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Herceptin Treatment Works Against Breast Cancer

Breaking News - October 2005 - Week 4

(Oct 26, 2005)

Healthcare in  the News

-- Women who have an aggressive form of breast cancer reap significant benefits when their treatment includes a one-year course of the medication Herceptin®, according to a report in the New England Journal of Medicine.

Picture of an African-American woman at a computer

In international and North American clinical trials, the intravenous medication cut the risk of recurrence of disease by half and markedly improved survival.

Since these results were first reported last spring at the annual meeting of the American Society of Clinical Oncology, breast cancer oncologists have altered the way they treat early-stage HER2-positive breast cancers.

"Herceptin is now being incorporated in the treatment regimen," says Dr. Larry Norton, deputy physician-in-chief for Breast Cancer Programs at Memorial Sloan-Kettering Cancer Center in New York City.

"The big change is the application of the drug earlier on in the disease," Dr. Norton says.

Herceptin Shows Enormous Benefits

HER-2 positive breast cancers produce too much of the HER-2 protein, which stands for human epidermal growth factor receptor 2 and is found on the surface of the cells. These tumors tend to grow faster and are more likely to recur than tumors that are HER-2 negative.

Dr. Harold J. Burstein, assistant professor of medicine at Dana-Farber Cancer Institute in Boston, says the studies make it clear that women who have HER2-positive breast cancers should consider using this medication.

"Women with this kind of breast cancer get dramatic benefit from adding Herceptin to chemotherapy," he notes.

HER2-positive breast cancers occur when the body makes too many copies of the "human epidermal growth factor receptor 2" gene and, as a consequence, produces an excess amount of the HER2 protein on the surface of cancer cells.

These two actions lead to the particularly aggressive growth and proliferation of these tumors, Dr. Burstein explains.

Herceptin, also known as trastuzumab, works by halting the growth of those cancer cells. It is currently approved for the treatment of HER2-positive breast cancer that has spread to other parts of the body.

But the new results show that women with early-stage breast cancer - before it metastasizes, or spreads to other parts of the body - realize enormous benefits as well.

The international clinical trial examined the effects of giving Herceptin after breast cancer surgery, any radiation that might be required, and chemotherapy.

HER2-positive women were randomly assigned to receive either observation alone or one or two years of the medication. Treatments were administered every three weeks, with striking results.

"At a point early on in the course of the disease, trastuzumab approximately halved the risk of the recurrence of the tumor," says Richard D. Gelber, Ph.D., a professor in the Department of Biostatistics and Computational Biology at Dana-Farber Cancer Institute, and one of the authors of the study.

That reduction in risk was relative to recurrences among the observation group, he says.

Results for the group of women assigned to receive two years of the medication have yet to be released.

Understanding the Progress Better

For the time being, oncologists do not really know whether two years of Herceptin therapy would work better than one.

In the North American study, which combined the results of two similar trials, Herceptin was administered along with chemotherapy, not afterward as in the international clinical trial.

The concurrent approach proved highly effective. Herceptin treatment was associated with a 33 percent reduction in the risk of death and an absolute reduction of 11.8 percentage points in the proportion of women who were alive and disease-free at three years .

At four years, the absolute difference in survival between the treatment and control groups was 18 percentage points, "which is really striking," notes study co-author Dr. Charles E. Geyer Jr., director of medical affairs for the National Surgical Adjuvant Breast and Bowel Project.

"We're not used to seeing that kind of large, dramatic step from the addition of one therapy like this," he says.

Overall, Herceptin boosted the chances of disease-free survival by 52 percent compared with the control group.

On the downside, Herceptin use carries a risk of potential heart problems, a problem the US Food and Drug Administration (FDA) warned about in August.

While the risk is low, it remains a legitimate concern. "There still are a handful of women who will suffer cardiac damage from this and you can't ignore that," Dr. Burstein says.

"Hopefully, we will determine which patients are likely to have major problems and which are not so that we can screen patients better and follow them in a more tailored fashion," he says.

Always consult your physician for more information.

For more information on health and wellness, please visit health information modules on this Web site.

Herceptin Facts

Earlier this year other studies proved that evidence is mounting that Herceptin works well against breast cancer.

In two North American trials of Herceptin, women with aggressive breast cancer who took the drug after surgery and chemotherapy had a 52 percent reduction in the risk of a recurrence, compared with women who did not take the medication.

Because of the positive results, the clinical trials were halted early.

Researchers meeting at the American Society of Clinical Oncology annual meeting also delivered more good news: A third trial of Herceptin showed a 46 percent reduction in risk among women who took the medication simultaneously with chemotherapy.

Another recent study raised caution about side effects caused by Herceptin. US Food and Drug Administration (FDA) health authorities warned about the potential heart problems associated with use of Herceptin.

According to the American Cancer Society (ACS), Herceptin is a monoclonal antibody that attaches to a growth-promoting protein known as HER2/neu, which is present in small amounts on the surface of normal breast cells and most breast cancers.

About one-third of breast cancers have too much of this protein and tend to grow and spread more aggressively, states the ACS.

Herceptin can prevent the HER2/neu protein from making breast cancer cells grow and may also stimulate the immune system to more effectively attack the cancer.

Herceptin can shrink some breast cancer metastases that return after chemotherapy or continue to grow during chemotherapy.

And treatment that combines Herceptin with chemotherapy may be more effective than chemotherapy alone in some patients.

Treatment with Herceptin is generally started after standard hormone therapy and/or chemotherapy is no longer effective, but clinical trials are now in progress to see if using it with adjuvant (used in addition to) chemotherapy can reduce the risk of recurrence and help women live longer.

The ACS explains that, compared with chemotherapy medications, the side effects of Herceptin are relatively mild.

They may include fever and chills, weakness, nausea, vomiting, cough, diarrhea, and headache.

Some women being treated with Herceptin, however, have experienced heart damage, the ACS notes.

The risk of heart problems increases about threefold when Herceptin is given with anthracyclines, a class of chemotherapy medications that includes doxorubicin (Adriamycin) and epirubicin (Ellence).

Major symptoms are shortness of breath and severe fatigue. Women experiencing these symptoms should call their physicians right away, the ACS states.

Always consult your physician for a diagnosis.

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