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According to a results recently presented at the 27th Annual Meeting of the European Society of Medical Oncology, the addition of adjuvant chemotherapy combinations involving an anthracycline (doxorubicin (Adriamycin®) or Ellence® (epirubicin)) to Nolvadex® appears to slightly improve long-term outcomes of postmenopausal women with hormone-positive localized breast cancer. However, it is important for this group of patients to discuss the risks and benefits of this treatment strategy with their physician.

Breast cancer is diagnosed in over 200,000 women and is responsible for approximately 40,000 deaths annually in the United States. Localized breast cancer refers to breast cancer that has not spread to distant sites in the body. Surgery is often used as initial therapy for localized breast cancer and may be followed by additional therapy (called adjuvant therapy) that may include chemotherapy, hormonal therapy, radiation therapy and/or biologic therapy. Adjuvant therapy is utilized to kill any undetectable cancer cells that may remain in the body following surgery, since these remaining cancer cells are responsible for cancer recurrences.

Hormone-positive breast cancer refers to a type of breast cancer that is stimulated to grow from exposure to two female hormones, estrogen and/or progesterone. Hormonal therapy is a type of therapy that blocks or reduces the formation of estrogen and/or progesterone in the body or blocks the effects of estrogen and/or progesterone on a cell. It has been well documented that postmenopausal women who have estrogen/progesterone receptor positive localized breast cancer benefit from anti-estrogen therapy with Nolvadex® (tamoxifen). It has also been shown that the addition of adjuvant radiation therapy decreases the frequency of local-regional recurrences in these women. However, in postmenopausal women with hormone-positive, localized breast cancer, the added benefit of chemotherapy to Nolvadex® and radiation therapy has not been well documented. Previous clinical trials evaluating this issue utilized non anthracycline-based chemotherapy combinations such as CMF (cyclophosphamide, methotrexate and 5-FU).

Since recent research has indicated that anthracyclines are very active in breast cancer, researchers from France conducted a clinical trial evaluating anthracycline-based adjuvant chemotherapy in postmenopausal women with hormone-positive, localized breast cancer. These researchers decided to utilize the chemotherapy combinations referred to as FAC (5-FU, doxorubicin and cyclophosphamide) or FEC (5-FU, epirubicin and cyclophosphamide).

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This multicenter clinical trial involved over 800 postmenopausal women with breast cancer that had spread to their axillary (under the arm) lymph nodes or was considered aggressive but had not spread elsewhere in the body. Patients were treated with surgery, radiation therapy and Nolvadex® either with or without adjuvant FAC or FEC. Five years following initial therapy, the overall survival and cancer-free survival rates were 87% and 79%, respectively for women treated with chemotherapy, compared to 82% and 73%, respectively for women not treated with chemotherapy. Distant and local recurrences of cancer occurred in 16% and 4%, respectively in patients treated with chemotherapy, compared to 22% and 6%, respectively in patients not treated with chemotherapy. A small number of patients in this trial were hormone receptor negative and appeared to benefit the most from treatment with chemotherapy.

These researchers concluded that adjuvant anthracycline-based chemotherapy in addition to Nolvadex® and radiation therapy appears to slightly improve long-term outcomes in postmenopausal women with localized breast cancer. However, it is important for patients to discuss the risks as well as the benefits of this chemotherapy regimen with their physician, particularly if a patient is suffering from other medical conditions.

Reference: Arriagada R, Spielmann M, Koscielny S, et al. Patterns of failure in a randomized trial of adjuvant chemotherapy in postmenopausal patients with early Breast Cancer treated with tamoxifen.

Annals of Oncology. 2002;13:33. Abstract 1170. Proceedings of the 27th annual meeting of the European Society of Medical Oncology.