Accuracy of Intraoperative Frozen-Section Analysis of Breast Cancer Lumpectomy-Bed Margins

Department of Surgery, University of Florida, Gainesville, Florida, United States
Journal of the American College of Surgeons (Impact Factor: 5.12). 08/2005; 201(2):194-8. DOI: 10.1016/j.jamcollsurg.2005.03.014
Source: PubMed


My colleagues and I have been using intraoperative frozen-section analysis (FSA) to evaluate lumpectomy margins in an attempt to reduce the number of additional operations that patients with ductal carcinoma in situ or stage I and II breast cancer would have to endure. We review our experience in breast-conservation therapy (BCT) at the University of Florida (Gainesville) to determine the effectiveness of this approach.
Operative reports, operative logs, and pathology reports were retrospectively reviewed for patients who had BCT from January 2001 to January 2004. Ninety-seven patients (116 operations) were reviewed.
Nineteen patients required an additional operation (19.6%). Forty-three patients had positive margins on paraffin-embedded histologic analysis (44.3%). Accuracy of FSA was 84% when evaluated on a per-case basis, and 96% on a per-slide basis. False negatives were identified in 22 patients, affecting the operative pathway of 19 patients (19.6%) and were identified more frequently in cases of ductal carcinoma in situ (p < 0.001). There were no false positives. Additional operative time required for FSA was approximately 13 minutes per case. Eighty-four (86.6%) patients had successful BCT and 13 patients (13.4%) required mastectomy.
Intraoperative analysis of margins using FSA is effective at minimizing the number of additional operations, with 19 patients benefiting from immediate intervention in this study. The authors believe that the number of second operations prevented and the high BCT rates justify performing FSA. Ductal carcinoma in situ is more difficult to identify in FSA. Preoperative discussions with the patient should reflect these findings.

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    • "Touch-prep cytology and frozen-section analysis can reduce surgical re-excision rates; reported sensitivities and specificities for touch-prep are 38–100% and 83–100%, respectively [15]–[22]. Sensitivity of frozen section ranges from 59–91% and specificity ranges from 86–100% [18], [23]–[29]. Although these two approaches have been shown to be beneficial to the surgeon, there are a number of limitations with each. "
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    ABSTRACT: Breast conserving surgery (BCS) is a recommended treatment for breast cancer patients where the goal is to remove the tumor and a surrounding rim of normal tissue. Unfortunately, a high percentage of patients return for additional surgeries to remove all of the cancer. Post-operative pathology is the gold standard for evaluating BCS margins but is limited due to the amount of tissue that can be sampled. Frozen section analysis and touch-preparation cytology have been proposed to address the surgical needs but also have sampling limitations. These issues represent an unmet clinical need for guidance in resecting malignant tissue intra-operatively and for pathological sampling. We have developed a quantitative spectral imaging device to examine margins intra-operatively. The context in which this technology is applied (intra-operative or post-operative setting) is influenced by time after excision and surgical factors including cautery and the presence of patent blue dye (specifically Lymphazurin™, used for sentinel lymph node mapping). Optical endpoints of hemoglobin ([THb]), fat ([β-carotene]), and fibroglandular content via light scattering (<µ(s)'>) measurements were quantified from diffuse reflectance spectra of lumpectomy and mastectomy specimens using a Monte Carlo model. A linear longitudinal mixed-effects model was used to fit the optical endpoints for the cautery and kinetics studies. Monte Carlo simulations and tissue mimicking phantoms were used for the patent blue dye experiments. [THb], [β-carotene], and <µ(s)'> were affected by <3.3% error with <80 µM of patent blue dye. The percent change in [β-carotene], <µ(s)'>, and [β-carotene]/<µ(s)'> was <14% in 30 minutes, while percent change in [THb] was >40%. [β-carotene] and [β-carotene]/<µ(s)'> were the only parameters not affected by cautery. This work demonstrates the importance of understanding the post-excision kinetics of ex-vivo tissue and the presence of cautery and patent blue dye for breast tumor margin assessment, to accurately interpret data and exploit underling sources of contrast.
    Full-text · Article · Dec 2012 · PLoS ONE
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    • "Frozen section histology, while relatively accurate in reflecting margin status, is limited due to time, cost, and loss of tissue for permanent section evaluation. Furthermore this method is very labor intensive and can only examine a limited amount of tissue, with false negative rates reported in 19% of patients [52]. Imprint cytology or “touch prep” involves touching the lumpectomy margins to a glass slide, then fixing and staining them based on the principle that cancer cells will stick to the slide and fat cells will not. "
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    ABSTRACT: Adequate surgical margins in breast-conserving surgery for breast cancer have traditionally been viewed as a predictor of local recurrence rates. There is still no consensus on what constitutes an adequate surgical margin, however it is clear that there is a trade-off between widely clear margins and acceptable cosmesis. Preoperative approaches to plan extent of resection with appropriate margins (in the setting of surgery first as well as after neoadjuvant chemotherapy,) include mammography, US, and MRI. Improvements have been made in preoperative lesion localization strategies for surgery, as well as intraoperative specimen assessment, in order to ensure complete removal of imaging findings and facilitate margin clearance. Intraoperative strategies to accurately assess tumor and cavity margins include cavity shave techniques, as well as novel technologies for margin probes. Ablative techniques, including radiofrequency ablation as well as intraoperative radiation, may be used to extend tumor-free margins without resecting additional tissue. Oncoplastic techniques allow for wider resections while maintaining cosmesis and have acceptable local recurrence rates, however often involve surgery on the contralateral breast. As systemic therapy for breast cancer continues to improve, it is unclear what the importance of surgical margins on local control rates will be in the future.
    Full-text · Article · Dec 2012 · International Journal of Surgical Oncology
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    • "(45–600 nm) and demonstrates a sensitivity and specificity of 79.45% and 66.7%, respectively, in an initial study. Dune Medical Devices, Inc., the sponsor of the MarginProbe is seeking premarket approval from the FDA [30]. "
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    ABSTRACT: Tumor surgical resection margin status is important for any malignant lesion. When this occurs in conjunction with efforts to preserve or conserve the afflicted organ, these margins become extremely important. With the demonstration of no difference in overall survival between mastectomy versus lumpectomy and radiation for breast carcinoma, there is a definite trend toward smaller resections combined with radiation, constituting "breast-conserving therapy." Tumor-free margins are therefore key to the success of this treatment protocol. We discuss the various aspects of margin status in this setting, from a pathology perspective, incorporating the past and current practices with a brief glimpse of emerging future techniques.
    Full-text · Article · Nov 2012 · International Journal of Surgical Oncology
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