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BMJ. Jul 29, 2000; 321(7256): 259.
PMCID: PMC1118266

Cancer drug may cause heart failure

A team of researchers is calling for long term studies investigating the risk of heart failure among women taking the breast cancer drug trastuzumab (Herceptin) as a result of new evidence that the drug might precipitate heart failure, especially in women with underlying cardiovascular problems.

Trastuzumab is a monoclonal antibody that binds to a protein found on the surface of some cells. The protein, HER2, helps to regulate cell growth. By binding to tumour cells, trastuzumab inhibits the growth of cancerous cells. It is currently approved for the use in meta-static breast cancer.

In an editorial in Circulation (2000;102:272-4), lead author Dr Arthur Feldman, director of the Cardiovascular Institute at the University of Pittsburgh Medical Center in Pennsylvania, and colleagues said that trastuzumab should not be given to any woman who has any prior problem with the heart muscle. That would include women with high blood pressure or a high cholesterol level.

They noted that heart failure occurs in 7% of women taking trastuzumab alone, and the rate jumps to 28% in women taking the drug alongside other chemotherapy drugs.

As a result, extending the use of trastuzumab to women whose breast cancer has not spread or metastasised seems irresponsible in view of the troublesome side effects on the heart, according to Dr Feldman and colleagues.

In May the biotechnology company Genentech, the drug's manufacturer, issued a letter to doctors alerting them that the deaths of 15 women with advanced metastatic breast cancer had been linked to the use of trastuzumab.

The Food and Drug Administration (FDA) said at that time that trastuzumab is “still a very safe drug” despite the reports of the 15 deaths. The administration said that the deaths were among patients with allergic or infusion reactions or respiratory problems, or a combination of those events, and not with cardiovascular complications.

Dr Feldman said he believed that fear of cancer, and particularly fear of breast cancer, was combining to cloud clinical judgment: “I think the most interesting thing is that if someone were to go to the FDA with a new drug for heart failure or cholesterol or high blood pressure—all of which are leading killers of people—and that drug was associated with even a 1% incidence of cancer, it would never be approved by the FDA.

“No manufacturer would take the drug to the FDA. Yet here is an anticancer drug that is associated with a 28% incidence of heart failure and it is approved.”


Articles from BMJ : British Medical Journal are provided here courtesy of BMJ Group

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