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According to results published in The Breast Journal, systemic chemotherapy administered after local treatment in patients with stage IV breast cancer with no evidence of disease may decrease the risk of subsequent recurrences.

Approximately 200,000 cases of breast cancer are diagnosed annually in the United States. Although women with breast cancer may respond to initial therapy, some will experience a recurrence of their cancer either near the site of the original cancer, or in a distant site in the body. If the recurrence is a single site, therapy such as surgery and/or radiation may eliminate the cancer. These patients are classified as having stage IV-no evidence of disease (NED) breast cancer. However, patients with stage IV-NED breast cancer are at a high risk for developing a subsequent cancer recurrence. This is due to the fact that cancer cells still exist in the body but are undetectable with current detection methods. Thus, researchers have been evaluating systemic (full body) therapy such as chemotherapy in patients with stage IV-NED breast cancer, in an attempt to kill any undetectable remaining cancer cells and improve chances of a cure.

Researchers from the M.D. Anderson cancer Center conducted a clinical trial to determine the effectiveness of systemic treatment following local therapy for patients with stage IV-NED. In this trial, 45 women had been treated for a local or distant recurrence with surgery, radiation or both. No patient had any evidence of disease following therapy. After local therapy, all patients were treated with six courses of chemotherapy consisting of 5-FU (fluorouracil), doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®), collectively referred to as FAC. Patients who had hormone-positive or unknown hormone status and who responded to Nolvadex® (tamoxifen) received Nolvadex® for five years following chemotherapy. The results from this group of patients were compared to another group of patients with stage IV-NED previously treated with only local therapy for their recurrence (historical control group). Disease characteristics were also compared to patients in two previous clinical trials that evaluated chemotherapy for stage IV-NED.

The overall survival at three years following therapy was 84% for patients in this trial, compared to 66% in the historical control group. The rate of cancer-free survival at three years following therapy was approximately 50% for patients in this trial, compared to 11% for patients in the historical control group. Patients in all four groups were analyzed for disease characteristics that may have led to improved survival. The only variable that was associated with improved overall and cancer-free survival was no detectable cancer in the axillary (under the arm) lymph nodes.

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These researchers concluded that doxorubicin-based systemic chemotherapy should be considered the standard of care for patients with stage IV-NED breast cancer. Future clinical trials are warranted to evaluate different chemotherapy regimens, as many women may receive doxorubicin-based chemotherapy as part of their initial treatment. Patients with stage IV-NED breast cancer may wish to speak with their physician regarding the risks and benefits of systemic therapy or the participation in a clinical trial further evaluating this therapeutic approach. Sources of information regarding ongoing clinical trials include the National Cancer Institute (

Reference: Rivera E, Holmes F, Buzdar A, et al. Fluorouracil, doxorubicin, and cyclophosphamide followed by tamoxifen as adjuvant treatment for patients with stage IV breast cancer with no evidence of disease.

The Breast Journal. 2002;8:2-9.