Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
2000-02-10
2003-11-04
Huff, Sheela (Department: 1642)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C435S007100, C435S007210
Reexamination Certificate
active
06642010
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The field of this invention is identifying, treating and monitoring women at risk for or having breast precancer or cancer.
2. Description of the Background Art
The approximate age of menopause for women in the United States is 51, and the mean life expectancy of such women is 85 years; thus most American women will live a third of their lives without significant estrogen production. Estrogen supplementation was first used in 1935 to ameliorate menopausal symptoms, and a few years later findings indicated that estrogen supplementation had beneficial effects on osteoporosis associated with aging. Around 1966 menopause was declared a “curable disease” by taking estrogen supplements. In 1975 articles warned that continuous estrogen supplementation alone increased the risk of endometrial cancer. By early 1980s, a new synthetic estrogen was prescribed that negated the endometrial cancer risk. Thereafter, attention was turned to the advantages of estrogen on cardiovascular mortality. Presently, concerns of estrogen therapy still exist with regard to breast cancer, but the issue is debated, with some reports indicating a causal linkage and other reports not identifying such a concern. (Summarized from page 771 Danforth's
Obstetrics and Gynecology, seventh edition,
ed. Scott et al., JB Lippincott Co., Philadelphia, 1994.)
Although the role of hormone replacement therapy (HRT) using estrogen or an estrogen/progestin combination in the etiology of breast cancer continues to be debated (Colditz, G A
J. Women 's Health
8(3): 347-57 (1999), the magnitude of increase in breast cancer risk per year of hormone use is comparable to that associated with delaying menopause by a year (Colditz, G A
J. Nat'l Cancer Inst
90(11): 814-23 (1998). Adding support to these conclusions is other research concluding that experimental and clinical evidence currently underway and recently completed suggests that breast neoplasia is a hormone-dependent process (Newman et al.,
J. Surg. Oncol.
71(4): 250-260 (1999)) and as such a postmenopausal patient may be placed at increased risk of breast neoplasia with prolonged HRT. Studies conducted by at least one group in Tavani and Vecchia,
Drugs Aging
14(5): 347-57 (1999) indicate that there is a 2.3% risk of breast cancer for women on HRT for from 5 to 15 years if the women start the therapy at age 50. Estrogens and estrogen/progestin combination are most frequently prescribed to patients experiencing menopausal symptoms, and generally the duration of treatment is about a year but sometimes up to 5 years for these patients. Less frequently, estrogen is prescribed to postmenopausal women experiencing osteoporosis (bone density loss). The treatment duration for osteoporosis, a potentially serious and life threatening condition, can be prolonged. Osteoporosis is associated with increased mortality due to increased fractures, particularly hip fractures and affects millions of people worldwide. Women of postmenopausal age (i.e., approximately over 50 years of age) are one category prone to the development of low bone density associated with osteoporosis. See, Watts,
Obstet Gynecol Surv
54(8): 532-8 (1999). Osteoporosis is reduced with estrogen administration. See, for example Shoupe D,
Hosp Pract
(
OffEd
) 34(8): 97-103, 107-8, 113-4 (1999).
Estrogen administration has also positive effects to reduce the risk of cardiovascular risk in postmenopausal women. (See, for example Shoupe D,
Hosp Pract
(
OffEd
) 34(8): 97-103, 107-8, 113-4 (1999). There is evidence that estrogen therapy decreases risk for coronary heart disease (and for hip fracture), but long-term estrogen therapy increases risk for endometrial cancer and may be associated with a small increase risk for breast cancer (See, Grady, D et al.,
Ann Intern Med
117(12): 1016-37 (1992)).
Accordingly, taking into account the risks and benefits of estrogen administration it has been recommended that women diagnosed with breast cancer should use hormones sparingly to ameliorate menopausal symptoms (See, Colditz G A,
Oncology
11(10): 1491-4, 1497, 1498, 1501 (1997). The call has also been made for alternatives to HRT for the long term prevention of heart disease and osteoporosis, See, Colditz G A,
Oncology
11(10): 1491-4, 1497, 1498, 1501 (1997) and Ettinger, B
Proc Soc Exp Biol Med
217:2-5 (1998), especially in view of research that indicates that long-term estrogen replacement therapy is associated with lower all-cause mortality and confers this apparent protection primarily through reduction in cardiovascular disease (See, Ettinger, B et al.,
Obstet Gynecol
87(1):6-12 (1996)). In general, postmenopausal hormone therapy may not be recommended for all postmenopausal women (See, Grady, D et al.,
Ann Intern Med
117(12): 1016-37 (1992) and Barrett-Connor E and Grady D,
Annu Rev Public Health
19:55-72 (1998)).
Thus, given the great benefits of estrogen, but the established sensitivity of estrogen positive breast cancer lesions to estrogen stimulation, it would be prudent to develop sensitive screening and monitoring methods to provide postmenopausal women and their prescribing physicians information to make informed treatment choices in the best interest of the patient. The present invention provides these benefits.
Relevant Literature
Breast fluid was collected from nonlactating Finnish women with no known breast disease and analyzed for markers including estrogen; levels of estrogen in the fluid were six-fold higher than in the serum, Wynder et al.,
Cancer
47(6): 1444-50 (1981); and a possible correlation was made to the high levels of estrogen found in the ductal fluid of Western women and the development of breast cancer, Wynder and Hill
Lancet,
2(8043): 840-2 (1977).
Estrogen (estrone and estradiol) levels were investigated (Petrakis et al.,
Int J Cancer
40(5): 587-91 (1987) in serum and nipple aspirates of breast fluid in relation to the reproductive and menopausal characteristics in 104 normal women; breast fluid and serum levels were not correlated; breast fluid estrogen levels were about 5 to 45 times higher than serum levels; serum estrogen levels were lower in postmenopausal women than premenopausal women; it was postulated that the high concentrations of estrogen in breast fluid and the absence of a relationship to serum estrogen levels may explain why serum studies have failed to link variations in serum estrogens with breast cancer risk.
Higher breast fluid E2 (estradiol) and E1 (estrone) levels were found in women with biopsied benign breast disease than in controls; but no evidence of a correlation of serum and breast fluid measurements was found. Ernster et al.,
J Natl Cancer Inst
79(5): 949-60 (1987).
Papanicolaou et al., (1958)
Cancer,
11:377-409 describes exfoliative cytology from spontaneous nipple discharge of the human mammary gland and its value in the diagnosis of breast cancer. Goodson W H & King E B,
Chapter
4:
Discharges and Secretions of the Nipple,
The Breast: Comprehensive Management of Benign and Malignant Diseases (1998) 2
nd
Ed. Vol 2, Bland & Kirby eds. W.B. Saunders Co, Philadelphia, Pa. pp. 51-74 describes nipple discharge and the ways in which it has been used to characterized conditions of the breast.
Sartorius et al., (1977) proposed cytologic evaluation of breast fluid for the detection of breast disease as describe in
Journal of the National Cancer Institute
59(4):1073-80. Love and Barsky, (1996)
Lancet
348(9033):997-9 demonstrated retrieval of ductal fluid by breast-duct endoscopy to study stages of cancerous breast disease.
Nipple aspirate cytology for the study of breast cancer precursors is described in King et al., (1983)
Journal of the National Cancer Institute
71(6):1115-21. Cytological epithelial hyperplasia and atypical hyperplasia diagnosed in nipple aspirate fluid are associated with increased risk of breast cancer in a study of 2701 women as
0
described in Wrensch et al., (1992)
Am. J. Epidemiology,
v. 135 (2): 130-141.
Nipple aspirate fluid is identif
Cen Hui
Hung David
Love Susan
Banner & Witcoff , Ltd.
Cytyc Health Corporation
Huff Sheela
LandOfFree
Identifying, monitoring, and treating women for breast... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Identifying, monitoring, and treating women for breast..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Identifying, monitoring, and treating women for breast... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3117764