[Federal Register Volume 74, Number 101 (Thursday, May 28, 2009)]
[Notices]
[Page 25568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12376]



[[Page 25568]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


NIH State-of-the-Science Conference: Diagnosis and Management of 
Ductal Carcinoma In Situ (DCIS); Notice

    Notice is hereby given of the National Institutes of Health (NIH) 
State-of-the-Science Conference: Diagnosis and Management of Ductal 
Carcinoma in Situ (DCIS) to be held September 22-24, 2009, in the NIH 
Natcher Conference Center, 45 Center Drive, Bethesda, Maryland 20892. 
The conference will begin at 8:30 a.m. on September 22 and 23, and at 9 
a.m. on September 24, and will be open to the public.
    Ductal carcinoma in situ (DCIS) is a condition in which abnormal 
cells are found in the lining of a breast duct. As ``in situ'' means 
``in place,'' this means the abnormal cells have not spread outside the 
duct to other tissues in the breast. Also referred to as intraductal 
carcinoma and stage zero breast cancer, DCIS is the most common 
noninvasive tumor of the breast.
    DCIS is most often discovered during routine mammograms, presenting 
as very small specks of calcium known as microcalcifications. However, 
not all microcalcifications indicate the presence of DCIS, and the 
diagnosis must be confirmed by biopsy. Magnetic Resonance Imaging (MRI) 
has also been used more recently as a diagnostic tool, but questions 
remain about the impact of the test on patient outcomes. Since the 
implementation of screening mammography, the rate of new DCIS cases has 
increased dramatically.
    DCIS currently accounts for approximately twenty percent of 
screening-detected breast cancer, but its true prevalence is 
challenging to measure because nearly all affected individuals are 
asymptomatic. By most reports, the risk factors associated with the 
development of DCIS are similar to those for invasive breast cancer: 
increased age, family history of breast cancer, previous biopsies, 
history of hormone replacement therapy, and older age at first 
childbirth. Tamoxifen, a hormonal drug, has demonstrated a reduction in 
the incidence of DCIS among high-risk women.
    Although the natural course of the disease is not well understood, 
DCIS can become invasive cancer and spread to other tissues. It is also 
a marker of increased risk for developing cancer elsewhere in the same 
or opposite breast. However, not all DCIS will progress to invasive 
disease, and it is thought that DCIS can be present in some individuals 
without causing problems over a long period of time. Recent research 
suggests that DCIS is a spectrum of disease and that certain tumor 
characteristics may be strong or weak risk factors for subsequent 
invasive breast cancer. Unfortunately, it is currently not clear which 
lesion types are more likely to become invasive, leading to difficult 
treatment decisions for patients and providers.
    Because of this uncertainty, DCIS patients are typically treated 
promptly following diagnosis and have a generally good prognosis. 
Standard DCIS therapies include breast conservation, with or without 
radiation or mastectomy, depending on patient and tumor 
characteristics. Sentinel lymph node biopsy may also be recommended to 
high-risk patients since this is the area where cancer spread is often 
first detected. Hormonal therapy may also be used in an effort to 
prevent DCIS recurrence and to lower the risk of developing invasive 
breast cancer. However, these drugs' potential side effects must be 
weighed carefully.
    Since the natural course of DCIS is not well understood and 
treatment benefit may depend on specific tumor and patient 
characteristics, the treatment of DCIS remains controversial. To 
examine these important issues, the NIH National Cancer Institute and 
Office of Medical Applications of Research will convene a State-of-the-
Science Conference from September 22-24, 2009. The questions to 
consider include:
     What are the incidence and prevalence of DCIS and its 
specific pathologic subtypes, and how are incidence and prevalence 
influenced by mode of detection, population characteristics, and other 
risk factors?
     How does the use of MRI or sentinel lymph node biopsy 
impact important outcomes in patients diagnosed with DCIS?
     How do local control and systemic outcomes vary in DCIS 
based on tumor and patient characteristics?
     In patients with DCIS, what is the impact of surgery, 
radiation, and systemic treatment on outcomes?
     What are the most critical research questions for the 
diagnosis and management of DCIS?
    An impartial, independent panel will be charged with reviewing the 
available published literature in advance of the conference, including 
a systematic literature review commissioned through the Agency for 
Healthcare Research and Quality. The first day and a half of the 
conference will consist of presentations by expert researchers and 
practitioners and open public discussions. On Thursday, September 24, 
the panel will present a statement of its collective assessment of the 
evidence to answer each of the questions above. The panel will also 
hold a press conference to address questions from the media. The draft 
statement will be published online later that day, and the final 
version will be released approximately six weeks later. The primary 
sponsors of this meeting are the NIH National Cancer Institute and the 
NIH Office of Medical Applications of Research.
    Advance information about the conference and conference 
registration materials may be obtained from American Institutes for 
Research of Silver Spring, Maryland, by calling 888-644-2667 or by 
sending e-mail to [email protected]. The American Institutes for 
Research's mailing address is 10720 Columbia Pike, Silver Spring, MD 
20901. Registration information is also available on the NIH Consensus 
Development Program Web site at http://consensus.nih.gov.

    Please Note: The NIH has instituted security measures to ensure 
the safety of NIH employees, guests, and property. All visitors must 
be prepared to show a photo ID upon request. Visitors may be 
required to pass through a metal detector and have bags, backpacks, 
or purses inspected or x-rayed as they enter NIH buildings. For more 
information about the security measures at NIH, please visit the Web 
site at http://www.nih.gov/about/visitorsecurity.htm.


    Dated: May 20, 2009.
Lawrence A. Tabak,
Acting Deputy Director, National Institutes of Health.
[FR Doc. E9-12376 Filed 5-27-09; 8:45 am]
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