35.15_suppl.1012.Peer-Reviewed Original ResearchProgression-free survivalAdvanced breast cancerRandomized trialsMedian progression-free survivalNegative advanced breast cancerBreast Cancer Research FoundationAddition of BevMultivariable Cox modelAddition of bevacizumabFirst-line treatmentCancer Research FoundationCardiovascular eventsPgR statusSecondary endpointsLiver eventsRecurrent diseaseMedian ageMultivariable analysisTreatment armsPatient populationBreast cancerGrade 3Prolonged benefitCox modelStudy-level differences
2013
Cognitive function in older women with breast cancer treated with standard chemotherapy and capecitabine on Cancer and Leukemia Group B 49907
Freedman RA, Pitcher B, Keating NL, Ballman KV, Mandelblatt J, Kornblith AB, Kimmick GG, Hurria A, Winer EP, Hudis CA, Cohen HJ, Muss HB, for the Alliance for Clinical Trials in Oncology. Cognitive function in older women with breast cancer treated with standard chemotherapy and capecitabine on Cancer and Leukemia Group B 49907. Breast Cancer Research And Treatment 2013, 139: 607-616. PMID: 23681403, PMCID: PMC3920483, DOI: 10.1007/s10549-013-2562-6.Peer-Reviewed Original ResearchConceptsSelf-reported cognitive functionCognitive function scoresCognitive functionOlder womenAdjuvant chemotherapyBreast cancerTime pointsStandard adjuvant chemotherapyAverage baseline scoreBaseline cognitive functionCALGB 49907Life substudyCognitive changesPerformance statusStandard chemotherapyMedian agePatient characteristicsTreatment armsTreatment regimenFunction scoresHealthy groupBaseline depressionCognitive screeningChemotherapyKruskal-Wallis test
2006
Quality of life (QOL) companion to CALGB 9840: A phase III study of paclitaxel (P) via weekly 1 hour (hr) versus standard 3 hour infusion every 3 weeks with trastuzumab in the treatment of patients with/without HER-2/neu-overexpressing metastatic breast cancer
Naughton M, Gu L, Wang X, Seidman A, Winer E, Kornblith A. Quality of life (QOL) companion to CALGB 9840: A phase III study of paclitaxel (P) via weekly 1 hour (hr) versus standard 3 hour infusion every 3 weeks with trastuzumab in the treatment of patients with/without HER-2/neu-overexpressing metastatic breast cancer. Journal Of Clinical Oncology 2006, 24: 674-674. DOI: 10.1200/jco.2006.24.18_suppl.674.Peer-Reviewed Original ResearchNegative patientsQOL differencesGreater efficacyMain trial resultsPrior radiation therapyMetastatic breast cancerPhase III studyTreatment of patientsMain outcome measuresEORTC-C30Prior chemotherapyBreast symptomsIII studyPerformance statusPatient ageHour infusionTreatment armsBreast moduleGlobal QoLCancer symptomsBreast cancerClinical dataQoL dataOutcome measuresRadiation therapyInterleukin-6, multidrug resistance protein-1 expression and response to paclitaxel in women with metastatic breast cancer: results of cancer and leukemia group B trial 159806
Rincon M, Broadwater G, Harris L, Crocker A, Weaver D, Dressler L, Berry D, Sutton L, Michaelson R, Messino M, Kirshner J, Fleming G, Winer E, Hudis C, Appel S, Norton L, Muss H, for the Cancer and Leukemia Group B. Interleukin-6, multidrug resistance protein-1 expression and response to paclitaxel in women with metastatic breast cancer: results of cancer and leukemia group B trial 159806. Breast Cancer Research And Treatment 2006, 100: 301-308. PMID: 16773437, DOI: 10.1007/s10549-006-9251-7.Peer-Reviewed Original ResearchConceptsMetastatic breast cancerInterleukin-6Breast cancerP-glycoproteinPgp expressionMultidrug resistance protein-1 expressionSingle-agent paclitaxelElevated serum levelsBreast cancer patientsBreast cancer cell linesProtein-1 expressionResult of cancerMulti-drug resistanceCancer cell linesClinical characteristicsOverall survivalPartial responseSerum levelsTreatment armsWorse prognosisPredictive factorsCancer patientsPredictive markerIHC expressionPaclitaxel sensitivity