BackgroundThe presence of tumor cells at the margins of breast lumpectomy specimens is associated with an increased risk of ipsilateral tumor recurrence. Twenty to 30 % of patients undergoing breast-conserving surgery require second procedures to achieve negative margins. This study evaluated the adjunctive use of the MarginProbe device (Dune Medical Devices Ltd, Caesarea, Israel) in providing real-time intraoperative assessment of lumpectomy margins.MethodsThis multicenter randomized trial enrolled patients with nonpalpable breast malignancies. The study evaluated MarginProbe use in addition to standard intraoperative methods for margin assessment. After specimen removal and inspection, patients were randomized to device or control arms. In the device arm, MarginProbe was used to examine the main lumpectomy specimens and direct additional excision of positive margins. Intraoperative imaging was used in both arms; no intraoperative pathology assessment was permitted.Results In total, 596 patients were enrolled. False-negative rates were 24.8 and 66.1 % and false-positive rates were 53.6 and 16.6 % in the device and control arms, respectively. All positive margins on positive main specimens were resected in 62 % (101 of 163) of cases in the device arm, versus 22 % (33 of 147) in the control arm (p < 0.001). A total of 19.8 % (59 of 298) of patients in the device arm underwent a reexcision procedure compared with 25.8 % (77 of 298) in the control arm (6 % absolute, 23 % relative reduction). The difference in tissue volume removed was not significant.ConclusionsAdjunctive use of the MarginProbe device during breast-conserving surgery improved surgeons’ ability to identify and resect positive lumpectomy margins in the absence of intraoperative pathology assessment, reducing the number of patients requiring reexcision. MarginProbe may aid performance of breast-conserving surgery by reducing the burden of reexcision procedures for patients and the health care system.
CAL is a superior alternative to wire localization. Ultrasonographic visualization of the ice ball allows the size of the margin and tissue resected to be individually tailored and accurate within millimeters. The created template allows a precise lumpectomy, adding a dimension of control not previously realized with any other technology.
Objectives: To describe observations of one-year follow-up of subjects treated on a multi-center, non-randomized study with a single fraction of intra-operative radiation therapy (IORT) using the Xoft® Axxent® Electronic Brachytherapy System® (eBx®) immediately following surgical resection of early stage breast cancer. Methods: Two-hundred forty three (243) subjects were treated at seventeen (17) US hospitals. Upon meeting the inclusion/exclusion criteria, patients underwent partial mastectomy, placement of a balloon applicator suitable to the surgical bed in the lumpectomy cavity and inflated with saline (30 – 75 cc). The skin was temporarily closed over the balloon and ultrasound examination performed to confirm that the balloon surface-to-skin distance was > 1.0 cm. A single fraction of intra-operative radiation therapy was delivered to the lumpectomy cavity using the Xoft System. The prescribed dose was 20 Gy at the balloon applicator surface, and the mean treatment time was 10.2 minutes. After treatment, the balloon was deflated and removed, and skin sutured. Results: Two-hundred forty two (242) subjects received the prescribed dose of 20 Gy; one subject received 21 Gy. Eighteen (18) subjects were removed from the primary analysis post-IORT due to positive surgical margins (N=2), positive sentinel lymph nodes (N=13), or balloon surface-to-skin distance < 1 cm (N=3). However, these eighteen subjects will continue to be followed for the duration of this 10-year study. The mean follow-up for the two-hundred twenty five evaluable subjects is 494 days (range 300-465 days). The mean patient age was 65 years (41-89). Forty-nine subjects (21.8%) had ductal carcinoma in situ, one-hundred seventy one (76%) had invasive ductal carcinoma, and five (2.2%) had unknown histology. The DCIS nuclear grade was evenly distributed between high (N=18) and low/intermediate (N=23); 5 were unknown. Invasive cancer was Grade 1-2 in 142/171 cases. Two-hundred twelve subjects (94.2%) had T1 lesions, eight (3.6%) had T2 lesions, and five (2.2%) were unknown. The mean tumor size was 10.6 mm ± 6.4 mm. At the time of the last subject visit, 49/318 reported adverse events were Grade 2 or higher, and only 1/100 had serious side effects, i.e. infection. One patient died of aortic aneurism and two developed secondary malignancies, i.e. ovarian cancer and chronic lymphocytic leukemia. The most frequent side effects were seroma (12.5%), erythema (9.1%), and induration (7.5%). Cosmesis was excellent to good in 95% of cases. Conclusions: IORT using the Xoft System as part of the conservative treatment of breast cancer is safe, with low morbidity. Early results from this multi-center trial demonstrate this short, convenient course of radiation therapy for select patients with early stage breast cancer has excellent-to-good cosmetic results and a low rate of low-grade adverse events. Citation Format: Syed AMN, Chang H, Schwartzberg BS, Bremner AK, Lopez-Penalver C, Coomer C, Boylan S, Chakravarthy A, Vito CA, Bhatnagar A, Proulx GM, Dooley WC, Davis M, Golder SL, Ivanov O, Fernandez K, Rahman S. One-year follow-up results of a multi-center trial of intra-operative radiation therapy using electronic brachytherapy at the time of breast conservation surgery for early stage breast cancer. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P3-12-11.
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