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Health Last Updated: Jul 2nd, 2008 - 21:15:22


Beyond Breast Cancer: The Fight Against Recurrence
By
Oct 30, 2007, 22:50

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Article Translations: English German Spanish French Italian Portuguese Japanese Korean Chinese
(NAPSI)-The science behind breast cancer continues to evolve, with more information becoming available to benefit women every day. Moreover, as breast cancer treatment improves, many are paying greater attention to managing the risk of the disease coming back after initial therapy.

Public announcements by high-profile patients like Robin Roberts and Elizabeth Edwards have helped to raise continued awareness about breast cancer. In the case of Edwards, media coverage of her breast cancer recurrence has also helped to educate consumers about this aspect of the disease.

Approximately one-third of women with estrogen receptor-positive early breast cancer experience a recurrence.

Even patients who are considered "low risk" continue to have some risk of the cancer coming back. Studies have shown that more than half of all breast cancer recurrences occur after completion of five years of standard tamoxifen therapy.

Of course, maintaining a healthy lifestyle is important, but it may not be enough. According to a study recently published in the Journal of the American Medical Association, women who followed a diet high in fruits and vegetables to reduce their risk of breast cancer recurrence showed no benefit from the regimen, with nearly equal recurrence rates between those on this diet and those on a normal diet.

So what can women who have lived through initial breast cancer treatment do to help reduce their risk of recurrence?

"With more than 2 million breast cancer patients in the U.S., the focus on reducing a patient's risk of recurrence has become an important aspect of treatment for physicians," said Dr. Bruce Feinberg, president and CEO of Georgia Cancer Specialists. "Treating postmenopausal early breast cancer patients with an aromatase inhibitor has been shown to greatly reduce their risk of a breast cancer recurrence."

Research has shown that aromatase inhibitors (AIs)-hormonal breast cancer therapies-may benefit women by reducing their risk of recurrence. AIs, such as Femara® (letrozole tablets), are given to postmenopausal women with early breast cancer and may help to reduce the risk of breast cancer from coming back.

In fact, results published from recent studies conducted by the International Breast Cancer Study Group have shown Femara to be more effective than tamoxifen in reducing the risk of early breast cancer recurring (based on 24 months of treatment), and significantly reduced risk of cancer spreading to other parts of the body.

Knowing one's own personal risk of recurrence and specific health factors can help further ward off potentially dangerous metastases in the future. Women with breast cancer should discuss appropriate treatment options to help reduce the risk of recurrence with their health care professional.

Femara is a once-daily oral prescription medication 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, including safety and efficacy.

You should not take Femara if you are premenopausal. Your doctor should discuss the need for adequate birth control if you have the potential to become pregnant, if you are not sure of your postmenopausal status, or if you recently became postmenopausal. Femara is only indicated for postmenopausal women. Patients should talk to their doctor if they are allergic to Femara or any of its ingredients. Femara should be used with caution by nursing mothers. Patients should not take Femara if they are pregnant as it may cause fetal harm. Some women reported fatigue and dizziness with Femara. Until patients know if Femara affects them, they should use caution before driving or operating machinery. Some patients taking Femara had an increase in cholesterol. Additional follow-up is needed to determine the risk of bone fracture associated with long-term use of Femara.

In the adjuvant setting, commonly reported side effects are generally mild to moderate. Side effects that are comparable between Femara and tamoxifen include night sweats, weight gain, nausea and tiredness. Side effects seen more often with tamoxifen vs. Femara were hot flashes and vaginal bleeding. Joint pain was experienced more often with Femara vs. tamoxifen. The incidence of stroke was 1.1% for women on Femara and 1.0% for women on tamoxifen, and the incidence of other cardiovascular events was 6.6% for Femara vs. 6.2% for tamoxifen. The percentage of women on Femara reporting bone fracture was 5.6% vs. 4% for women on tamoxifen. The percentage of women reporting osteoporosis was 2% for Femara vs. 1.1% for tamoxifen. Additional side effects for both Femara and tamoxifen were heart attack, thromboembolic events, endometrial cancer and second malignancies.

For more information about these medications, please talk to your doctor and visit www.Femara.com or www.NovartisOncology.com.



Note to Editors: Important Safety Information

You should not take Femara if you are premenopausal. Your doctor should discuss the need for adequate birth control if you have the potential to become pregnant, if you are not sure of your postmenopausal status or if you recently became postmenopausal. Femara is only indicated for postmenopausal women. Patients should talk to their doctor if they are allergic to Femara or any of its ingredients. Femara should be used with caution by nursing mothers. Patients should not take Femara if they are pregnant as it may cause fetal harm. Some women reported fatigue and dizziness with Femara. Until patients know if Femara affects them, they should use caution before driving or operating machinery. Some patients taking Femara had an increase in cholesterol. Additional follow-up is needed to determine the risk of bone fracture associated with long-term use of Femara.

In the adjuvant setting, commonly reported side effects are generally mild to moderate. Side effects that are comparable between Femara and tamoxifen include night sweats, weight gain, nausea and tiredness. Side effects seen more often with tamoxifen vs. Femara were hot flashes and vaginal bleeding. Joint pain was experienced more often with Femara vs. tamoxifen. The incidence of stroke was 1.1% for women on Femara and 1.0% for women on tamoxifen, and the incidence of other cardiovascular events was 6.6% for Femara vs. 6.2% for tamoxifen. The percentage of women on Femara reporting bone fracture was 5.6% vs. 4% for women on tamoxifen. The percentage of women reporting osteoporosis was 2% for Femara vs. 1.1% for tamoxifen. Additional side effects for both Femara and tamoxifen were heart attack, thromboembolic events, endometrial cancer and second malignancies.

In the extended adjuvant setting, commonly reported side effects are generally mild to moderate. Those seen more often with Femara vs. placebo were hot flashes (50% vs. 43%), joint pain (22% vs. 18%) and muscle pain (7% vs. 5%). Other side effects, which were comparable to placebo, include fatigue (34% vs. 32%), swelling due to fluid retention (18% vs. 16%), headache (20% vs. 20%), increase in sweating (24% vs. 22%) and increase in cholesterol (16% vs. 16%). The percentage of patients on Femara vs. placebo reporting a fracture was 5.9% vs. 5.5%. The percentage of patients reporting osteoporosis was 6.9% vs. 5.5%. Bisphosphonates, drugs to increase bone strength, were given to 21.1% of Femara patients and 18.7% of placebo patients. Additional side effects seen in study were arthritis, dizziness, constipation, nausea and cardiovascular ischemic events.

In the metastatic setting, commonly reported side effects are generally mild to moderate and may include bone pain, hot flashes, back pain, nausea, joint pain, shortness of breath, fatigue, coughing, constipation, limb pain, chest pain, and headache.

About Novartis

Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

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