Breast Cancer Early Diagnosis: Halo Breast Pap Test

Second leading cause of death in women (after lung cancer) is breast cancer. 1 Cancer is a disease distinguished by three characteristics regarding abnormal cells (contain nutrients to provide energy, specialized functions and reproduction) that grow, invade adjacent tissues, and/or metastasize (spread to other locations in the body). However, benign tumor compared to cancerous tumors, do not grow in an aggressive manner, do not invade surrounding tissues and do not metastasize. 2 Ninety-five percent of breast cancers originates in cells that line ducts 15 (Small tubes that carry breast milk from the lobules -- glands that make breast milk) and adjoining tissues. Through the lymph system (Supplies blood through a network of lymph vessels to every cell in the body 3) cancer can spread. 4 In 2007, according to the American Cancer Society 178,480 women in the United States will be diagnosed with breast cancer and approximately 40,460 will die (1 in 35). Statistically one in eight women will have breast cancer during their life. 1 "Breast cancer can develop at any age, but the risk of developing it increases as women get older." 5 Especially women over the age of 65 more than half develop breast cancer. 6 However, five to ten percent of breast cancer linked to hereditary defect. 5 Also, other factors increase risk a woman develop breast cancer include: Previous diagnosis breast cancer, hormone replacement therapy, women starting their period in early puberty or have late menopause, women who do not have children, taking contraceptive pill, never breastfed, obesity, and alcoholism. 6 Certainly smoking has direct correlation to breast cancer, according to a study, older women who smoke cigarettes or have smoked for long periods of time may be up to forty percent more likely to develop breast cancer. 7 Fortunately, the survival rate of breast cancer has been declining because of early detection and improved treatment.1

Three stages of breast cancer diagnosed:

a) Cancer confined to the ducts (ductal carcinoma) that transport milk to the nipple during lactation or ductal carcinoma (only to the lobules)

b) Cancer has spread to the surrounding breast tissue and detected through a breast self -- examination.

c) Cancer has spread to other areas of the body.

Depending upon the stage of cancer diagnosed a surgeon; oncologist and/or radiologist would be consulted. 5

Women who have multiple breast cancer risk factors, ductal lavage is an early diagnosis procedure, detect presence of breast pre-cancerous cells called atypical cells. 8 The procedure collects cells from the milk ducts ("Each breast has 6 to 9 separate ducts, which function independently of each other. Cancer that begins in one duct may be contained to that duct if caught early, making treatment more effective and increasing survival. ") from the breast for analysis. 10 "A woman with atypia (abnormal Cytology) has a 4 - 5 times greater risk of developing breast cancer than women who do not produce fluid." 18 Ductal lavage performed in a doctor's office or outpatient center, under local anesthetic. During the procedure, an anesthetic cream is applied to numb the nipple area. A hair thin catheter (small tube) inserted into the opening (additional anesthetic is delivered) of ducts that produce fluid. The catheter delivers saline (salt and water) solution to rinse the duct, which releases cells from the duct lining. Sample of cells are analysis in a laboratory, evaluation for normal or abnormal (atypical cells) development. Evaluation of atypical cells increase the risk of developing breast cancer and options include frequent clinical breast examinations, medication (lowers the risk of breast cancer including tamoxifen), and surgery to remove a breast before cancer develops (prophylactic or risk - reducing mastectomy - 9). 10 Women undergoing ductal lavage, rarely an infection may develop at the site of the catheter insertion and no permanent damage may result if a perforation or puncture of a milk duct. 8

In 2005, The United States Food and Drug Administration approved Halo Breast Pap test machine (manufactured by NeoMatrix, LLC) first automated noninvasive Papanicolaou (Pap) test system to collect cells from nipple aspirate fluid (NAF) for evaluating normal, pre-malignant and malignant cells. The presence of abnormal cells may identify future breast cancer risk up to eight years prior mammogram or self - examination of a lesion (non-cancerous or malignancy - 11). Shari Sandberg, spokeswoman for NeoMatrix recommends annually Halo Breast Pap test annually for women ages 25 - 55 (or less frequent between 25 - 30 years old). The test is approximately 66 percent accurate and repeated testing improves accuracy. Shari Sandberg said: "You're unlikely to miss bad cells three years in a row when your sampling, and it's the same thing with cervical Pap." 14

A trained obstetrician / gynecologist performs the Halo Breast Pap test or performed in a primary care facility. During a five-minute cycle, adjustable breast cups generate mild compression on both breasts while continuously applying heat. A gentle suction retrieves ductal fluid toward the end of the cycle. 12 Janet Summers (58) of Louisville, said regarding the test: "nothing like being squeezed with a mammogram", despite some discomfort. 14 According to Dr. Iacob Marcovici, an obstetrician and gynecologist practicing in Avon Connecticut, extracted fluid taken to a lab and tested for cancerous growth. Also, Dr. Marcovci said: "As a screening test, (it) has a sensitivity of about 70 to 80 percent, similar to other screening tests, such as the regular pap or a mammogram. In other words, in average, all those screening test are missing about 20 percent of checked a symptomatic persons. By repeating the test, let's say once a year, the test sensitivity is expected to rise." 13

According to NeoMatrix (Irvine, California) Halo Breast Pap test developer approximately 50 machines are in use nationally. Dr. Divya Cantor, an obstetrician - gynecologist said regarding the test: "It's used to try to find patients who are at risk (of breast cancer) or who have the potential for developing breast cancer in the future." The practice where Dr. Cantor works in Louisville OB/GYN, charges (September 2007) $95.00 for Halo Breast Pap test; it is not covered by insurance. Contrarily, the test been criticized for unnecessarily at times giving women concern for future cancer development. Dr. Anees Chagpar, director of the multidisciplinary breast program at the James Graham Brown Cancer Center in Louisville, said: " If the nipple aspirate fluid is negative for atypical cells, that does not mean that you are not harboring a breast cancer. Conversly, if you have a typical cells, it does not necessarily mean that you have a cancer, so in that sense, the information that you get (from Halo testing) is really of little value... This is only an added expense." 14

Dr. April Rubin gynecologist (Board Certified Obstetrician/Gynecologist Performing brit milah (bris) in DC, Virginia and Maryland 17) said regarding Halo Breast Pap test should not replace mammography. "Right now they are two different, but complimentary approaches to the same problem. However, she is recommending that her 30 - something -- year -- old patients add the Halo Breast Pap to their regular clinical exams instead of waiting until age 40 for a mammogram." 16

References:

1) Overview; Breast Cancer - How Many Women Get Breast Cancer? - http://www.cancer.org/docroot/CRI/content/CRI_2_2_1X_How_many_people_get_breast_cancer_5.asp?sitearea=

2) Cancer - http://www.cancer.org/docroot/CRI/content/CRI_2_2_1X_How_many_people_get_breast_cancer_5.asp?sitearea=

3) The lymph system and your health - http://www.womentowomen.com/detoxification/lymphaticsystem.asp

4) The Lymph System - http://www.cancer.org/docroot/CRI/content/CRI_2_2_1X_What_is_breast_cancer_5.asp?sitearea=

5) Breast Cancer - http://www.labtestsonline.org/understanding/conditions/breast.html

6) Causes of breast cancer - http://www.cancerbackup.org.uk/Cancertype/Breast/Causesdiagnosis/Causes

7) Smokig-Breast Cancer Link Appear Stronger - Current or Long-Term Smokers up to 40% More Likely to Get Breast Cancer -

http://www.webmd.com/smoking-cessation/news/20050930/smoking-breast-cancer-link-appears-stronger

8) Breast Cancer: Ductal Lavage - http://www.webmd.com/breast-cancer/guide/ductal-lavage

9) Preventive Mastecomy: Questions and Answers -http://www.cancer.gov/cancertopics/factsheet/Therapy/preventive-mastectomy

10) Ductal Lavage - http://www.clevelandclinic.org/health/health-info/docs/3000/3023.asp?index=10741

11) A Lesion... What Does The Doctor Mean? - http://www.medicinenet.com/script/main/art.asp?articlekey=9695

12) FDA Approvals: Halo Breast Pap Test, Aluma OsteoChondral Transplant System - http://www.medscape.com/viewarticle/517458

13) New Breast Cancer Test May Replace Mammograms - http://media.www.dailycampus.com/media/storage/paper340/news/2007/10/29/News/New-Breast.Cancer.Test.May.Replace.Mammograms-3062653.shtml

14) Halo effect - http://www.courier-journal.com/apps/pbcs.dll/article?AID=/20071004/FEATURES03/710040317

15) New Noninvasive Pap Test for Breast May Indentify Breast Disease Up to Eight Years Earliar - http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/11-14-2005/0004214900&EDATE=

16) Halo Breast Pap - http://www.wusa9.com/rss/vodcasting_article.aspx?ref=Vodcast&storyid=54828

17) April Rubin, M.D. - Mohei in Washington, D.C. - http://www.dcmohel.com/

18) Cancer News - Breast Cancer Screening Test To Be Showcased At American Society of Breast Surgeons Meeting - http://www.cancercompass.com/cancer-news/1,12530,00.htm?rss=y