| ||||
| ||||
file:///C|/windows/TEMP/nscomm40/tmp/tmp4/edt1.htmTitle: The Tamoxifen Trials
this is a series of articles about breast cancer. HOw to avoid, how to treat and how to overcome. Hope these series are beneficial. I am aware there is much controversy in whether to be administered with Tamoxifen or not. The following is an eduational aspect to this drug. We do not advocate the use or not to be used, but to educate. There are a number of other therapies that may be administered in lieu of. Please ask your Doctor for the latest and less toxic of treatments.
God Bless You,
marty auslander
See also... NIH Clinical Alert: Adjuvant Therapy of Breast Cancer - Tamoxifen Update.
Drugs mentioned:
Tamoxifen has a beneficial effect in approximately 50% of women with metastatic breast cancer. It reduces cancer recurrence and mortality rates in stage I and II disease and reduces the risk of new primary cancer in the other breast. The possibility that the drug may prevent or delay the development of breast cancer in healthy women with a family history of the disease has prompted the initiation of large-scale, double-blind controlled trials of tamoxifen (20 mg/kg/day) in the United States, the United Kingdom, Italy, and Australia. The US clinical trial, begun in 1992, is the most ambitious and controversial trial ever undertaken by the National Cancer Institute (NCI). This $68 million trial is being conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP), a group headed for years by Bernard Fisher at the University of Pittsburgh.
NSABP had signed up some 11,000 healthy women aged 35 to 78 and was attempting to recruit another 5000 -- half of whom were to receive tamoxifen for 5 years, and half to receive placebo, with follow-up for 7 years -- when NCI suspended the trial. Government audits had turned up irregularities in NSABP data (in particular, data concerning the merits of lumpectomy versus mastectomy). As a result, NCI suspended all NSABP clinical trials, including the tamoxifen study, and forced the resignation of Fisher and his deputy, Carol Redmond. Currently NSABP is installing a new data auditing system, forming a new management team, and electing new leaders. [Anderson C. Science. 1994; 263:1679. Marshall E. Science. 1994; 264:1524-1527.]
Some of the best tamoxifen data are from a large trial coordinated by NSABP (the B-14 trial) involving a dozen centers and nearly 3000 patients with hormone-sensitive, nonmetastatic breast cancer. Tamoxifen was shown to reduce the incidence of new breast cancer by about 40% and to reduce cholesterol levels and prevent bone loss. It was also shown to increase the risk of endometrial cancer (Oncolink-NCI-PDQ), deep-vein thrombosis, and possibly ocular degeneration. Most cases of endometrial cancer were detected early enough to treat, but there were some deaths. However, the increase in mortality was more than offset by the decrease in mortality from breast cancer. [Fisher B et al. J Natl Cancer Inst. 1994; 86:527-537.]
A number of other clinical trials also found that tamoxifen increased the risk of endometrial cancer. In a Swedish study involving 1372 subjects randomized to tamoxifen or placebo, endometrial cancer developed in 23 women in the tamoxifen group compared with 4 in the placebo group during 9-year follow-up. A British study of 111 subjects enrolled in the UK Pilot Breast Cancer Prevention trial found that tamoxifen- treated women had more uterine abnormalities than patients in the placebo group (39% had a thickened endometrium, compared with 10% of placebo subjects, and 16% had atypical hyperplasia, compared with none in the placebo group). [Kedar RP et al. Lancet. 1994;1318-1324.] There is also evi-dence that tamoxifen may increase the risk of gastrointestinal cancer and damage the fetus when taken during pregnancy.
An NCI panel has imposed two conditions on the current NSABP trial: stronger warnings about uterine cancer and annual endometrial testing for all participants. Patients are urged to see their physicians promptly if they experience any menstrual irregularities, abnormal vaginal discharge, change in vaginal discharge, or pelvic pain or pressure. The drug is still indicated for the treatment of breast cancer, but the NCI emphasizes that tamoxifen should not be taken as a breast cancer preventive outside of a clinical trial. Nevertheless, physicians are already prescribing tamoxifen as a prophylactic agent for women with a family history of breast cancer.
 |
 |
| Medical Sciences Bulletin Contents | PharmInfoNet Homepage |
|
