000			04868nam a22007577a 4500
008			190621s20192019 xxu||||| |||| 00| 0 eng d
022			_a0167-6806
040			_aOvid MEDLINE(R)
099			_a30852761
245			_aProspective evaluation of the cardiac safety of HER2-targeted therapies in patients with HER2-positive breast cancer and compromised heart function: the SAFE-HEaRt study.
251			_aBreast Cancer Research & Treatment. 175(3):595-603, 2019 Jun.
252			_aBreast Cancer Res Treat. 175(3):595-603, 2019 Jun.
253			_aBreast cancer research and treatment
260			_c2019
260			_fFY2019
265			_sppublish
266			_d2019-06-21
520			_aCONCLUSION: This study provides safety data of HER2-targeted therapies in patients with breast cancer and reduced LVEF while receiving cardioprotective medications and close cardiac monitoring. Our results demonstrate the importance of collaboration between cardiology and oncology providers to allow for delivery of optimal oncologic care to this unique population.
520			_aMETHODS: Patients with stage I-IV HER2-positive breast cancer candidates for trastuzumab, pertuzumab or ado-trastuzumab emtansine (TDM-1), with left ventricular ejection fraction (LVEF) 40-49% and no symptoms of heart failure (HF) were enrolled. All patients underwent cardiology visits, serial echocardiograms and received beta blockers and ACE inhibitors unless contraindicated. The primary endpoint was completion of the planned HER2-targeted therapies without developing either a cardiac event (CE) defined as HF, myocardial infarction, arrhythmia or cardiac death or significant asymptomatic worsening of LVEF. The study was considered successful if planned oncology therapy completion rate was at least 30%.
520			_aPURPOSE: HER2-targeted therapies have substantially improved the outcome of patients with breast cancer, however, they can be associated with cardiac toxicity. Guidelines recommend holding HER2-targeted therapies until resolution of cardiac dysfunction. SAFE-HEaRt is the first trial that prospectively tests whether these therapies can be safely administered without interruptions in patients with cardiac dysfunction.
520			_aRESULTS: Of 31 enrolled patients, 30 were evaluable. Fifteen patients were treated with trastuzumab, 14 with trastuzumab and pertuzumab, and 2 with TDM-1. Mean LVEF was 45% at baseline and 46% at the end of treatment. Twenty-seven patients (90%) completed the planned HER2-targeted therapies. Two patients experienced a CE and 1 had an asymptomatic worsening of LVEF to <= 35%.
546			_aEnglish
650			_a*Adrenergic beta-Antagonists/tu [Therapeutic Use]
650			_a*Angiotensin-Converting Enzyme Inhibitors/tu [Therapeutic Use]
650			_a*Breast Neoplasms/dt [Drug Therapy]
650			_a*Molecular Targeted Therapy/ae [Adverse Effects]
650			_a*Receptor, ErbB-2/me [Metabolism]
650			_a*Ventricular Dysfunction, Left/dt [Drug Therapy]
650			_aAdo-Trastuzumab Emtansine
650			_aAdult
650			_aAged
650			_aAntibodies, Monoclonal, Humanized/ad [Administration & Dosage]
650			_aAntibodies, Monoclonal, Humanized/ae [Adverse Effects]
650			_aBreast Neoplasms/me [Metabolism]
650			_aFemale
650			_aHumans
650			_aMaytansine/aa [Analogs & Derivatives]
650			_aMaytansine/ad [Administration & Dosage]
650			_aMaytansine/ae [Adverse Effects]
650			_aMiddle Aged
650			_aNeoplasm Staging
650			_aPilot Projects
650			_aProspective Studies
650			_aTrastuzumab/ad [Administration & Dosage]
650			_aTrastuzumab/ae [Adverse Effects]
650			_aTreatment Outcome
650			_aVentricular Dysfunction, Left/ci [Chemically Induced]
650			_aVentricular Dysfunction, Left/pp [Physiopathology]
651			_aMedStar Health
651			_aMedStar Health Research Institute
651			_aMedStar Heart & Vascular Institute
651			_aWashington Cancer Institute
656			_aAssociate Dean for Research Development
657			_aJournal Article
700			_aAsch, Federico M
700			_aBarac, Ana
700			_aCunningham, A
700			_aGallagher, Christopher
700			_aHofmeyer, Mark
700			_aSrichai, M B
700			_aSwain, Sandra M
790			_aAsch FM, Barac A, Cunningham A, Dang C, Gallagher C, Geng X, Herbolsheimer P, Hofmeyer M, Isaacs C, Lynce F, Nunes R, Pohlmann PR, Shajahan-Haq A, Smith KL, Srichai MB, Swain SM, Tan MT, Timothee P, Warren R, Yu AF
856			_uhttps://dx.doi.org/10.1007/s10549-019-05191-2 _zhttps://dx.doi.org/10.1007/s10549-019-05191-2
858			_ySwain, S M _uhttp://orcid.org/0000-0002-1320-3830 _zhttp://orcid.org/0000-0002-1320-3830
942			_cART _dArticle
999			_c11118 _d11118