Two newer drugs used for the treatment of advanced renal cell carcinoma may be associated with an elevated risk of hypertension and other cardiovascular side effects, according to results of two separate studies.
Patients taking sunitinib (Sutent) should be monitored for side effects such as hypertension and signs of heart failure, especially those patients with a history of coronary artery disease or cardiac risk factors, suggests a study in The LancetOncology (2008; 9:117-23).
Ming Hui Chen, MD, of Harvard Medical School and her colleagues retrospectively analyzed the medical records of 75 patients with gastrointestinal stromal tumor (GIST) treated at the Dana-Farber Cancer Institute, Boston, during a phase I/II study. (Sunitinib is indicated for both GIST and advanced RCC.) A total of 11% of patients had a cardiovascular event. In addition, 47% of patients developed hypertension and 20% had reduced heart function.
Most cardiac problems, including hypertension, were manageable, and the majority of patients with heart failure resumed sunitinib therapy. Histories of coronary artery disease and/or hypertension were predictors of cardiovascular events.
“The paradigm remains to treat the cancer while caring for the heart,” said Dr. Chen.
She noted that although the cardiotoxicity in this study was not seen in phase III trials, the patients may be more similar to patients in the general population now being treated with sunitinib.
In a separate study, researchers at the State University of New York, Stony Brook, found that sorafenib (Nexavar) significantly raises the risk of hypertension, and patients taking the drug should be closely monitored and treated for high blood pressure to prevent cardiovascular complications (Lancet Oncol 2008; 9:117-23).
“Early detection and effective management of hypertension might allow for safer use of this drug,” said co-author Shenhong Wu, MD. “Future studies will be needed to identify the mechanism and appropriate treatment of sorafenib-induced hypertension.”
Dr. Wu's team conducted a meta-analysis of nine studies that were published between January 2006 and July 2007. Of 4,599 patients included in the studies, patients treated with sorafenib had a 23% higher chance of having an increase in blood pressure than those not given the drug, the researchers reported.