© 2001 by Oxford University Press
Journal of the National Cancer Institute, Vol. 93, No. 21, 1624-1632,
November 7, 2001
© 2001 Oxford University Press
ARTICLE |
Ductal Lavage for Detection of Cellular Atypia in Women at High Risk for Breast Cancer
Affiliations of authors: W. C. Dooley, Institute for Breast Health, University of Oklahoma Health Sciences Center, Oklahoma City; B.-M. Ljung, E. B. King (Department of Pathology), L. J. Esserman (Department of Surgery), University of California, San Francisco; U. Veronesi, M. Cazzaniga, Istituto Europeo di Oncologia, Milan, Italy; R. M. Elledge, Breast Care Center, Baylor College of Medicine, Houston, TX; J. A. O'Shaughnessy, Baylor–Sammons Cancer Center, US Oncology, Dallas, TX; H. M. Kuerer, Department of Surgery, The University of Texas M. D. Anderson Cancer Center, Houston; D. T. Hung, Pro
Duct Health, Inc., Menlo Park, CA; S. A. Khan, Department of Surgery, Northwestern Memorial Hospital, Chicago, IL; R. F. Phillips, Metro Surgical Associates, Decatur, GA; P. A. Ganz, Division of Cancer Prevention and Control Research, Jonsson Comprehensive Cancer Center, University of California, Los Angeles; D. M. Euhus, Division of Surgical Oncology, The University of Texas Southwestern Medical Center, Dallas; B. G. Haffty, B. L. King, Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, CT; M. C. Kelley, Division of Surgical Oncology, Vanderbilt University Medical Center, Nashville, TN; M. M. Anderson, Department of Surgery, Martin Luther King/Charles Drew Medical Center, Los Angeles; P. J. Schmit, Department of Surgery, Olive View–University of California at Los Angeles Medical Center, Sylmar; R. R. Clark, The Breast Care Center, Santa Barbara, CA; F. C. Kass, Cancer Center of Santa Barbara; B. O. Anderson, Department of Surgery, University of Washington, Seattle; S. L. Troyan, Department of Surgery, Beth Israel Deaconess Medical Center, Boston, MA; R. D. Arias, Department of Obstetrics and Gynecology, University of Southern California, Los Angeles; J. N. Quiring, QST Consultations, Ltd., Allendale, MI; S. M. Love, University of California, Los Angeles; D. L. Page, Department of Pathology, Vanderbilt University.
Correspondence to: William C. Dooley, M.D., Institute for Breast Health, University of Oklahoma Health Sciences Center, 920 Stanton Young Blvd., Rm. WP-1140, Oklahoma City, OK 73104 (e-mail: william-dooley{at}ouhsc.edu).
Background: Breast cancer originates in breast epithelium and is associated with progressive molecular and morphologic changes. Women with atypical breast ductal epithelial cells have an increased relative risk of breast cancer. In this study, ductal lavage, a new procedure for collecting ductal cells with a microcatheter, was compared with nipple aspiration with regard to safety, tolerability, and the ability to detect abnormal breast epithelial cells. Methods: Women at high risk for breast cancer who had nonsuspicious mammograms and clinical breast examinations underwent nipple aspiration followed by lavage of fluid-yielding ducts. All statistical tests were two-sided. Results: The 507 women enrolled included 291 (57%) with a history of breast cancer and 199 (39%) with a 5-year Gail risk for breast cancer of 1.7% or more. Nipple aspirate fluid (NAF) samples were evaluated cytologically for 417 women, and ductal lavage samples were evaluated for 383 women. Adequate samples for diagnosis were collected from 111 (27%) and 299 (78%) women, respectively. A median of 13 500 epithelial cells per duct (range, 43–492 000 cells) was collected by ductal lavage compared with a median of 120 epithelial cells per breast (range, 10–74 300) collected by nipple aspiration. For ductal lavage, 92 (24%) subjects had abnormal cells that were mildly (17%) or markedly (6%) atypical or malignant (<1%). For NAF, corresponding percentages were 6%, 3%, and fewer than 1%. Ductal lavage detected abnormal intraductal breast cells 3.2 times more often than nipple aspiration (79 versus 25 breasts; McNemar's test, P<.001). No serious procedure-related adverse events were reported. Conclusions: Large numbers of ductal cells can be collected by ductal lavage to detect atypical cellular changes within the breast. Ductal lavage is a safe and well-tolerated procedure and is a more sensitive method of detecting cellular atypia than nipple aspiration.
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