Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
1999-05-17
2003-10-28
Huff, Sheela (Department: 1642)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C424S195110, C435S007200, C435S007100, C435S007400, C436S063000, C436S064000, C436S501000, C436S503000
Reexamination Certificate
active
06638727
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The field of this invention is identifying, treating and monitoring patients having breast cancer or patients at risk of getting breast cancer.
2. Description of the Background Art
Estrogen activity has an established relationship to breast cancer. Thus, drugs are presently being developed and tested that modulate estrogen activity in an attempt to treat patients having hormone responsive breast cancer. These new drugs can be classified as estrogen activity modulators. Estrogen activity modulators include estrogen receptor modulators (e.g. selective estrogen receptor modulators or SERMs), estrogen antagonists, and modulators of estrogen synthesis.
Whether estrogen activity modulators can be used for reducing the risk of or therapeutically treating breast cancer depends almost entirely on identifying a patient population that will benefit from the drug. Previously, determinations of a patient's likelihood of contracting cancer have been largely developed based on epidemiology and genetics. Tests directed to specific individuals to screen for patients at risk for contracting breast cancer have not existed. However, some patients who have precancer of the breast can be identified haphazardly by incidental or accidental detection during other procedures. See Fisher et al, (1998)
J. Nat'l Cancer Inst
, vol. 90 (18): 1371-1388 using incidental or random biopsy to identify patients having atypical ductal hyperplasia.
Patients having breast cancer are presently identified by such means as mammography, fine needle aspiration biopsy (FNAB), FNAB guided by mammography, biopsy, magnetic resonance imaging (MRI), or other standard means that may include dosing a patient with radiation or incurring tissue damage in the process of getting a tissue sample to analyze. These methods are deficient because they do not detect early cancer, cannot detect precancer, and may cause damage to patients that have cancer by disrupting tissue near and around the cancerous lesion, and may also cause a serious risk of unclean margins after lesion removal. In addition, standard methods to screen for cancer such as mammography, FNAB, and biopsy also provide frequent opportunity for an ambiguous or false result. Thus, the medical community would benefit greatly from the application of a sensitive, non-radiation based, and non-invasive identification means for breast cancer, and a method to identify breast precancer.
There is every indication that estrogen activity modulators may be most effective if administered to patients having breast pre-cancer, or to patients having very early breast cancer (i.e. breast cancers not presently routinely detectable by standard methods). Additionally, patients having cancer may be most benefited from administration of an estrogen activity modulator if the breast tissue has not been broken or disturbed to identify the cancer. It follows that a patient having breast cancer may be most optimally treated if that cancer is detected non-invasively, and thus if the cancer is not disrupted by a surgeon's tool, which risks unclean margins and exacerbation of the cancerous lesion in the duct and surrounding tissue.
A recent study of the benefits of the selective estrogen receptor modulator (SERM) tamoxifen found that tamoxifen administration benefits both patients with cancer, and patients having pre-cancer. The study showed a 49% reduction in incidence of breast cancer with administration of tamoxifen to high risk women, and that the risk of getting invasive cancer was reduced by 86% in women with a history of atypical ductal hyperplasia (ADH), a precancerous state. See Fisher et al, (1998)
J. Nat'l Cancer Inst
, vol. 90 (18): 1371-1388. Because the women with ADH were identified by accident, the problem remains how to systematically and confidently identify such women. The present invention solves this problem.
The results from the NASBP Fisher et al study may point to the future of treatment options for women having hormone responsive breast cancers. Therapeutic treatment or risk reduction of breast cancer with estrogen activity modulators may indeed reduce the mortality risk in patients having cancer or may reduce the risk of developing breast cancer in women at high risk. Such treatment protocols depend, however, on accurate, sensitive and nondisruptive identification of the patients who can benefit from the estrogen activity modulator. The invention provides such methods of identification. The invention also provides methods of treating patients so identified and for monitoring such patients who are candidates for the treatment.
In addition, because estrogen activity modulators are not benign drugs and effect an important hormone in the female life cycle (e.g. tamoxifen increases a patient's risk for other reproductive cancers, cardiac problems and other undesirable side effects (Fisher et al, (1998)
J. Nat'l Cancer Inst
, vol. 90 (18): 1371-1388)), being able to treat the patient (once identified) when the patient is most likely to respond favorably to the modulator, and thus keeping the length of the treatment time and the treatment dose at a minimum, while maximizing the benefits against a cancer or precancer, would clearly be a benefit to the patient population. The present invention provides this benefit.
3. Relevant Literature
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 described in Wrensch et al, (1992)
Am. J. Epidemiology
, v. 135 (2): 130-141.
Nipple aspirate fluid is identified as a promising non-invasive method to identify cellular markers of breast cancer risk in Sauter et al, (1997)
British Journal of Cancer
76(4):494-501.
A Company called Diagnostics, Inc. formed in 1968, produced devices to obtain breast ductal fluid for cytological evaluation. The devices included a nipple aspiration device to collect NAF from subjects, and catheters to retrieve ductal fluid. The devices were sold prior to May 28, 1976 for the purpose of collecting breast ductal fluid for cytological evaluation.
U.S. Pat. No. 5,763,415 to Sukumar discloses prophylactic and therapeutic methods of treating the ductal epithelium of a breast duct by treating the duct with an epithelium destroying agent, and claims a method of treating the ductal epithelium of a mammary gland prophylactically or therapeutically for cancer by ductal cannulation of a duct, and administration of a vector comprising thymidine kinase to the duct and its prodrug ganciclovir. U.S. Pat. No. 4,981,692 to Popescu et al discloses and claims a method of treating infections in an animal by administration of a therapeutically effective amount of aminoglycoside in liposome form by intramammary infusion.
U.S. Pat. No. 4,202,329 and U.S. Pat. No. 4,365,632 to Kortum disclose a process and apparatus for stimulating immune resistance by the introduction of at least one relatively small solid non-toxic substantiall
Hung David T.
Love Susan
Cytyc Health Corporation
Huff Sheela
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