Help In Reducing Breast Cancer Recurrence

A recent publication in the Journal of Clinical Oncology suggests that women with breast cancer may help to reduce their risk of recurrence and distant metastases by taking Femara® (letrozole tablets), instead of the standard therapy, tamoxifen.

"This four-year research found that letrozole not only helped reduce breast cancer recurrence better than tamoxifen, but also did a better job of reducing distant metastases, which can be even more deadly," said lead study investigator Clinical Professor Alan Coates, M.D., University of Sydney, Australia. "The publication of this information may help physicians more clearly identify the more effective treatment for their patients in managing breast cancer and the associated distant metastases."

The most commonly reported adverse events for Femara include hot flashes, joint pain and muscle pain. Women should be postmenopausal and should not be pregnant to be considered for Femara.

Femara is the only medicine indicated for women with hormone-dependent breast cancer taken as either initial treatment immediately after surgery and after they have completed five years of tamoxifen therapy (extended adjuvant setting).

How can women help decrease their risk of recurrence?

• Maintain a healthy weight

• Exercise

• Stay informed about new treatment options

• Learn if you are a candidate for an aromatase inhibitor

• Avoid products containing estrogen, progesterone and pesticides

• Communicate regularly with your health care professional. Questions you can ask:

• Can you talk to me about my personal risk of recurrence?

• What is my nodal status, and how does it affect my risk of recurrence?

• What can I do to help prevent a recurrence of my cancer?

• What are the benefits of the various treatments?

Note to Editors-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. Femara is also approved for the extended adjuvant treatment of early-stage breast cancer in postmenopausal women who are within three months of completion of five years of adjuvant tamoxifen therapy. The benefits of Femara in the extended adjuvant setting are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, including side effects. Femara is also approved for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer. Femara is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following anti-estrogen therapy.

Important safety information

Patients should talk to their doctor if they are allergic to Femara or any of its ingredients. 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.

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.

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.

Additional information regarding Femara or Novartis Oncology can be found at www.femara.com or www.novartisoncology.com. For helpful information about breast cancer, questions to ask your doctor and ways to reduce the risk of recurrence, visit www.breastcancer.org, www.NCCN.org, www.cancer.org, www.ribbonofpink.com and www.cancer.gov.

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