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Research needed to learn which DCIS patients may be candidates for less invasive therapy

September 25, 2009

Ductal carcinoma in situ (DCIS), the most common non-invasive lesion of the breast, presents unique challenges for patients and providers largely because the natural course of the untreated disease is not well understood. Because most women diagnosed with DCIS are treated, it is difficult to determine the comparative benefits of different treatment strategies versus active surveillance, meaning systematic followup. An independent panel convened by the NIH urged the scientific community to identify appropriate biomarkers and other prognostic factors to better predict the risk of developing breast cancer.

"Instead of treating all women diagnosed with DCIS, we need to determine which individuals are likely to develop invasive breast cancer and which will not," said Dr. Carmen Allegra, panel chair and Chief of Hematology and Oncology at the University of Florida. "If we could accurately predict this, we might save some women from undergoing unnecessary invasive treatments while achieving the same positive outcomes."

DCIS is a condition in which a spectrum of abnormal cells are found in the breast duct and have not spread outside the duct to other tissues in the breast. Since the advent of widespread screening mammography in the early to mid 1980's, rates of DCIS have increased sharply. It is estimated that more than one million U.S. women will be living with a prior diagnosis of DCIS by 2020.

Despite the connotations associated with the term carcinoma, DCIS is associated with ten-year survival rates close to 100% when treated with currently available therapies. These include breast-conserving surgery (local excision, with or without radiation), removal of the breast (mastectomy), and/or tamoxifen. It is important to stress that each of these treatment options has physical and emotional impacts to patients and should be weighed accordingly. The panel recognized that there are relatively few reliable data on the comparative effectiveness of both diagnostic and therapeutic options in DCIS.

To improve our understanding of this complex disease, the panel recommended efforts to ensure detailed collection of clinical, pathological, imaging, and molecular data about DCIS using standardized reporting measures, annotated specimen repositories, and multicenter databases.

The panel emphasized the importance of patient preferences and recommended improved communication between patients and providers, and serious consideration of new nomenclature that more closely reflects the excellent survival rates for this condition.

Efforts to improve communication would also include further development of formal decision aids. Such tools would reduce misinformation and improve understanding of a DCIS diagnosis and the risks and benefits of various treatment options. Individuals who have DCIS should have access to the best possible information and guidance to aid them in making care decisions that reflect their unique circumstances, perspectives, and preferences.

The panel's updated draft state-of-the-science statement will be available later today at http://consensus.nih.gov. The conference was sponsored by the NIH Office of Medical Applications of Research and the National Cancer Institute along with other NIH and Department of Health and Human Services components. This conference was conducted under the NIH Consensus Development Program, which convenes conferences to assess the available scientific evidence and develop objective statements on controversial medical issues.

The 14-member conference panel included experts in the fields of oncology, radiology, surgery (general and reconstructive), pathology, radiation oncology, internal medicine, epidemiology, biostatistics, nursing, obstetrics and gynecology, preventative medicine and population health, and social work. A complete listing of the panel members and their institutional affiliations is included in the draft conference statement. Additional materials, including panel bios, photos, and other related resources, are available at http://consensus.nih.gov/2009/dcismedia.htm.

In addition to the material presented at the conference by speakers and the comments of conference participants presented during discussion periods, the panel considered pertinent research from the published literature and the results of a systematic review of the literature. The systematic review was prepared through the Agency for Healthcare Research and Quality Evidence-based Practice Centers (EPC) program, by the Minnesota Evidence-based Practice Center. The EPCs develop evidence reports and technology assessments based on rigorous, comprehensive syntheses and analyses of the scientific literature, emphasizing explicit and detailed documentation of methods, rationale, and assumptions. The evidence report on diagnosis and management of DCIS is available at http://www.ahrq.gov/clinic/tp/dcistp.htm.

The panel's statement is an independent report and is not a policy statement of the NIH or the federal government. The NIH Consensus Development Program was established in 1977 as a mechanism to judge controversial topics in medicine and public health in an unbiased, impartial manner. NIH has conducted 119 consensus development conferences, and 32 state-of-the-science (formerly "technology assessment") conferences, addressing a wide range of issues. A backgrounder on the NIH Consensus Development Program process is available at http://consensus.nih.gov/backgrounder.htm.

NIH/National Institutes of Health, Office of Disease Prevention