Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial

dc.contributor.authorBarroso-Sousa, Romualdo
dc.contributor.authorTarantino, Paolo
dc.contributor.authorTayob, Nabihah
dc.contributor.authorDang, Chau
dc.contributor.authorYardley, Denise A.
dc.contributor.authorIsakoff, Steven J.
dc.contributor.authorValero, Vicente
dc.contributor.authorFaggen, Meredith
dc.contributor.authorMulvey, Therese
dc.contributor.authorBose, Ron
dc.contributor.authorHu, Jiani
dc.contributor.authorWeckstein, Douglas
dc.contributor.authorWolff, Antonio C.
dc.contributor.authorReeder-Hayes, Katherine
dc.contributor.authorRugo, Hope S.
dc.contributor.authorRamaswamy, Bhuvaneswari
dc.contributor.authorZuckerman, Dan
dc.contributor.authorHart, Lowell
dc.contributor.authorGadi, Vijayakrishna K.
dc.contributor.authorConstantine, Michael
dc.contributor.authorCheng, Kit
dc.contributor.authorBriccetti, Frederick
dc.contributor.authorSchneider, Bryan
dc.contributor.authorMerrill Garrett, Audrey
dc.contributor.authorMarcom, Kelly
dc.contributor.authorAlbain, Kathy
dc.contributor.authorDeFusco, Patricia
dc.contributor.authorTung, Nadine
dc.contributor.authorArdman, Blair
dc.contributor.authorNanda, Rita
dc.contributor.authorJankowitz, Rachel C.
dc.contributor.authorRimawi, Mothaffar
dc.contributor.authorAbramson, Vandana
dc.contributor.authorPohlmann, Paula R.
dc.contributor.authorVan Poznak, Catherine
dc.contributor.authorForero-Torres, Andres
dc.contributor.authorLiu, Minetta
dc.contributor.authorRuddy, Kathryn J.
dc.contributor.authorZheng, Yue
dc.contributor.authorRosenberg, Shoshana M.
dc.contributor.authorGelber, Richard D.
dc.contributor.authorTrippa, Lorenzo
dc.contributor.authorBarry, William
dc.contributor.authorDeMeo, Michelle
dc.contributor.authorBurstein, Harold
dc.contributor.authorPartridge, Ann
dc.contributor.authorWiner, Eric P.
dc.contributor.authorKrop, Ian
dc.contributor.authorTolaney, Sara M.
dc.contributor.departmentMedicine, School of Medicine
dc.date.accessioned2025-03-11T12:29:31Z
dc.date.available2025-03-11T12:29:31Z
dc.date.issued2022-02-16
dc.description.abstractThe excellent outcomes seen in patients treated with adjuvant trastuzumab emtansine (T-DM1) in the ATEMPT trial and the favorable toxicity profile associated with this agent make T-DM1 a potential therapeutic option for select patients with stage I HER2-positive breast cancer. Moreover, T-DM1 is an established adjuvant treatment for patients with HER2-positive breast cancer with the residual invasive disease after neoadjuvant therapy. Given that cardiotoxicity is the most significant adverse event of trastuzumab, which is a main molecular component of T-DM1, we conducted a sub-analysis of the ATEMPT trial to determine the cardiac safety of adjuvant T-DM1. In this analysis, the incidence of grade 3-4 left ventricular systolic dysfunction (LVSD) in T-DM1 or trastuzumab plus paclitaxel arms were respectively 0.8 and 1.8%. In addition, three (0.8%) patients in the T-DM1 arm and six (5.3%) patients in the adjuvant paclitaxel with trastuzumab (TH) arm experienced a significant asymptomatic left ventricular ejection fraction (LVEF) decline that per-protocol required holding T-DM1 or trastuzumab. All patients with available follow-up data experienced full resolution of cardiac symptoms and LVEF normalization. Furthermore, we performed an exploratory analysis to assess the relationship between age, baseline LVEF, and body mass index with cardiac outcomes. No significant association between these baseline characteristics and the incidence of significant asymptomatic LVEF decline or symptomatic LVSD was identified. The low incidence of significant cardiac adverse events in this population during therapy with adjuvant T-DM1 suggests that studies on the cost-effectiveness of cardiac monitoring during adjuvant therapy using anthracycline-free regimens are needed.
dc.eprint.versionFinal published version
dc.identifier.citationBarroso-Sousa R, Tarantino P, Tayob N, et al. Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial. NPJ Breast Cancer. 2022;8(1):18. Published 2022 Feb 16. doi:10.1038/s41523-022-00385-2
dc.identifier.urihttps://hdl.handle.net/1805/46308
dc.language.isoen_US
dc.publisherSpringer Nature
dc.relation.isversionof10.1038/s41523-022-00385-2
dc.relation.journalNPJ: Breast Cancer
dc.rightsAttribution 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourcePMC
dc.subjectBreast cancer
dc.subjectAdjuvant trastuzumab emtansine (T-DM1)
dc.subjectCardiotoxicity
dc.subjectTrastuzumab
dc.titleCardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial
dc.typeArticle
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