A Three-Dimensional Bioabsorbable Tissue Marker for Volume Replacement and Radiation Planning: A Multicenter Study of Surgical and Patient-Reported Outcomes for 818 Patients with Breast Cancer.

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.

Definitive diagnosis for high-risk breast lesions without open surgical excision: the Intact Percutaneous Excision Trial (IPET).

BACKGROUND: Open surgical excision (OSE) is generally recommended when image-guided core-needle breast biopsy demonstrates a high-risk lesion (HRL). We evaluated intact percutaneous excision (IPEX) with standard radiologic and histologic criteria for definitive diagnosis of HRL, particularly atypical ductal hyperplasia (ADH). The primary aim is to confirm criteria associated with <2% risk for upgrade to carcinoma, equivalent to risk associated with Breast Imaging Reporting and Data System (BI-RADS) 3 lesions, for which imaging surveillance is considered sufficient. METHODS: In a prospective trial, 1,170 patients recommended for breast biopsy at 25 institutions received IPEX with a vacuum- and radiofrequency-assisted device. ADH patients in whom the imaged lesion had been removed and the lesion adequately centered for definitive characterization were designated as the potential surgical avoidance population (PSAP) before OSE. Subsequent OSE specimen pathology was compared with IPEX findings. RESULTS: In 1,170 patients, 191 carcinomas and 83 (7%) HRL, including 32 ADH (3%), were diagnosed via IPEX. None of the 51 non-ADH HRL were upgraded to carcinoma on OSE (n = 24) or, if OSE was declined, on radiologic follow-up (n = 27). No ADH lesions meeting PSAP criteria (n = 10) were upgraded to carcinoma on OSE; 3 (14%) of 22 non-PSAP ADH lesions were upgraded to carcinoma on OSE. In summary, no upgrades to carcinoma were made in patients with non-ADH lesions who underwent IPEX or in ADH patients who had IPEX, met histologic and radiologic criteria, and underwent OSE or follow-up. CONCLUSION: IPEX combined with straightforward histologic and radiologic criteria and imaging surveillance constitutes acceptable management of image-detected HRL, including ADH.

Detection of chromosomal instability in paired breast surgery and ductal lavage specimens by interphase fluorescence in situ hybridization.

PURPOSE: Ductal lavage is a new modality for collecting exfoliated breast cells with the goal of detecting early neoplasia. The purpose of our study was to evaluate the correlation between cancer-associated abnormalities in breast lesions and exfoliated breast cells collected by ductal lavage. EXPERIMENTAL DESIGN: We performed histopathologic, cytologic, and molecular cytogenetic analyses on 39 paired cases of surgically excised breast lesions and ductal lavage specimens collected immediately before surgery. RESULTS: Abnormal cytology was detected in 7 of 15 (47%) of the evaluable lavages collected from malignant cases, versus 4 of 19 (21%) of the evaluable lavages harvested from benign cases for a sensitivity and specificity of 47 and 79%, respectively. Interphase fluorescence in situ hybridization analysis of all evaluable lavages revealed numeric changes on chromosomes 1, 8, 11, and/or 17 in 10 of 14 (71%) specimens from malignant cases versus 2 of 18 (11%) from benign cases for a sensitivity and specificity of 71 and 89%, respectively. CONCLUSIONS: Our study demonstrates that cytologic and genetic abnormalities associated with breast cancer progression can be detected in ductal lavage cells collected from women with in situ and invasive breast cancer and suggests that fluorescence in situ hybridization may have superior sensitivity and specificity compared with conventional cytology.

Enhancing cancer control programmatic and research opportunities for African-Americans through technical assistance training.

African-Americans remain severely underrepresented in cancer control program delivery and research. Community-based organizational leaders and minority junior investigators have received little attention as representatives of target populations, or as agents to deliver and evaluate efforts to eliminate cancer health disparities. This paper describes activities of the National Black Leadership Initiative on Cancer II: Network Project, which has sought to address these issues. Community leaders and junior investigators received technical assistance (TA) and mentoring to develop applications for cancer education and community-based participatory research (CBPR) projects. TA was provided to 35 community leaders and 32 junior investigators. Twenty-nine community leaders won funding through the Community Partners for Cancer Education Program. Three pilot research applications were funded. Technical assistance may improve minority recruitment/retention in CBPR cancer control research and enhance understanding and elimination of cancer health disparities among African-Americans. Cancer 2006. (c) American Cancer Society.

Immunocytochemical analysis of breast cells obtained by ductal lavage.

BACKGROUND: Intraductal breast fluids containing exfoliated mammary epithelial cells can be harvested from the breast by ductal lavage to screen for disease-associated cytologic abnormalities. In addition to epithelial cells, breast fluids contain large numbers of mammary foam cells, and the tissue of origin of these foam cells has been the subject of controversy for many years. Immunocytochemical, morphologic, and molecular studies variously have supported a mammary epithelial origin versus a histiocytic origin for this cell type. In the current study, the authors performed immunocytochemical analysis with epithelial specific and macrophage specific antibodies to characterize and quantify breast cells obtained by ductal lavage. METHODS: Breast fluids were harvested from 19 individual breast ducts in 15 female patients by ductal lavage. Cells from each specimen were processed for immunocytochemical staining using the AE1/AE3 multicytokeratin and CD68 (clone KP1) monoclonal antibodies. Cells were classified as mammary epithelial cells or mammary foam cells on the basis of morphologic criteria, and the cells were counted and evaluated for immunoreactivity with epithelial specific and macrophage specific antibodies. RESULTS: The CD68 macrophage specific antibody stained all ductal lavage cells that exhibited foam cell morphology. The AE1/AE3 multicytokeratin antibody demonstrated strong, positive staining of cells that exhibited epithelial morphology but failed to demonstrate significant staining of mammary foam cells. The lavage specimens contained a range of 3040-278,850 epithelial cells and 2230-90,480 foam cells. The median numbers of epithelial cells and foam cells per lavage sample were 15,680 and 29,200, respectively. The ratio of epithelial cells to foam cells varied among specimens ranging from 3.4 to 0.09 (median, 0.8). Seven of 19 lavage specimens contained more epithelial cells than foam cells, whereas 12 samples contained a greater proportion of foam cells. CONCLUSIONS: Immunocytochemical analysis using the AE1/AE3 multicytokeratin and CD68 antibodies supports a histiocytic origin for the majority of mammary foam cells harvested from the ductal system of the human breast by ductal lavage. Although mammary foam cells constitute a significant proportion of the cellular population obtained by ductal lavage, thousands of epithelial cells also are harvested.