Sunitinib Recipients Should Receive Cardiac Monitoring

May 31, 2008

Routine cardiac monitoring is suggested for patients receiving sunitinib, as cardiotoxicity, particularly left ventricular (LV) dysfunction, is common, said Melinda Telli, MD.

Routine cardiac monitoring is suggested for patients receiving sunitinib, as cardiotoxicity, particularly left ventricular (LV) dysfunction, is common, said Melinda Telli, MD.

In the pivotal Phase 3 trials of sunitinib for the treatment of metastatic renal-cell carcinoma, 21% of sunitinib-treated patients experienced a reversible decline in left ventricular ejection fraction (LVEF) to less-than normal.

After observing a higher-than-expected incidence of symptomatic heart failure with sunitinib at Stanford University, Dr. Telli and colleagues conducted a retrospective analysis of 48 patients who received the drug for the treatment of renal-cell carcinoma or gastrointestinal stromal tumors at their institution.

Of the 48, seven (15%) experienced symptomatic grade three-quarters LV dysfunction 22 to 435 days after initiating sunitinib. Three of the five patients with subsequent cardiac evaluations had persistent LV dysfunction after discontinuing sunitinib and undergoing standard therapy for heart failure.

Factors associated with an increased risk of LV dysfunction in sunitinib recipients were a history of congestive heart failure, coronary artery disease, and low body mass index. "This was true even among those patients with a remote history of heart disease and normal heart function at the time of initiation of sunitinib," said Dr. Telli, a postdoctoral fellow in medical oncology at Stanford.

She noted that the study was more representative of the general population of patients receiving sunitinib than those seen in clinical trials; two-thirds of the patients had been treated with the drug off protocol.

Because sunitinib is currently being investigated in clinical trials in more than 30 different tumor types for advanced and early forms of cancer, careful study of adverse cardiac events is needed in these trials, the authors believe.