Herceptin Shows Benefits in Early Stage Breast Cancer Article date:

American Cancer Society ^ | 2005/04/27 | NA

[neverdem]

ACS News Center

Herceptin Shows Benefits in Early Stage Breast Cancer

Recurrences Cut in Half, Survival Improved

Article date: 2005/04/27

Herceptin (trastuzumab), a drug used to treat some types of advanced breast cancer, also appears to help some women with early stages of the disease, according to two studies. The results were so promising that the National Cancer Institute (NCI) stopped the research ahead of schedule to make the findings public.

In the studies, women who received Herceptin along with chemotherapy had half the risk of the cancer returning as women treated only with chemotherapy. They also lived longer.

Even though Herceptin works in only 20% -30% of breast cancers, experts said those results are dramatic.

"These are truly life-saving results in a major disease," said JoAnne Zujewski, MD, head of NCI's Cancer Therapy Evaluation Program.

An Edge Earlier in the Fight

Herceptin targets a specific protein called HER-2/neu, working only against breast cancers that have too much of it (HER-2 positive cancers). These cancers tend to grow faster and are more likely to return after treatment than cancers that don't have too much of the protein.

The drug has been approved since 1998 to treat advanced breast cancers that are HER-2-positive. It has been shown to improve survival for women in this situation when given with chemotherapy. Those findings are what prompted the new research in early stage disease, manufacturer Genentech said.

The current findings come from a preliminary analysis of more than 3,300 women (out of more than 5,000 total) enrolled in the two studies. All the women had early stage, HER-2-positive breast cancer that had first been treated with surgery. After surgery some women received chemotherapy with doxorubicin and cyclophosphamide, followed by paclitaxel; others received the same chemotherapy regimen plus Herceptin.

Full results of the analysis won't be released until next month, when the studies are presented at the annual meeting of the American Society of Clinical Oncology. But for now, the researchers and NCI said the women on Herceptin had a 52% decrease in cancer recurrence compared to women who only took chemotherapy. That difference was statistically significant. So was the survival difference between the two groups, though those percentages were not reported.

"[Herceptin] has a lot of impact," said Edith Perez, MD, chair of one of the studies and a medical oncologist at the Mayo Clinic in Jacksonville, Fla. "We were hoping to get a 25% improvement and instead we found a 52% improvement."

Perez said she would begin treating appropriate patients with Herceptin right away.

"I'm really thrilled because we've changed the standard of care," she said.

Heart Side Effects a Potential Concern

Herman Kattlove, MD, a medical editor with the American Cancer Society and a practicing oncologist, agreed that the findings are important because reducing recurrences improves quality of life for breast cancer survivors and may lead to longer survival.

But he said that doctors and patients need to be cautious about using Herceptin to treat early stage breast cancer until the full study results -- including information about side effects -- are known.

Doxorubicin, one of the chemotherapy drugs used in the studies, can cause heart damage. So can Herceptin. NCI said the risk of congestive heart failure from the chemotherapy is less than 1%. Women in the studies who took Herceptin increased their risk of congestive heart failure by 3% or 4%. More safety information will be released at the conference, the agency said, and the women will continue to be monitored for side effects.

Kattlove said long-term safety data is important because these heart problems can take years to develop.

Perez said the rate of heart problems seen in the studies was what researchers expected. She said other studies are being done to try to find blood markers that will help doctors predict which patients are more likely to develop heart failure.

Other side effects in these studies were similar to those seen in other studies of Herceptin, Genentech said. Those can include fever and chills, weakness, nausea, vomiting, cough, diarrhea, and headache.

Genentech said it would approach the US Food and Drug Administration about approving Herceptin for use in early stage breast cancer patients.

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ACS News Center stories are provided as a source of cancer-related news and are not intended to be used as press releases.

[Stellar Dendrite]

Can Laura Ingraham take this??

[neverdem]

Can Laura Ingraham take this??

"The drug has been approved since 1998 to treat advanced breast cancers that are HER-2-positive."

I should think so if she's HER-2-positive, but that test result may still be pending.

[neverdem]

FReepmail me if you want on or off my health and science ping list.

[lainde]

bttt