Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial
- PMID: 17646669
- DOI: 10.1200/JCO.2006.09.1611
Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial
Abstract
Purpose: The purpose of this analysis was to investigate trastuzumab-associated cardiac adverse effects in breast cancer patients after completion of (neo)adjuvant chemotherapy with or without radiotherapy.
Patients and methods: The Herceptin Adjuvant (HERA) trial is a three-group, multicenter, open-label randomized trial that compared 1 or 2 years of trastuzumab given once every 3 weeks with observation in patients with HER-2-positive breast cancer. Only patients who after completion of (neo)adjuvant chemotherapy with or without radiotherapy had normal left ventricular ejection fraction (LVEF > or = 55%) were eligible. A repeat LVEF assessment was performed in case of cardiac dysfunction.
Results: Data were available for 1,693 patients randomly assigned to 1 year trastuzumab and 1,693 patients randomly assigned to observation. The incidence of trastuzumab discontinuation due to cardiac disorders was low (4.3%). The incidence of cardiac end points was higher in the trastuzumab group compared with observation (severe congestive heart failure [CHF], 0.60% v 0.00%; symptomatic CHF, 2.15% v 0.12%; confirmed significant LVEF drops, 3.04% v 0.53%). Most patients with cardiac dysfunction recovered in fewer than 6 months. Patients with trastuzumab-associated cardiac dysfunction were treated with higher cumulative doses of doxorubicin (287 mg/m(2) v 257 mg/m(2)) or epirubicin (480 mg/m(2) v 422 mg/m(2)) and had a lower screening LVEF and a higher body mass index.
Conclusion: Given the clear benefit in disease-free survival, the low incidence of cardiac adverse events, and the suggestion that cardiac dysfunction might be reversible, adjuvant trastuzumab should be considered for treatment of breast cancer patients who fulfill the HERA trial eligibility criteria.
Comment in
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Is trastuzumab associated with adverse cardiac effects in patients with breast cancer?Nat Clin Pract Oncol. 2008 Apr;5(4):192-3. doi: 10.1038/ncponc1045. Epub 2008 Jan 22. Nat Clin Pract Oncol. 2008. PMID: 18212766 No abstract available.
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Trastuzumab-related cardiotoxicity in the herceptin adjuvant trial.J Clin Oncol. 2008 Apr 20;26(12):2052-3; author reply 2053-4. doi: 10.1200/JCO.2007.15.5044. J Clin Oncol. 2008. PMID: 18421060 No abstract available.
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