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###### Department of Health and Human Services

###### National Institutes of Health

      ( print page 25568)    
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                     *consensus@mail.nih.gov.*                     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]

BILLING CODE 4140-01-P