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ASCO MEETING: Tamoxifen Lowers Breast Cancer Risk In Women With Prior History ATLANTA, GA -- May 18, 1999 -- May 18, 1999 -- New data from the landmark Breast Cancer Prevention Trial (BCPT) presented today at the American Society of Clinical Oncologists (ASCO) suggests that five years of prophylactic treatment with Roche Laboratories Inc.'s and Zeneca Pharmaceuticals’ Nolvadex(R) (tamoxifen citrate) may have a particularly significant impact on breast cancer risk for women with prior histories of lobular carcinoma in situ (LCIS) or atypical hyperplasia (AH). "Our analysis shows that for women with a prior history of LCIS, five years of Nolvadex reduces the incidence of invasive breast cancer by 66 percent. For those with a prior history of AH, the reduction in invasive breast cancer is a striking 86 percent," said Dr. D. Lawrence Wickerham, clinical director of the National Adjuvant Surgical Breast and Bowel Project (NASBP), who conducted the Breast Cancer Prevention Trial (BCPT). "For the entire BCPT study population, we observed a highly significant 49 percent reduction in invasive breast cancers among women who took tamoxifen for five years." Of the more than 13,000 women who took part in BCPT, 826 had a prior history of LCIS, a microscopic breast disorder that is restricted to cell walls in the milk-producing lobules of the breast. A total of 1,193 women in BCPT had a prior history of AH, an abnormal cell growth pattern in the breast that is not malignant. To date, the majority of patients with LCIS or AH have been treated by surgical excision alone. "We know from epidemiological studies that the rate of invasive breast cancers for women with a prior history of LCIS is 13 per 1,000 patients annually, while for AH it is 10 per 1,000 patients annually,” Dr. Wickerham said. “Our new analysis of the BCPT data suggests that it may be important to consider prophylactic treatment with tamoxifen for women whose risk profiles include prior diagnosis and surgical excision of LCIS or AH.” The LCIS and AH data from the BCPT Study takes on added significance in light of data from another NSABP study (B-24) reported late last year and discussed this year at ASCO. The B-24 study examined the effect of five years of tamoxifen therapy on cancer recurrence in women who had been treated for ductile carcinoma in situ (DCIS), the most localised (Stage 0) form of breast cancer. In the DCIS study, 1,804 women who had been treated with lumpectomy and radiation therapy between 1990 and 1994 were randomised to five years of treatment with tamoxifen or placebo. After an average follow-up period of five years, NSABP found that the addition of tamoxifen significantly reduced the five-year incidence of invasive cancer in the same breast by 44.8 percent (29 cases on placebo versus 16 cases on tamoxifen). Additionally, the researchers analysed the occurrence of all new breast cancer events including contralateral (in the opposite breast) breast cancer and new non-invasive breast cancers. They found that the addition of tamoxifen reduced the five-year incidence of a new breast cancer by 31.7 percent (104 cases on placebo versus 71 cases on tamoxifen). The course of breast cancer in a woman's body can be viewed as a sequence, or continuum. For most women, the pace at which breast cancer moves along that continuum is a function of how rapidly cancer cells grow when fuelled by the estrogen in her body. The LCIS and AH findings from BCPT together with the DCIS data from B-24 appear to present a consistent rationale for the therapeutic and prophylactic effect of tamoxifen. Nolvadex has been available in the United States for more than 20 years. 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. In the BCPT study, the drug 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. Related Link: Tamoxifen E-mail this page to a friend or colleague! To print, use this version