New Treatment Significantly Improves Long-term........

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New Treatment Significantly Improves Long-term Outlook For Breast

Cancer Survivors:

International clinical trial concludes women should consider taking

letrozole after five years of tamoxifen treatment to continue to

reduce risk of recurrence

http://www.nih.gov/news/pr/oct2003/nci-09.htm

A Canadian-led international clinical trial has found that post-

menopausal survivors of early-stage breast cancer who took the drug

letrozole after completing an initial five years of tamoxifen therapy

had a significantly reduced risk of cancer recurrence compared to

women taking a placebo. The results of the study appear in today's

advance on-line edition of the New England Journal of Medicine.

The clinical trial has been halted early because of the positive

results and researchers are notifying the 5,187 women worldwide who

have participated in the study. Women on letrozole will continue

taking the drug and those on the placebo can begin taking letrozole,

if they wish.

" This very important advance in breast cancer treatment will improve

the outlook for many thousands of women, " said von Eschenbach,

M.D., director of the National Cancer Institute which led the study

in the United States. " This is one more example of the ability to

interrupt the progression of a cancer using a drug that blocks a

crucial metabolic pathway in the tumor cell. "

Study researchers found that letrozole, when taken after five years

of tamoxifen therapy, substantially increased the chance of remaining

cancer free. In total, 132 women taking the placebo had their disease

recur compared to 75 on letrozole. Overall, letrozole reduced the

risk of recurrence by 43 percent, so that after four years of

participating in the trial, 13 percent of the women on the placebo,

but only seven percent, of those on letrozole had recurred. Deaths

from breast cancer were also reduced. Seventeen women taking the

placebo died of breast cancer compared to nine taking letrozole.

While tamoxifen is widely used to prevent breast cancer recurrence in

post-menopausal women, it stops being effective after five years

because, researchers believe, tumours become resistant to it.

" More than half of women who develop recurrent breast cancer do so

more than five years after their original diagnosis, " says Goss,

M.D., of Princess Margaret Hospital in Toronto. " For years, we have

thought that we had reached the limit of what we could do to reduce

the risk of recurrence with five years of tamoxifen. Our study ushers

in a new era of hope by cutting these ongoing recurrences and deaths

from breast cancer after tamoxifen by almost one half. " Goss, a

leading expert in novel hormone therapies for the treatment and

prevention of breast cancer, conceived and chaired the international

trial with letrozole.

A form of hormone therapy for the treatment of breast cancer,

letrozole works by limiting the ability of an enzyme called aromatase

to produce estrogen, a major growth stimulant in many breast cancers.

Mayo Clinic medical oncologist Ingle, M.D., says, " Based on our

findings, all post-menopausal women with hormone-receptor positive

tumours completing about five years of tamoxifen should discuss

taking letrozole with their doctors to reduce their risk of breast

cancer recurrence. " Ingle, from Rochester, Minn., led the research

study in the United States.

With Canadian Cancer Society funding, the clinical trial was

coordinated by the National Cancer Institute of Canada Clinical

Trials Group at Queen's University, in partnership with the U.S.

National Cancer Institute and its Clinical Trials ative Groups.

Novartis, which manufactures letrozole, also known as Femara®,

provided the drug for the trial.

Women participated in the study for an average of 2.4 years and for

as long as five years. The study found that women taking letrozole

had a reduction in the number of recurrences of cancer in their

previously affected breast, a reduction in the number of new cancers

in their opposite breast, and a reduction in the spread of the cancer

outside their breast.

The side effects of letrozole, a pill which is taken once a day, are

very similar to those experienced by women undergoing menopause. They

were generally mild in study participants. Women in the study will

continue to be followed to more thoroughly assess any effects of long-

term use of letrozole on bone strength or other organs. Until these

are known, patients should be monitored closely.

" The Canadian Cancer Society is pleased to have made a key

contribution to this study, " says Barbara Whylie, M.D., director of

Cancer Control Policy for the Canadian Cancer Society. " We estimate

that more than 20,000 Canadian women will be diagnosed with breast

cancer this year and just over half of those are going to be eligible

for this drug. That means these women will have a significantly

improved hope for a future without cancer. "

" This large trial only began in 1998 and we already have important

results that will change clinical practice, " says Abrams,

M.D., coordinator of the U.S. National Cancer Institute's ative

Group breast cancer treatment trials. " This is a tribute to the

patients and physicians who participated since their efforts will now

have a positive impact on so many lives. "

Participants in the clinical trial were enrolled through hospitals,

cancer centers and institutes throughout Canada, the United States,

England, Belgium, Ireland, Italy, Poland, Portugal and Switzerland.

The European Organization for Research and Treatment of Cancer and

the International Breast Cancer Study Group coordinated the European

component of the trial.

The Canadian Cancer Society is the largest charitable funder of

cancer research in Canada. It funds clinical trials research through

its support of the National Cancer Institute of Canada Clinical

Trials Group.

The National Cancer Institute is the primary U.S. agency for cancer

research.

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