FDA Approves New Breast Cancer Treatment

A pharmacist holding a tray of pills, surrounded by prescription drug bottlesThe Food and Drug Administration has approved a breast cancer treatment: Kadcyla (kad-SY’-luh) is designed to target only the tumor cells, while leaving healthy cells intact.

Kadcyla, from Roche, is a combination of the drug Herceptin, a powerful chemotherapy drug, as well as a third chemical that links the two treatments together and keep everything intact until it can bind to the cancer cell.

Researchers say that Kadcyla may be superior to its predecessors because it delivers more potent treatment – with less side effects.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2.

Kadcyla will cost $9,800 per month, compared to $4,500 per month for rHerceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug.

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

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The Food That May Lower Your Breast Cancer Risk

 

African American woman eating salad

Eating plenty of fruits and vegetables may lower women’s risk for a tough-to-treat form of breast cancer, but it does not reduce their odds of getting breast cancer overall, a new study finds.

Specifically, the new study found lower rates of what’s known as “estrogen receptor-negative breast cancer” among women who ate high amounts of fruits and vegetables.

These tumors — which do not respond to circulating estrogen — account for 15 percent to 20 percent of breast cancers, and have a lower survival rate than other types of breast cancer.

According to a team led by Seungyoun Jung, formerly at the department of nutrition at the Harvard School of Public Health, previous research has suggested that consuming higher amounts of fruits and vegetables might lower breast cancer risk, but there haven’t been enough data to prove it.

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In their new investigation, Jung’s team analyzed data from 20 prior studies of women who were followed for a maximum of 11 to 20 years.

They found a statistically significant link between higher fruit and vegetable consumption and a lower risk for estrogen receptor-negative breast cancer, but not with a lower risk of estrogen receptor-positive breast cancers (those that do respond to estrogen) or for breast cancer overall.

The lower risk for estrogen receptor-negative breast cancer was mostly associated with higher intake of vegetables, Jung’s team noted in a journal news release.

Two breast cancer experts responded to the findings with caution, noting that a cause-and-effect relationship is far from certain.

“It is plausible that estrogen receptor-negative breast cancer is influenced by nutritional factors,” said Dr. Paolo Boffetta, director of the Institute for Translation Epidemiology at the Mount Sinai Medical Center, in New York City.

“However, eating fruits and vegetables is closely tied to environmental factors and healthy lifestyle, such as weight control, physical activity and other healthy eating habits,” he noted. “Since these are so closely tied together, it is difficult to disentangle the specific effect of fruits and vegetables.”

And Dr. Stephanie Bernik, chief of surgical oncology at Lenox Hill Hospital in New York City, agreed.

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“The study fails to control for some bias that may occur when observing the two populations,” she said. “Perhaps the women that eat well also exercise, drink little alcohol, don’t smoke and eat less animal fats overall.”

Still, living healthily is always a good idea, and “the study does add some evidence that a healthy lifestyle can perhaps help decrease the risk of breast cancer,” Bernik said.

The study was published Jan. 24 in the Journal of the National Cancer Institute.