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NATIONAL INSTITUTES OF HEALTH
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Adding TaxolŽ to Initial Chemotherapy May Be
New Option When Breast Cancer Has Spread to Lymph Nodes

Early findings from a large, multicenter trial suggest that the drug TaxolŽ (paclitaxel), in combination with other standard chemotherapy agents, may have a small but significant benefit for breast cancer patients whose disease has spread to nearby lymph nodes. The findings were presented Monday at the annual meeting of the American Society of Clinical Oncology in Los Angeles.

The trial, which was carried out by the Cancer and Leukemia Group B (CALGB), compared TaxolŽ combined with CytoxanŽ (cyclophosphamide) and AdriamycinŽ (doxorubicin) to CytoxanŽ and AdriamycinŽ alone. After 18 months, overall survival was about 2 percent higher in groups of women taking the TaxolŽ combination. Survival without recurrence of the disease was about 4 percent higher in the TaxolŽ groups.

Although the survival advantage does not appear dramatic at this point in the trial, the study is considered important because it is the first to show that TaxolŽ may be beneficial in the initial, post-surgical treatment of some women with localized, node-positive breast cancer. Up to now, TaxolŽ has been used primarily for the treatment of women with more advanced disease.

As patients in the trial are followed over the next few years, more mature data should allow a better understanding of Taxol's role, noted National Cancer Institutes (NCI) Jeff Abrams, M.D., senior investigator in the Division of Cancer Treatment and Diagnosis. The CALGB investigators expect to collect more information on critical details, such as which subgroups of patients benefit most and which benefit least from the addition of TaxolŽ, and how the side effects of the two regimens compare.

"The preliminary results of this trial, while encouraging, should be viewed by physicians and patients with caution as the follow-up of patients is quite short," Abrams said. "Both longer follow-up of this trial and results from other confirmatory trials are needed before the addition of Taxol or similar drugs becomes routine."

Other trials now under way will provide much needed data on the optimal, adjuvant treatment for node positive breast cancer patients. One trial involving the same three drugs, conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP), should finish recruiting patients soon. Early findings could be available in the next one to two years. Another NSABP trial for node-positive breast cancer, using TaxotereŽ (docetaxel), a drug similar to TaxolŽ, is still open to new patients.

The Cancer and Leukemia Group B and the NSABP are two of the Cooperative Trials Groups sponsored by the NCI. Cooperative Groups are networks of academic and community cancer centers around the country that conduct studies jointly and pool their data. Patients interested in participating in clinical trials may call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information.

For more information about cancer visit NCI's Website for patients, public and the mass media at http://rex.nci.nih.gov or NCI's main website at http://www.nci.nih.gov.