Annals of Oncology Advance Access published online on May 27, 2009
Annals of Oncology, doi:10.1093/annonc/mdp025
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Cardiovascular toxicity following sunitinib therapy in metastatic renal cell carcinoma: a multicenter analysis
1 Dipartimento di Endocrinologia e Oncologia Molecolare e Clinica, Università Federico II, Napoli
2 Clinica Urologica, Seconda Università degli Studi, Napoli
3 UOC Oncologia, INT Fondazione ‘G. Pascale’, Napoli
4 UOC Oncologia, Ospedale Cardarelli, Napoli
5 UO Oncologia, Università Dell'Aquila, L'Aquila
6 UO Oncologia, Ospedale Oncologico Regionale, Rionero in Vulture, Potenza
7 UOC Urologia, Ospedale Sant'Andrea, Roma
8 UO Oncologia, AO ‘Cotugno’, Napoli, Italy
9 Department of Cardiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
* Correspondence to: Dr G. Di Lorenzo, Dipartimento di Endocrinologia e Oncologia Clinica e Molecolare, Università Federico II, Napoli, Italy. Tel: +39-081-7463660; Fax: +39-081-8997370; E-mail: giuseppedilorenzoncol{at}hotmail.com
Background: Recent data have shown that cardiotoxicity represents a potentially important side-effect in patients treated with sunitinib. We reviewed cardiac adverse events in patients with metastatic renal cell carcinoma (RCC) who underwent treatment with this agent.
Patients and methods: The medical records of 175 patients with metastatic RCC treated with sunitinib at eight Italian institutions were retrospectively reviewed. Alterations in left ventricular ejection fraction (LVEF) and blood pressure were evaluated. Patients with preexisting cardiac risk factors were specifically scrutinized for increased expression of cardiac changes.
Results: Grade 3 hypertension was seen in 17 patients (9.7%); in 12 of these 17, hypertension developed after receiving the third sunitinib cycle. Among these 17 patients, 12 (70.6%) also experienced left ventricular systolic (LVEF) dysfunction; in all, 33 of the 175 patients (18.9%) developed some degree of cardiac abnormality, of which 12 were classified as grade 3 LVEF dysfunction and/or congestive heart failure (CHF) (6.9%). Significant univariate associations for predictors of CHF were history of hypertension (P = 0.008), history of coronary heart disease (P = 0.0005) and prior treatment with an angiotensin-converting enzyme inhibitor (P = 0.04). Multivariate analysis suggested that a history of coronary artery disease [odds ratio (OR) 18, 95% confidence interval (CI) 4–160, P = 0.005] and hypertension (OR 3, 95% CI 1.5–80, P = 0.04) was the only significant independent predictors of CHF.
Conclusions: Patients undergoing sunitinib, especially those with a previous history of hypertension and coronary heart disease, are at increased risk for cardiovascular events and should be monitored for exacerbations of their hypertension and for evidence of LVEF dysfunction during treatment.
cardiotoxicity, hypertension, metastatic kidney cancer, sunitinib
Received for publication November 4, 2008. Revision received December 18, 2008. Accepted for publication January 19, 2009.
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  G. Di Lorenzo, G. Carteni, R. Autorino, G. Bruni, M. Tudini, M. Rizzo, M. Aieta, A. Gonnella, P. Rescigno, S. Perdona, et al. Phase II Study of Sorafenib in Patients With Sunitinib-Refractory Metastatic Renal Cell Cancer J. Clin. Oncol., September 20, 2009; 27(27): 4469 - 4474. [Abstract] [Full Text] [PDF]
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