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The U.S. Food and Drug Administration (FDA) has approved the drug Femara (generic name,
letrozole) for the treatment of post-menopausal, early-stage breast cancer after surgery. The approval comes after the
results of a recent study found that Femara was better than the standard
drug tamoxifen (brand name, Nolvadex) at preventing
a recurrence of breast cancer in patients with early stages of the disease who had undergone
surgery. Femara is already FDA-approved to treat advanced breast cancer. The new approval
provides more treatment options for early-stage breast cancer patients after surgery.
According to study results published in the December 29, 2005 issue of The New England Journal of
Medicine, 84% post-menopausal early-stage breast cancer patients who receive Femara would survive
five years after their diagnosis versus 81.4% who receive tamoxifen.
The study was conducted by researchers of the International Breast Cancer Study Group, a non-profit
group, in 27 countries. It included more than 8,000 post-menopausal women who had been diagnosed with
estrogen-receptor-positive, early-stage breast cancer. Researchers followed the women for a
median time of 26 months, with 1,100 women having completed five years of treatment with Femara
or tamoxifen. Financial support for the study was provided by Novartis, the manufacturer of Femara.
Early-stage breast cancer is cancer that has not spread past the breast and/or underarm
lymph nodes. Most early-stage breast cancer patients undergo surgery and may also receive
radiation and/or chemotherapy. About 80% of breast cancer cases are estrogen-receptor-positive, meaning
that the cancer cells depend on estrogen for survival and reproduction. Tamoxifen is also
indicated for this type of breast cancer.
According to Novartis, the manufacturer of Femara, the study found that Femara was especially effective in
women at high risk for a breast cancer recurrence. For example, in women whose breast cancer had spread
to the underarm lymph nodes, Femara reduced the risk of a breast cancer recurrence by 29%. Similarly, Femara
reduced the risk of a recurrence by 30% in women who had received chemotherapy. Moreover, Femara
appeared to reduce the risk of a recurrence of breast cancer in distant body parts (such as the bone)
in these women by 33% and 31%, respectively.
"One of the greatest fears confronted by women who have been treated for early breast cancer is
that their cancer will come back," said Matthew Ellis, MD, PhD, FRCP, director of the Breast Cancer
Program at Washington University and associate professor and section head of the Medical Oncology
Division in the Department of Medicine at Washington University in St. Louis, in a Novartis
news release. "With Femara, we now have an option that can help address that fear early on, even
in the patients who we know face the greatest risk of recurrence."
Side effects differ among the two drugs. In the study, women who received tamoxifen were more likely
to experience blood clots (venous thrombosis and embolism), vaginal bleeding, or abnormalities of
the endometrium (the lining of the uterus). In contrast, women who received Femara were more likely to experience
bone fractures or joint pain. In addition, women who received tamoxifen were more likely to
develop invasive endometrial cancer and women who received Femara were more likely to
experience life-threatening cardiac events, though the occurrence of these complications was rare--occurring
in less than 1% of study participants.
Further research will likely continue to study the benefits of both Femara and
tamoxifen in the treatment of early-stage breast cancer. Women diagnosed with breast
cancer should talk to their cancer treatment team about the most appropriate treatments given their
individual medical situations.
Additional Resources and References
- The study, "Comparison of Letrozole and Tamoxifen in Postmenopausal Women with Early Breast Cancer," is published
in the December 29, 2005 issue of The New England Journal of Medicine (http://content.nejm.org/)
- The December 28, 2005 International Breast Cancer Study Group news release, "Letrozole Better
Than Tamoxifen in Reducing Risk of Recurrence for Breast Cancer Survivors," was published on the
group's website, http://www.ibcsg.org/
- The December 28, 2005 Novartis news release, "FemaraŽ Approved in the US as Initial
Therapy for Postmenopausal Women with Early Breast Cancer After Surgery," was published on
the company's website, http://www.novartis.com/
- The February 21, 2005 Imaginis.com article, "Large Study Shows Femara May Be More Effective
Than Tamoxifen at Treating Early-Stage Breast Cancer" is available at
http://www.imaginis.com/breasthealth/news/news2.21.05.asp
- To learn more about drugs used to treat breast cancer, please visit
http://www.imaginis.com/breasthealth/bc_drugs.asp
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