Study Demonstrates Ductal Lavage Collects Abnormal Breast Cells That Can Help Assess Breast Cancer Risk

First-Prize Abstract to be Presented at the 50th Annual Clinical Meeting Of

The American College of Obstetricians and Gynecologists



Apr 30, 2001, 01:00 ET from University of Oklahoma College of Medicine

    CHICAGO, April 30 /PRNewswire/ -- Atypical cells were detected in
 23 percent of women at high risk of developing breast cancer, according to
 updated results of a large-scale clinical trial, presented today at the
 American College of Obstetricians and Gynecologists (ACOG) annual meeting in
 Chicago.  These data expand upon preliminary data included in the meeting
 abstract. Ductal lavage is a minimally invasive method of collecting large
 numbers of cells from the breast milk ducts, where 95 percent of breast cancer
 originates. The procedure involves inserting a hair-thin catheter into the
 milk ducts, and washing (lavaging) the ducts with saline to collect cells.
     "Atypical cells significantly increase the risk of breast cancer
 development.  Currently, ductal lavage is the only method allowing physicians
 to detect atypical cells in a minimally invasive fashion," said
 William C. Dooley, M.D., an early pioneer of ductal lavage and principal
 investigator of the study, University of Oklahoma College of Medicine.  "This
 procedure is important news for high-risk women and their physicians who are
 searching for ways to understand their current risk of developing breast
 cancer."
     Ductal lavage is premised on the fact that most breast cancers originate
 in the ductal systems. Atypical cells have been shown to increase relative
 risk of breast cancer development by five to 18 times depending on family
 history status. Published, peer reviewed data with long-term follow-up
 demonstrates that women with atypical cells face a significantly elevated,
 near-term risk of developing breast cancer. It is not known whether all
 atypical cells progress to breast cancer, however the risk implications are
 clear.
 
     High Risk Women Tested
     The multi-center study enrolled 507 women who were determined to be at
 high risk for breast cancer if they scored a minimum of 1.7 percent on the
 five-year Gail Index, previously had breast cancer or were positive for
 BRCA1/2 mutations.
      Ductal lavage was well tolerated and identified the presence of atypical
 cells in 23 percent of the women.  Approximately seventeen percent of the
 study participants were found to have mildly atypical cells in their breasts
 while six percent had markedly atypical cells.
 
     Assessing Breast Cancer Risk
     The most widely used risk assessment tool today is the Gail Index
 developed by the National Cancer Institute (NCI). This model calculates a
 woman's risk of developing an invasive breast cancer over the next five years
 and takes into account several factors including:  current age, age at
 menarche (first period), age at first live birth, number of previous breast
 biopsies, presence of atypical hyperplasia and the number of first-degree
 relatives with breast cancer.
     The Gail Index is known to under-estimate breast cancer risk in certain
 populations including women who have previously had breast cancer, are BRCA1/2
 gene mutation carriers and in non-white populations. The Gail Index is further
 limited in that it assesses a woman's breast cancer risk based on population
 statistics, rather than on current, individualized, biological information
 about her breast health.
     Ductal lavage provides physicians with the ability to collect large
 numbers of cells for cytological evaluation and real-time biological
 assessment of breast cancer risk. This information is currently being used by
 oncologists, breast cancer surgeons and their patients to weigh management
 options such as ongoing surveillance and risk reduction drug therapy.
 
     About Ductal Lavage
     Before ductal lavage begins, an anesthetic cream is applied to the nipple
 to numb the area.  Next, a small suction cup akin to a manual breast pump, is
 used to help draw tiny amounts of ductal fluid up to the nipple surface.
 These fluid droplets help locate the natural opening of the ducts on the
 nipple.
     Once the duct is identified, a tiny microcatheter is inserted into the
 ductal opening.  Some anesthetic is delivered through the microcatheter to
 numb the inside of the duct.  The anesthetic is followed by about a teaspoon
 of saline, which "washes" cells out of the duct.  The fluid is then put into a
 collection vial and sent to a laboratory.  It is analyzed under a microscope
 using standard cytologic techniques to determine whether the cells are normal,
 atypical or malignant.
     "Today, physicians are using ductal lavage in clinical practice nationwide
 to provide women with personal information about their breast health," said
 Dooley.  "Last week's publication in the Lancet Medical Journal regarding
 innovative research applications of ductal lavage also speaks to the exciting
 potential for it to one day be developed as a cancer detection tool.  This
 area is just one of many exciting future research applications for ductal
 lavage being explored by leading breast cancer experts."
     Ductal lavage does not replace standard breast cancer detection tools and
 should be used in conjunction with mammography, breast-self examination and
 clinical examination.
 
     University of Oklahoma College of Medicine
     The University of Oklahoma College of Medicine is recognized as a premiere
 source of medical expertise in the heartland of the United States.  More than
 one-third of the 214 Oklahoma physicians named to the Best Doctors in America
 list are OU faculty members, and five OU physicians have been named to the
 Country's Best Doctors surveys compiled by Good Housekeeping magazine.   The
 OU College of Medicine is known for research programs in cellular and
 molecular medicine, gene regulation, structural biology, microbiology and
 immunology, cardiovascular physiology and neuroscience.
     In addition to his faculty position and research leadership, Dr. Dooley is
 medical director of the University Physicians Medical Group's Institute for
 Breast Health where he provides medical care for women from Oklahoma and
 across the nation.
 
     Further Information
     ACOG has awarded first prize to Dr. Dooley for his abstract regarding
 ductal lavage. Updated data referenced in this abstract will be presented at
 ACOG's annual meeting in Chicago on Monday, April 30 at 1:30 p.m.  Dr. Dooley
 will be available for interviews directly following the session.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X27874550
 
 

SOURCE University of Oklahoma College of Medicine
    CHICAGO, April 30 /PRNewswire/ -- Atypical cells were detected in
 23 percent of women at high risk of developing breast cancer, according to
 updated results of a large-scale clinical trial, presented today at the
 American College of Obstetricians and Gynecologists (ACOG) annual meeting in
 Chicago.  These data expand upon preliminary data included in the meeting
 abstract. Ductal lavage is a minimally invasive method of collecting large
 numbers of cells from the breast milk ducts, where 95 percent of breast cancer
 originates. The procedure involves inserting a hair-thin catheter into the
 milk ducts, and washing (lavaging) the ducts with saline to collect cells.
     "Atypical cells significantly increase the risk of breast cancer
 development.  Currently, ductal lavage is the only method allowing physicians
 to detect atypical cells in a minimally invasive fashion," said
 William C. Dooley, M.D., an early pioneer of ductal lavage and principal
 investigator of the study, University of Oklahoma College of Medicine.  "This
 procedure is important news for high-risk women and their physicians who are
 searching for ways to understand their current risk of developing breast
 cancer."
     Ductal lavage is premised on the fact that most breast cancers originate
 in the ductal systems. Atypical cells have been shown to increase relative
 risk of breast cancer development by five to 18 times depending on family
 history status. Published, peer reviewed data with long-term follow-up
 demonstrates that women with atypical cells face a significantly elevated,
 near-term risk of developing breast cancer. It is not known whether all
 atypical cells progress to breast cancer, however the risk implications are
 clear.
 
     High Risk Women Tested
     The multi-center study enrolled 507 women who were determined to be at
 high risk for breast cancer if they scored a minimum of 1.7 percent on the
 five-year Gail Index, previously had breast cancer or were positive for
 BRCA1/2 mutations.
      Ductal lavage was well tolerated and identified the presence of atypical
 cells in 23 percent of the women.  Approximately seventeen percent of the
 study participants were found to have mildly atypical cells in their breasts
 while six percent had markedly atypical cells.
 
     Assessing Breast Cancer Risk
     The most widely used risk assessment tool today is the Gail Index
 developed by the National Cancer Institute (NCI). This model calculates a
 woman's risk of developing an invasive breast cancer over the next five years
 and takes into account several factors including:  current age, age at
 menarche (first period), age at first live birth, number of previous breast
 biopsies, presence of atypical hyperplasia and the number of first-degree
 relatives with breast cancer.
     The Gail Index is known to under-estimate breast cancer risk in certain
 populations including women who have previously had breast cancer, are BRCA1/2
 gene mutation carriers and in non-white populations. The Gail Index is further
 limited in that it assesses a woman's breast cancer risk based on population
 statistics, rather than on current, individualized, biological information
 about her breast health.
     Ductal lavage provides physicians with the ability to collect large
 numbers of cells for cytological evaluation and real-time biological
 assessment of breast cancer risk. This information is currently being used by
 oncologists, breast cancer surgeons and their patients to weigh management
 options such as ongoing surveillance and risk reduction drug therapy.
 
     About Ductal Lavage
     Before ductal lavage begins, an anesthetic cream is applied to the nipple
 to numb the area.  Next, a small suction cup akin to a manual breast pump, is
 used to help draw tiny amounts of ductal fluid up to the nipple surface.
 These fluid droplets help locate the natural opening of the ducts on the
 nipple.
     Once the duct is identified, a tiny microcatheter is inserted into the
 ductal opening.  Some anesthetic is delivered through the microcatheter to
 numb the inside of the duct.  The anesthetic is followed by about a teaspoon
 of saline, which "washes" cells out of the duct.  The fluid is then put into a
 collection vial and sent to a laboratory.  It is analyzed under a microscope
 using standard cytologic techniques to determine whether the cells are normal,
 atypical or malignant.
     "Today, physicians are using ductal lavage in clinical practice nationwide
 to provide women with personal information about their breast health," said
 Dooley.  "Last week's publication in the Lancet Medical Journal regarding
 innovative research applications of ductal lavage also speaks to the exciting
 potential for it to one day be developed as a cancer detection tool.  This
 area is just one of many exciting future research applications for ductal
 lavage being explored by leading breast cancer experts."
     Ductal lavage does not replace standard breast cancer detection tools and
 should be used in conjunction with mammography, breast-self examination and
 clinical examination.
 
     University of Oklahoma College of Medicine
     The University of Oklahoma College of Medicine is recognized as a premiere
 source of medical expertise in the heartland of the United States.  More than
 one-third of the 214 Oklahoma physicians named to the Best Doctors in America
 list are OU faculty members, and five OU physicians have been named to the
 Country's Best Doctors surveys compiled by Good Housekeeping magazine.   The
 OU College of Medicine is known for research programs in cellular and
 molecular medicine, gene regulation, structural biology, microbiology and
 immunology, cardiovascular physiology and neuroscience.
     In addition to his faculty position and research leadership, Dr. Dooley is
 medical director of the University Physicians Medical Group's Institute for
 Breast Health where he provides medical care for women from Oklahoma and
 across the nation.
 
     Further Information
     ACOG has awarded first prize to Dr. Dooley for his abstract regarding
 ductal lavage. Updated data referenced in this abstract will be presented at
 ACOG's annual meeting in Chicago on Monday, April 30 at 1:30 p.m.  Dr. Dooley
 will be available for interviews directly following the session.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X27874550
 
 SOURCE  University of Oklahoma College of Medicine