FEMARA® is the only aromatase inhibitor versus tamoxifen that significantly reduces the early risk of distant metastases in postmenopausal women with hormone-receptor positive (HR+) early breast cancer receiving initial adjuvant treatment at 26-month median follow-up.3,4†‡
Distant metastases, which initially peak 2 years after surgery, are the most common types of breast cancer recurrence and are associated with the lowest overall survival rates1,2* Click here for more information.
At 26-month median follow-up, FEMARA® delivered a significant 27% reduction in the risk of distant metastases versus tamoxifen (P=0.001) (HR=0.73, 95% Cl: 0.60-0.88)3
Click here for more information.
FEMARA® delivered a significant 19% reduction in the overall risk of recurrence versus tamoxifen (P=0.003) (HR=0.81, 95% Cl: 0.70-0.93)3
FEMARA® provided a nonsignificant 14% reduction in risk of mortality versus tamoxifen (P=0.15)3
At 73-month median follow-up, FEMARA® remains the only aromatase inhibitor versus tamoxifen to both5,6:
- Significantly improve disease-free survival5 and
- Significantly improve time to distant recurrence5
Click here for more information.
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
In the initial adjuvant setting, start and stay with FEMARA® to help reduce the early risk of distant metastases in postmenopausal women with HR+ early breast cancer.3
For more information on the significant clinical benefits of FEMARA®, click here.
To find out how FEMARA® works to deliver its benefits, please see Mechanism of Action, click here.
*In postmenopausal patients with HR+ early breast cancer.1,2
†Distant disease-free survival is a secondary end point of BIG 1-98; the primary
end point of the study is disease-free
survival. Approval is based on a median
26-month follow-up.3
‡Standard adjuvant treatment duration is 5 years or until relapse.3
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. 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. 2. Rugo H, Rourke M, Dranitsaris G, Kaura S. Letrozole or anastrozole for the prevention of early recurrences in post menopausal women with early stage breast cancer: using number needed to treat (NNT) to compare benefit (abstract). EJC Supplements. 2008;6(7):118 (Abstract 236). 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.
