2023
Impact of BMI in Patients With Early Hormone Receptor–Positive Breast Cancer Receiving Endocrine Therapy With or Without Palbociclib in the PALLAS Trial
Pfeiler G, Hlauschek D, Mayer E, Deutschmann C, Kacerovsky-Strobl S, Martin M, Meisel J, Zdenkowski N, Loibl S, Balic M, Park H, Prat A, Isaacs C, Bajetta E, Balko J, Bellet-Ezquerra M, Bliss J, Burstein H, Cardoso F, Fohler H, Foukakis T, Gelmon K, Goetz M, Haddad T, Iwata H, Jassem J, Lee S, Linderholm B, Los M, Mamounas E, Miller K, Morris P, Munzone E, Gal-Yam E, Ring A, Shepherd L, Singer C, Thomssen C, Tseng L, Valagussa P, Winer E, Wolff A, Zoppoli G, Machacek-Link J, Schurmans C, Huang X, Gauthier E, Fesl C, Dueck A, DeMichele A, Gnant M, Cameron D, El-Abed S, Rugo H, Steger G, Traina T, Werutsky G, Wolmark N. Impact of BMI in Patients With Early Hormone Receptor–Positive Breast Cancer Receiving Endocrine Therapy With or Without Palbociclib in the PALLAS Trial. Journal Of Clinical Oncology 2023, 41: 5118-5130. PMID: 37556775, DOI: 10.1200/jco.23.00126.Peer-Reviewed Original ResearchConceptsImpact of BMIPALLAS trialBMI categoriesHigher BMIEarly hormone receptor-positive breast cancerHormone receptor-positive breast cancerReceptor-positive breast cancerAddition of palbociclibEfficacy of palbociclibEarly treatment discontinuationRelative dose intensityTreatment discontinuation ratesDisease-free survivalSide effect profileMultivariable logistic regressionBreast cancer riskSignificant decreaseNeutropenia ratesPalbociclib armEndocrine therapyTreatment discontinuationDiscontinuation ratesDose intensityEarly discontinuationNormal weight
2022
Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03).
Mayer EL, Fesl C, Hlauschek D, Garcia-Estevez L, Burstein HJ, Zdenkowski N, Wette V, Miller KD, Balic M, Mayer IA, Cameron D, Winer EP, Ponce Lorenzo JJ, Lake D, Pristauz-Telsnigg G, Haddad TC, Shepherd L, Iwata H, Goetz M, Cardoso F, Traina TA, Sabanathan D, Breitenstein U, Ackerl K, Metzger Filho O, Zehetner K, Solomon K, El-Abed S, Theall KP, Lu DR, Dueck A, Gnant M, DeMichele A. Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03). Journal Of Clinical Oncology 2022, 40: 449-458. PMID: 34995105, PMCID: PMC9851679, DOI: 10.1200/jco.21.01918.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansNeoplasm StagingPiperazinesProtein Kinase InhibitorsPyridinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneRisk FactorsTime FactorsConceptsInvasive disease-free survivalAdjuvant endocrine therapyHuman epidermal growth factor receptorEndocrine therapyEpidermal growth factor receptorPalbociclib exposureGrowth factor receptorBreast cancerHormone Receptor-Positive/Human Epidermal Growth Factor ReceptorAddition of palbociclibNovel adjuvant treatmentDisease-free survivalEarly breast cancerFactor receptorOral cancer therapyProtocol analysisPALLAS studyAdjuvant treatmentEarly discontinuationAdjuvant studiesDiscontinuation ratesDose modificationAnalysis populationCDK4/6 inhibitorsDrug persistence
2014
Impact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance)
Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance). Journal Of Clinical Oncology 2014, 33: 13-21. PMID: 25092775, PMCID: PMC4268249, DOI: 10.1200/jco.2014.57.0572.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCyclophosphamideDose-Response Relationship, DrugDoxorubicinDrug Administration ScheduleFatigueFemaleHumansHypertensionMiddle AgedNeoadjuvant TherapyNeoplasm StagingNeutropeniaPaclitaxelRemission InductionThrombocytopeniaTreatment OutcomeTriple Negative Breast NeoplasmsConceptsTriple-negative breast cancerPathologic complete responseNeoadjuvant chemotherapyBreast/axillaStage IIBreast cancerPathologic complete response rateRandomized phase II trialAddition of carboplatinDose-dense doxorubicinRole of carboplatinComplete response ratePhase II trialStandard neoadjuvant chemotherapyThird of patientsAdjuvant trialsConcurrent carboplatinSkipped dosesWeek paclitaxelEarly discontinuationII trialPostoperative complicationsThromboembolic eventsDose modificationOverall survivalFrailty and Adherence to Adjuvant Hormonal Therapy in Older Women With Breast Cancer: CALGB Protocol 369901
Sheppard VB, Faul LA, Luta G, Clapp JD, Yung RL, Wang JH, Kimmick G, Isaacs C, Tallarico M, Barry WT, Pitcher BN, Hudis C, Winer EP, Cohen HJ, Muss HB, Hurria A, Mandelblatt JS. Frailty and Adherence to Adjuvant Hormonal Therapy in Older Women With Breast Cancer: CALGB Protocol 369901. Journal Of Clinical Oncology 2014, 32: 2318-2327. PMID: 24934786, PMCID: PMC4105485, DOI: 10.1200/jco.2013.51.7367.Peer-Reviewed Original ResearchConceptsAdjuvant hormonal therapyHormonal therapyBreast cancerOlder womenInfluence of frailtyCovariate adjustmentRisk of discontinuationNonmetastatic breast cancerBreast cancer ageProportional hazards modelIIB diseaseEarly discontinuationMost patientsOlder patientsProspective cohortBaseline frailtyCancer ageHigher oddsDiscontinuationHazards modelMost womenPsychosocial dataNoninitiationTherapyLogistic regression