Journal Information
Vol. 33. Issue 4.
Pages 202-207 (January 2009)
Vol. 33. Issue 4.
Pages 202-207 (January 2009)
Full text access
Cardiotoxicity associated with trastuzumab in normal clinical practice
Cardiotoxicidad asociada a trastuzumab en la práctica clínica asistencial
Visits
2295
C. Vicente
Corresponding author
cvicente@salud.aragon.es

Corresponding author.
, N. Serrano, M.J. Agustín, V. Alonso, P. Palomo, R. Huarte
Servicio de Farmacia, Hospital Universitario Miguel Servet, Zaragoza, Spain
This item has received
Article information
Abstract
Objective

To evaluate the incidence of cardiotoxicity associated with treatment with trastuzumab in clinical practice by describing its characteristics, progress, and associated risk factors.

Methods

Retrospective observational study of patients with HER2-positive breast cancer treated with trastuzumab in the first quarter of 2007 in a tertiary hospital. Follow-up was performed from start of treatment until the end of March 2008. The data sources used were the oncological computer program Oncowin® from the pharmacy department and the patient clinical history. We gathered variables related to patient baseline characteristics, treatment, and safety.

Results

The study included 61 patients. 19 women (32.8%) presented cardiotoxicity, which was the second most common adverse affect of those frequently attributed to the treatment. The average time for toxicity to appear was 7 months, with an average FEVI decrease of 15.6 (9.1) points. In 63.2% of the patients it was symptomatic, and its most frequent manifestation was stress-induced dyspnoea, with a single case of congestive heart failure. Cardiotoxicity led to suspension of treatment in 22.9% of the total patients, which was definitive for 7 out of the 14 patients who interrupted the treatment. No statistically significant differences were found for the possible risk factors.

Conclusions

The incidence of cardiotoxicity in clinical practice is much higher than expected. The important clinical implication of this information and the increasing use of trastuzumab mean that there is a new challenge for the optimal treatment of HER2-positive breast cancer.

Keywords:
HER2-breast cancer
Cardiotoxicity
Trastuzumab
Adverse effects
Resumen
Objetivo

Evaluar la incidencia de cardiotoxicidad asociada al tratamiento con trastuzumab en la práctica clínica asistencial, describiendo sus características, su manejo y los factores de riesgo asociados.

Método

Estudio observacional retrospectivo que incluyó a pacientes con cáncer de mama HER-2 positivo en tratamiento con trastuzumab durante el primer trimestre de 2007 en un hospital de tercer nivel. Se realizó un seguimiento desde el inicio del tratamiento hasta finales de marzo de 2008. Las fuentes de datos utilizadas fueron el programa informático de oncología del servicio de farmacia, Oncowin®, y la historia clínica del paciente. Se recogieron variables relacionadas con las características basales del paciente, con el tratamiento y con la seguridad.

Resultados

Se incluyó a 61 pacientes en el estudio; 19 (32,8 %) mujeres presentaron cardiotoxicidad, que supuso el segundo efecto adverso atribuido el tratamiento en frecuencia. La mediana de tiempo de aparición de la toxicidad fue de 7 meses, con un descenso medio de fracción de eyección del ventrículo izquierdo (FEVI) de 15,6 ± 9,1 puntos. En el 63,2 % fue sintomática, la manifestación más frecuente fue la disnea de esfuerzo y hubo un único caso de fallo cardíaco congestivo. La cardiotoxicidad supuso la suspensión del tratamiento en el 22,9% del total de pacientes, y fue de forma definitiva en 7 de las 14 pacientes que interrumpieron el tratamiento. No se hallaron diferencias estadísticamente significativas en cuanto a los posibles factores de riesgo.

Conclusiones

La incidencia de cardiotoxicidad en la práctica clínica asistencial se muestra mucho más elevada que la esperada. Su importante implicación clínica y el uso creciente de trastuzumab hacen que suponga un nuevo reto para el tratamiento óptimo del cáncer de mama HER-2 positivo.

Palabras clave:
Cáncer de mama HER-2
Cardiotoxicidad
Trastuzumab
Efectos adversos
Full text is only available in PDF
References
[1.]
O. Yavas, M. Yazici, O. Eren, B. Oyan.
The acute effect of trastuzumab infusion on ECG parameters in metastatic breast cancer patients.
Swiss Med Wkly, 137 (2007), pp. 556-558
[2.]
A. Lin, H.S. Rugo.
The role of trastuzumab in early stage breast cancer: current data and treatment recommendations.
Curr Treat Options Oncol, 8 (2007), pp. 47-60
[3.]
R.H. Engel, V.G. Kaklamani.
HER2-positive breast cancer: current and future treatment strategies.
Drugs, 67 (2007), pp. 1329-1341
[4.]
Herceptin® (trastuzumab).
Ficha técnica.
Roche Farma, (2005),
[5.]
C.A. Hudis.
Trastuzumab –mechanism of action and use in clinical practice.
N Engl J Med, 357 (2007), pp. 39-51
[6.]
G.A. Viani, S.L. Afonso, E.J. Stefano, L.I. de Fendi, F.V. Soares.
Adjuvant trastuzumab in the treatment of her-2-positive early breast cancer: a meta-analysis of published randomized trials.
BMC Cancer, 7 (2007), pp. 153
[7.]
K. McKeage, C.M. Perry.
Trastuzumab: a review of its use in the treatment of metastatic breast cancer overexpressing HER2.
Drugs, 62 (2002), pp. 209-243
[8.]
M.S. Ewer, H.R. Gibbs, J. Swafford, R.S. Benjamin.
Cardiotoxicity in patients receiving trastuzumab (Herceptin): primary toxicity, synergistic or sequential stress, or surveillance artefact?.
Semin Oncol, 26 (1999), pp. 96-101
[9.]
J.D. Floyd, D.T. Nguyen, R.L. Lobins, Q. Basir, D.C. Doll, M.C. Perry.
Cardiotoxicity of cancer therapy.
J Clin Oncol, 23 (2005), pp. 7685-7696
[10.]
National Library for Health-News & RSS Article. Long-term herceptin use poses “acceptable” cardiac risk. [Accessed Jan 13, 2008]. Available from: http://www.library.nhs.uk/rss/newsAn-dRssArticle.aspx
[11.]
T.M. Suter, M. Procter, D.J. van Veldhuisen, M. Muscholl, J. Bergh, C. Carlomagno, et al.
Trastuzumab-associated cardiac adverse effects in the Herceptin Adyuvant Trial.
J Clin Oncol, 25 (2007), pp. 3859-3865
[12.]
M.J. Piccart-Gebhart, M. Procter, B. Leyland-Jones, A. Goldhirsch, M. Untch, I. Smith, for the Herceptin Adyuvant (HERA) Trial Study Team, et al.
Trastuzumab after adyuvant chemotherapy in HER2-positive breast cancer.
N Engl J Med, 353 (2005), pp. 1659-1672
[13.]
V. Guarneri, D.J. Lenihan, V. Valero, J.B. Durand, K. Broglio, K.R. Hess, et al.
Long-term cardiac tolerability of trastuzumab in metastatic breast cancer: The MD Anderson Cancer Center Experience.
J Clin Oncol, 24 (2006), pp. 4107-4115
[14.]
H.L. McArthur, S. Chia.
Cardiotoxicity of trastuzumab in clinical practice.
N Engl J Med, 357 (2007), pp. 94-95
[15.]
F. Montemurro, S. Redana, G. Valabrega, R. Martinello, M. Aglietta, R. Palmiero.
Trastuzumab-related cardiotoxicity in the Herceptin Adyuvant Trial.
J Clin Oncol, 26 (2008), pp. 2052-2053
[16.]
M.L. Telli, S.A. Hunt, R.W. Carlson, A.E. Guardino.
Trastuzumab-related cardiotoxicity: calling into question the concept of reversibility.
J Clin Oncol, 25 (2007), pp. 3525-3533
[17.]
M. Ewer, M.T. Vooletich, J.B. Durand, M.L. Woods, J.R. Davis, V. Valero, et al.
Reversibility of trastuzumab-related cardiotoxicity: new insights based on clinical course and response to medical treatment.
J Clin Oncol, 23 (2005), pp. 7820-7826
[18.]
P.P. Sengupta, D.W. Northfelt, F. Gentile, J.L. Zamorano, B.K. Khandheria.
Trastuzumab-induced cardiotoxicity: heart failure at the crossroads.
Mayo Clin Proc, 83 (2008), pp. 197-203
[19.]
E.A. Perez, R. Rodeheffer.
Clinical cardiac tolerability of trastuzumab.
J Clin Oncol, 22 (2004), pp. 322-329
[20.]
E.H. Romond, E.A. Perez, J. Bryant.
Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer.
N Engl J Med, 353 (2005), pp. 1673-1684

Preliminary results were accepted in poster format at the 53rd National SEFH Congress in Valencia, 2008 (register no. 556).

Copyright © 2009. Sociedad Española de Farmacia Hospitalaria
Download PDF
Idiomas
Farmacia Hospitalaria
Article options
Tools
es en

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?

es en
Política de cookies Cookies policy
Utilizamos cookies propias y de terceros para mejorar nuestros servicios y mostrarle publicidad relacionada con sus preferencias mediante el análisis de sus hábitos de navegación. Si continua navegando, consideramos que acepta su uso. Puede cambiar la configuración u obtener más información aquí. To improve our services and products, we use "cookies" (own or third parties authorized) to show advertising related to client preferences through the analyses of navigation customer behavior. Continuing navigation will be considered as acceptance of this use. You can change the settings or obtain more information by clicking here.