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Access of estrogen to the receptor, as well as by receptor-mediated antiestrogenic effects. Dr. Ettinger: There are many in vitro studies showing that raloxifene blocks the estrogen alpha receptors in breast and endometrium. It could also have a moderating effect on cell growth by stimulating estrogen beta receptors. What kinds of hormonal treatments are reasonable for women at high risk for breast cancer? Dr. Birge: Paradoxically, women at increased risk for breast cancer by virtue of a family history or other risk factors should initiate estrogen replacement. All studies have come to the same conclusion; namely, that women who have taken estrogen for more than 5 years have a consistent and significant 20-50% ; reduction in their risk of dying from breast cancer, including those women with a first-degree relative with breast cancer. Recent studies indicate that the breast cancers that arise in women on estrogen are different from those that occur in nonusers of estrogen, in that estrogen users are more likely to develop lobular or in situ cancers and less likely to have metastasis to the regional lymph nodes. These studies also suggest that the actual increase in breast cancer incidence is small, on the order of 2-3% per 5 years of use. This increase is within the error of measurement and is, therefore, not significant. However, the addition of a progestin does significantly increase the incidence of breast cancer, including invasive breast cancers. What can we expect from antiestrogens, such as tamoxifen and raloxifene? As noted above, the long-term exposure to tamoxifen might actually increase the risk, not only of breast cancer expression but also of the expression of more malignant forms of breast cancer--for example, estrogen-receptor-negative tumors-- thereby actually increasing one's risk of.
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1. Parker SL, Tong T, Bolden S, Wingo PA. Cancer statistics. CA Cancer J Clin 1996; 46: 5-27. Berliere M, Charles A, Galant C, Donnez J. Uterine side effects of tamoxifen: A need for systemic pretreatment screening. Obstet Gynecol 1998; 91: 40-4. Fleischer AC, Kalemaris G, Machin JE. Sonographic depiction of normal and abnormal endometrium with histopathologic correlation. J Ultrasound Med 1986; 5: 445-52. Fleischer AC, Kalemaris G, Entman S.Sonographic depiction of endometrium during normal cycles. Ultrasound Med Biol 1986; 12: 271-7. Jemal A, Thomas A, Murray T. Cancer Statistics, 2002. CA Cancer J Clin 2002; 52: 23-47.
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1. McKinlay SM, Jefferys M. The menopausal syndrome. Br J Prev Soc Med. 1974; 28: 108-15. Fisher B, Costantino J, Redmond C, Poisson R, Bowman D, Couture J, et al. A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors. N Engl J Med. 1989; 320: 479-84. Casper RF, Yen SS. Neuroendocrinology of menopausal flushes: an hypothesis of flush mechanism. Clin Endocrinol Oxf ; . 1985; 22: 293-312. Wren BG, Brown LB. A double-blind trial with clonidine and a placebo to treat hot flushes. Med J Aust. 1986; 144: 369-70. Clayden JR, Bell JW, Pollard P. Menopausal flushing: double-blind trial of a non-hormonal medication. Br Med J. 1974; 1: 409-12. Edington RF, Chagnon JP, Steinberg WM. Clonidine Dixarit ; for menopausal flushing. Can Med Assoc J. 1980; 123: 23-6. Laufer LR, Erlik Y, Meldrum DR, Judd HL. Effect of clonidine on hot flashes in postmenopausal women. Obstet Gynecol. 1982; 60: 583-6. Goldberg RM, Loprinzi CL, O'Fallon JR, Veeder MH, Miser AW, Mailliard JA, et al. Transdermal clonidine for ameliorating tamoxifen-induced hot flashes. J Clin Oncol. 1994; 12: 155-589. Pandya KJ, Loughner J, Raubertas R, Bennett JM. A double blind placebo controlled trial of clonidine for vasomotor symptoms in breast cancer patients on tamoxifen. Proceedings of the Annual Meeting of the American Society of Clinical Oncology. 1990; 9: 340. Swartzman LC, Edelberg R, Kemmann E. The menopausal hot flush: symptom reports and concomitant physiological changes. J Behav Med. 1990; 13: 15-30. Morrow GR. Clinical trials in psychosocial medicine: methodological and statistical considerations. Part III. Assessing measurement techniques in psychosocial oncology. Cancer Treat Rep. 1980; 64: 451-6. Erlik Y, Meldrum DR, Lagasse LD, Judd HL. Effect of megestrol acetate on flushing and bone metabolism in post-menopausal women. Maturitas. 1981; 3: 167-72. Bullock JL, Massey FM, Gambrell RD Jr. Use of medroxyprogesterone acetate to prevent menopausal symptoms. Obstet Gynecol. 1975; 46: 165-8. Albrecht BH, Schiff I, Tulchinsky D, Ryan KJ. Objective evidence that placebo and oral medroxyprogesterone acetate therapy diminish menopausal vasomotor flushes. J Obstet Gynecol. 1981; 139: 631-5. Loprinzi CL, Michalak JC, Quella SK, O'Fallon JR, Hatfield AK, Nelimark RA, et al. Megestrol acetate for the prevention of hot flashes. N Engl J Med. 1994; 331: 347-52. Barton DL, Loprinzi CL, Quella SK, Sloan JA, Veeder MH, Egner JR, et al. Prospective evaluation of vitamin E for hot flashes in breast cancer survivors. J Clin Oncol. 1998; 16: 495-500 and terazosin.
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A.7-1 In-class facilitation The socratic approach has been applied successfully to large classes for Problem-based learning by Lea Ann Hansen, in Pharmacy at the Virginia Commonwealth University, Richmond and by Ted Cleary, Pathology, University of Adelaide, Adelaide, South Australia. Table A-15 summarizes their approaches to model the eight-stage problem solving process used in a typical PBL activity. Also given in Table A-15 is another option for socratic facilitation of the problem solving process. Tables A-16 and A-17 show the context and timing of the process used by Hansen and Cleary, respectively. Table A-18 illustrates the transparencies that might be used in Guided Design facilitation of the process. A.7-2 Personalized self-directed DA-E dialogue The socratic facilitation approach was used in printed format for engineers by Rudd and Watson 1968 ; through their Devil's Advocate- Engineer dialogue. Herethe problem is posed and, through an imaginary conversation between the Devil's Advocate DA or tutor ; and the Engineer, E or student ; , the student is asked to answer a series of questions posed by the tutor. The questions and answers are printed such that the student can wrestle with the question and arrive at his her answer before uncovering the recommended answer. Table A-19 shows a paper computer individualized layout of the process. The line in the left hand margin visually reminds the student when to stop uncovering the information, when to pause and formulate a student response. Computer technology makes this style obsolete, but Table A-19 illustrates an approach. A.7-3 References Cleary, Ted 1994 ; Pathology, University of Adelaide, Adelaide, South Australia, e-mail communication, Oct 4 tcleary medicine.adelaide .au Erskine, J.A. M.R. Leenders and L.A. Mauffette-Leenders 1981 ; "Teaching with Cases, " School of Business Administration, University of Western Ontario, London, ON. Hansen, Lea Ann 1994 ; Pharmacy, Medical College of Virginia Virginia Commonwealth University, Richmond, VA, e-mail communication, Sept 29 lhansen gems.vcu.
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Edwards D and McGuire W. Presentation of monoclonal antibody to progesterone receptor, Workshop on Estrogen and Antiestrogen Action: Basic and Clinical Aspects, Wisconsin Clinical Cancer Center, Madison, WI, June 26-29, 1984. Greene GL, Fitch FW, and Jensen EV. Monoclonal antibodies to oestrophilin: probes for the study of oestrogen receptors. Proceedings National Academy of Sciences, USA, 77: 157-161, 1980. Greene GL, Jensen EV. Monoclonal antibodies as probes for estrogen receptor detection and characterization. J of Steroid Biochemistry, 16: 349-353, 1982. Jensen EV, Greene GL, Hospelhorn VD, and DeSombre ER. Improved procedures for the determining of oestrogen receptors in breast cancers. Reviews on Endocrine Related Cancer Suppl 9: 13-21, 1981. King RJB, Coffer AI, and Louis K. Studies with monoclonal antibody raised against partially purified oestradiol receptor from human myometrium, Second Interational Symposium on Antihormones in Breast Cancer, Berlin, West Germany, October 21-24, 1984, page 24. Kodama F, Salmon SE, Soehnlen B, and Greene GL. Expression of estrogen receptor as a clonal marker of differentiation in MCF-7 cells. Assoc for Cancer Research, 25: 218 Abstract 863 ; , 1984. Poulsen HS, Ozzello L, King WJ, Greene GL. The use of monoclonal antibodies to estrogen receptors for immunoperoxidasedetection of ER in human breast cancer, Second International Symposium on Antihormones in Breast Cancer, Berlin, West Germany, October 21-24, 1984, page 25. Tate AC, DeSombre ER, Greene GL, Jensen EV, and Jordan VC. Interaction of 3H ; estradiol- 3H ; monohydroxytamoxifen-estrogen receptor complexes with a monoclonal antibody. Breast Cancer Research and Treatment, 3: 267-277, 1983 and tiazac.
Jennifer R. Zebrack, MD Associate Professor of GIM University of Nevada School of Medicine Reno, Nevada Joan M. Neuner, MD, MPH Assistant Professor of GIM Medical College of Wisconsin Milwaukee, WI Alda Maria R. Gonzaga, MD, MS Assistant Professor of GIM University of Pittsburgh Pittsburgh, PA Ann B. Nattinger, MD, MPH Professor and Chief of GIM Medical College of Wisconsin Milwaukee, WI.
Purpose: Patients with hormone-sensitive breast cancer who have responded to tamoxfen TAM ; may receive additional benefit from a second endocrine agent after progression or relapse after TAM therapy. Fulvestrant FVT; Faslodex; i.m. injection, ICI 182, 780; AstraZeneca Pharmaceuticals, Wilmington, DE ; was developed as a selective antagonist of estrogen. In postmenopausal women, FVT is reported to inhibit the proliferative effects of estrogen on sensitive tissues and has no apparent measurable estrogenic activity. In this report, we describe the data and analyses supporting marketing approval for FVT by the United States Food and Drug Administration FDA ; . Experimental Design: The FDA review of 16 clinical trials and 6 pharmacokinetic trials, as well as preclinical pharmacology and chemistry data, are described. The bases for marketing approval are summarized. Results: Toxicology studies in the mouse, rat, and dog showed minimal toxicity except for antiestrogenic effects. Because of FVT aqueous insolubility, an i.m. formulation, given at monthly intervals, was selected for clinical studies. Pharmacokinetic studies demonstrated sustained concentrations with monthly injection. In in vitro studies FVT was extensively metabolized, primarily by hepatic cytochrome P450 3A4. Phase I studies showed minimal toxicity, and the maximal dose 250 mg ; was limited by FVT solubility. In two Phase III trials, 851 patients were randomized to either 250 mg FVT i.m. monthly or to anastrozole ANZ ; 1 mg p.o. daily. Ninety-six percent of patients had received TAM previously for early adjuvant treatment ; or advanced breast cancer. Response rates RR ; were 17% for both FVT and ANZ study arms in the North American trial, and were 20% versus 15% for FVT versus ANZ, respectively, in the European trial. There were no observed differences between study arms with respect to time to progression or survival. The most common FVT adverse events reported as poten and tobradex.
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Disease-free survival at 3 years was 8 4% on anastrozole and 8 4% on tamoxifn hazard ratio 83 , p 013 and toprol.
M isotretinoin, 3 10 M tretinoin, TGF-b1 3 ng ml ; and 10 M tamoxifen; exposure time 24 h. Data presented as mean values S.D. n 4 statistically significant differences relative to the control group; n.s., statistically not significant.
Yet few have opted to take tamoxifen, the only drug now approved for breast cancer risk reduction, because it raises the risk of uterine cancer and potentially deadly blood clots and trazodone.
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Benefits of Treatment Table 2 summarizes the estimates used for the benefits of treatment in terms of a 10-year odds reduction in mortality. The benefits of adjuvant therapy vary with patient age and the type of adjuvant therapy used. For hormone therapy, tamoxifen use for five years is not age-sensitive, with odds reduction of mortality ranging from 0.32-0.34 for those between the age of 45-75. The use of tamoxifen for two years has much less impact in younger patients aged 45 and 65. However, for patients over 75, data suggests equivalent or better effect with two years of tamoxifen 0.36 ; compared to five 0.34 ; . For adjuvant chemotherapy, there is a benefit in younger women 45-65 at risk for recurrent breast cancer, but the benefit is substantially greater for younger women. The use of AC x cycles is a little more effective than CMF x 6 cycles in women under 50. Chemotherapy is much less efficacious in older women. For a 65-year old woman, hormone therapy is much more efficacious than chemotherapy. There is an advantage in treating with combined chemotherapy and hormone therapy in younger women. Since there are no good outcomes data on the use of hormone therapy in patients age 85 and chemotherapy in patients age 75 and 85, a range of values were considered. The high bound used assumes that older patients, 75 and 85, have a response equal in magnitude to a 65 year old. The middle bound assumes that affect of chemotherapy decreases with age almost linearly. The low bound assumes almost no benefit from chemotherapy. The life expectancy without breast cancer is 36.41, 19.27, 12.29, and 6.94 years for a 45, 65, 75 and 85 year old, respectively, Tables 3-7. With breast cancer prior to adjuvant therapy BCPATH ; , the life expectancy for a 45 year old is 16.27 years in node - ; disease and 12.06 years in node + ; disease, Table 3. The BCPATH life expectancy for a 65 year old is 11.78 and 9.58 years for node - ; and node + ; disease, respectively Table 4 ; . The BCPATH life expectancy for a 75 year old is 8.75 and 7.52 years for node - ; and node + ; disease, respectively Table 5 ; . The BCPATH life expectancy for a 85 and triamterene.
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NOTE NO. 50 - June 11 1998 Page 3 of 3 DIRECT DETERMINATION OF TAMOXIFEN AND ITS FOUR MAJOR METABOLITES IN PLASMA USING AN SPS NITRILE GUARD COLUMN IN A COLUMN-SWITCHING CONFIGURATION.
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Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: preliminary results of the italian tamoxifen anastrozole trial and triphasil and tamoxifen.
Braunsberg, H. Studies on the effect of anti-oestrogens and dithiothreitol on oestrogen binding by preparations from human breast cancer tissue Abstract ; . Acta Endocrinol. Suppl. 177: 27, 1973. Brewin, T.B. Clinical experience with tamoxifen ICI 46, 474 ; in the management of breast cancer Abstract B19 ; . VIII International Congress of Chemotherapy, September 8-14, 1973. Brewin, T.B. In-vitro oestrogen sensitivity of breast cancer Letter ; . Lancet. 1: 1339 June 17 ; 1972. Carbone, P.P. Antiestrogens and breast cancer treatment. Ann. Intern. Med. 83 5 ; : 730-731 Nov. ; 1975. Carbone, P.P. The role of chemotherapy in the treatment of cancer of the breast. Am. J. Clin. Pathol. 64 6 ; : 774-779 Dec. ; 1975. Cole, M.P. and Todd, I.D.H. Tamoxfen ICI 46, 474 ; - clinical experience in 129 patients with advanced breast cancer. INSERM.55: 245-246, 1975. Cole, M.P., Jones, C.T.A., and Todd, I.D.H. The treatment of advanced carcinoma of the breast with the anti-oestrogenic agent tamoxifen ICI 46, 474 ; -- a series of 96 patients. Adv. Antimicrobial Antineoplas. Chemother. 2: 529531, 1972. Cole, M.P., Jones, C.T.A., and Todd, I.D.H. A new anti-oestrogenic agent in late breast cancer. An early clinical appraisal of ICI 46, 474, Brit. J. Cancer. 25: 270-275 June ; 1971. Cruickshank, J. Hormonal effects of the anti-oestrogen agent Nolvadex tamoxifen ; . Aust. N.Z. J. Med. 6 3 ; : 250 June ; 1976. Dao, T.L., Sinha, D.K. and Patel, J. Effect of estrogen and progesterone on cellular replication of human breast tumors. Canc. Res. 42 1 ; : 359-362 1982 ; . Engelsman, E., Korsten, C.B., Persijn, J.P., and Cleton, F.J. Anti-oestrogens and breast cancer. Lancet. 2: 171-172 July 20 ; 1974. Fisher, B., et al. Tampxifen for Prevention of Breast Cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 1998; 90 18 ; : 1371-1388.
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