To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: First Clinical Guidelines For Breast Cancer Risk Reduction Published URL: http://www.pslgroup.com/dg/106B5A.htm Doctor's Guide June 11, 1999
WILMINGTON, DE -- June 11, 1999 -- The American Society of Clinical Oncology's Technology Assessment on Breast Cancer Risk Reduction Strategies: Tamoxifen and Raloxifene, published in this month's issue of the Journal of Clinical Oncology, clearly underscores the unique role that Roche Laboratories Inc.'s and AstraZeneca Pharmaceuticals' Nolvadex(R) (tamoxifen citrate) plays in reducing the incidence of breast cancer in high risk women and managing the disease in women diagnosed with breast cancer. The Technology Assessment also clears up confusion concerning the use of raloxifene stating that it is premature to recommend raloxifene use to lower the risk of developing breast cancer outside of a clinical trial setting since there is limited evidence of its efficacy. According to ASCO, the technology assessment represents the first major independent review of new data on the use of hormonal agents not just to treat breast cancer but to reduce the risk of its occurrence. Development of the Technology Assessment was prompted by last year's report of the National Surgical Adjuvant Breast and Bowel Project (NSABP) Breast Cancer Prevention Trial (BCPT or P-1) which proved the effect of tamoxifen in reducing the incidence of breast cancer on average by 44 percent in women at high risk of the disease as assessed by the Gail Model and the subsequent Food and Drug Administration approval of this drug for this use. The ASCO Technology Assessment makes a number of important statements about Nolvadex as a strategy for breast cancer risk reduction: -- "An extensive body of clinical information from randomised trials supports a role for tamoxifen... This information together with the strongly positive and appropriately powered NSABP P-1 Trial conducted in a population at increased risk for this disease, support a role for tamoxifen therapy in reducing risk of breast cancer" -- "For women with a defined five-year projected risk of breast cancer of 1.67%, corresponding to eligibility requirement of the P-1 study, tamoxifen may be offered to reduce their risk. Consideration of tamoxifen use is appropriate if the primary goal is to lower the risk of breast cancer rather than focus on other health-related issues. In all circumstances, tamoxifen use should be discussed as part of an informed decision-making process with careful consideration of risks and benefits" -- "Similarly, women with a history of invasive breast cancer who have not received hormonal therapy regardless of receptor status may also be candidates for tamoxifen consideration given the Early Breast Cancer Trialists' Collaborative Group Overview results (contralateral breast cancer incidence decrease with tamoxifen regardless of primary tumour's receptor status) and the preliminary information on "delayed" adjuvant tamoxifen therapy on breast cancer recurrence risk." In response to preliminary reports that raloxifene may also have an effect in reducing breast cancer risk, the ASCO Working Group concluded that it is premature at this time to recommend raloxifene for breast cancer risk reduction. -- "It is premature at this time to recommend raloxifene use to lower the risk of developing breast cancer outside of a clinical trial setting. In addition, there is currently not sufficient data to recommend raloxifene as a treatment for established breast cancer..." -- "Based on available information, use of raloxifene should currently be reserved for its approved indication to prevent bone loss in postmenopausal women." Nolvadex is now available by prescription to women 35 years and older at high risk for breast cancer as determined by the Gail Model Risk Assessment tool. The Breast Cancer Prevention Trial involving over 13,000 women proved that healthy women at high risk for developing breast cancer can reduce their risk by 44 percent with Nolvadex. The data were published in the Journal of the National Cancer Institute on Sept. 16, 1998. In this study, Nolvadex reduced but did not eliminate the risk of breast cancer and did not increase survival. Nolvadex is not appropriate for all women at high risk. An informed discussion between doctor and patient weighing the potential risk and benefit of Nolvadex is essential before beginning therapy. With Nolvadex therapy, the risk of endometrial cancer or blood clots in the lung and legs increased two to three times compared to placebo, although each event occurred in less than one percent of women. Stroke, cataracts and cataract surgery occur more frequently with Nolvadex. Most women experience vaginal discharge and some level of hot flashes. Pregnant women should not take Nolvadex. Women who have a history of blood clots or who use warfarin or coumarin to thin their blood should not take Nolvadex to reduce their risk of breast cancer. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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