More than 215,000 women are diagnosed with breast cancer every year. For many of them, surgery to remove the tumor is just the first step in the battle against the disease, often followed by radiation and/or chemotherapy. After that, these women may need to decide with their doctor whether to have "adjuvant therapy"-medication to help prevent their cancer from coming back.
When a woman's breast cancer does come back or spreads to other parts of the body, she may be at greater risk of dying from the disease. Women whose breast cancer is detected in the nearby lymph nodes at diagnosis and those who receive chemotherapy after surgery are considered to be at increased risk for breast cancer recurrence.
Postmenopausal women whose early-stage breast cancer is hormone-sensitive have a new option as their first hormone therapy following surgery. The U.S. Food and Drug Administration recently approved Femara® (letrozole tablets) on December 28, 2005 for this type of use. This approval was based on a median of 24 months of treatment. The study is still ongoing to determine the long-term safety and efficacy of Femara. Already a leading breast cancer treatment, Femara is now the only medicine in a group called aromatase inhibitors that is approved for use both immediately following surgery and after five years of tamoxifen. The FDA granted Femara a priority review, a distinction reserved for medications that could potentially offer a significant improvement compared to products currently on the market.
A panel from the American Society of Clinical Oncology, the country's leading group of oncologists, recommends aromatase inhibitors, such as Femara, be part of the optimal adjuvant treatment for this group of women.
"One of the greatest fears confronted by women who have been treated for early breast cancer is that their cancer will come back. With Femara, we now have an option that can help address that fear early on, even in patients who we know face the greatest risk of recurrence," said Matthew Ellis, MD, PhD, FRCP, director of the Breast Cancer Program at Washington University in St. Louis.
In a large clinical study of post-surgery breast cancer treatment, researchers compared the effectiveness of Femara and tamoxifen, another drug prescribed after surgery. An analysis performed after 26 months showed that Femara reduced the risk of breast cancer coming back by 21% over the reduction offered by tamoxifen. Patients taking Femara also showed a 27 percent reduction in the risk of the cancer spreading to distant parts of the body.
In this study, women at increased risk of recurrence experienced the greatest benefit from Femara. Femara lowered this risk by 29 percent in women whose breast cancer had already spread to the lymph nodes at the time of diagnosis and by 30 percent in women who had prior chemotherapy. The results also showed that in these high-risk women, Femara reduced the risk of cancer spreading to distant parts of the body by 33 percent and 31 percent, respectively.
In this study, Femara was generally well tolerated with the most common side effects including hot flashes, joint pain, night sweats, weight gain and nausea.
Tips for Living Healthy
Discuss postsurgery treatment options with an oncologist. Whether you're one, five or 10 years beyond your diagnosis, taking care of your overall health and well-being can also reduce your risk of cancer coming back and give you the energy to do the things in life that you love.
• Practice good nutrition
• Exercise regularly
• Tap into a support network
• Take time out for yourself
Editors Note: Important safety information
Femara® (letrozole tablets) is approved for the adjuvant (following surgery) treatment of postmenopausal women with hormone receptor−positive early breast cancer. The benefits of Femara in clinical trials are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, safety and effectiveness.
Talk to your doctor if you're allergic to Femara or any of its ingredients. You should not take Femara if you are pregnant as it may cause fetal harm. You must be postmenopausal to take Femara. Some women reported fatigue and dizziness with Femara. Until you know how it affects you, use caution before driving or operating machinery. There was an increase in cholesterol in patients on Femara versus tamoxifen (5.4% vs. 1.2%).
In the adjuvant setting, commonly reported side effects were generally mild to moderate. Side effects seen in Femara versus tamoxifen included hot flashes (33.7% vs. 38%), joint pain (21.2% vs. 13.5%), night sweats (14.1% vs. 13.5%), weight gain (10.7% vs. 12.9%) and nausea (9.5% vs. 10.4%). Other side effects seen were bone fractures and osteoporosis.
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