[Lani]

There is, however, concern regarding the actual risk of heart failure with sunitinib, which may be higher in the real world than expected. Dr. Telli and colleagues from Stanford conducted a review of patients treated with sunitinib to further explore potential cardiotoxicity associated with the drug.

Previous studies that led to the FDA approval of sunitinib reported cardiotoxicity ranging from greater than 8% to more than 20%. For the most part, these cardiotoxicities were reversible and did not result in sustained, negative clinical effects. However, these trials typically did not include patients with pre-existing heart conditions. Conversely, in a “real world” setting, a significant portion of patients may indeed have comorbid cardiac conditions, a situation that needs to be addressed if sunitinib exacerbates their condition.

Researchers at Stanford noticed a higher-than-usual rate of cardiac complications among their patients on sunitinib, prompting analysis of data including 48 patients with kidney cancer or gastrointestinal stromal tumors (GIST) treated with sunitinib at Stanford between 2004 and 2007.[8]

15% of patients developed symptomatic and clinically significant heart failure.
Patients with coronary artery disease, low body mass index, or pre-existing heart failure were at a higher risk for developing subsequent heart failure on sunitinib.
The majority of patients who developed heart failure on sunitinib did so within the first three weeks of treatment.
The researchers suggested that cardiac monitoring should be routine among patients treated with sunitinib. Because this was a retrospective analysis including a small number of patients, the true incidence of heart failure associated with sunitinib may be greater or less than 15%.