Twelve-month follow-up results of a trial utilizing Axxent electronic brachytherapy to deliver intraoperative radiation therapy for early-stage breast cancer.

BACKGROUND: Accelerated partial breast irradiation (APBI) is emerging as a valid alternative to whole-breast radiation therapy (WBRT) in breast-conserving therapy (BCT) for early-stage breast cancer. Axxent electronic brachytherapy (EBX) is a form of portable, balloon-based APBI that utilizes an electronic source of kilovoltage irradiation delivery with minimal shielding requirements. As such, EBX becomes a logical and convenient modality for delivery of intraoperative radiation therapy (IORT). We report 1-year results and clinical outcomes of a trial that utilizes EBX to deliver IORT for patients with early-stage breast cancer. METHODS: Eleven patients were enrolled on an institutional review board (IRB)-approved protocol. Inclusion criteria were patient age >45 years, unifocal tumors with infiltrating ductal or ductal carcinoma in situ (DCIS) histology, tumors ≤3 cm, and uninvolved lymph nodes. Preloaded radiation plans were used to deliver radiation prescription dose of 20 Gy to the balloon surface. RESULTS: The mean time for radiation delivery was 22 min; the total mean procedure time was 1 h 39 min. All margins of excision were negative on final pathology. At mean follow-up of 12 months, overall cosmesis was excellent in 10 of 11 patients. No infection, fat necrosis, desquamation, rib fracture or cancer recurrence has been observed. There was no evidence of fibrosis at last follow-up. CONCLUSION: IORT utilizing EBX is emerging as a feasible, well-tolerated alternative to postsurgical APBI. Further research and longer follow-up data on EBX and other IORT methods are needed to establish the clinical efficacy and safety of this treatment.

Ductal lavage in the high-risk patient.

BACKGROUND: [corrected] This analysis was conducted in a single-surgeon clinical practice to evaluate the utility and practicality of performing ductal lavage in a population determined to be at high risk for breast cancer. METHODS: One hundred twenty patients with negative mammograms and/or negative breast examinations had nipple aspiration and ductal lavage performed by a single surgeon. All were at high risk either according to Gail risk score, a previous breast carcinoma, or nipple discharge. RESULTS: One hundred twenty patients underwent nipple aspiration. Thirty-two did not undergo lavage: 29 had no fluid, and 3 had unsuccessful cannulation. Eighty-eight underwent lavage: 15 had insufficient epithelial content, 51 had benign cytology, and 22 had abnormal cells. Of the 22, 20 had mild atypia, 1 had marked atypia, and 1 had malignant cells. CONCLUSIONS: Ductal lavage can be done in a surgical practice and can stratify risk for the individual patient. This is important to both patient and surgeon in formulating a treatment plan based on objective cytologic criteria.

Ductal lavage using medically aseptic technique in women at high risk for breast cancer.

Ductal lavage of the breast is a minimally invasive procedure used to collect epithelial cells from the lumen of the ductolobular system for cytologic analysis. The purpose of this study was to determine the safety of using an aseptic technique in performing ductal lavage. The study included 114 consecutive patients at high risk for breast cancer with clinically negative mammograms and no palpable masses. Ductal lavage could not be performed on 32 of the 114 patients (28%): 26 because nipple aspirate fluid could not be obtained, and 6 because a fluid-yielding duct could not be cannulated. Ductal lavage was successfully performed on 82 patients (72%). Local anesthetic cream was used on the nipple area and local anesthetic was infused into each duct. The nipple, the cup of the nipple aspirator device, and any dilator tools were cleansed with alcohol before use. Separate sterile microcatheters were used for each duct. Sterile saline solution was used for the infusions. No patient reported any symptoms indicating infection after lavage. Cytologic analysis from the 82 lavage cases showed 45 benign cells (55%), 17 cases of mild atypia (21%), 1 case of marked atypia, and 1 case with malignant cells. Eighteen samples (22%) had inadequate cellularity for medical diagnosis. The results of the study indicate that an aseptic technique is safe and appropriate for ductal lavage of the breast.

Current comprehensive assessment and management of women at increased risk for breast cancer.

The potential for reducing the risk of breast cancer through selective estrogen receptor modulators, aromatase inhibitors, and surgery has generated interest in the use of quantitative models of risk assessment. With the addition of ductal lavage cytology to traditional epidemiologic risk factors, a discovery of cellular atypia can result in refinement of assigned risk values, while simultaneously optimizing patient selection for selective estrogen receptor modulators utilization. In view of increasing complexity in this arena, a Risk Assessment Working Group was formed to outline management strategies for the patient at an elevated risk for the development of breast cancer. No longer a statistical exercise, quantitative risk assessment is part of basic breast care and comprehensive management includes a discussion of the following: ductal lavage for improved risk stratification, multiple options for risk reduction, and high risk surveillance strategies that might incorporate investigational imaging protocols.

Laser therapy for small breast cancers.

BACKGROUND: Widespread mammography has resulted in the increased detection of breast cancer <1.5 cm. It may be possible to treat these small tumors with in-situ laser ablation. Prior to ablation tumor size is determined by ultrasound and mammogram. Histologic diagnosis and determination of prognostic factors are obtained from image-guided needle core samples. Invasive and in-situ tumors may be percutaneously ablated by a stereotactically guided laser needle and subsequently evaluated by imaging methods and needle biopsy. METHODS: Fifty-four patients (50 invasive, 4 in-situ); 51 mass, 3 microcalcification; mean diameter 12 (5 to 23) mm were treated by a stereotactically guided 805 nm laser beam via a fiber in a 16G needle delivered to the cancer. One to 8 weeks later the coagulated lesions were surgically removed for pathologic evaluation. In 2 additional patients, the laser-treated tumors were not removed but were monitored by mammography, ultrasonography, and needle core biopsy. RESULTS: None of the patients sustained any adverse effect. The average treatment time was 30 minutes. Pathology analysis revealed a 2.5 to 3.5 hemorrhagic ring surrounding the necrotic tumor. Under steady conditions, in two groups of 14 patients, 93% and 100% of the tumors showed complete destruction, with no residual cancer report. In the 2 unresected cases kept under surveillance for 6 to 24 months, the laser-treated tumors first showed shrinkage, followed by a 2 to 3 cm oil cyst. Fibrosis was demonstrated on needle core biopsies. CONCLUSIONS: Laser energy delivered through a stereotactically guided needle appears to ablate mammographically detected breast cancer. A multicenter clinical trail is planned.