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Patients Exhibited 30 Percent Fewer Early Breast Cancer Recurrences in Letrozole Study

FRIMLEY, SURREY, England, April 30/PRNewswire-FirstCall/ -- Newly published data in the May issue of Annals of Oncology, Oxford University Press show that after two years of post-surgical therapy, postmenopausal women with hormone-sensitive early breast cancer treated with Femara experienced 30 percent fewer early breast cancer recurrences at sites away from the breast (distant metastases) compared with tamoxifen(1).

The spread of breast cancer to other parts of the body means that it is extremely likely that a woman will die from the disease(2). Recurrences that occur locally, regionally, or in the opposite breast (contra-lateral) are more easily treated than those that spread far from the original tumour, and they are associated with better long-term outcomes(3,4).

In the retrospective analysis of more than 7,700 women at a median follow-up of two years, approximately 75 percent of early recurrences occurred at distant sites such as bone or vital organs. However, there were 30 percent fewer distant recurrences in the Femara group than in the tamoxifen group (87 vs. 125, respectively)(1).

Maria Leadbeater, Secondary Breast Cancer Nurse Specialist at Breast Cancer Care commented, "Breast Cancer Care speaks to women with breast cancer daily and knows that they welcome any treatment development that could help to reduce the likelihood of their cancer recurring. Having been treated for breast cancer the first time round, one of the greatest fears is that the disease might return. These findings confirm earlier results from this trial, and suggest that Femara may be a treatment option for postmenopausal women with early breast cancer that could help reduce the risk of this happening to them."

Compared with tamoxifen Femara also demonstrated a significant reduction in the risk of recurrence to the same breast (local recurrence), the other breast and to the lymph nodes (regional recurrence).

"Femara is the only aromatase inhibitor shown to significantly reduce the risk of distant metastases versus tamoxifen as initial adjuvant therapy in postmenopausal women with hormone-sensitive early breast cancer. This is particularly good news since we know that this type of recurrence significantly worsens the prognosis for these women," said Dr Andrew Wardley, study investigator and consultant medical oncologist at the Christie Hospital, Manchester, and the South Manchester University Hospitals NHS Trust.

The retrospective analysis also identified patients at higher risk of recurrence based on clinical and pathological disease characteristics. The results showed that patients with the highest risk of early recurrence had tumours larger than five centimetres, four or more positive nodes, positive oestrogen receptor status but negative progesterone status, grade three tumours and invasive disease. Notably, women with node positive disease, who are considered to be at a higher risk of recurrence, maintained this lower risk of relapse when treated with upfront Femara than with tamoxifen(1).

"These results provide the tip of the iceberg and for the bigger picture, physicians will be eagerly awaiting the results of the BIG 1-98 sequencing arms, which hope to indicate the optimal strategy for using Femara post surgery and are due to be ready for 2008. This is why Novartis has made a significant commitment to sponsor this important study", said Hugh O'Dowd, Business Unit Director, Novartis Oncology UK.

About BIG 1-98
BIG 1-98 is the only clinical trial that incorporates both a head-to-head comparison and a sequencing of Femara and tamoxifen as adjuvant treatment for postmenopausal women with hormone receptor positive breast cancer. The results of the primary core analysis of the head-to-head comparison based on a median follow up of 26 months were published in the December 29, 2005, issue of the New England Journal of Medicine(5). The BIG 1-98 trial was conducted by the International Breast Cancer Study Group (IBCSG) with many independent centres and was supported by Novartis.

About Femara
Femara is the only AI with the widest range of licences - before surgery, directly post-surgery, after five years of standard tamoxifen treatment and in advanced cancer(6).

A once-a-day oral AI, Femara is currently indicated in the UK for:

- Adjuvant (post-surgery) treatment of postmenopausal women with hormone receptor-positive invasive early breast cancer

- The treatment of early invasive breast cancer in postmenopausal women who have completed prior standard adjuvant tamoxifen therapy (extended adjuvant)

- Newly diagnosed postmenopausal women with advanced breast cancer

- Postmenopausal women with advanced breast cancer in whom tamoxifen, or other anti-oestrogen therapy has failed

- Neoadjuvant (pre-operative) therapy in postmenopausal women with localised hormone receptor-positive breast cancer, to allow subsequent breast conserving surgery in women not originally considered candidates for breast-conserving therapy

References
(1). Mauriac L, et al. Predictors of early relapse in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial. Annal of Oncology 2007. Feb 14 online edition

(2). American Cancer Society. Breast Cancer Detailed Guide. How is Breast Cancer Staged? https://www.cancer.org/docroot/cri/content/cri_2_4_7x_crc_breast_cancer_pdf.asp. Accessed 23.04.07

(3). National Cancer Institute. Breast Cancer PDQ: Treatment, Health Professional version. https://www.cancer.gov/types/breast/hp/breast-treatment-pdq. Accessed 23.04.07

(4). Imaginis, the breast cancer resource. https://www.imaginis.com/breasthealth/metastatic.asp. Accessed 23.04.07

(5). Thurlimann B et al. Adjuvant letrozole reduces the risk of relapse in postmenopausal women with receptor positive early breast cancer compared with tamoxifen: first results of the BIG 1-98 trial. N Engl J Med, December 2005

(6). Femara Summary of Product Characteristics. December 2005

Source: Novartis

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