Researchers from Harvard University have reported that treatment with Sutent® (sunitinib) was linked with the development of heart problems in some patients with imatinib-resistant metastatic gastrointestinal stromal tumors. The details of this study were published in the December 15, 2007 issue of the Lancet. 

Sutent is an oral targeted agent that works by inhibiting multiple biologic pathways involved in the growth, replication, and spread of cancer cells. It deprives cancer cells of blood and nutrients needed for growth. Sutent has been shown to improve progression-free survival among patients with metastatic renal cell cancer as well as patients with metastatic gastrointestinal stromal tumors (GIST). ^1 2

The possibility of Sutent-related heart problems has been raised by previous studies. To provide more detailed information about the heart effects of Sutent, researchers evaluated 75 patients with Gleevec® (imatinib)-resistant, metastatic GIST. ³ The patients had been enrolled in a Phase I/II clinical trial of Sutent.

The primary cardiovascular events of interest were cardiac death, myocardial infarction, and congestive heart failure. The study also assessed left ventricular ejection fraction (LVEF; a measure of heart function) and blood pressure.

• Of the 75 patients, one died of a cardiovascular cause, one had a myocardial infarction, and six experienced congestive heart failure. Overall, 11% of patients experienced one of these cardiovascular outcomes.
• LVEF fell below the normal range in 20% of patients.
• 47% of patients developed high blood pressure.
• Cardiovascular problems were more common among patients with a history of coronary artery disease than among patients without such a history.
• In most cases the cardiovascular problems that arose could be medically managed.

The researchers conclude: “Patients treated with sunitinib should be closely monitored for hypertension and LVEF reduction, especially those with a history of coronary artery disease or cardiac risk factors.” They note: “Close monitoring could be a prudent approach until large studies can clearly define the nature and rate of sunitinib-associated cardiovascular adverse effects, especially in patients with cardiac risk factors, or history of coronary artery disease, or both.”

Comments: This is important information for physicians treating patients with Sutent.

Related News:

Sutent® Improves Progression-Free Survival Over Interferon in Kidney Cancer (01/18/2007)

Sutent® Treatment of Gastrointestinal Stromal Tumors Associated With Hypothyroidism (11/14/2006)

Sutent® Effective for Gleevec®-Resistant Gastrointestinal Stromal Tumor (10/16/2006)

Multicenter Trial Confirms Effectiveness of Sutent® for Treatment of Metastatic Renal Cell Carcinoma (06/23/2006)

Sutent® Shows Promise in Advanced Non-Small Cell Lung Cancer (06/13/2006)

Phase III Trials Demonstrate Improved Outcomes for Metastatic Renal Cell Carcinoma After First-Line Therapy with Sutent or Temsirolimus (06/12/2006)

Sutent® Approved by FDA for Treatment of Renal Cell Carcinoma and Gastrointestinal Stromal Tumor (04/04/2006)

Sutent® Approved for Gastrointestinal Stromal Tumors and Advanced Renal Cell Carcinoma (02/03/2006)  

Reference:

¹ Motzer R, Hutson T, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. New England Journal of Medicine. 2007; 356:115-124.

² Demetri G, van Oosterom A, Garrett C, et al. Efficacy and Safety of Sunitinib with Advanced Gastrointestinal Stromal Tumor After Failure of Imatinib: A Randomised Controlled Trial. The Lancet. 2006;368:1329-38.

³ Chu TF, Rupnick MA, Kerkela R et al. Cardiotoxicity associated with tyrosine kinase inhibitor sunitinib. Lancet. 2007;370:2011-19.