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Talimogene laherparepvec (T-VEC) is an immunotherapy that generates local tumor lysis and systemic antitumor immune response. We studied the efficacy of intratumoral administration of T-VEC as monotherapy for inoperable locoregional recurrence of breast cancer. T-VEC was injected intratumorally at 10 6 PFU/mL on day 1 (cycle 1), 10 8 PFU/mL on day 22 (cycle 2), and 10 8 PFU/mL every 2 weeks thereafter (cycles ≥ 3). Nine patients were enrolled, 6 with only locoregional disease and 3 with both locoregional and distant disease. No patient completed the planned 10 cycles or achieved complete or partial response. The median number of cycles administered was 4 (range, 3-8). Seven patients withdrew prematurely because of uncontrolled disease progression, 1 withdrew after cycle 3 because of fatigue, and 1 withdrew after cycle 4 for reasons unrelated to study treatment. Median progression-free survival and overall survival were 77 days (95% CI, 63-NA) and 361 days (95% CI, 240-NA). Two patients received 8 cycles with clinically stable disease as the best response. The most common grade 2 or higher adverse event was injection site reaction (n = 7, 78%). Future studies could examine whether combining intratumoral T-VEC with concurrent systemic therapy produces better outcomes., (© 2021. The Author(s).)

Background and Objectives: We assessed the cumulative incidence, symptoms, and risk factors for upper-extremity lymphedema in breast cancer and melanoma patients undergoing sentinel lymph node biopsy or axillary lymph node dissection., Methods: Patients were recruited preoperatively (time 0) and assessed at 6, 12, and 18 months postoperatively. Limb volume change (LVC) was measured by perometry. Lymphedema was categorized as none, mild (LVC 5-9.9%), or moderate/severe (LVC≥10%). Symptoms were assessed with a validated lymphedema instrument. Longitudinal logistic regression analyses were conducted to identify risk factors associated with moderate/severe lymphedema., Results: Among 205 breast cancer and 144 melanoma patients, the cumulative incidence of moderate/severe lymphedema at 18 months was 36.5% and 35.0%, respectively. However, in adjusted analyses, factors associated with moderate/severe lymphedema were breast cancer (OR 2.0, P = 0.03), body mass index ≥ 30 kg/m(2) (OR 1.6, P = 0.04), greater number of lymph nodes removed (OR 1.05, P < 0.01), and longer interval since surgery (OR 2.33 at 18 months, P < 0.01)., Conclusions: Lymphedema incidence increased over time in both cohorts. However, the adjusted risk of moderate/severe lymphedema was two-fold higher in breast cancer patients. These results may be attributed to surgical treatment of the primary tumor in the breast and more frequent use of radiation., (© 2015 Wiley Periodicals, Inc.)

Objective: This study was performed to evaluate long-term local-regional control rates after breast-conserving therapy (BCT) for patients undergoing surgery before or after neoadjuvant chemotherapy., Methods: There were 2983 patients who underwent segmental mastectomy with whole-breast irradiation from 1987 to 2005. Clinicopathological and outcome data were reviewed, and comparisons were made between those undergoing surgery before and those undergoing surgery after neoadjuvant chemotherapy., Results: There were 2331 patients (78%) who underwent surgery first and 652 (22%) received neoadjuvant chemotherapy. Patients receiving neoadjuvant chemotherapy had more advanced disease at baseline and more adverse clinicopathological features. The 5- and 10-year local-regional recurrence (LRR)-free survival rates were 97% [95% confidence interval (CI), 96-98) and 94% (95% CI, 93-95) for surgery first and 93% (95% CI, 91-95) and 90% (95% CI, 87-93) after neoadjuvant chemotherapy (P < 0.001). However, there were no differences in LRR-free survival rates when comparing the presenting clinical stage (P = NS). Of 607 patients presenting with clinical stage II/III disease, chemotherapy downstaged 313 patients (52%) to pathological stage 0/I disease; 294 (48%) had residual stage II/III disease. In multivariate analysis, an age less than 50 years, clinical stage III, grade 3, estrogen receptor (ER)-negative disease, estrogen receptor-positive disease without receipt of endocrine therapy, lymphovascular invasion, multifocal disease on pathology, and close/positive margins were associated with LRR. Use of neoadjuvant chemotherapy was not significant when added to the model. Adjusting for adverse factors, there were no differences in LRR between patients who underwent surgery before and those who underwent neoadjuvant chemotherapy after surgery., Conclusions: LRR after BCT is driven by tumor biology and disease stage. Appropriately selected patients can achieve high rates of local-regional control with BCT with either upfront surgery or surgery after neoadjuvant chemotherapy.

Background: Psychological effects of mastectomy for women with breast cancer have driven treatments that optimize cosmesis while strictly adhering to oncologic principles. Although skin-sparing mastectomy is oncologically safe, questions remain regarding the use of nipple-areola complex (NAC)-sparing mastectomy (NSM). We prospectively evaluated NSM for patients undergoing mastectomy for early-stage breast cancer or risk reduction., Methods: We enrolled 33 early-stage breast cancer and high-risk patient; 54 NSMs were performed. NAC viability and surgical complications were evaluated. Intraoperative and postoperative pathologic assessments of the NAC base tissue were performed. NAC sensory, cosmetic and quality of life (QOL) outcomes were also assessed., Results: Twenty-one bilateral and 12 unilateral NSMs were performed in 33 patients, 37 (68.5%) for prophylaxis and 17 (31.5%) for malignancy. Mean age was 45.4 years. Complications occurred in 16 NACs (29.6%) and 6 skin flaps (11.1%). Operative intervention for necrosis resulted in 4 NAC removals (7.4%). Two (11.8%) of the 17 breasts with cancer had ductal carcinoma-in-situ at the NAC margin, necessitating removal at mastectomy. All evaluable patients had nipple erection at 6 and 12 months postoperatively. Cosmetic outcome, evaluated by two plastic surgeons, was acceptable in 73.0% of breasts and 55.8% of NACs, but lateral displacement occurred in most cases. QOL assessment indicated patient satisfaction., Conclusions: NSM is technically feasible in select patients, with a low risk for NAC removal resulting from necrosis or intraoperative detection of cancer, and preserves sensation and QOL. Thorough pathologic assessment of the NAC base is critical to ensure disease eradication.

Background and Objective: Sentinel lymph node (SLN) metastasis size is an important predictor of non-SLN involvement. The goal of this study was to construct a nomogram incorporating SLN metastasis size to accurately predict non-SLN involvement in patients with SLN-positive disease., Methods: We identified 509 patients with invasive breast cancer with a positive SLN who underwent completion axillary lymph node dissection (ALND). Clinicopathologic data including age, tumor size, histology, grade, presence of multifocal disease, estrogen and progesterone receptor status, HER2/neu status, presence of lymphovascular invasion (LVI), number of SLN(s) identified, number of positive SLN(s), maximum SLN metastasis size and the presence of extranodal extension were recorded. Univariate and multivariate logistic regression analyses identified factors predictive of positive non-SLNs. Using these variables, a nomogram was constructed and subsequently validated using an external cohort of 464 patients., Results: On univariate analysis, the following factors were predictive of positive non-SLNs: number of SLN identified (P < 0.001), number of positive SLN (P < 0.001), SLN metastasis size (P < 0.001), extranodal extension (P < 0.001), tumor size (P = 0.001), LVI (P = 0.019), and histology (P = 0.034). On multivariate analysis, all factors remained significant except LVI. A nomogram was created using these variables (AUC = 0.80; 95% CI, 0.75-0.84). When applied to an external cohort, the nomogram was accurate and discriminating with an AUC = 0.74 (95% CI, 0.68-0.77)., Conclusion: SLN metastasis size is an important predictor for identifying non-SLN disease. In this study, we incorporated SLN metastasis size into a nomogram that accurately predicts the likelihood of having additional axillary metastasis and can assist in personalizing surgical management of breast cancer.

Background: Although the use of SSM is becoming more common, there are few data on long-term, local-regional, and distant recurrence rates after treatment. The purpose of this study was to examine the rates of local, regional, and systemic recurrence, and survival in breast cancer patients who underwent skin-sparing mastectomy (SSM) or conventional mastectomy (CM) at our institution., Methods: Patients with stage 0 to III unilateral breast cancer who underwent total mastectomy at our center from 2000 to 2005 were included in this study. Kaplan-Meier curves were calculated, and the log-rank test was used to evaluate the differences between overall and disease-free survival rates in the 2 groups., Results: Of 1810 patients, 799 (44.1%) underwent SSM and 1011 (55.9%) underwent CM. Patients who underwent CM were older (58.3 vs 49.3 years, P<.0001) and were more likely to have stage IIB or III disease (53.0% vs 31.8%, P<.0001). Significantly more patients in the CM group received neoadjuvant chemotherapy and adjuvant radiation therapy (P<.0001). At a median follow-up of 53 months, 119 patients (6.6%) had local, regional, or systemic recurrences. The local, regional, and systemic recurrence rates did not differ significantly between the SSM and CM groups. After adjusting for clinical TNM stage and age, disease-free survival rates between the SSM and CM groups did not differ significantly., Conclusions: SSM is an acceptable treatment option for patients who are candidates for immediate breast reconstruction. Local-regional recurrence rates are similar to those of patients undergoing CM. Cancer 2011. © 2010 American Cancer Society., (Copyright © 2010 American Cancer Society.)

Objective: To classify ipsilateral breast tumor recurrences (IBTR) as either new primary tumors (NP) or true local recurrence (TR). We utilized 2 different methods and compared sensitivities and specificities between them. Our goal was to determine whether distinguishing NP from TR had prognostic value., Background: After breast-conservation therapy, IBTR may be classified into 2 distinct types (NP and TR). Studies have attempted to classify IBTR by using tumor location, histologic subtype, DNA flow cytometry data, or gene-expression profiling data., Methods: A total of 447 (7.9%) of 5660 patients undergoing breast-conservation therapy from 1970 to 2005 experienced IBTR. Clinical data from 397 patients were available for review. We classified IBTRs as NP or TR on the basis of either tumor location and histologic subtype (method 1) or tumor location, histologic subtype, estrogen receptor status and human epidermal growth factor receptor 2 status (method 2). Kaplan-Meier curves and log-rank tests were used to evaluate overall and disease-specific survival differences between the 2 groups. Classification methods were validated by calculating sensitivity and specificity values using a Bayesian method., Results: Of 397 patients, 196 (49.4%) were classified as NP by method 1 and 212 (53.4%) were classified as NP by method 2. The sensitivity and specificity values were 0.812 and 0.867 for method 1 and 0.870 and 0.800 for method 2, respectively. Regardless of method used, patients classified as NP developed contralateral breast carcinoma more often but had better 10-year overall and disease-specific survival rates than those classified as TR. Patients with TR were more likely to develop metastatic disease after IBTR., Conclusion: Ipsilateral breast tumor recurrences classified as TR and NP had clinically different features, suggesting that classifying IBTR may provide clinically significant data for the management of IBTR.

Background: Previous studies suggested that sentinel lymph node (SLN) identification rates are lower in older breast cancer patients. This study was undertaken to compare identification rates in patients 70 years of age and older versus those younger than 70 years in a large cohort undergoing sentinel lymph node dissection (SLND)., Study Design: Patients undergoing SLND between August 1993 and December 2006 were identified and grouped by age. Clinicopathologic data and details regarding the procedure were reviewed., Results: Of the 3995 patients undergoing SLND, 3406 (85.3%) were under 70 years of age, and 589 (14.7%) were 70 years or older. Age was significantly associated with clinical stage (P = .001) and tumor grade (P < .0001). A greater proportion in the older group had clinical stage I disease (74.7% vs. 66.8%), and a lower proportion had grade 3 tumors (24.0% vs. 36.1%). There were no significant differences by age in the mapping method or site of injection. Overall SLN identification rate was 97.2% and did not differ significantly by age. The SLN was positive in 23.1% of younger patients and 18.2% of older patients (P = .01)., Conclusion: Sentinel lymph node dissection can be performed with high identification rates regardless of patient age. Breast cancer patients 70 years and older with clinically negative axillary lymph nodes should be offered SLND, as the presence of lymph node metastasis may alter adjuvant therapy recommendations.

Background: A wide range of false-negative rates has been reported for sentinel lymph node (SLN) biopsy after preoperative chemotherapy. The purpose of this study was to determine whether histologic findings in negative SLNs after preoperative chemotherapy are helpful in assessing the accuracy of SLN biopsy in patients with confirmed lymph node-positive disease before treatment., Methods: Eighty-six patients with confirmed lymph node-positive disease at presentation underwent successful SLN biopsy and axillary dissection after preoperative chemotherapy at a single institution between 1994 and 2007. Available hematoxylin and eosin-stained sections from patients with negative SLNs were reviewed, and associations between histologic findings in the negative SLNs and SLN status (true negative vs false negative) were evaluated., Results: Forty-seven (55%) patients had at least 1 positive SLN, and 39 (45%) patients had negative SLNs. The false-negative rate was 22%, and the negative predictive value was 67%. The negative SLNs from 17 of 34 patients with available slides had focal areas of fibrosis, some with associated foamy parenchymal histiocytes, fat necrosis, or calcification. These histologic findings occurred in 15 (65%) of 23 patients with true-negative SLNs and in only 2 (18%) of 11 patients with false-negative SLNs (P = .03, Fisher exact test, 2-tailed). The lack of these histologic changes had a sensitivity and specificity for identifying a false-negative SLN of 82% and 65%, respectively., Conclusions: Absence of treatment effect in SLNs after chemotherapy in patients with lymph node-positive disease at initial presentation has good sensitivity but low specificity for identifying a false-negative SLN.

Objective: Sentinel lymph node (SLN) surgery is widely used for nodal staging in early-stage breast cancer. This study was performed to evaluate the accuracy of SLN surgery for patients undergoing neoadjuvant chemotherapy versus patients undergoing surgery first., Summary Background Data: Controversy exists regarding the timing of SLN surgery in patients planned for neoadjuvant chemotherapy. Proponents of SLN surgery after chemotherapy prefer a single surgical procedure with potential for fewer axillary dissections. Opponents cite early studies with low identification rates and high false-negative rates after chemotherapy., Methods: A total of 3746 patients with clinically node negative T1-T3 breast cancer underwent SLN surgery from 1994 to 2007. Clinicopathologic data were reviewed and comparisons made between patients receiving neoadjuvant chemotherapy and those undergoing surgery first., Results: Of the patients, 575 (15.3%) underwent SLN surgery after chemotherapy and 3171 (84.7%) underwent surgery first. Neoadjuvant patients were younger (51 vs. 57 years, P < 0.0001) and had more clinical T2-T3 tumors (87.3% vs. 18.8%, P < 0.0001) at diagnosis. SLN identification rates were 97.4% in the neoadjuvant group and 98.7% in the surgery first group (P = 0.017). False-negative rates were similar between groups (5/84 [5.9%] in neoadjuvant vs. 22/542 [4.1%] in the surgery first group, P = 0.39). Analyzed by presenting T stage, there were fewer positive SLNs in the neoadjuvant group (T1: 12.7% vs. 19.0%, P = 0.2; T2: 20.5% vs. 36.5%, P < 0.0001; T3: 30.4% vs. 51.4%, P = 0.04). Adjusting for clinical stage revealed no differences in local-regional recurrences, disease-free or overall survival between groups., Conclusions: SLN surgery after chemotherapy is as accurate for axillary staging as SLN surgery prior to chemotherapy. SLN surgery after chemotherapy results in fewer positive SLNs and decreases unnecessary axillary dissections.

Background: Isolated tumor cells (ITC) are more likely to be identified when serial sectioning and immunohistochemical staining are used to evaluate sentinel lymph nodes (SLN). Our goal was to identify clinicopathologic features associated with ITC in patients undergoing sentinel lymph node dissection (SLND)., Methods: We reviewed clinicopathologic data for 3557 patients with no clinical evidence of lymph node metastases undergoing SLND between November 1993 and March 2007. Patients were staged according to the 6th edition of the American Joint Committee on Cancer staging system, with metastasis

Background: We determined the incidence of positive sentinel lymph nodes (SLNs) in patients with ductal carcinoma in situ (DCIS) or microinvasive breast cancer (MIC) and the predictive factors of SLN metastasis in these patients., Methods: Of 4,503 patients who underwent SLN dissection between March 1994 and March 2006 at our institution, we identified those with a preoperative diagnosis or final diagnosis of DCIS or MIC. Clinicopathologic factors were examined by logistic regression analysis., Results: Of the 624 patients with a preoperative diagnosis of DCIS or MIC, 40 had positive SLNs (6.4%). Of the 475 patients with a final diagnosis of DCIS or MIC, 9 had positive SLNs (1.9%). Clinical DCIS size >5 cm was the only independent predictor of positive SLN for patients with a preoperative diagnosis and patients with a final diagnosis of DCIS or MIC. Core biopsy as the method of preoperative diagnosis and DCIS size >5 cm were independent predictors for a final diagnosis of invasive carcinoma in the 149 patients who had a preoperative diagnosis of DCIS or MIC., Conclusions: SLN dissection for patients with a diagnosis of DCIS should be limited to patients who are planned for mastectomy or who have DCIS size >5 cm. Patients who have a core-needle biopsy diagnosis of DCIS have a higher risk of invasive breast cancer on final pathologic assessment of the primary tumor. This information can be used in preoperative counseling of patients with DCIS regarding the timing of SLN biopsy.

Background: : It remains unclear how many sentinel lymph nodes (SLNs) must be removed to accurately predict lymph node status during SLN dissection in breast cancer. The objective of this study was to determine how many SLNs need to be removed for accurate lymph node staging and which patient and tumor characteristics influence this number., Methods: : The authors reviewed data for all patients in their prospective database with clinical tumor, lymph node, metastasis (TNM) T1 through T3, N0, M0 breast cancer who underwent lymphatic mapping at their institution during the years 1994 through 2006. There were 777 patients who had at least 1 SLN that was positive for cancer. Simple and multiple quantile regression analyses were used to determine which patient and tumor characteristics were associated with the number of positive SLNs. The baseline number of SLNs that needed to be dissected for detection of 99% of positive SLNs in the total group of patients also was determined., Results: : The mean number of SLNs removed in the 777 lymph node-positive patients was 2.9 (range, 1-13 SLNs). Greater than 99% of positive SLNs were identified in the first 5 lymph nodes removed. On univariate analysis, tumor histology, patient race, tumor location, and tumor size significantly affected the number of SLNs that needed to be removed to identify 99% of all positive SLNs. On multivariate analysis, mixed ductal and lobular histology, Caucasian race, inner quadrant tumor location, and T1 tumor classification significantly increased the number of SLNs that needed to be removed to achieve 99% recovery of all positive SLNs., Conclusions: : In general, the removal of a maximum of 5 SLNs at surgery allowed for the recovery of >99% of positive SLNs in patients with breast cancer. The current findings indicated that tumor histology, patient race, and tumor size and location may influence this number., ((Copyright) 2008 American Cancer Society.)

Background: The utility of sentinel lymph node (SNL) biopsy (SLNB) as a predictor of axillary lymph node status is similar in patients who receive neoadjuvant chemotherapy and patients who undergo surgery first. The authors of this study hypothesized that patients with positive SLNs after neoadjuvant therapy would have unique clinicopathologic factors that would be predictive of additional positive non-SLNs distinct from patients who underwent surgery first., Methods: One hundred four patients were identified who received neoadjuvant chemotherapy, had a positive SLN, and underwent axillary dissection between 1997 and 2005. At the time of presentation, 66 patients had clinically negative lymph nodes by ultrasonography, and 38 patients had positive lymph nodes confirmed by fine-needle aspiration. Eighteen factors were assessed for their ability to predict positive non-SLNs using chi-square and logistic regression analysis with a bootstrapped, backwards elimination procedure. The resulting nomogram was tested by using a patient cohort from another institution., Results: Patients with clinically negative lymph nodes at presentation were less likely than patients with positive lymph nodes to have positive non-SLNs (47% vs 71%; P=.017). On multivariate analysis, lymphovascular invasion, the method for detecting SLN metastasis, multicentricity, positive axillary lymph nodes at presentation, and pathologic tumor size retained grouped significance with a bootstrap-adjusted area under the curve (AUC) of 0.762. The resulting nomogram was validated in the external patient cohort (AUC, 0.78)., Conclusions: A significant proportion of patients with positive SLNs after neoadjuvant chemotherapy had no positive non-SLNs. The use of a nomogram based on 5 predictive variables that were identified in this study may be useful for predicting the risk of positive non-SLNs in patients who have positive SLNs after chemotherapy., (Copyright (c) 2008 American Cancer Society.)

Background: Recent studies demonstrate improved progression-free survival (PFS) and improved overall survival (OS) with extirpation of the primary tumor in breast cancer patients who present with metastatic disease at initial diagnosis. The subset of patients who would most benefit from surgery remains unclear. This study evaluates the pathological attributes and optimum timing for surgery in patients who present with stage IV breast cancer and an intact primary., Methods: Retrospective, single-institution review of all breast cancer patients between 1997 and 2002 presenting with an intact tumor and synchronous metastatic disease. Information collected included: demographics, tumor characteristics, metastatic sites, type/timing of surgery, and radiation/systemic therapy received. Patients initiated treatment within 3 months of their diagnosis. Patients were divided into three groups based on time interval from diagnosis date to surgery date. Disease progression and vital status at last follow-up were evaluated. Analysis of metastatic PFS (defined by progression of systemic disease) benefit in relation to surgical timing was performed., Results: Multivariate analysis revealed patients having only one site of metastasis, negative margins, and Caucasian race had improved PFS. Further analysis revealed non-Caucasian patients more often underwent surgical intervention for palliation versus surgery for curative intent, possibly explaining their worse outcome. Patients who underwent surgery in the 3-8.9 month or later period had improved metastatic PFS., Conclusions: Surgical extirpation of the primary tumor in patients with synchronous stage IV disease is associated with improved metastatic PFS when performed more than 3 months after diagnosis. Resection should be planned with the intent of obtaining negative margins.

Background: Patients who have invasive breast cancer identified after prophylactic mastectomy (PM) require axillary lymph node dissection (ALND) for lymph node staging (ie, directed ALND). Because the majority of these patients will be lymph node negative, sentinel lymphadenectomy (SLND) has been advocated at the time of PM to avoid the sequelae of unnecessary ALND. The objective of this study was to compare the efficacy of 2 surgical strategies, routine SLND versus directed ALND, in PM patients., Methods: A decision-analytic model was created to compare the 2 surgical strategies. Model estimates were derived from a systematic literature review. The endpoints that were examined to compare the 2 strategies were the number of SLNDs performed per breast cancer detected, the number of SLNDs attempted to avoid 1 ALND in a lymph node-negative patient with occult invasive cancer, and the number of axillary complications associated with each strategy., Results: The prevalence of invasive cancer in patients undergoing PM was estimated at 1.9%. At this rate, 37 SLNDs were performed per 1 breast cancer detected, and 73 SLNDs were required to avoid 1 ALND in a lymph node-negative PM patient. In 1 model scenario, the probability of complications per breast cancer detected was 9-fold greater with the SLND strategy than with the directed ALND strategy (2.7 vs 0.3). The complication rates for the 2 strategies become equivalent in the model scenario when the prevalence of occult invasive cancer was projected to 28%., Conclusions: Routine SLND for patients undergoing PM is not warranted given the large number of procedures required to benefit 1 patient and the potential complications associated with performing SLND in all patients.

Background: Metastasis to the breast is rare, but it must be considered in the differential diagnosis of a breast mass. The purpose of this study was to identify clinical characteristics and outcomes associated with this entity to identify determinants of survival., Methods: Between 1983 and 1998, 169 patients were confirmed by pathology to have metastasis to the breast from nonbreast solid organ primary tumors at University of Texas M. D. Anderson Cancer Center. Medical records were retrospectively reviewed for clinicopathological characteristics. Survival was determined by Kaplan-Meier analysis., Results: The median age was 51 years (range, 13-85). One hundred forty-nine (88.2%) patients had a prior history of cancer. Ninety-one (53.9%) patients presented with additional systemic metastases. The most common histology identified was melanoma (65 patients, 38.5%). In most patients (77%), the diagnosis was initially made through physical examination. The median survival from the time the breast metastasis was diagnosed was 10 months (range, 0.4-192.7). On univariate analysis, a significantly better survival was observed in patients who had no evidence of other disease at the time of diagnosis (P = .0036), patients with neuroendocrine tumors (P = .023), and patients who underwent surgical resection for breast metastases (P = .0001). On multivariate analysis, patients who did not have surgery were 88% more likely to die than those who did (P < 0.001)., Conclusions: Expected survival with metastasis to the breast is poor, therefore, local therapy should be tailored to each individual. The association between overall survival and surgical resection of metastases to the breast should be further investigated.

Background: The feasibility and accuracy of sentinel lymph node (SLN) biopsy in patients with breast cancer after preoperative chemotherapy has been demonstrated in a number of large, single-institution studies. However, a relative contraindication to SLN biopsy after preoperative chemotherapy is the presence of axillary metastases at initial diagnosis. The objective of this study was to determine the feasibility and accuracy of SLN biopsy after preoperative chemotherapy in patients with documented axillary metastases at presentation., Methods: Between 1994 and 2002, 69 patients who had axillary metastases identified by ultrasound-guided, fine-needle aspiration underwent SLN biopsy after treatment on prospective, preoperative chemotherapy protocols. All but 8 patients underwent axillary lymph node dissection (ALND). Those 8 patients either declined additional surgery or were offered enrollment in other institutional protocols., Results: The median patient age was 49 years, and the median primary tumor size was 4 cm. The SLN identification rate was 92.8%. Thirty-one of 64 patients (48.4%) had successfully mapped, positive SLNs. Sixty-one patients underwent ALND, including 5 patients who did not have an SLN identified. In the 56 patients in whom a SLN was identified and an ALND was performed, 10 patients had a false-negative SLN (25%)., Conclusions: SLN biopsy was feasible after preoperative chemotherapy, even in patients who initially presented with cytologically proven, lymph node-positive disease. However, the false-negative rate of SLN biopsy in this group of patients was much higher than that observed in clinically lymph node-negative patients. Based on the current results, the status of the SLN cannot be used as a reliable indicator of the presence or absence of residual disease in the axilla in this patient population., ((c) 2007 American Cancer Society.)

Background: Positive/close margins are associated with higher in-breast failure rates after breast-conserving surgery (BCS). We investigated whether intraoperative margin assessment aids in obtaining negative margins, and to evaluate the local control thus achieved., Methods: Between 1994 and 1996, 264 patients underwent BCS for stages 0-III breast cancer [invasive, n = 200; ductal carcinoma in situ (DCIS), n = 64]. Intraoperative margin assessment included gross tissue inspection, specimen radiography, with or without frozen section., Results: Ninety-two patients (46%) with invasive cancer and 24 (38%) with DCIS had positive/close margins on the permanent section analysis of their initial surgical specimens. Fifty-eight patients (29%) with invasive cancer and six (9%) with DCIS had initial positive/close margins, and were rendered margin-negative by intraoperative analysis and immediate re-excision. Final margins on permanent pathology were positive/close in 52 patients (20%): 34 patients (17%) with invasive cancer and 18 patients (28%) with DCIS. By multivariate analysis, excisional biopsy for diagnosis, larger tumor size, and multifocality were associated with final positive/close margins. Of these 52 patients, 23 underwent a second operation to achieve widely negative margins (13 completion mastectomies, 10 re-excisions). The 5-year ipsilateral breast recurrence-free survival rates after BCS and radiation were 99% for invasive cancer (n = 167) and 100% for DCIS (n = 27)., Conclusions: Intraoperative assessment of margins assisted in identifying positive/close margins and allowed over a quarter of the patients to be rendered margin-negative with intraoperative re-excision at their original operation. This approach resulted in excellent local control in patients treated with BCS and radiation.

Background: Sentinel lymph nodes (SLNs) are generally evaluated postoperatively, requiring 5-7 days for assessment. SLNs can also be evaluated intraoperatively by using touch imprint cytology (TIC), thus providing the surgeon immediate feedback and allowing for concurrent completion node dissection (CND) for positive SLNs. The authors hypothesized that TIC, when compared with standard postoperative SLN assessment alone, would permit a cost-effective evaluation of SLNs in patients with clinically node-negative breast cancer., Methods: A decision-analysis model was created to compare TIC with standard postoperative SLN assessment alone. Sensitivity and specificity of TIC were determined prospectively from 342 patients who underwent SLN biopsy assessed by both techniques. Short-term health states associated with surgical staging were defined, and utilities were estimated using EuroQol-5D. Base-case analysis was performed to estimate quality-adjusted life years and the incremental cost-effectiveness ratio. Sensitivity analyses were performed to examine stability of model parameters., Results: For each tumor stage, TIC was cost effective, and for patients with larger tumors (T3 and T4), TIC was the dominant strategy. The analysis was robust to changes in sensitivity and specificity of TIC, prevalence of metastasis, probability of complications, and cost. However, when utility associated with standard SLN assessment was 0.9 or greater, this became the preferred strategy., Conclusions: TIC is cost effective for assessing SLN metastasis intraoperatively. For patients with larger tumors, it is not only more effective, but also less costly than standard SLN assessment alone. TIC may be particularly useful for patients who experience significant anxiety while awaiting results of standard SLN assessment.

DNA double-strand breaks (DSBs) may lead to genomic instability and cancer if unrepaired. Nijmegen breakage syndrome 1 (NBS1) protein is one of the key proteins that participates in recognition and repair of DSBs in humans. We hypothesized that polymorphisms of NBS1 are associated with breast cancer risk. We selected three NBS1 haplotype-tagging polymorphisms (i.e. 924T>C, 8360G>C and 30537G>C) to represent all common (>or=5%) haplotypes reported in the National Institute of Environmental Health Sciences database and to reconstruct haplotypes. In a hospital-based case-control study of 421 non-Hispanic white patients with sporadic breast cancer (C polymorphism. Furthermore, the derived haplotypes were associated with risk in a dose-response manner as the number of variant (risk) alleles (i.e. 8360C, 924C or 30537C) increased (adjusted OR = 1.07, 95% CI = 0.78-1.46 for 1-2 variant alleles; adjusted OR = 2.47, 95% CI = 1.48-4.14 for 3-6 variant alleles; P(trend) = 0.006). These findings suggest that NBS1 polymorphisms and haplotypes may contribute to the etiology of sporadic breast cancer in young non-Hispanic white women. Large studies are warranted to confirm these findings.

Background: Although sentinel lymph node biopsy is rapidly replacing complete axillary lymph node dissection for lymph node staging in women with clinically node-negative breast cancer, it is unclear what impact the transition to sentinel lymph node biopsy will have on the practice of breast reconstruction., Methods: To determine the effect of the transition from complete axillary lymph node dissection to sentinel lymph node biopsy on their practice of breast reconstruction, the authors reviewed the records of 717 patients with breast cancer who underwent sentinel lymph node biopsy and 1887 breast reconstructions-487 were performed in patients who also underwent sentinel lymph node biopsy at The University of Texas M. D. Anderson Cancer Center between 1998 and 2003., Results: Before 1999, sentinel lymph node biopsy was performed infrequently. Between 1999 and 2003, the number of sentinel lymph node biopsy procedures performed per year increased almost 50-fold. Concurrent with this increase in the use of sentinel lymph node biopsy, there was a corresponding increase in the proportion of breast reconstruction procedures performed in patients who had also undergone sentinel lymph node biopsy (13 percent per year, p = 0.0001). In 2003, 54 percent of all breast reconstructions were performed in patients who had sentinel lymph node biopsy. In 2000, 1 year after the use of sentinel lymph node biopsy began to increase, the choice of recipient vessels for free transverse rectus abdominis myocutaneous (TRAM) flap breast reconstruction began to change. Between 2001 and 2002, the internal mammary vessels replaced the thoracodorsal vessels as the preferred recipient vessels for TRAM flap reconstruction (p < 0.0001). Over the study period, the authors noted a decrease in the percentage of free TRAM flap procedures requiring revision, more frequent use of contralateral implant-based augmentation to achieve symmetry, an increase in the percentage of patients desiring a second attempt at reconstruction after loss of a TRAM flap, and a decrease in the percentage of patients being referred for physical therapy or treatment of lymphedema after free TRAM flap reconstruction., Conclusions: The transition from axillary lymph node dissection to sentinel lymph node biopsy has resulted in a change in breast reconstruction practices. The increased use of the internal mammary vessels reflects the decreased dissection of axillary tissue to expose the thoracodorsal vessels with sentinel lymph node biopsy in addition to concern that a subsequent axillary surgery to remove additional axillary nodes might injure the thoracodorsal vessels should they be used in breast reconstruction. Awareness of the decreased morbidity associated with sentinel lymph node biopsy has led patients to expect less morbidity and better aesthetic outcomes from TRAM flap reconstruction.

Background: Patients with invasive cancer identified at the time of prophylactic mastectomy (PM) will require axillary lymph node dissection for staging; therefore, many surgeons advocate sentinel lymph node (SLN) surgery at the time of PM. The current study investigates the invasive cancer rate in PM and evaluates factors associated with invasive cancer to guide SLN surgery use., Methods: Patients undergoing PM at the M. D. Anderson Cancer Center between January 2000 and July 2005 were identified from a prospective database. Clinical, radiographic, and pathologic data were collected., Results: A total of 409 patients (436 PM cases) were identified; 382 underwent contralateral PM (CPM) and 27 underwent bilateral PM (BPM). Cancer was identified in 22 of 436 PM cases (5%). Of these, 14 patients (64%) had ductal carcinoma in situ (DCIS). Only 8 patients (1.8%) had invasive cancer, with a mean tumor size of 5 mm (range, 2-9 mm). There was no difference in the occult cancer rate between CPM and BPM. No cases of invasive cancer were identified in the 23 patients with BRCA mutations. Significantly increased risk of invasive cancer in the PM breast was seen in postmenopausal patients (3.7%; P = .007), patients age >60 years (7.5%; P = .008), and patients with history of invasive lobular carcinoma (9.7%; P = .0002) or lobular carcinoma in situ (LCIS) (7.7%; P = .008)., Conclusions: The frequency of cancer in PM is very low and the majority represents DCIS. Therefore, routine use of SLN surgery in all patients undergoing PM is not warranted. However, patients at higher risk for whom SLN surgery should be considered include older women and patients with a history of lobular cancer or LCIS., ((c) 2006 American Cancer Society.)

Background: Patients with locally recurrent breast cancer can also harbor regional nodal disease. Sentinel lymph node (LN; SLN) surgery is an accepted method for LN evaluation in early-stage breast cancer. We sought to evaluate the feasibility of SLN surgery in patients with locally recurrent breast cancer., Patients and Methods: Patients undergoing SLN surgery at the time of treatment for recurrent breast cancer were identified. Clinical, pathologic, and operative details of initial and recurrent breast cancer events were analyzed., Results: From 2001 to 2005, 21 patients underwent SLN surgery for locally recurrent breast cancer. Previous breast procedures included segmental mastectomy in 17 patients and mastectomy in 4 patients. Previous axillary procedures included axillary LN dissection in 12 patients, SLN surgery in 5 patients, and no axillary surgery in 4 patients. Twelve patients had received breast irradiation. The SLN was identified and excised in 13 patients (62%). Six patients had drainage to nodal basins outside of the axilla (internal mammary and/or contralateral axilla). As the number of axillary nodes removed at primary surgery increased, the incidence of alternative lymphatic drainage increased: no previous axillary surgery, 0; 1-10 LNs removed, 30%; > 10 LNs removed, 50%., Conclusion: Sentinel LN surgery is feasible in patients with locally recurrent breast cancer regardless of previous axillary node surgery or radiation. The incidence of alternative lymphatic drainage is increased in patients with > 10 axillary LNs removed at original operation or when radiation was part of the previous treatment. Sentinel LN surgery is a tool for guiding local-regional management of patients with locally recurrent breast cancer.

Background: Lymphoscintigraphy (LSG) can identify lymphatic drainage patterns before sentinel lymph node (SLN) biopsy is performed in patients with early-stage breast cancer, but the importance of extraaxillary SLNs seen on LSG is unknown. We assessed whether drainage patterns seen on LSG were associated with histologic findings in axillary SLNs recovered at SLN biopsy., Study Design: From a prospectively maintained database, we identified 1,201 clinically node-negative patients with invasive breast cancer who underwent preoperative LSG and axillary SLN biopsy. Patient and tumor characteristics, LSG results, and final SLN pathology results were examined., Results: LSG showed drainage to internal mammary (IM) nodes in 1.6% of patients, axillary nodes in 68.1%, both IM and axillary nodes in 19.8%, and no drainage in 10.3%. Drainage to IM nodes was observed for tumors in all quadrants of the breast. Patients with IM drainage had a younger median age than patients without IM drainage (51.8 versus 58.3 years, respectively; p < 0.001). The intraoperative axillary SLN identification rate was higher when axillary drainage was observed on LSG than when it was not observed (98.7% versus 93.0%, respectively; p < 0.001), but the LSG drainage pattern was not associated with pathologic status of the SLN or number of metastatic SLNs. At a median followup of 32 months, 4 patients had regional nodal recurrence., Conclusions: Almost one-fourth of patients had lymphatic drainage to the extraaxillary lymph nodes, particularly the IM nodes, seen on LSG. Extraaxillary drainage seen on LSG did not preclude identification of axillary SLNs at operation. Longterm followup of patients with lymphoscintigraphic evidence of extraaxillary drainage is needed to determine whether regional and systemic recurrence patterns differ in these patients.

Background: Currently, therapy for breast cancer patients with stage IV disease and an intact primary tumor is metastasis directed; the primary tumor is treated only when it causes symptoms. A recent review suggested that surgery may improve long-term survival in such patients. We evaluated the effect of surgery in such patients on long-term survival and disease progression., Methods: We reviewed the records of all breast cancer patients treated at our institution between 1997 and 2002 who presented with stage IV disease and an intact primary tumor. Information collected included demographics, tumor characteristics, site(s) of metastases, type/date of operation, use of radiotherapy, chemotherapy and hormonal therapy, disease progression (time to progression and location of progression) in the first year after diagnosis, and last follow-up. Overall and metastatic progression-free survival were compared between surgery and nonsurgery patients., Results: Of 224 patients identified, 82 (37%) underwent surgical extirpation of the primary tumor (segmental mastectomy in 39 [48%] and mastectomy in 43 [52%]), and 142 (63%) were treated without surgery. The median follow-up time was 32.1 months. After adjustment for other covariates, surgery was associated with a trend toward improvement in overall survival (P=.12; relative risk, .50; 95% confidence interval, .21-1.19) and a significant improvement in metastatic progression-free survival (P=.0007; relative risk, .54; 95% confidence interval, .38-.77)., Conclusions: Removal of the intact primary tumor for breast cancer patients with synchronous stage IV disease is associated with improvement in metastatic progression-free survival. Prospective studies are needed to validate these findings.

The purpose of this study was to determine the usefulness of ultrasound (US) as an adjunct to mammography (MMG) in the surgical treatment planning for patients with ductal carcinoma in situ (DCIS) of the breast. A total of 119 patients diagnosed with DCIS, who were treated between 1999 and 2002, were identified from the institutional database. US and MMG size of suspicious abnormalities, pathologic tumor size, and findings of axillary US and surgical axillary evaluation were analyzed. The median size difference of US versus pathologic tumor size and MMG versus pathologic tumor size was 1.0 and 2.0 cm, respectively. Correlation coefficients for US versus pathologic tumor size and MMG versus pathologic tumor size were 0.53 and -0.09, respectively. The negative and positive predictive values of axillary US to predict nodal disease were 93% and 27%, respectively. US evaluation appears to be a useful tool in conjunction with MMG in determining the extent of disease in patients diagnosed with DCIS. However, the low positive predictive value of US for evaluating metastases to axillary lymph nodes does not justify the routine use of this modality for axillary evaluation in patients with DCIS. Therefore the use of US for patients diagnosed with DCIS needs further investigation.

Background: Although completion lymph node dissection (CLND) is the standard of care for breast cancer patients with sentinel lymph node (SLN) metastases, the SLN is the only node with tumor in 40% to 60% of cases. To assist with decision-making regarding CLND, investigators at Memorial Sloan-Kettering Cancer Center devised and validated a nomogram for predicting the likelihood of non-SLN metastases. To assess the generalizable use of this nomogram, validation analysis was performed by using an external database., Methods: Eight clinicopathologic variables for 200 consecutive breast cancer patients at the University of Texas M. D. Anderson Cancer Center with SLN metastases and CLND were entered into the nomogram. The accuracy of the nomogram to predict non-SLN metastases was assessed by the receiver operating characteristic (ROC) curve and linear regression analysis. The accuracy of the nomogram with touch-imprint cytology (TIC) as a substitute variable for frozen section was also evaluated., Results: The linear correlation coefficient of the nomogram-predicted probabilities correlated with the observed incidence of non-SLN metastases for all patients (.97). The accuracy of the nomogram as measured by the area under the ROC curve was .71. When applied solely to patients who had TIC assessment of the SLN, the area under the ROC curve was .74., Conclusions: This study validated the Memorial Sloan-Kettering Cancer Center breast cancer nomogram by using an external database. TIC seems to be an acceptable substitute for frozen section as a nomogram variable. The nomogram may help predict an individual's risk of non-SLN metastases and assist in patient decision making regarding the benefit of CLND.

Objective: To assess the accuracy of physical examination, ultrasonography, and mammography in predicting residual size of breast tumors following neoadjuvant chemotherapy., Background: Neoadjuvant chemotherapy is an accepted part of the management of stage II and III breast cancer. Accurate prediction of residual pathologic tumor size after neoadjuvant chemotherapy is critical in guiding surgical therapy. Although physical examination, ultrasonography, and mammography have all been used to predict residual tumor size, there have been conflicting reports about the accuracy of these methods in the neoadjuvant setting., Methods: We reviewed the records of 189 patients who participated in 1 of 2 protocols using doxorubicin-containing neoadjuvant chemotherapy, and who had assessment by physical examination, ultrasonography, and/or mammography no more than 60 days before their surgical resection. Size correlations were performed using Spearman rho analysis. Clinical and pathologic measurements were also compared categorically using the weighted kappa statistic., Results: Size estimates by physical examination, ultrasonography, and mammography were only moderately correlated with residual pathologic tumor size after neoadjuvant chemotherapy (correlation coefficients: 0.42, 0.42, and 0.41, respectively), with an accuracy of +/-1 cm in 66% of patients by physical examination, 75% by ultrasonography, and 70% by mammography. Kappa values (0.24-0.35) indicated poor agreement between clinical and pathologic measurements., Conclusion: Physical examination, ultrasonography, and mammography were only moderately useful for predicting residual pathologic tumor size after neoadjuvant chemotherapy.

Background: The purpose of the study was to determine the risk of ipsilateral breast carcinoma recurrence (IBCR) and contralateral breast carcinoma (CBC) development in patients with a concurrent diagnosis of ductal carcinoma in situ (DCIS) with atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), or lobular carcinoma in situ (LCIS)., Methods: Records of all 307 patients with DCIS treated with breast-conserving treatment (BCT) from 1968 to 1998 were analyzed. Initial pathology reports and all slides available were re-reviewed for evidence of ADH, ALH, or LCIS. Actuarial local recurrence rates were calculated., Results: Fifty-five cases of DCIS were associated with ADH, 11 with ALH or LCIS, and 14 with both ADH and ALH or LCIS. Overall, IBCR occurred in 14% and no significant difference in the IBCR rate was identified for patients with proliferative lesions compared with patients without these lesions (P = 0.38). Development of CBC in patients with concurrent DCIS and ADH was 4.4 times (95% confidence interval [CI], 1.44-13.63) that in patients with DCIS alone (P < 0.01). The 15-year cumulative rate of CBC development was 22.7% in patients with ALH or LCIS compared with 6.5% in patients without these lesions (P = 0.30) and 19% in patients with ADH compared with 4.1% in patients with DCIS alone (P < 0.01)., Conclusion: The risk of CBC development is higher with concurrent ADH than in patients with DCIS alone, and these patients may therefore be appropriate candidates for additional chemoprevention strategies. Concurrent ADH, ALH, or LCIS with DCIS is not a contraindication to BCT., (Copyright 2005 American Cancer Society.)

Objective: To minimize treatment variations, we have implemented clinical pathways for all breast cancer patients undergoing surgery. We sought to determine the incidence of postoperative venous thromboembolism (VTE) in patients treated on these pathways., Summary Background Data: Cancer patients have an increased risk of VTE because of a hypercoagulable state. The risk of VTE following breast cancer surgery is not well established., Methods: We retrospectively reviewed prospectively collected data for all patients who underwent breast cancer surgery and were treated on the clinical pathways with mechanical antiembolism devices and early ambulation in the postoperative period between January 2000 and September 2003., Results: During the study period, 3898 patients underwent 4416 surgical procedures. Seven patients with postoperative VTE within 60 days were identified, for a rate of 0.16% per procedure. Six patients presented with only a deep venous thrombosis or a pulmonary embolism; 1 patient had both. The median time from surgery to diagnosis of VTE was 14 days (range, 2-60 days; mean, 22 days). No relationship was identified between stage of breast cancer or type of breast surgery and development of VTE. Two (29%) of the 7 patients with VTE had received neoadjuvant chemotherapy. VTE treatment consisted of subcutaneous low-molecular-weight heparin (n = 5) or intravenous heparin (n = 2) followed by warfarin. There were no deaths., Conclusions: VTE following breast cancer surgery is rare in patients who are treated on clinical pathways with mechanical antiembolism devices and early ambulation in the postoperative period. We conclude that systemic VTE prophylaxis is not indicated in this group of patients.

Objective: Invasive lobular carcinoma (ILC) presents special challenges to treating physicians because of the diffuse infiltrative growth pattern. As sentinel lymph node dissection (SLND) is rapidly replacing axillary lymph node dissection (ALND) in the management of patients with early-stage breast cancer, we sought to evaluate the safety of SLND in providing axillary control in breast cancer patients with lobular histology and a negative sentinel node., Methods: We identified 239 patients with T1-2,N0,M0 lobular breast cancer from the prospective databases of 2 institutions; all were treated between March 1994 and December 2003., Results: A total of 202 patients had SLND and 37 had SLND followed by ALND. There was no significant difference between the 2 groups with respect to tumor size, presence of lymphovascular invasion, estrogen receptor (ER)/progesterone receptor (PR) and HER-2/neu status, type of breast surgery, margin status, or nuclear grade. Use of chemotherapy, radiation, and hormonal therapy was not significantly different between groups. At a median follow-up of 48 months in the ALND group and 26 months in the SLND group (range 6 to 80 months), none of the 202 patients in the SLND group had experienced an axillary recurrence, while 2 (5.4%) of the 37 patients who underwent ALND had experienced an axillary recurrence., Conclusions: SLND provided axillary control equivalent to that of ALND for patients with lobular breast cancer. SLND alone appears to be adequate axillary management of patients with lobular breast cancer and a negative sentinel node.

Background: Severe anaphylactoid reactions to isosulfan blue dye requiring resuscitation are reported to occur in 1.1% of patients with breast carcinoma undergoing sentinel lymphadenectomy. In December 2001, the authors began administering a prophylactic regimen before dye injection to determine whether prophylaxis reduced the incidence of life-threatening reactions., Methods: All patients were mapped with technetium-99m-labeled sulfur colloid. Those also receiving isosulfan blue dye were administered a glucocorticoid, diphenhydramine, and famotidine intravenously just before or at induction of anesthesia. Adverse reactions at the time of surgery were analyzed., Results: Between December 2001 and July 2003, 1013 consecutive patients underwent sentinel lymphadenectomy for breast carcinoma. Six hundred sixty-seven patients (65.8%) received prophylaxis and isosulfan blue dye, 33 (3.3%) received prophylaxis but no dye, 12 (1.2%) received dye but no prophylaxis, and 301 (29.7%) received no prophylaxis or dye. Blue urticaria and facial edema were observed in 3 (0.5%) of 667 patients receiving prophylaxis and dye and in 1 (8.3%) of 12 patients receiving dye but no prophylaxis. There were no episodes of hypotension, and no patients required vasopressors, ventilatory support, or intensive care observation. Adverse reactions to agents other than blue dye were observed in 2 (0.3%) of 667 patients receiving prophylaxis and dye and in 3 (1.0%) of 301 receiving no prophylaxis and no dye (P = 0.1773)., Conclusions: Preoperative prophylaxis was found to reduce the severity, but not the overall incidence, of adverse reactions to isosulfan blue dye. No life-threatening reactions were noted in patients treated with preoperative prophylaxis. Based on these results, the authors now routinely recommend administration of prophylaxis to patients receiving isosulfan blue for lymphatic mapping and sentinel lymph node biopsy.

Background: In patients with breast carcinoma, ipsilateral breast tumor recurrence (IBTR) after breast-conserving therapy (BCT) is an independent predictor of systemic recurrence and disease-specific survival (DSS). However, only a subgroup of patients with IBTR develop systemic recurrences. Therefore, the management of isolated IBTR remains controversial. The objective of the current study was to identify determinants of systemic recurrence and DSS after IBTR., Methods: The medical records of 120 women who underwent BCT for Stage 0-III breast carcinoma between 1971 and 1996 and who subsequently developed isolated IBTR were reviewed. Clinicopathologic factors were studied using univariate and multivariate analyses for their association with DSS and the development of systemic recurrence after IBTR., Results: The median time to IBTR was 59 months. At a median follow-up of 80 months after IBTR, 45 patients (37.5%) had a systemic recurrence. Initial lymph node status was the strongest predictor of systemic recurrence according to the a univariate analysis (P = 0.001). Other significant factors included lymphovascular invasion (LVI) in the primary tumor, time to IBTR < or = 48 months, clinical and pathologic IBTR tumor size > 1 cm, LVI in the recurrent tumor, and skin involvement at IBTR. In a multivariate logistic regression analysis, initially positive lymph node status (relative risk [RR], 5.3; 95% confidence interval [95% CI], 1.4-20.1; P = 0.015) and skin involvement at IBTR (RR, 15.1; 95% CI, 1.5-153.8; P = 0.022) remained independent predictors of systemic recurrence. The 5-year and 10-year DSS rates after IBTR were 78% and 68%, respectively. In a multivariate Cox proportional hazards model analysis, only LVI in the recurrent tumor was found to be an independent predictor of DSS (RR, 4.6; 95% CI, 1.5-14.1; P = 0.008)., Conclusions: Patients who initially had lymph node-positive disease or skin involvement or LVI at IBTR represented especially high-risk groups that warranted consideration for aggressive, systemic treatment and novel, targeted therapies after IBTR. Determinants of prognosis after IBTR should be taken into account when evaluating the need for further systemic therapy and designing risk-stratified clinical trials., ((c) 2005 American Cancer Society.)

Background: The optimal surgical management of Paget's disease of the breast remains to be defined. Mastectomy has been the standard of care, but several institutions have recently advocated breast-conserving surgery, particularly for patients with minimal disease. In an effort to develop rational treatment guidelines, we examined our institutional experience with Paget's disease of the breast., Methods: Patients with Paget's disease of the breast who had surgical therapy at our institution between 1949 and 1993 were reviewed. In addition to patient and tumor characteristics, charts were reviewed for treatment modalities, locoregional recurrence patterns, and survival. Subgroups were compared for differences in survival in both univariate and multivariate analyses., Results: A total of 104 patients met the study criteria. The most common presenting symptoms were nipple discharge and eczematous changes of the nipple/areola complex. Ninety-seven patients (93.2%) had an underlying invasive or noninvasive cancer associated with Paget's disease. Ninety-two patients (88.5%) underwent mastectomy, and 12 (11.5%) had a breast-conserving procedure. On univariate analysis, patients with age <60 years at diagnosis, stage II disease, positive lymph nodes, invasive disease, or a palpable mass had significantly lower 10-year disease-specific and recurrence-free survival. There were four locoregional recurrences (three after mastectomy and one after breast conservation). There were no significant differences in overall, disease-specific, or recurrence-free survival according to the type of surgery., Conclusions: Paget's disease of the breast is almost always associated with an underlying breast cancer. Breast-conserving approaches result in local control and survival rates similar to those achieved with mastectomy.

Background: The ideal pathologic assessment of sentinel lymph nodes (SLNs) in patients with breast carcinoma remains controversial. The authors evaluated how detailed assessment of SLNs using immunohistochemistry (IHC) and serial sectioning would affect treatment decisions and outcomes in patients with breast carcinoma who had negative SLNs on standard hematoxylin and eosin staining., Methods: The SLNs from patients who were treated between June 1998 and June, 1999 and who had negative lymph node status determined by hematoxylin and eosin staining (n = 84 patients) were evaluated further with serial sectioning and cytokeratin IHC. Patients were offered adjuvant therapy based on primary tumor factors., Results: The median patient age was 57 years, and the median tumor size was 1.2 cm. At a median follow-up of 40.2 months, 81 patients (96%) were alive with no evidence of disease, 1 patient was alive with disease, 1 patient had died of disease, and 1 patient had died of other causes. Fifteen patients (18%) had micrometastases identified on IHC. Of the total 84 patients, information regarding adjuvant therapy was not available for 5 patients. Of the remaining 79 patients, 10 patients (13%) were not offered adjuvant chemotherapy but had positive SLN status determined by IHC. SLN status based on IHC evaluation did not correlate with age (P = 0.077), tumor size (P = 0.717), grade (P = 0.148), estrogen receptor status (P = 1.000), or lymphovascular invasion (P = 0.274). Furthermore, IHC-detected positive SLN status did not correlate with distant metastasis (P = 0.372) or overall or distant metastasis-free survival (P = 0.543 and P = 0.540, respectively)., Conclusions: Although the finding of SLN micrometastases by IHC may change management in > 12% of patients, preliminary results suggested that such micrometastases do not affect outcomes significantly., ((c) 2005 American Cancer Society.)

Background: The role of sentinel lymph node biopsy (SLNB) in patients with an initial diagnosis of ductal carcinoma in situ (DCIS) has not been well defined. The purpose of our study was to determine when the risk of finding invasive disease on final pathology in patients with an initial diagnosis of DCIS was sufficiently high to justify use of SLNB., Study Design: The records of 398 consecutive patients from our prospective database with an initial diagnosis of DCIS, treated between July 1999 and December 2002, were analyzed. Associations between clinical and pathologic factors and patient selection for SLNB and outcomes were analyzed for significance using univariate and multivariate analyses., Results: Of the 398 patients, 80 (20%) were found to have invasive disease on final pathology. Multivariate analysis revealed 4 independent predictors of invasive cancer on final pathology: 55 years of age or younger (odds ratio [OR], 2.19; p = 0.024), diagnosis by core-needle biopsy (OR, 3.76; p = 0.006), mammographic DCIS size of at least 4 cm (OR, 2.92; p = 0.001), and high-grade DCIS (OR, 3.06; p = 0.002). A total of 141 patients (35%) underwent SLNB as a component of their initial operation. Multivariate analysis revealed that the presence of comedonecrosis (OR, 2.69; p = 0.007) and larger mammographic DCIS size (OR, 1.18; p = 0.0002) were independent predictors of patients' undergoing SLNB. Of these 141 patients, 103 (73%) were diagnosed by core-needle biopsy, 42 (30%) had invasive disease on final pathology, and 14 (10%) had a positive sentinel lymph node: 12 (86%) by hematoxylin and eosin staining and 2 by immunohistochemistry. The only independent predictor of a positive SLN was the presence of a palpable tumor (OR, 4.28, p = 0.042). Of these 14 patients with a positive sentinel node, only 11 (79%) had invasive cancer on final pathology., Conclusions: SLNB should not be performed routinely for all patients with an initial diagnosis of DCIS. Risks and benefits of SLNB should be discussed with patients who are younger, are diagnosed by core-needle biopsy, or have large or high-grade DCIS.

Background: Radiation to the internal mammary chain (IMC) may be indicated for breast carcinoma patients with positive axillary sentinel lymph nodes (SLNs) and lymphoscintigraphic evidence of drainage to the IMC. The purpose of this study was to identify predictors of IMC drainage in patients with positive axillary SLNs., Methods: The records of 297 breast carcinoma patients with positive axillary SLNs and preoperative lymphoscintigraphy were reviewed between 1995 and 2002. Radiolabeled colloid was injected peritumorally with lymphoscintigraphy performed 30-60 minutes later. Drainage to the regional nodes of 279 patients was seen on lymphoscintigraphy. Associations among patient and tumor-related factors and drainage to the IMC were examined., Results: Drainage to the IMC on lymphoscintigraphy was seen in 63 patients (21%). IMC drainage only occurred in 4 patients, and 59 patients had both axillary and IMC drainage. The only variable that correlated with IMC drainage was tumor location (P = 0.017). Rates of drainage to the IMC were 14.1% for upper outer quadrant (n = 128), 16.7% for upper inner quadrant (n = 30), 31.6% for lower outer quadrant (n = 19), 42.9% for lower inner quadrant (n = 14), and 28.4% for central tumors (n = 88). IMC drainage rates differed significantly between upper and lower tumors (lower 36.4% vs. central 28.4% vs. upper 14.6%, P = 0.003) but not between medial and lateral tumors (medial 25.0% vs. central 28.4% vs. lateral 16.3%, P = 0.077)., Conclusions: Patients with tumors in the lower or central breast and positive axillary SLNs have increased incidence of drainage to the IMC. Preoperative lymphoscintigraphy can help to define the nodal basins at risk for harboring disease., (Copyright 2005 American Cancer Society.)

Background: The appropriate selection criteria for breast-conserving therapy (BCT) after neoadjuvant chemotherapy are poorly defined. The purpose of the current report was to develop a prognostic index to help refine selection criteria and to serve as a general framework for clinical decision-making for patients treated by this multimodality approach., Methods: From a group of 340 patients treated with BCT after neoadjuvant chemotherapy, the authors previously determined 4 statistically significant predictors of ipsilateral breast tumor recurrence (IBTR) and locoregional recurrence (LRR): clinical N2 or N3 disease, residual pathologic tumor size > than 2 cm, a multifocal pattern of residual disease, and lymphovascular space invasion in the specimen. The M. D. Anderson Prognostic Index (MDAPI) was developed by assigning scores of 0 (favorable) or 1 (unfavorable) for each of these 4 variables and using the total to give an overall MDAPI score of 0-4., Results: The MDAPI stratified the 340 patients into 3 subsets with statistically different levels of risk for IBTR and LRR after neoadjuvant chemotherapy and BCT. Actuarial 5-year IBTR-free survival rates were 97%, 88%, and 82% for patients in the low (MDAPI overall score 0 or 1, n=276), intermediate (MDAPI score 2, n=43), and high (MDAPI score 3 or 4, n=12) risk groups, respectively (P<0.001). Corresponding actuarial 5-year LRR-free survival rates were 94%, 83%, and 58%, respectively (P<0.001)., Conclusions: Patients with an MDAPI score of 0 or 1, which made up 81% of the study population, had very low rates of IBTR and LRR. The MDAPI enabled the identification of a small group (4%) of patients who are at high risk for IBTR and LRR and who may benefit from alternative locoregional treatment strategies., (Copyright (c) 2005 American Cancer Society.)

The axillary lymph node status is the most important predictor of prognosis and aids in breast cancer treatment planning. Patients with breast cancer now frequently undergo sentinel lymph node (SLN) biopsy rather than axillary lymph node dissection to determine the status of the regional lymph nodes. However, the optimal timing of radionuclide injection relative to the timing of SLN biopsy remains controversial. The objective of this study was to compare the lymphatic drainage patterns on lymphoscintigraphy performed at 15 minutes to 4 hours and at 18 to 24 hours after injection of filtered Tc-99m sulfur colloid, and to determine whether, over time, radiocolloid migrates to second-echelon nodes that are not the SLNs. Fifteen women with breast cancer (mean age, 55 years; range, 38-78 years) were scheduled to undergo SLN biopsy after each received an injection of 18.5 MBq (0.5 mCi) filtered Tc-99m sulfur colloid into the breast parenchyma surrounding the tumor or biopsy cavity. Both early (15 minutes to 4 hours after radionuclide injection) and delayed (18-24 hours after radionuclide injection) lymphoscintigraphy was performed in each patient. SLN biopsy was performed, followed by completion axillary lymph node dissection and planned breast surgery. In each patient the patterns of distribution of the radionuclide in the lymph nodes were the same on early and delayed lymphoscintigrams. These findings, that the distributions of radionuclide in lymph nodes are identical on early and delayed images obtained after injection of filtered Tc-99m sulfur colloid, suggest that performing SLN biopsy on the day after injection does not diminish the accuracy of the technique in predicting the potential site of metastasis in the regional lymph nodes in patients undergoing this procedure for breast cancer.

Background: Women with unilateral breast carcinoma are at increased risk for developing contralateral breast carcinoma (CBC). The authors sought to identify predictors of malignant or moderate to high-risk histologic findings in contralateral prophylactic mastectomy (CPM) specimens, and to determine the efficacy of CPM., Methods: The authors performed a retrospective review of 239 patients with unilateral early-stage breast carcinoma who underwent CPM. The number of CBCs expected if the contralateral breast had been left intact was calculated based on CBC rates observed in the Surveillance, Epidemiology, and End Results (SEER) database and on life-table analysis by family history., Results: In the current study, 11 patients (4.6%) had occult contralateral malignancies (4 invasive carcinomas and 7 ductal carcinomas in situ) and 44 (18.4%) patients had moderate to high-risk pathology (8 lobular carcinoma in situ, 11 atypical lobular hyperplasia, 25 atypical ductal hyperplasia). At 1846 patient-years of follow-up, only 1 patient (0.4%) developed a new CBC compared with 11 expected cancers based on SEER data. One CBC was observed among 140 patients with a family history of breast carcinoma, compared with 16 expected cancers based on life-table analysis adjusted for adjuvant therapy. The determinants of significant findings at CPM were invasive lobular histology, estrogen and progesterone receptor positivity, additional ipsilateral moderate to high-risk pathology, and age > 40 years at cancer diagnosis., Conclusions: CPM was associated with a low risk of subsequent development of breast carcinoma. Evaluation of histologic findings in the ipsilateral breast may help to predict the likelihood of significant disease in the contralateral breast and assist in risk stratification.

Background: Multiple factors may influence whether patients undergo immediate breast reconstruction along with mastectomy for breast cancer. The authors investigated whether ethnicity was an independent predictor of immediate breast reconstruction., Methods: The authors identified 1004 patients who underwent mastectomy for breast cancer during the period 2001-2002. The rates of immediate reconstruction among different ethnicities were evaluated using the chi-square test. Logistic regression was used to adjust for covariates, including age and disease stage. Medical records were analyzed to identify factors that influenced each patient's decision for or against immediate breast reconstruction., Results: Three hundred seventy-six women (37.5%) underwent immediate breast reconstruction: This included 20.2% of African-American women, compared with 40.0% of white women, 42.0% of Hispanic women, 42.2% of Asian women, and 10.0% of Middle Eastern women (P < 0.001). The unadjusted odds ratio (OR) for immediate reconstruction for African-Americans versus whites was 0.38 (95% confidence interval [95% CI], 0.23-0.63; P < 0.001). After multivariate analysis, this disparity persisted, with an adjusted OR of 0.34 (95% CI, 0.18-0.62; P = 0.001). Asian women had lower rates of immediate reconstruction compared with white women (adjusted OR, 0.50; 95% CI, 0.24-1.04; P = 0.06). Hispanic women did not have immediate reconstruction rates that differed significantly from white women. Middle Eastern women had lower rates of immediate reconstruction compared with white women (adjusted OR, 0.08; 95% CI, 0.02-0.38; P = 0.002), but they had a corresponding increase in the rate of delayed reconstruction. In a stepwise analysis of the decision pathway to immediate reconstruction, it was found that African-American women were less likely to be offered referrals for reconstruction, were less likely to accept offered referrals, were less likely to be offered reconstruction, and were less likely to elect reconstruction if it was offered., Conclusions: African-American women underwent immediate breast reconstruction at significantly lower rates compared with white women, Hispanic women, and Asian women. After adjusting for covariates, including age and disease stage, African-American women and Asian women had lower rates of reconstruction compared with white women. The factors that contribute to these differences warrant further study., ((c) 2004 American Cancer Society.)

In this article, we report on a case of a pregnant patient with synchronous bilateral breast cancer treated with weekly paclitaxel. She presented after right mastectomy and anthracycline-based chemotherapy at an outside facility. Staging studies at our hospital before taxane administration demonstrated a 19-20-week gravid uterus and tumor in the remaining left breast. Weekly paclitaxel was given preoperatively during pregnancy. A normal male infant was delivered. Upon completion of chemotherapy, the patient underwent mastectomy and axillary lymph node dissection followed by comprehensive radiation therapy to the chest wall.

Background: Breast carcinoma with intramammary lymph node (intraMLN) metastases is considered to be Stage II disease, even in the absence of axillary lymph node involvement. Nonetheless, little is known regarding the clinical significance of intraMLN metastases. The goals of the current retrospective analysis were to elucidate the clinical relevance of intraMLN metastases and to assess the relation between such metastases and outcome in patients with breast carcinoma., Methods: One hundred ninety-six intraMLN specimens obtained between 1983 and 2003 were identified in the pathology database at The University of Texas M. D. Anderson Cancer Center (Houston, TX); 130 of these specimens were obtained in association with a primary breast malignancy. Data on the clinical and pathologic features of these specimens were collected and evaluated on univariate and multivariate analysis for potential correlations with 5-year rates of disease-free survival (DFS), disease-specific survival (DSS), and overall survival (OS). The median follow-up duration was 36 months (range, 12-180 months)., Results: The median age of the 130 patients in the current study was 53 years (range, 27-84 years). Twenty-four patients (18%) had intraMLNs that were identified preoperatively by either mammographic or sonographic methods; in the remaining 106 cases, intraMLNs were detected on pathologic examination of surgical breast specimens. IntraMLN metastases were found in 28% of all cases (n = 36). Most patients who had intraMLN metastases (81%) also had axillary metastases; however, isolated intraMLN metastases were documented in 6 patients (5%). Univariate analysis revealed that patients with intraMLN metastases (compared with all other patients) had poorer 5-year rates of DFS (54% vs. 89%; P = 0.001), DSS (66% vs. 90%; P = 0.001), and OS (64% vs. 88%; P = 0.004). Furthermore, multivariate analysis indicated that intraMLN involvement was an independent predictor of reduced DFS (hazard ratio, 2.33; P = 0.03), DSS (hazard ratio, 5.32; P = 0.002), and OS (hazard ratio, 3.22; P = 0.006)., Conclusions: The current retrospective analysis demonstrated that the presence of intraMLN metastases is an independent predictor of poor outcome in patients with breast carcinoma. Identification of an intraMLN on preoperative imaging should prompt further histopathologic assessment. Identification of malignant intraMLNs by lymphatic mapping may help to identify high-risk patients for whom further evaluation of the axillary lymph nodes is warranted despite otherwise clinically negative findings in the axilla., (Copyright 2004 American Cancer Society.)

Background: The presence of skin involvement has been accepted as a relative contraindication to breast preservation because it is believed to be associated with an increased local failure rate. This study was conducted to assess the outcome of a carefully selected group of patients who presented with breast cancer involving the skin and who had breast conservation therapy (BCT) following neoadjuvant chemotherapy., Methods: Between 1987 and 1999, 33 patients with stage IIIB or IIIC breast cancer completed treatment consisting of four cycles of neoadjuvant chemotherapy, lumpectomy, radiation therapy, and consolidative chemotherapy. Clinicopathologic factors were analyzed and patients were followed for locoregional and distant recurrence., Results: Initial median tumor size was 7 cm. All patients had skin involvement, defined as erythema, skin edema, direct skin invasion, ulceration, or peau d'orange. Following chemotherapy, median pathologic tumor size was 2 cm. Complete resolution of skin changes occurred in 29 patients (88%). At median follow-up time of 91 months in surviving patients, 26 patients (79%) were alive without evidence of disease. The 5-year, disease-free survival rate was 70%, and the 5-year overall survival rate was 78%. The actuarial ipsilateral breast cancer recurrence rate was 6% at 5 years., Conclusions: Patients who present with T4 breast cancer who experience tumor shrinkage and resolution of skin changes with neoadjuvant chemotherapy represent a select group of patients who can have BCT. These patients have favorable rates of long-term local control and survival. Mastectomy is not mandatory for all patients with breast cancer who present with skin involvement.

Background: Few studies in the literature address the surgical management of patients with breast carcinoma who present with associated nipple discharge. The purpose of the current study was to determine the feasibility of breast-conserving surgery (BCS) for these patients., Methods: The medical records of patients who presented with pathologic nipple discharge and underwent diagnostic or curative surgery between January 1990 and December 2002 were retrospectively reviewed., Results: A total of 188 patients presented with nipple discharge during the study period. Of those, 47 had breast carcinoma. One patient had metachronous bilateral nipple discharge associated with malignant disease. Therefore, medical records associated with a total of 48 cases were reviewed. The median patient age was 52 years (range, 29-87 years), and the median follow-up duration was 45 months (range, 6-109 months). Twenty-nine patients had ductal carcinoma in situ (DCIS), 14 had Stage I disease, 3 had Stage II disease, and 2 had Stage III disease. Twenty-four patients were ultimately treated with mastectomy. For 16 of these patients, mastectomy was required because extensive disease was found in reexcisional segmental mastectomy specimens. Among patients with Stage 0 or I disease, the incidence of occult nipple-areola complex (NAC) involvement was 16% (3 of 19 patients). Twenty-four patients were ultimately treated with BCS with (n = 13) or without (n = 11) adjuvant radiotherapy. Local disease recurrence was noted at 14, 28, and 40 months, respectively, in 3 patients who declined adjuvant radiotherapy after BCS for DCIS. Among patients treated with BCS, comedonecrosis, multifocality, and the absence of adjuvant radiotherapy were associated with decreased local recurrence-free survival (P = 0.0005, P = 0.045, and P = 0.013, respectively). However, disease-free survival (mean +/- standard error) was similar for patients who underwent mastectomy and patients who underwent BCS (90 +/- 6 months; 95% confidence interval [CI], 78-101 months vs. 82 +/- 6 months; 95% CI, 69-94 months; P = 0.528). One patient with Stage I disease died of distant metastases at 99 months., Conclusions: Patients with breast carcinoma accompanied by nipple discharge presented primarily with early-stage breast carcinoma associated with DCIS. Occult NAC involvement was not an uncommon finding in patients with early-stage breast carcinoma. Nonetheless, BCS can be performed safely if negative margins are achieved and if appropriate adjuvant radiotherapy or systemic therapy is administered.

Purpose: The optimal design of radiation fields for patients with positive sentinel lymph nodes (SLNs) who do not undergo axillary dissection is unknown. We have previously shown that modified breast tangent fields can include most axillary Level I-II lymph nodes. We have also reported that irradiation of the axillary apex/supraclavicular fossa is indicated for patients with four or more positive axillary lymph nodes. To determine the optimal arrangement for patients with positive SLNs, we studied what factors predicted for having four or more positive lymph nodes., Methods and Materials: We reviewed the records of 339 consecutive patients with one to three positive SLNs who underwent complete axillary dissection at our institution between 1995 and 2002. We separately analyzed the outcome for those initially treated with surgery (n = 265) and those receiving neoadjuvant chemotherapy (n = 74). A logistic regression model was used to identify independent factors predictive for four or more positive lymph nodes., Results: A total of 28 of 265 patients in the initial surgery group and 20 of 74 patients in the neoadjuvant group had four or more positive lymph nodes. In the initial surgery group, the independent factors associated with four or more positive lymph nodes were no drainage seen on lymphoscintigraphy (rate, 38%, odds ratio [OR] = 5.4, p = 0.03), more than one positive SLN (rate, 24-42%, OR = 2.9, p = 0.02), and lymphovascular space invasion (LVSI; rate, 25%, OR = 4.8, p = 0.01). Of the 106 patients without any of these factors, only 2 had four or more positive lymph nodes. For the patients treated with neoadjuvant chemotherapy, the independent factors were clinical Stage III (rate, 48%, OR = 3.1, p = 0.03), more than one positive SLN (rate, 37-67%, OR = 4.8, p = 0.03), and LVSI (rate, 62%, OR = 8.1, p = 0.02). Of the 28 patients without any of these factors, only 1 had four or more positive lymph nodes., Conclusion: It is reasonable to treat with modified tangents fields that include most axillary Level I-II nodes for patients with one positive SLN who do not undergo axillary dissection if drainage is seen on lymphoscintigraphy and no LVSI is present. This approach is also reasonable for patients treated with neoadjuvant chemotherapy who have Stage II disease, no LVSI, and only one positive SLN. The remaining patients have a greater risk of having four or more positive lymph nodes, and, therefore, the high axilla/supraclavicular fossa should also be included in the radiation fields.

Purpose: To determine patterns of local-regional recurrence (LRR) and ipsilateral breast tumor recurrence (IBTR) among patients treated with breast conservation therapy after neoadjuvant chemotherapy., Patients and Methods: Between 1987 and 2000, 340 cases of breast cancer were treated with neoadjuvant chemotherapy followed by conservative surgery and radiation therapy. Clinical stage at diagnosis (according to the 2003 American Joint Committee on Cancer system) was I in 4%, II in 58%, and III in 38% of patients. Only 4% had positive surgical margins., Results: At a median follow-up period of 60 months (range, 10 to 180 months), 29 patients had developed LRR, 16 of which were IBTRs. Five-year actuarial rates of IBTR-free and LRR-free survival were 95% and 91%, respectively. Variables that positively correlated with IBTR and LRR were clinical N2 or N3 disease, pathologic residual tumor larger than 2 cm, a multifocal pattern of residual disease, and lymphovascular space invasion in the specimen. The presence of any one of these factors was associated with 5-year actuarial IBTR-free and LRR-free survival rates of 87% to 91% and 77% to 84%, respectively. Initial T category (T1-2 v T3-4) correlated with LRR but did not correlate with IBTR (5-year IBTR-free rates of 96% v 92%, respectively, P =.19)., Conclusion: Breast conservation therapy after neoadjuvant chemotherapy results in acceptably low rates of LRR and IBTR in appropriately selected patients, even those with T3 or T4 disease. Advanced nodal involvement at diagnosis, residual tumor larger than 2 cm, multifocal residual disease, and lymphovascular space invasion predict higher rates of LRR and IBTR.

Purpose: To determine the feasibility and safety of ultrasonographically (US) guided percutaneous radiofrequency (RF) ablation in the local treatment of invasive breast carcinomas 2 cm or less in greatest diameter., Materials and Methods: RF ablation of 21 malignant lesions was performed in 20 patients immediately before their scheduled lumpectomy or mastectomy. A 15-gauge needle electrode was placed in the lesions, and the prongs of the needle electrode were deployed with real-time US guidance. A temperature of approximately 95 degrees C was maintained for 15 minutes at the tips of the prongs. Histopathologic examination of the resected specimens included use of nicotinamide adenine dinucleotide in its reduced form-diaphorase stain, which is specifically used to confirm thermal cell injury and lack of viability. The desired outcome of the procedure was ablation of the tumor and of an adequate margin around it, as confirmed by the absence of viable tissue in the surgical specimen., Results: In all 21 cases, complete ablation of the target lesion was visualized at US. In one patient, who had undergone preoperative chemotherapy for a mass that was initially judged to be a T2 tumor but who was found to have a small residual tumor at mammography and US performed at the time of ablation, the target lesion was ablated but residual in situ mammographically and US occult invasive carcinoma was found at histopathologic examination. There were no adverse effects., Conclusion: US-guided percutaneous ablation of small invasive breast carcinomas is feasible and safe., (Copyright RSNA, 2004)