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This is an international site for FEMARA® (letrozole) and is intended for Health Care Professionals outside the U.S. The information on the site is not country-specific, and may contain information that is outside the approved indications in the country in which you are located. Please contact your local Novartis representative for the latest information specific to your country.

Femara and Breast Cancer Information for International Healthcare Professionals Femara and Breast Cancer Information for US residents Femara and Breast Cancer Information for Patients Outside the US

In the initial adjuvant setting,

Emma has a 36% risk for distant metastases1*

... so her main concern is staying free from recurrence, specifically distant metastases

Distant metastases account for the majority of recurrences at the 2-year peak of recurrence following surgery. In fact, at the 2-year peak of risk, distant metastases comprised >75% of recurrences.2

Annual recurrence rate in postmenopausal hormone receptor positive patients2
Chart: Annual recurrence rate in postmenopausal hormone-receptor-positive patients

The information reflected in this chart are estimates only and do not take into account individual results.

Adapted from Mansell et al. Kaplan-Meier–estimated 2.5-year recurrence rates include the following (N=4245): distant metastases in 191 patients (4.5%); 42 patients (1.0%) and 21 patients (0.5%) with locoregional and contralateral recurrences, respectively.2

FEMARA® (letrozole) is the only aromatase inhibitor versus tamoxifen that significantly reduces the early risk of distant metastases3,4†‡

At 26-month follow-up, FEMARA® delivered:



At 73-month median follow-up, FEMARA® remains the only aromatase inhibitor versus tamoxifen to both5,6:



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At a median follow-up of 73 months and a median treatment duration of 60 months, the risk of a disease-free survival event was significantly reduced with FEMARA® compared with tamoxifen (intent-to-treat [ITT] analysis: HR 0.87; 95% CI: 0.76-0.99; P=0.03; censored analysis: HR 0.84; 95% CI: 0.73-0.95), confirming the 2005 PCA results.7

Similarly, the updated analysis confirmed the superiority of FEMARA® in reducing the risk of distant metastases (HR 0.85; 95% CI: 0.72-1.00). Additionally, while not statistically significant, overall survival trended toward significance in the ITT analysis.7

Explanation of ITT versus censored analyses

ITT analyses were conducted ignoring the selective crossover. Censored analyses were conducted censoring follow-up/event times at the date of selective crossover in 632 women (26%) who crossed to FEMARA® or another aromatase inhibitor after the tamoxifen arms were unblinded in 2005, based on superior efficacy of FEMARA® over tamoxifen and following the recommendations of the Data Monitoring Committee.7

Of these 632 women, 448 (70%) crossed to FEMARA® to complete initial adjuvant therapy. All of these women were in Option 1 and most crossed in Years 3 to 4, at a median 43 months from randomization. Median duration of FEMARA® after crossing was 17 months. The remaining 184 women crossed to FEMARA® (172 women) or another aromatase inhibitor (12 women) to start extended adjuvant treatment, having received tamoxifen for 4.5 to 5 years.7

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Your patients' main concern after surgery is staying free of recurrence, specifically distant metastases.

Start and stay with FEMARA® (letrozole) to help prevent distant metastases3,5

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To read more about the unique efficacy profile of FEMARA®, click here.

*Average risk over 15 years based on prognostic factors of nodal status and tumor size.1
†Distant disease-free survival is a median secondary end point of BIG 1-98; the primary end point of the study is disease-free survival.
 Approval is based on a 26-month follow-up.3
‡Standard adjuvant treatment duration is 5 years or until relapse.

FEMARA® is indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.

Click here for Important Safety Information for FEMARA®.

 

References: 1. Heimann R, Hellman S. Clinical progression of breast cancer malignant behavior: what to expect and when to expect it. J Clin Oncol. 2000;18(3):591-599. 2. Mansell J, Monypenny IJ, Skene AI, et al. Distant metastasis-the most common type of early recurrence with adjuvant tamoxifen therapy. Poster presented at: 30th Annual San Antonio Breast Cancer Symposium; December 13-16, 2007; San Antonio, Texas. 3. FEMARA® (letrozole) [summary of product characteristics]. Basel, Switzerland: Novartis Pharma AG; 2009. 4. Gradishar W. Landmark trials in endocrine adjuvant therapy for breast carcinoma. Cancer. 2006;106(5):975-981. 5. Mouridsen H, for the BIG 1-98 Collaborative Group. Letrozole monotherapy vs. tamoxifen monotherapy or vs. letrozole in sequence with tamoxifen for postmenopausal women with endocrine-responsive early breast cancer. Presented at: 31st Annual San Antonio Breast Cancer Symposium (SABCS); December 10-14, 2008; San Antonio, Texas. 6. The Arimidex, Tamoxifen, Alone or in Combination (ATAC) Trialists’ Group. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol 2008;9:45-53. 7. Data on file. Novartis Oncology, East Hanover, NJ.