Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial

Thomas M. Suter, Marion Procter, Dirk J. Van Veldhuisen, Michael Muscholl, Jonas Bergh, Chiara Carlomagno, Timothy Perren, Rodolfo Passalacqua, Claudia Bighin, Jan G M Klijn, Fail T. Ageev, E. Hitre, Juergen Groetz, Hiroji Iwata, Malgorzata Knap, Michael Gnant, Susanne Muehlbauer, Alison Spence, Richard D. Gelber, Martine J. Piccart-Gebhart

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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 ≥ 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/m2 v 257 mg/m 2) or epirubicin (480 mg/m2 v 422 mg/m2) 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.

Original languageEnglish
Pages (from-to)3859-3865
Number of pages7
JournalJournal of Clinical Oncology
Volume25
Issue number25
DOIs
Publication statusPublished - Sep 1 2007

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Observation
Adjuvant Chemotherapy
Breast Neoplasms
Incidence
Radiotherapy
Heart Failure
Trastuzumab
Epirubicin
Stroke Volume
Doxorubicin
Disease-Free Survival
Body Mass Index
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Suter, T. M., Procter, M., Van Veldhuisen, D. J., Muscholl, M., Bergh, J., Carlomagno, C., ... Piccart-Gebhart, M. J. (2007). Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. Journal of Clinical Oncology, 25(25), 3859-3865. https://doi.org/10.1200/JCO.2006.09.1611

Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. / Suter, Thomas M.; Procter, Marion; Van Veldhuisen, Dirk J.; Muscholl, Michael; Bergh, Jonas; Carlomagno, Chiara; Perren, Timothy; Passalacqua, Rodolfo; Bighin, Claudia; Klijn, Jan G M; Ageev, Fail T.; Hitre, E.; Groetz, Juergen; Iwata, Hiroji; Knap, Malgorzata; Gnant, Michael; Muehlbauer, Susanne; Spence, Alison; Gelber, Richard D.; Piccart-Gebhart, Martine J.

In: Journal of Clinical Oncology, Vol. 25, No. 25, 01.09.2007, p. 3859-3865.

Research output: Contribution to journalArticle

Suter, TM, Procter, M, Van Veldhuisen, DJ, Muscholl, M, Bergh, J, Carlomagno, C, Perren, T, Passalacqua, R, Bighin, C, Klijn, JGM, Ageev, FT, Hitre, E, Groetz, J, Iwata, H, Knap, M, Gnant, M, Muehlbauer, S, Spence, A, Gelber, RD & Piccart-Gebhart, MJ 2007, 'Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial', Journal of Clinical Oncology, vol. 25, no. 25, pp. 3859-3865. https://doi.org/10.1200/JCO.2006.09.1611
Suter TM, Procter M, Van Veldhuisen DJ, Muscholl M, Bergh J, Carlomagno C et al. Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. Journal of Clinical Oncology. 2007 Sep 1;25(25):3859-3865. https://doi.org/10.1200/JCO.2006.09.1611
Suter, Thomas M. ; Procter, Marion ; Van Veldhuisen, Dirk J. ; Muscholl, Michael ; Bergh, Jonas ; Carlomagno, Chiara ; Perren, Timothy ; Passalacqua, Rodolfo ; Bighin, Claudia ; Klijn, Jan G M ; Ageev, Fail T. ; Hitre, E. ; Groetz, Juergen ; Iwata, Hiroji ; Knap, Malgorzata ; Gnant, Michael ; Muehlbauer, Susanne ; Spence, Alison ; Gelber, Richard D. ; Piccart-Gebhart, Martine J. / Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. In: Journal of Clinical Oncology. 2007 ; Vol. 25, No. 25. pp. 3859-3865.
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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 ≥ 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/m2 v 257 mg/m 2) or epirubicin (480 mg/m2 v 422 mg/m2) 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.",
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AU - Bergh, Jonas

AU - Carlomagno, Chiara

AU - Perren, Timothy

AU - Passalacqua, Rodolfo

AU - Bighin, Claudia

AU - Klijn, Jan G M

AU - Ageev, Fail T.

AU - Hitre, E.

AU - Groetz, Juergen

AU - Iwata, Hiroji

AU - Knap, Malgorzata

AU - Gnant, Michael

AU - Muehlbauer, Susanne

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N2 - 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 ≥ 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/m2 v 257 mg/m 2) or epirubicin (480 mg/m2 v 422 mg/m2) 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.

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