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.
IPEX combined with straightforward histologic and radiologic criteria and imaging surveillance constitutes acceptable management of image-detected HRL, including ADH.
B reast carcinoma arises in the epithelial cells lining the milk ducts and lobules that comprise the ductal system of the breast. 1,2 Ductal lavage is a minimally invasive office procedure performed on women who are considered to be at high risk for breast carcinoma to collect breast ductal epithelial cells for cytologic analysis to provide further risk stratification. The procedure involves the insertion of a microcatheter approximately 1.5 cm into a nipple orifice after topical anesthesia; lavaging the cannulated ductal system with normal saline; and analyzing the collected lavage effluent for the presence of normal, atypical, or malignant breast ductal cells.The purpose of this commentary is to review the data supporting breast ductal cytology as a tool to provide high-risk women with individualized information regarding their risk of developing breast carcinoma, and to provide a discussion of clinical management options based on the results of ductal lavage cytology.
Significance of Atypical Ductal Epithelial CellsPublished, peer-reviewed data with long-term follow-up have demonstrated that women with atypical ductal epithelial cells have an elevated, near-term risk of developing breast carcinoma. Wrensch et al. collected ductal epithelial cells from 2701 women volunteers by nipple aspiration, analyzed those cells cytologically, and performed prospective longitudinal follow-up on 2343 women with an average follow-up period of 12.7 years. 3 This study demonstrated that women with cellular atypia in nipple aspirate fluid (NAF) had a relative risk of developing breast carcinoma that was 4.9 times greater than women whose breasts did not yield NAF. Women with a family history of breast carcinoma and cellular atypia on NAF had an increase in their relative risk that was 18 times greater than that for women without cellular atypia on NAF. 3 292
Background
Accurate identification of the tumor bed after breast-conserving surgery (BCS) ensures appropriate radiation to the tumor bed while minimizing normal tissue exposure. The BioZorb® three-dimensional (3D) bioabsorbable tissue marker provides a reliable target for radiation therapy (RT) planning and follow-up evaluation while serving as a scaffold to maintain breast contour.
Methods
After informed consent, 818 patients (826 breasts) implanted with the BioZorb® at 14 U.S. sites were enrolled in a national registry. All the patients were prospectively followed with the BioZorb® implant after BCS. The data collected at 3, 6, 12, and 24 months included all demographics, treatment parameters, and provider/patient-assessed cosmesis.
Results
The median follow-up period was 18.2 months (range, 0.2–53.4 months). The 30-day breast infection rate was 0.5 % of the patients (n = 4), and re-excision was performed for 8.1 % of the patients (n = 66), whereas 2.6 % of the patients (n = 21) underwent mastectomy. Two patients (0.2 %) had local recurrence. The patient-reported cosmetic outcomes at 6, 12, and 24 months were rated as good-to-excellent by 92.4 %, 90.6 %, and 87.3 % of the patients, respectively and similarly by the surgeons. The radiation oncologists reported planning of target volume (PTV) reduction for 46.2 % of the patients receiving radiation boost, with PTV reduction most commonly estimated at 30 %.
Conclusions
This report describes the first large multicenter study of 818 patients implanted with the BioZorb® tissue marker during BCS. Radiation oncologists found that the device yielded reduced PTVs and that both the patients and the surgeons reported good-to-excellent long-term cosmetic outcomes, with low adverse effects. The BioZorb® 3D tissue marker is a safe adjunct to BCS and may add benefits for both surgeons and radiation oncologists.
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