Health
Herceptin linked to heart problems
NEWS IN BRIEF — Posted Sept. 19, 2005
The Food and Drug Administration notified physicians and others on Aug. 31 that analysis from data in a randomized phase III trial of the breast cancer drug Herceptin, or trastuzumab, uncovered a significant increase in heart problems among women who took the drug, compared with those who received chemotherapy alone.
A warning letter from the drug's maker, Genentech, posted on the FDA Web site, was sent to help with the early identification of cardiac toxicity, according to the company.
Preliminary analysis of safety data from the study revealed a statistically significant increase in the three-year cumulative incident of cardiotoxicity among the 1,019 women who took Herceptin, about 4%, compared with 0.8% among a similar number of controls.
Although there were no cardiac deaths among women taking Herceptin, there was one such death among the controls. The company said further analysis is ongoing.
Earlier results from randomized clinical trials showed that patients with early-stage HER-2 positive invasive breast cancer who received Herceptin in combination with chemotherapy had a significant decrease in risk for recurrence of their diseases, compared with patients who received only chemotherapy.
Approximately 20% to 30% of breast cancers produce too much of the HER-2 protein. These tumors tend to grow faster and are generally more likely to recur than are tumors that do not overexpress HER-2.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2005/09/19/hlbf0919.htm.
