Raloxifene Helps Reduce Risk for Breast Cancer

A study has found that women taking raloxifene for osteoporosis have an added benefit - the medication may also significantly reduce the risk for developing breast cancer.

Women taking raloxifene, also called Evista, for eight years had a 59 percent lower risk of invasive breast cancer and a 66 percent lower risk of developing estrogen-receptor positive breast cancer than women who had taken a placebo (an inactive substance), say researchers in the Journal of the National Cancer Institute.

"These data demonstrate that the incidence of ER-positive invasive breast cancer continues to be reduced through eight years of raloxifene treatment in postmenopausal women with osteoporosis," the authors write.

Experts Debate Medication's Benefit

The caveat, according to Dr. Powel Brown, one of the authors of an editorial in the same journal, is that this study addresses only postmenopausal women with osteoporosis.

"Raloxifene is an option for breast cancer risk reduction for a specific group of women," says Dr. Brown, an associate professor of medicine at Baylor College of Medicine. "It is not for everyone."

More than 200,000 women are diagnosed with breast cancer every year, according to the American Cancer Society (ACS). The ACS estimates that a woman's lifetime risk of developing invasive breast cancer is one in seven.

Estrogen-receptor positive breast cancers are fueled by the hormone estrogen. Raloxifene and tamoxifen, another drug used to reduce breast cancer risk, work as anti-estrogens in breast tissue.

The current study is a continuation of the Multiple Outcomes of Raloxifene Evaluation (MORE) trial. It sought to assess raloxifene's effectiveness in treating osteoporosis and, as a secondary measure, how effective it was in reducing breast cancer risk.

That clinical trial lasted four years and found that the incidence of breast cancer was 72 percent lower in women taking raloxifene than it was in women taking a placebo.

Called Continuing Outcomes Relevant to Evista (CORE), the current study was designed to see if the reduction in the incidence of breast cancer continued to be significantly lower after another four years of treatment.

Just over 3,500 women who had randomly been assigned to take raloxifene in the first clinical trial continued taking the drug (60 mg daily), while 1,703 women who had been assigned to the placebo group continued to take a placebo for up to an additional four years.

All of the women were postmenopausal and had osteoporosis.

Over the four years of the CORE trial, the incidence of invasive breast cancer was 59 percent lower and the rate of estrogen-receptor positive breast cancer was 66 percent lower for women who took raloxifene than for women taking the placebo.

Overall, the eight-year incidence of invasive breast cancer (combined results from MORE and CORE) was 66 percent lower for women who were on raloxifene therapy. The incidence of estrogen-receptor positive breast cancer was down by 76 percent for women taking raloxifene compared to placebo over the eight years for both studies.

Raloxifene's most troubling side effect - an increased risk of blood clots - remained stable, at about 2 percent, throughout both studies.

"On the surface, the results of this study sound great," says Dr. Brown. But, he and the other authors of the editorial expressed some concerns about its design.

Despite those reservations, Dr. Brown says, "One can say continued treatment with raloxifene is associated with a reduced incidence of breast cancer in women with osteoporosis."

Studies Continue Comparing Medications

Dr. Jay Brooks, chief of hematology/oncology at the Ochsner Clinic Foundation Hospital in Baton Rouge, La., points out that women with osteoporosis may already have a reduced risk of breast cancer.

"People who are heavier, who have very dense bones, have a higher risk of developing breast cancer," he says, so women with osteoporosis who are often slim may have a lower risk of getting breast cancer to begin with.

Dr. Brown says that for the prevention of breast cancer in women who are at high risk for the disease, treatment with tamoxifen is still the "gold standard." Dr. Brooks agreed.

Both indicated that a large, ongoing trial is comparing the use of tamoxifen and raloxifene for breast cancer prevention to see which medication is more effective. Dr. Brown says those results are due in early 2006.

In the meantime, Dr. Brooks suggests that if a woman is concerned about developing breast cancer, losing weight could reduce her risk.

"The evidence is clear: Obesity clearly increased the risk of breast cancer, and it also increases the risk of recurrence," he says.

The study was funded by Eli Lilly and Co., the maker of Evista.

Always consult your physician for more information.

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American Cancer Society

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Susan G. Komen Breast Cancer Foundation

January 2005

Raloxifene Helps Reduce Risk of Breast Cancer

Experts Debate Medication's Benefit

Studies Continue Comparing Medications

Aromatase Inhibitor Therapy Touted 

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Aromatase Inhibitor Therapy Touted

A group of medications called aromatase inhibitors should be used after surgery to treat postmenopausal women with hormone-receptor-positive breast cancer, new guidelines recommend.

The guidelines are an updated technology assessment from the American Society of Clinical Oncology (ASCO), and they appear in the Journal of Clinical Oncology.

This is first time ASCO has recommended that this class of drugs be used in this group of women.

"We've done this yearly for the past three years," says Dr. Eric Winer, lead author of the technology assessment and director of the Breast Oncology Center at Dana Farber Cancer Institute in Boston.

"The difference this year was that, in our minds, there was enough data for us to say that in a woman who is postmenopausal at diagnosis and who has hormone-receptor-positive breast cancer, that the very best hormonal therapy includes an aromatase inhibitor at some point in time for most women," Dr. Winer says.

Like tamoxifen, aromatase inhibitors work by decreasing the amount of circulating estrogen in the body. Tamoxifen has dominated the breast-cancer treatment landscape for more than 20 years.

This new class of medications, three of which have been approved by the US Food and Drug Administration, represents the first real challenge to tamoxifen's reign.

"Over the past 20 years, the use of tamoxifen has revolutionized the prevention and treatment of breast cancer," Dr. Brooks says. "This is a next step. I think this will eventually replace tamoxifen in postmenopausal women."

Previous clinical trials had shown promise with the aromatase inhibitor called anastrozole (Arimidex). As a result, previous ASCO recommendations had singled out this medication.

Three new randomized trials have shown encouraging results for two other aromatase inhibitors as well. Those drugs are letrozole (Femara) and exemestane (Aromasin).

Based on results from these clinical trials, the new ASCO recommendations state that physicians and patients can substitute one of the three FDA-approved aromatase inhibitors for tamoxifen as the initial adjuvant (after surgery) therapy.

Women can also choose to start with tamoxifen, then switch to an aromatase inhibitor after two to five years. A woman who switches to an aromatase inhibitor after tamoxifen should take the aromatase inhibitor from two to three years but no longer than five years because there is no clinical data on taking the medication longer than that. There is also no data on taking tamoxifen after an aromatase inhibitor, the guidelines state.

In a new study published in the medical journal Lancet, researchers say anastrozole could replace tamoxifen as the standard drug for postmenopausal breast cancer patients whose cancer is fueled by estrogen.

Anastrozole was found significantly more effective than tamoxifen in increasing the number of women who remained free of cancer, lengthening the time before cancer recurred in many patients, and reducing the incidence of cancer spreading, particularly to the other breast.

The results were so significant that the authors of the international study recommend replacing tamoxifen with anastrozole as the drug given to women for five years following their initial cancer treatment.

"Results from studies suggest that it is reasonable to switch patients currently on tamoxifen to an aromatase inhibitor," write the authors of the study, which was led by Anthony Howell, a professor at Christie Hospital NHS Trust, in Manchester, England.

However, some cancer experts note that aromatase inhibitors can come with significant side effects, including increased risk of osteoporosis.

Many questions remain to be answered, notably what are the long-term effects of aromatase inhibitors. There is some evidence they may reduce the risk of blood clots and uterine cancer but may increase the risk of osteoporosis and fractures, the ASCO recommendations state.

Always consult your physician for more information.