An exploratory clinical trial of preoperative non-invasive localization before breast-conserving surgery using augmented reality technology.

PURPOSE: This single-center, randomized, prospective, exploratory clinical trial was conducted to assess the clinical efficacy of an augmented reality (AR)-based breast cancer localization imaging solution for patients with breast cancer. METHODS: This clinical trial enrolled 20 women who were diagnosed with invasive breast cancer between the ages of 19 and 80, had a single lesion with a diameter ≥ 5 mm but ≤ 30 mm, had no metastases to other organs, and had not received prior chemotherapy. All patients underwent mammography, ultrasound, computed tomography, and magnetic resonance imaging for preoperative assessment. Patients were randomly assigned to ultrasound-guided skin marking localization (USL) and AR-based localization (ARL) groups (n = 10 in each group). Statistical comparisons between USL and ARL groups were made based on demographics, radiologic features, pathological outcomes, and surgical outcomes using chi-square and Student t-tests. RESULTS: Two surgeons performed breast-conserving surgery on 20 patients. Histopathologic evaluation of all patients confirmed negative margins. Two independent pathologists evaluated the marginal distances, and there were no intergroup differences in the readers' estimates (R1, 6.20 ± 4.37 vs. 5.04 ± 3.47, P = 0.519; R2, 5.10 ± 4.31 vs. 4.10 ± 2.38, P = 0.970) or the readers' average values (5.65 ± 4.19 vs. 4.57 ± 2.84, P = 0.509). In comparing the tumor plane area ratio, there was no statistically significant difference between the two groups in terms of either reader's mean values (R1, 15.90 ± 9.52 vs. 19.38 ± 14.05, P = 0.525; R2, 15.32 ± 9.48 vs. 20.83 ± 12.85, P = 0.290) or the overall mean values of two readers combined (15.56 ± 9.11 vs. 20.09 ± 13.38, P = 0.388). Convenience, safety, satisfaction, and reusability were all superior in the AR localization group (P < 0.001) based on the two surgeons' responses. CONCLUSION: AR localization is an acceptable alternative to ultrasound-guided skin marking with no significant differences in surgical outcomes.

Effects of Prostaglandin E1 on Mastectomy Flap Necrosis in Immediate Implant-based Breast Reconstruction.

PURPOSE: Necrosis of a cutaneous flap including the nipple-areolar complex is a common complication in immediate implant-based breast reconstruction following nipple/skin-sparing mastectomy (NSM/SSM). This study aimed to evaluate the efficacy of prostaglandin E1 (PGE1) in reducing such complications. METHODS: A retrospective analysis of prospectively collected data was conducted at two centers, and the cohort consisted of patients undergoing NSM/SSM followed by immediate reconstruction with a prosthesis. Patients who were randomly allocated to the treatment group were administered daily intravenous PGE1 (10 mcg/2 mL) beginning intraoperatively through postoperative day 6. Skin flap complications including nipple/skin necrosis, delayed wound healing, and postoperative wound revision were recorded. Complication rates were compared between the PGE1 and control groups. RESULTS: A total of 276 breasts in 259 patients were included for analysis (139 breasts to the treatment group and 137 breasts to the control group). There was no difference in patient demographics between the control and treatment group. Reconstructed breasts receiving PGE1 had significantly lower rates for overall skin complications (21.6% vs. 34.3%, p=0.022) and wound revision (2.9% vs. 9.5%, p=0.025). Among NSM cases, the PGE1 group showed a significantly lower rate of nipple necrosis (15.5% vs. 29.4%, p=0.027). In the multivariate analysis, the use of PGE1 significantly reduced the risk of overall skin flap complications (odds=0.491, p=0.018), wound revision (odds=0.213, p=0.018) in NSM/SSM cases, and nipple necrosis (odds=0.357 p=0.008) in NSM cases. CONCLUSION: PGE1 can be effective in reducing risk of mastectomy flap complications in immediate implant-based breast reconstructions.

Risk factor for axillary lymph node metastases in microinvasive breast cancer.

BACKGROUND: Sentinel lymph node biopsy (SLNB) in patients with ductal carcinoma in situ (DCIS) was controversial. Usually we did not do a SLN biopsy when we performed conserving operations with small-sized DCIS. However, sometimes we find DCIS with microinvasive breast cancer (MIC) after the operation. Must reoperations be performed in all patients? The incidence of axillary metastases in microinvasive breast cancer (MIC) has not been extensively studied. We determined the incidence of positive axillary lymph node (ALN) in patients with MIC and the predictive factors of ALN metastases in these patients. METHODS: Between July 1989 and December 2008, 9635 patients had operation on invasive breast cancer in Asan Medical Center. Among these patients, 319 patients had MIC. The research conducted on the 293 patients (excluded were 26 who did not receive axillary lymph node dissection or SLN biopsy). We retrospectively checked clinical and pathologic variables. RESULTS: There were 22 cases of ALN metastases identified in this group of patients (7.5%). Lymphatic invasion (P < .001) and positive estrogen receptor status (P = 03) were independent significant predictors of axillary metastases. CONCLUSIONS: Microinvasive breast cancer is associated with a low rate of lymph node metastases. Some breast cancer patients with MIC at low likelihood of lymph node metastases may be spared lymph node evaluation.

Impact of omission of axillary lymph node dissection after negative sentinel lymph node biopsy: 70-month follow-up.

BACKGROUND: The objective of this study is to assess the oncologic safety of sentinel lymph node biopsy (SLNB), especially with regard to the axillary recurrence (AR) rate, and to determine the risk factors for AR and disease-free survival (DFS) and overall survival (OS) after negative SLNB. MATERIALS AND METHODS: Between 2003 and 2006, a total of 1626 patients with invasive breast cancer and clinically axillary node-negative tumors underwent SLNB using a radioisotope at the Asan Medical Center. Of these patients, 1196 were negative on SLNB. Among these, 709 underwent SLNB only, and 487 underwent SLNB and axillary lymph node dissection (ALND). We included patients with any size tumors, except for those with inflammatory breast cancer, if patients had clinically negative lymph nodes. RESULTS: Mean follow-up was 70.2 months for the SLNB-only group and 71.5 months for the SLNB and ALND group. The 5-year axillary-free survival rates were 98.91% (95% confidence interval [95% CI] 70.2-71.0) and 99.36% (95% CI 71.3-72.0), respectively; the 5-year DFS rates were 95.17% and 95.18%, respectively (log rank P = .543); and the 5-year OS rates were 98.36% and 98.75%, respectively (log rank P = .380). Univariate analysis showed that negative hormone receptor status (P = .002) and high tumor grade (P = .032) were significant prognostic factors for AR in the SLNB only group. Multifocality and tumor size did not affect the rate of AR. CONCLUSION: SLNB alone is an oncologically safe procedure in clinically node negative patients abrogating the need for further ALND. Negative hormone receptor status and high tumor grade might be risk factors for AR.

Nipple areola skin-sparing mastectomy with immediate transverse rectus abdominis musculocutaneous flap reconstruction is an oncologically safe procedure: a single center study.

OBJECTIVE: The present study evaluated the oncological safety and technical outcomes following nipple areola skin-sparing mastectomy (NASSM), skin-sparing mastectomy (SSM), and mastectomy. SUMMARY BACKGROUND DATA: Cosmetic issues associated with breast cancer surgery are important. The original SSM technique included removal of the gland and the nipple areola complex (NAC). However, the risk of tumor involvement of the NAC has been overestimated. PATIENTS AND METHODS: This retrospective study included 520 patients who underwent SSM (368 patients) or NASSM (152 patients) with immediate breast reconstruction using a pedicled transverse rectus abdominis musculocutaneous (TRAM) flap, and 1990 patients who underwent a mastectomy between July 2001 and December 2006. The indications for NASSM were any stage, any tumor size, and any tumor areola distance. Briefly, the NAC was preserved when the shape, color, and palpation of the nipple were normal. RESULTS: The median follow-up durations for NASSM and SSM were 60 and 67 months, respectively. Complete nipple areola necrosis developed in 11 (9.6%) NASSM patients. The 5-year disease-free survival rates were 89% and 87.2% for NASSM and SSM, respectively (P = 0.695). The 5-year overall survival rates were similar for NASSM and SSM (97.1% and 95.8%, respectively; P = 0.669). Local failure occurred in 3 (2%) NASSM and 3 (0.8%) SSM patients (P = 0.27). There were 2 (1.3%) nipple areola recurrences in NASSM patients. The LRRs were similar for NASSM and mastectomy patients. CONCLUSION: NASSM with immediate transverse rectus abdominis musculocutaneous reconstruction is a viable surgical treatment in breast cancer patients in any stage. Recurrence and complication rates for NASSM were similar to those for standard surgical breast cancer treatments.

Axillary recurrence after negative sentinel lymph node biopsy.

BACKGROUND: Sentinel lymph node biopsy (SLNB) has almost totally replaced axillary lymph node dissection as the first-line axillary procedure for node-negative breast cancer. SLNB has a false-negative rate of 0-22%, and regional nodal recurrence is a major concern after SLNB. In this study, we assessed axillary recurrence and risk factors in breast cancer patients 40 months after negative SLNB. METHODS: Of 940 patients with node-negative breast cancer who underwent SLNB between December 2003 and January 2006 at Asan Medical Center, 720 were negative on SLNB, as determined using 99-m TC radiocolloid and subareolar injection technique. Of the 720 patients negative on SLNB, 174 underwent further axillary dissection, 253 underwent node sampling, and 293 received SLNB only. RESULTS: A mean of 2.1 SLNs was removed per patient. At a median follow-up of 40 months (range 24-49 months), recurrence in the axilla was observed in three patients, all of whom had undergone SLNB only; two of these patients also had recurrences in internal mammary lymph nodes. Tumors in all three patients were hormone-receptor negative, and two were c-erbb2 negative. CONCLUSION: The axillary recurrence rate was low in patients negative on SLNB. Negative hormone-receptor status and high nuclear grade may be risk factors for regional nodal failure after SLNB.

Sentinel node biopsy in patients with multiple breast cancer.

BACKGROUND: Multicentric or multifocal breast cancer is considered a limitation for sentinel lymph node biopsy (SLNB). Studies showing that all quadrants of the breast drain via common afferent lymphatic channels indicate that multiple tumors do not affect lymphatic drainage. We therefore assessed the accuracy of SLNB in patients with multiple breast tumors. METHODS: Of the 942 breast cancer patients who underwent SLNB using radioisotope at Asan Medical Center between January 2003 and December 2006, 803 had unifocal and 139 had multiple tumors. Axillary dissection after SLNB was performed on 884 patients, 757 with unifocal and 127 with multiple tumors. All patients underwent lymphatic scintigram for removal of sentinel lymph nodes (SLNs). The clinical characteristics and accuracy of SLNB was compared in patients with unifocal and multiple breast cancer. RESULTS: In the multiple tumor group, 2.68 +/- 0.84 SLNs were identified in 136 of 139 patients (identification rate, 97.84%); 81.5% of SLNs were identified by scintigram. The incidence of axillary metastases was 29.50% (41/139). SLNB accuracy was 97.63% (124/127), with a false negative (FN) rate of 7.89% (3/38). In the unifocal group, 2.67 +/- 0.96 SLNs were identified in 787 of 803 patients (identification rate, 98.00%); 84.8% of SLNs were identified by scintigram. The incidence of axillary metastasis was 22.04% (177/803). SLNB accuracy was 98.02% (742/757), with a FN rate of 8.62% (15/174). The accuracy and FN rate of SLNB did not differ significantly between unifocal and multiple breast cancer. CONCLUSION: The accuracy of SLNB in multiple breast cancer is comparable to its accuracy in unifocal cancer. These findings indicate that SLNB can be used an as alternative to complete axillary lymph node dissection in patients with multiple breast tumors.