Digital Mammography Trial Results Announced: Women with Dense Breasts, Women Younger than 50, and Those Who are Perimenopausal May Benefit from Digital Mammograms
Preliminary results from a large, clinical trial of digital vs. film
mammography show no difference in detecting breast cancer for the general
population of women in the trial. However, those women with dense breasts, who
are pre- or perimenopausal (women who had a last menstrual period within 12
months of their mammograms), or who are younger than age 50 may benefit from
having a digital rather than a film mammogram. The results were reported
September 16, 2005 in a special online publication of the New England Journal
of Medicine* and at a meeting of the American College of Radiology Imaging
Network (ACRIN) in Pentagon City, Va.
The trial, sponsored by the National Cancer Institute (NCI), part of the
National Institutes of Health, was conducted by a network of researchers led by
ACRIN. "These results will give clinicians better guidance and greater choice
in deciding which women would benefit most from various forms of mammography,"
said senior author, Etta Pisano, M.D., University of North Carolina at Chapel
Hill.
Secondary goals measuring the relative cost-effectiveness of both digital and
film technologies, and the effect on participant quality of life due to the
expected reduction of false positives are still being assessed and will be
reported at a later date.
"This digital mammography study demonstrates how new technologies are expanding
our ability to detect breast cancer earlier in more women. The study
corroborates NCI's commitment to exploring advanced technologies in a wide
range of clinical applications and the critical role they can play in making
cancer a manageable disease," said NCI Director Andrew C. von Eschenbach, M.D.
Starting in October 2001, the Digital Mammographic Imaging Screening Trial (DMIST)
enrolled 49,528 women who had no signs of breast cancer at 33 sites in the
United States and Canada. Women in the trial were given both digital and film
examinations. Examinations were interpreted independently by two different
radiologists. Breast cancer status was determined through available breast
biopsy information within 15 months of study entry or through follow-up
mammography ten months or later after study entry.
Digital mammography takes an electronic image of the breast and stores it
directly in a computer, allowing the recorded data to be enhanced, magnified,
or manipulated for further evaluation. The electronic image also can be printed
on film. Film mammography units use film to both capture and display the image.
The sensitivity of film mammography is somewhat limited in women with dense
breasts, a population at higher risk for breast cancer.
General Electric Medical Systems, Fuji Medical Systems, Fischer Imaging, and
Hologic digital mammography systems were tested in the trial. Of these, all
except for the Fuji system are already approved by the U.S. Food and Drug
Administration and are available for clinical use in the United States.
An estimated 211,240 women will be diagnosed with breast cancer in the U.S.
this year, making it the most commonly diagnosed cancer in women. An estimated
40,410 women will die of the disease this year in the United States.
# # #
For a Q&A on this study, go to
http://www.nci.nih.gov/newscenter/pressreleases/DMISTQandA
For more information about the Digital Mammographic Imaging Screening Trial
(DMIST), please go to the DMIST Web site at
http://www.cancer.gov/dmist.
For more information about cancer, visit the NCI Web site at
http://www.cancer.gov or call NCI's Cancer Information Service at 1-800-4
CANCER (1-800-422-6237).
* Pisano E, Gatsonis C, Hendrick E, Yaffe M, Baum J, Acharyya S, Conant E,
Fajardo L, Bassett L, D'Orsi C, Jong R, and Rebner M. Diagnostic Performance of
Digital versus Film Mammography for Breast Cancer Screening - The Results of
the American College of Radiology Imaging Network (ACRIN) Digital Mammographic
Imaging Screening Trial (DMIST). NEJM, published online September 16, 2005 and
in print on October 27, 2005.
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