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578 Background: Advances in radiotherapy allow the ability to deliver ablative treatments without compromising outcomes, but there has been limited application of these treatments to early-stage breast cancers. The purpose of this study was to explore patients’ interest in pursuing nonsurgical treatment approaches for their early-stage breast cancer. Methods: Investigators conducted a qualitative descriptive study involving semi-structured interviews with 21 early-stage breast cancer patients eligible for participation in a phase 2 trial offering omission of surgery. Interviews were transcribed, and three independent reviewers performed an inductive, thematic analysis to generate themes and subthemes. Results: Data analysis revealed the following factors that impacted patients’ willingness and desire to explore nonsurgical treatment options: Perceptions and feelings about their cancer; Current quality of life and the level of support available in their daily life; External conversations focusing on family members’ and friends’ experiences with cancer and/or cancer treatments; Personal healthcare experiences, including with their current breast cancer diagnosis; Perceptions and feelings about their physicians; Conversations with their physicians about their treatment options; and Self-identified desire to direct care decisions. Specifically, patients described fearing surgery and surgical recovery and wanting to avoid negative surgery-related events previously experienced by friends, family, and themselves. Participants also expressed a desire to preserve their breast(s), receive treatment per the latest research, match the level of treatment with the severity of their cancer, and avoid other comorbidities as reasons for omitting surgery. Patient reasons for pursuing surgery included the desire to remove their cancer immediately, prior positive experiences of friends, family, and themselves with surgery, lack of concern about preserving their breast(s), and prior negative experiences of friends, family, and themselves with radiation. Conclusions: The results of this study highlight that there is patient interest in nonsurgical options for biologically favorable early stage breast cancers. A key factor hindering patient education and awareness of nonsurgical options is how the physician frames the discussion and presents treatment options. In addition, patients’ self-identity and the prior experiences of friends, family, and self with cancer treatment and surgery in general appear to be key factors in their decision-making. The findings from this study demonstrate an unmet need to explore nonsurgical options for early-stage breast cancer. Study results can help shape conversations around shared decision making and clinical trial design and result in more personalized treatment options for women with early-stage breast cancer.

Purpose The Radiation Therapy Oncology Group 9804 study identified good-risk patients with ductal carcinoma in situ (DCIS), a breast cancer diagnosis found frequently in mammographically detected cancers, to test the benefit of radiotherapy (RT) after breast-conserving surgery compared with observation. Patients and Methods This prospective randomized trial (1998 to 2006) in women with mammographically detected low- or intermediate-grade DCIS, measuring less than 2.5 cm with margins ≥ 3 mm, compared RT with observation after surgery. The study was designed for 1,790 patients but was closed early because of lower than projected accrual. Six hundred thirty-six patients from the United States and Canada were entered; tamoxifen use (62%) was optional. Ipsilateral local failure (LF) was the primary end point; LF and contralateral failure were estimated using cumulative incidence, and overall and disease-free survival were estimated using the Kaplan-Meier method. Results Median follow-up time was 7.17 years (range, 0.01 to 11.33 years). Two LFs occurred in the RT arm, and 19 occurred in the observation arm. At 7 years, the LF rate was 0.9% (95% CI, 0.0% to 2.2%) in the RT arm versus 6.7% (95% CI, 3.2% to 9.6%) in the observation arm (hazard ratio, 0.11; 95% CI, 0.03 to 0.47; P < .001). Grade 1 to 2 acute toxicities occurred in 30% and 76% of patients in the observation and RT arms, respectively; grade 3 or 4 toxicities occurred in 4.0% and 4.2% of patients, respectively. Late RT toxicity was grade 1 in 30%, grade 2 in 4.6%, and grade 3 in 0.7% of patients. Conclusion In this good-risk subset of patients with DCIS, with a median follow-up of 7 years, the LF rate was low with observation but was decreased significantly with the addition of RT. Longer follow-up is planned because the timeline for LF in this setting seems protracted.

508 Background: PBI is an alternative to WBI, with potentially greater therapy (tx) compliance, and better integration with chemotherapy (CTX). NSABP B-39/RTOG 0413 clinical outcome results from 2018 did not show equivalence of PBI to WBI in local tumor control; PBI was statistically inferior, but with clinically small differences. PBI may be an acceptable alternative to WBI for some women. Understanding cosmesis and quality of life (QOL) treatment outcomes is important. Methods: B-39/0413 included a prospective QOL substudy with PRO evaluation of breast cancer treatment outcomes (cosmesis, function, pain) and fatigue using BCTOS and SF-36 vitality scales. Secondary QOL parameters included treatment related symptoms, perceived convenience of care, and the BPI pain scale. The study sample was stratified by CTX or not, as CTX is given before WBI but after PBI. PRO assessments occurred before randomization, the last day of adjuvant tx [CTX or radiation], 4 wks later, and 6, 12, 24, and 36 mo later. Primary aims included comparisons of change in fatigue from baseline to end of tx and equivalency of change in cosmesis from baseline to 36 mo for PBI v WBI. Separate analyses were done for CTX and non-CTX pts, controlling for axillary dissection. Each comparison used α=0.0125. Planned sample size was 964. Results: From 3-23-05 to 5-27-09, 975 pts were enrolled in the PRO study; 950 had follow-up data. 504 did not receive CTX and 446 received CTX. In non-CTX pts, PBI had less fatigue (p=0.011) and did not meet criteria for cosmesis equivalence (97.5% CI, -0.02 to 0.22; ∆=0.20). In CTX pts, PBI had worse fatigue (p=0.011) and equivalent cosmesis to WBI (97.5% CI, -0.09 to 0.21; ∆=0.24). In both groups, PBI pts reported less pain at end of tx. In non-CTX pts, PBI had more pain at 36 mo but in CTX pts, there was no difference. Convenience of care and treatment related symptom outcomes will be presented. Conclusions: In non-CTX pts, PBI is more convenient with less fatigue and slightly poorer cosmesis at 36 mo. Cosmesis was equivalent at 36 mo in CTX pts. Support: U10CA180868, -180822, UG1CA189867. Clinical trial information: NCT00103181.

Purpose Prediction of patients at highest risk for ipsilateral breast tumor recurrence (IBTR) after local excision of ductal carcinoma in situ (DCIS) remains a clinical concern. The aim of our study was to evaluate a published nomogram from Memorial Sloan-Kettering Cancer Center to predict for risk of IBTR in patients with DCIS from our institution. Patients and Methods We retrospectively identified 794 patients with a diagnosis of DCIS who had undergone local excision from 1990 through 2007 at the MD Anderson Cancer Center (MDACC). Clinicopathologic factors and the performance of the Memorial Sloan-Kettering Cancer Center nomogram for prediction of IBTR were assessed for 734 patients who had complete data. Results There was a marked difference with respect to tumor grade, prevalence of necrosis, initial presentation, final margins, and receipt of endocrine therapy between the two cohorts. The biggest difference was that more patients received radiation in the MDACC cohort (75% at MDACC v 49% at MSKCC; P < .001). Follow-up time in the MDACC cohort was longer than in the MSKCC cohort (median 7.1 years v 5.6 years), and the recurrence rate was lower in the MDACC cohort (7.9% v 11%). The median 5-year probability of recurrence was 5%, and the median 10-year probability of recurrence was 7%. The nomogram for prediction of 5- and 10-year IBTR probabilities demonstrated imperfect calibration and discrimination, with a concordance index of 0.63. Conclusion Predictive models for IBTR in patients with DCIS who were treated with local excision are imperfect. Our current ability to accurately predict recurrence on the basis of clinical parameters alone is limited.

e18799Background: Post-operative analgesia requirements vary, but no guidelines exist for opioid prescription (Rx) after breast surgical oncology (BSO) procedures. Given the national opioid epidemi...

513Background: Lymphedema (LE) is a known complication of breast cancer treatment. Herein we report the factors associated with LE after neoadjuvant chemotherapy (NAC) and axillary dissection (ALND...

Purpose Although most breast cancer patients who receive neoadjuvant chemotherapy (NCT) have a tumor response, a small proportion experience progressive disease (PD). Predictors of response have been reported, but predictors for progression have not been identified. We sought to identify predictors of tumor progression during NCT with the ultimate aim of identifying patients who might benefit from a first-line surgical approach or from novel targeted therapies. Patients and Methods Data were obtained from reviewing medical records of patients with stage I to III breast cancer who received NCT (anthracycline and/or taxane based). Statistical analysis was performed to compare patients with any response or stable disease with patients with PD. Results One thousand nine hundred twenty-eight patients received NCT; 1,762 patients (91%) had some response, 107 (6%) had stable disease, and 59 (3%) had PD at some point during NCT. Factors predictive of PD included African American race (P = .002), tumor (T) status (P = .002), and American Joint Committee on Cancer clinical stage (P = .02). Histopathologic features of PD were high tumor grade (P = .005), high Ki-67 score (P = .002), and negative estrogen receptor (ER)/progesterone receptor (PR) status (P < .001/P < .001). Pre-NCT T status, race, and ER status were independent predictors of progression in multivariate analysis. Disease progression was a negative predictor of distant disease–free survival and overall survival in multivariate analysis (P < .001). Conclusion Factors predictive of PD include race, advanced tumor stage, high nuclear grade, high Ki-67 score, and ER/PR negativity. Because many of these variables are also associated with response to NCT, novel molecular predictors are needed to identify patients at risk for progression on standard NCT.

Purpose The genomic grade index (GGI) is a 97-gene measure of histological tumor grade. High GGI is associated with decreased relapse-free survival in patients receiving either endocrine or no systemic adjuvant therapy. Herein we examined whether GGI predicts pathologic response to neoadjuvant chemotherapy in patients with HER-2–normal breast cancer. Methods Gene expression data (gene chips) was generated from fine-needle aspiration biopsies (n = 229) prospectively collected before neoadjuvant paclitaxel, fluorouracil, doxorubicin, and cyclophosphamide chemotherapy. Pathologic response was quantified using the residual cancer burden (RCB) method. The association between the GGI and pathologic response was assessed in univariate and multivariate analyses. The performance of a response predictor combining clinical variables and GGI was evaluated under cross-validation. Results Eighty-five percent of grade 1 tumors had low GGI, 89% of grade 3 tumors had high GGI, and 63% of grade 2 tumors had low GGI. Among both estrogen receptor (ER)-positive and -negative cancers, high GGI score was associated with pathologic complete response (RCB-0) or minimal residual disease (RCB-1). A multivariate model combining GGI and clinical parameters had an overall accuracy of 71%, compared with 58% for the GGI alone, for prediction of pathologic response. However, high GGI score was also associated with significantly worse distant relapse-free survival in patients with ER-positive cancer (P = .005), and was not associated with survival in patients with ER-negative cancer. Conclusion High GGI is associated with increased sensitivity to neoadjuvant paclitaxel plus fluorouracil, adriamycin, and cyclophosphamide chemotherapy in both ER-negative and ER-positive patients, but it remains a predictor of worse survival in ER-positive patients.

Purpose The National Surgical Adjuvant Breast and Bowel Project B-24 trial, published in June 1999, demonstrated that tamoxifen after breast-conserving surgery (BCS) and radiotherapy for ductal carcinoma in situ (DCIS) reduced the absolute occurrence of ipsilateral and contralateral breast cancer. We assessed the impact of B-24 on practice patterns at selected National Comprehensive Cancer Network (NCCN) centers. Patients and Methods Tamoxifen use after surgery was examined among 1,622 patients presenting for treatment of unilateral DCIS between July 1997 and December 2003 at eight NCCN centers. Associations of clinicopathologic and treatment factors with tamoxifen use were assessed in univariate and multivariable logistic regression analyses. Results Overall, 41% of patients (665 of 1,622) received tamoxifen. The proportion increased from 24% before July 1, 1999, to 46% on or after July 1, 1999. Factors significantly associated with receipt of tamoxifen included diagnosis on or after July 1, 1999 (odds ratio [OR], 3.85; P < .0001), BCS in patients younger than 70 years (OR, 3.21; P = .0073), no history of cerebrovascular or peripheral vascular disease (OR, 3.13; P = .0071), receipt of radiotherapy (OR, 1.82; P = .0009), and previous hysterectomy (OR, 1.34; P = .0459). Tamoxifen use varied significantly by center, from 34% to 74% after BCS and 17% to 53% after mastectomy (P < .0001). Conclusion Tamoxifen use after surgery for DCIS at NCCN centers increased after presentation of the B-24 results. Rates varied substantially by institution, suggesting that physicians differ in how they weigh the modest reduction in breast cancer risk with tamoxifen against its potential adverse effects in this population.

Purpose To identify clinicopathological factors predictive of distant metastasis in patients who had a pathologic complete response (pCR) after neoadjuvant chemotherapy (NC). Methods Retrospective review of 226 patients at our institution identified as having a pCR was performed. Clinical stage at diagnosis was I (2%), II (36%), IIIA (27%), IIIB (23%), and IIIC (12%). Eleven percent of all patients were inflammatory breast cancers (IBC). Ninety-five percent received anthracycline-based chemotherapy; 42% also received taxane-based therapy. The relationship of distant metastasis with clinicopathologic factors was evaluated, and Cox regression analysis was performed to identify independent predictors of development of distant metastasis. Results Median follow-up was 63 months. There were 31 distant metastases. Ten-year distant metastasis-free rate was 82%. Multivariate Cox regression analysis using combined stage revealed that clinical stages IIIB, IIIC, and IBC (hazard ratio [HR], 4.24; 95% CI, 1.96 to 9.18; P < .0001), identification of ≤ 10 lymph nodes (HR, 2.94; 95% CI, 1.40 to 6.15; P = .004), and premenopausal status (HR, 3.08; 95% CI, 1.25 to 7.59; P = .015) predicted for distant metastasis. Freedom from distant metastasis at 10 years was 97% for no factors, 88% for one factor, 77% for two factors, and 31% for three factors (P < .0001). Conclusion A small percentage of breast cancer patients with pCR experience recurrence. We identified factors that independently predicted for distant metastasis development. Our data suggest that premenopausal patients with advanced local disease and suboptimal axillary node evaluation may be candidates for clinical trials to determine whether more aggressive or investigational adjuvant therapy will be of benefit.

It has now been over 10 years since lymphatic mapping and sentinel lymph node (SLN) biopsy was first used in patients with breast cancer. Since the procedure was introduced, over 1,500 studies on SLN biopsy in breast cancer have been published in the cited world medical literature. Over 11,000 women have been enrolled in National Cancer Institute–sponsored SLN biopsy trials for breast cancer, the final results of which will not be available until several years from now. In the meantime, both the National Comprehensive Cancer Network treatment guidelines in the United States and the Saint Gallen International Consensus Conference on the treatment of breast cancer have now indicated that SLN biopsy is an acceptable alternative to axillary lymph node dissection in patients with clinically nodenegative breast cancer, provided that the SLN team has documented experience with this technique. Simply stated, although long-term follow-up data are not yet available from randomized trials comparing SLN biopsy with axillary lymph node dissection, SLN biopsy has become an acceptable alternative to routine level I and II axillary lymph node dissection for women with clinically node-negative early-stage breast cancer in the United States and in several other developed countries. However, despite a clear picture of increasing integration of SLN biopsy into standard diagnostic and therapeutic strategies for breast cancer, there are several clinical scenarios in which the utility of this technique has been questioned. This article will focus on current and resolving controversies associated with breast cancer lymphatic mapping and SLN biopsy.

Purpose To evaluate the efficacy of radiation in patients treated with neoadjuvant chemotherapy and mastectomy. Patients and Methods We retrospectively analyzed the outcomes of 542 patients treated on six consecutive institutional prospective trials with neoadjuvant chemotherapy, mastectomy, and radiation. These data were compared to those of 134 patients who received similar treatment in these same trials but without radiation. Results Irradiated patients had a lower rate of local-regional recurrence (LRR) (10-year rates: 11% v 22%, P = .0001). Radiation reduced LRR for patients with clinical T3 or T4 tumors, stage ≥ IIB disease (AJCC 1988), pathological tumor size >2 cm, or four or more positive nodes (P ≤ .002 for all comparisons). Patients who presented with clinically advanced stage III or IV disease but subsequently achieved a pathological complete response to neoadjuvant chemotherapy still had a high rate of LRR, which was significantly reduced with radiation (10-year rates: 33% v 3%, P = .006). Radiation improved cause-specific survival (CSS) in the following subsets: stage ≥ IIIB disease, clinical T4 tumors, and four or more positive nodes (P ≤ .007 for all comparisons). On multivariate analyses of LRR and CSS, the hazard ratios for lack of radiation were 4.7 (95% CI, 2.7 to 8.1; P < .0001) and 2.0 (95% CI, 1.4 to 2.9; P < .0001), respectively. Conclusion After neoadjuvant chemotherapy and mastectomy, comprehensive radiation was found to benefit both local control and survival for patients presenting with clinical T3 tumors or stage III-IV (ipsilateral supraclavicular nodal) disease and for patients with four or more positive nodes. Radiation should be considered for these patients regardless of their response to initial chemotherapy.

559 Background: Recent national consensus guidelines regarding optimal margin width for the management of DCIS have been published; however, controversy remains for managing margins

16 Background: Value in healthcare (patient-centered outcomes achieved per dollar spent) unifies performance improvement goals with health outcomes of importance to patients. We describe the process through which value-based measures for breast cancer patients and dynamic capture of these metrics via our new electronic health record (EHR) were developed at our institution. Methods: A review of the breast cancer literature was conducted on treatment options as well as expected outcomes and potential treatment complications. Patient perspective was obtained via focus groups. Multidisciplinary teams met to inform a 3-phase process of (1) concept development, (2) measure specification, and (3) implementation via EHR integration, planned for spring 2016. Results: Outcomes were divided into 3 previously defined tiers (NEJM 2010; 363:2477-2481) that reflect the entire cycle of care (Table).Within these tiers, 22 patient-centered outcomes were defined with inclusion/exclusion criteria, specifications for reporting, and sources for data including the EHR and validated patient-reported outcome questionnaires (e.g., FACT-B+4) administered via our patient portal. Conclusions: A value-based approach to cancer care with transparently reported patient outcomes not only creates opportunity for performance improvement but also enables benchmarking within and across providers, healthcare systems, and even countries. Our value-based framework for breast cancer is the first of its kind in the United States, with a similar model being pursued internationally as well. [Table: see text]

118 Background: Guidelines for treating inflammatory breast cancer (IBC) using trimodality (chemotherapy, surgery and radiation) therapy (TT) remain largely unchanged since 2000. However, many such patients did not receive TT. It is unknown how patient-level (PL) and facility-level (FL) factors contribute to TT utilization. Methods: Using the National Cancer Data Base (NCDB), patients who underwent surgical treatment of locoregional IBC from 2003-2011 were identified. We correlated patient, tumor, and treatment data with TT. An observed to expected (O/E) ratio of number of patients treated with TT was calculated for each hospital by adjusting for PL factors. Hierarchical mixed effects models were used to assess the proportion of variation in the use of TT attributable to PL and FL factors, respectively. Results: Among 5,537 patients who met the study criteria, the use of TT fluctuated annually (67.3%-75.7%) and was less likely for patients who were over 70, had a lower income or had an N0 tumor (all p < 0.05). By insurance type, TT use was lowest among Medicare patients. Of the 542 hospitals examined, 55 (10.1%) and 24 (4.4%) were identified as significantly low and high outliers for the use of TT (p < 0.05), respectively. While comprehensive cancer centers represented the majority of high outliers, the TT use by facility type overall was not significantly different demonstrating variability within comprehensive cancer center practice. The percentage of the total variance in the use of TT attributable to facility (11%) was almost triple the variance attributable to the measured PL factors (3.4%). Conclusions: The use of standard of care TT varied widely across facilities with some high volume centers clearly underutilizing TT. To improve clinical outcomes for this rare and aggressive malignancy, it is critical to identify facility level factors impacting the use of TT to ensure the guideline adherence of IBC treatment.

1034 Background: Many clinically node positive breast cancer patients receive neoadjuvant chemotherapy (NAC), with 40% converting to node negative. Recent trials suggest a potential role for limiti...

42 Background: Patients with ductal carcinoma in situ (DCIS) are at increased risk for developing contralateral breast cancer (CBC). Consequently, more women with DCIS are electing to undergo contralateral prophylactic mastectomy (CPM). We previously reported a 27% CPM rate among patients with DCIS who were evaluated for BRCA genetic testing (positive, negative, not tested). In this specific cohort, we further evaluated factors associated with CPM in patients with DCIS who tested negative for a BRCA mutation. Specifically, we aimed to identify differences within BRCA-negative patients who underwent CPM and those who did not. Methods: This retrospective study from a prospective registry included 100 women with DCIS referred for genetic counseling between 2003 and 2011. Patient characteristics included: age, marital and educational status, tumor markers, nuclear grade, family history of breast cancer (BC) and ovarian cancer (OC), race, Ashkenazi Jewish ancestry, and BRCA results. Univariate and multivariate logistic regression analyses were used to determine predictive factors associated with CPM election. Results: Of 100 BRCA-negative patients, 31 (31%) underwent CPM. Univariate analysis revealed patients who had a first-degree relative with OC were more likely to elect CPM that those who did not (p = 0.0278). Patients who had a family history of OC (53.3%) were more likely to choose CPM than those with no family history (p = 0.0425). Married patients were more likely to elect CPM than those who were not married (p = 0.0235). In multivariate analysis, married patients were more likely to elect CPM than those who were not married (OR = 4.367; 95% CI, 1.198-15.924; p = 0.0255). Conclusions: The CPM rate among patients with DCIS who tested negative for a BRCA mutation is high. Factors associated with increased rate of CPM among this group include a family history of OC and being married. Further studies are needed to evaluate patients' perceptions of CBC risk and their role in the likelihood of CPM choice.

104 Background: Since 1990 breast conserving therapy (BCT) has become a widely accepted modality in the treatment of breast cancer. However, many women continue to undergo mastectomy over BCT. The objective of this study was to provide a comprehensive population based review of the factors that influence utilization of BCT. Methods: Using the National Cancer Database (NCDB), we evaluated women who underwent a mastectomy or BCT for T1/T2, any N breast cancer between 1998 and 2011. We conducted a retrospective review of patient and facility variables associated with undergoing BCT and the trends over time. Logistic regression analysis was used to assess the multivariate relationship between these variables and the probability of undergoing BCT. Results: Among the 727,927 patients who met study criteria, BCT rates increased from 54% in 1998 to 59% in 2006 and then stabilized. After adjusting for demographic and clinical characteristics, BCT utilization was more likely in patients aged 52-61 compared to younger patients (odds ratio (OR) 1.14 {95% CI 1.12-1.15}) and in those with the highest education level (OR 1.16 {95% CI 1.14-1.19}). BCT rates were higher in patients with private insurance compared to the uninsured (OR 1.33 {95% CI 1.28-1.38}) and in those with the highest median income (OR 1.09 {95% CI 1.06-1.11}) (all p < 0.0001). Academic Cancer Programs, facilities in the Northeast and patients who lived within 17 miles of a treatment facility had higher utilization of BCT than Community Cancer Programs (OR 1.13 {95% CI 1.11-1.15}), facilities located in the South (OR 1.50 {95% CI 1.48-1.52}) and those who lived further from a treatment facility (OR 1.25 {95% CI 1.23-1.27}) (all p

99 Background: Staging of breast cancer patients is enhanced by axillary ultrasound (US) and needle biopsy of abnormal lymph nodes (LN). When clips are placed in sampled metastatic LNs, they can be evaluated for nodal response to neoadjuvant chemotherapy (NCT). The goals of this study were to determine if pathologic changes in clipped LNs reflect nodal response to NCT and if targeted axillary dissection (TAD), which includes sentinel lymph node dissection (SLND) in addition to selective localization and removal of clipped LNs, could increase the accuracy of nodal assessment. Methods: This prospective study included patients with US-identified axillary metastases confirmed by needle biopsy with a clip placed in the sampled LN. After NCT, patients underwent axillary lymphadenectomy (ALND) with x-ray of the axillary contents to identify the clip-containing LN. In 38 patients, the clipped LN was selectively removed using wire (n=2) or I125seed localization (n=36) before ALND was performed. Five patients did not undergo ALND. The pathologic findings of the clipped LN were reported separately from the other nodes. Results: Ninety node positive patients were enrolled. Forty (44%) had a complete nodal response to NCT and 50 (56%) had residual disease. Pathologic evaluation of the clipped LN revealed metastases in 47/50 patients with residual disease, resulting in a false negative rate (FNR) of 6% (95% CI 1.3-16.6). In 52 patients who underwent SLND, the clipped LN was not a SLN in 23% (n=12). Thirty-one of these patients had residual disease; metastases were not seen in SLNs in 5 cases resulting in a FNR for SLND alone of 16% (95% CI 5.4-34). Evaluation of the clipped LN in addition to SLND improved the FNR to 3% (1/31, 95% CI 0.1-17). Thirty-one patients underwent TAD while an additional 7 had localization and selective removal of the clipped LN without SLND with one false negative result. Conclusions: US-guided marking of LNs with documented metastatic disease allows for their selective removal and improved pathologic evaluation for residual nodal disease. The FNR of SLND can be reduced by ensuring removal and evaluation of the clipped LN. TAD is technically feasible and allows for improved assessment of nodal response after NCT.

95 Background: In early-stage breast cancer patients, the number of positive lymph nodes (LN) is considered in decisions regarding surgery and radiation. The goal of this study was to characterize the extent of axillary nodal involvement based on clinicopathologic and imaging features. Methods: A prospective database was used to identify T1-2 patients who underwent regional nodal ultrasound (US) and axillary lymph node dissection (ALND) from 2002-2012. Patients who received neoadjuvant chemotherapy or had extra-axillary LN metastases were excluded. Subjects were grouped by whether axillary metastases (AxM) were identified by US confirmed by needle biopsy or by sentinel lymph node dissection (SLND) after a negative US, then compared using X2 and Rank-Sum tests as appropriate. Results: AxM were identified by US in 190 patients and SLND in 518 patients. When compared to US-detected patients, SLND patients had fewer positive nodes (2.2 vs. 4.1, p < 0.0001), smaller metastases (5.3 vs. 13.8 mm, p < 0.0001), and a lower incidence of extranodal extension (ENE) (24% vs. 53%, p < 0.0001). Limiting analyses to patients with ≤ 2 abnormal LN on US, US-detected patients still had more positive LN (3.6, p < 0.001), larger metastases (13.4 mm, p < 0.0001), and a higher incidence of ENE (50%, p < 0.001) with more than 2 positive LN found in 45% of the US group versus 19% of the SLND group (p < 0.001). In patients with lobular histology there were no differences in number of positive LN (4 in SLND vs. 3.6 in US, p = 0.36), or ENE (34% SLND vs. 36% US, p = 0.9). Positive non-SLN were found in 23% (96/415) of patients with ductal tumors and 36% (21/59) of those with lobular tumors. In multivariate analysis, having metastases found by US (OR 4.01, 95% CI 2.75-5.84) and lobular histology (OR 1.77, 95% CI 1.06-2.95) predicted having > 2 positive LN adjusting for tumor size, receptor subtype, and histology. Conclusions: Patients with AxM found by US have more positive nodes, larger metastases, and higher risk of ENE, even if ≤ 2 suspicious LN are seen on US compared to patients with SLND-detected AxM. Tumor histology also predicts nodal burden. Clinicians can use imaging and clinicopathologic features to predict extent of nodal involvement and appropriately counsel patients regarding treatment decisions.

1017 Background: Pathologic complete response (pCR) of tumors in the breast and axillary lymph nodes (ALN) after primary systemic chemotherapy (PST) is associated with an excellent outcome. A previous analysis showed superior 5-year overall survival (OS) and relapse-free survival (RFS) for patients who achieved an ALN pCR after PST compared to those without a pCR in 5 prospective clinical trials. This study is an expanded analysis of all patients treated with PST at our institution examining the impact of ALN pCR on 10-year OS and RFS. Methods: Patients with clinical stage II/III and pathologically confirmed ALN metastases who underwent PST were categorized into 1 of 2 groups: ALN pCR and ALN residual disease. Additional data were collected, including breast cancer subtype, clinical tumor size, and lymph node staging, pathologic tumor (T) stage, and class of PST. RFS and OS were estimated by the Kaplan-Meier product limit method. Subset analyses were performed on patients with HER2-positive cancer. Results: 1,600 women diagnosed between 1989 and 2007 were identified. Median follow-up was 79 months (5-277); 454 (28.4%) achieved an ALN pCR. ALN pCR was associated with triple-negative and higher grade cancers, lower clinical stage, and lower pathologic breast T stage. 5-year OS and RFS estimates were similar to prior analysis. The 10-year OS was 85% and 58% and the 10-year RFS 83% and 55% (p < 0.001), for patients who achieved an ALN pCR and those with residual ALN disease. For HER2-positive breast cancers, 67.3% of patients who received HER2-targeted therapy achieved an ALN pCR vs. 32.3% without HER2-targeted therapy (p < 0.001). For patients receiving HER2-targeted therapy for HER2-positive breast cancer (n = 153), the 10-year OS was 92% and 52% (p = 0.006), and the 10-year RFS was 89% and 59% (p < 0.001) for those with and without an ALN pCR. Conclusions: ALN pCR is an excellent early surrogate marker for long-term outcome, 10-year RFS and OS. In HER2-positive breast cancers, HER2-targeted therapy is associated with high rates of pCR. Despite the aggressive nature of their disease, patients who achieve ALN pCR with PST have an excellent 10-year prognosis.

11060 Background: Recently we demonstrated the ability to detect the presence of invasive breast cancer by next generation sequence (NGS) analysis of cell-free DNA (cfDNA) in serum without prior knowledge of the specific gene perturbations of the neoplasm (J. Clin. Oncology 2010; 28 (15S):10505). We hypothesized that cfDNA levels would hold promise as a marker to monitor therapeutic efficacy in breast cancer. In this study, we sought to determine whether cfDNA decreases after surgery in patients with operable invasive breast cancer. Methods: Serum was collected before and 1-4 weeks after surgery from 16 breast cancer patients and also from 24 age and gender matched controls. cfDNA was isolated from the serum, amplified by Chronix proprietary method and sequenced on an Illumina HiSeq platform. The breast cancer derived cfDNA sequences from each patient were compartmentalized in 250kbp bins, normalized, and compared to the mean (+/- 3SD) of the controls to identify regions of chromosomal number imbalance (CNI). Genomic DNA was isolated from the primary tumor and blood WBC buffy coat, pre-amplified, sequenced and subjected to comparative analysis with cfDNA. Results: Analysis of pre- and post surgery serum demonstrate that CNIs are present in the pre-surgery serum cfDNA that correlated with the associated tumor CNI and was not observed in WBC genomic DNA. The number of tumor associated CNI DNA biomarkers ranged from as low as 3 to as high as 865. In 13 of 16 patients (81%) analyzed, the post-surgery cfDNA was free of detectable tumor related-CNI DNA. In the remaining 3 patients, only a partial reduction in tumor specific CNI DNA serum biomarkers was observed, since some markers were still detectable after surgery. Conclusions: cfDNA from primary breast carcinomas accurately reflects tumor CNI. Removal of the primary tumor results in the elimination of tumor cfDNA in the majority of patients. Thus cfDNA may be of clinical value in evaluation of therapeutic efficacy on a real time basis. Further work is needed to determine if residual tumor CNI in cfDNA after surgery is a marker of minimal residual disease which can be pursued as a prognostic marker.

152 Background: Nipple sparing mastectomy is for treatment of early stage breast cancer and risk reduction in patients at high risk for breast cancer. A high rate of nipple loss after NSM (10% to 30%) has slowed incorporation of NSM into clinical practice. No study has evaluated whether clinical and technical factors contribute to nipple loss by decreasing blood supply to the nipple areola complex (NAC). The objective here was to determine the impact of patient variables and surgical factors on survival of the nipple following NSM and to compare rates of complications of NSM to those of SSM. Methods: We evaluated 233 cases of immediate breast reconstruction following mastectomy at MD Anderson Cancer Center between September 2003 and May 2011. 113 NSM procedures were randomly matched to 120 SSMs based on stage, comorbidities, and age. The NSM group was analyzed for variables that correlated with partial or total nipple loss. Results: In the NSM group, the complication rate was 28%, compared to 27% in SSM (p > 0.99). The nipple loss rate in NSM was 20%. In SSM, axillary node dissection increased complications compared to sentinel lymph node biopsy (p = 0.01). Body mass index, breast ptosis, breast cancer pathology, distance of the lesion to the NAC and use of neoadjuvant chemo or radiation therapy had no effect on nipple loss. Vascular comorbidities and smoking lead to increased nipple loss, with borderline p values (p = 0.09 and p = 0.08, respectively). When compared to A- and B-cup breasts, larger breasts had higher nipple loss (6% and 34%, respectively; p=0.003). Surgical incision location did not affect nipple loss, neither did number of prior NSM procedures performed by the breast surgeon (p = 0.86). Axillary lymphadenectomy (p = 0.13), separate axillary incision (p = 0.25), type of breast reconstruction (p = 0.23), and application of bioprosthetic sling (p = 0.27) may have impacted nipple loss if a larger sample size was studied. Conclusions: Patient variables and surgical technique can alter the rate of nipple loss with NSM. This study helps to define patient populations that may be at risk for necrosis and informs surgeon’s as to the best techniques for reconstruction to decrease the occurrence of nipple loss.

119 Background: Published studies from Europe have shown the presence of disseminated tumor cells (DTCs) to independently predict outcomes in patients with non-metastatic breast cancer. The purpose of this study was to assess the experience with DTCs at a tertiary cancer center and to see if these cells indeed predict outcomes in patients with stage I-III breast cancer. Methods: Clinical stage I-III breast cancer patients seen at a single tertiary cancer center provided consent to participate in an IRB-approved study involving collection of bone marrow (5 ml x 2 tubes) at the time of surgery for their primary breast cancer. DTCs were assessed by anti-CK antibody cocktail (AE1/AE3, CAM5.2, MNF 116, CK 8 and 18) following cytospin. A positive result was defined as the presence of one or more cells per 5 ml of bone marrow. Statistical analyses used chi-square and Fischer’s exact tests. Results: Three hundred and sixty-six patients were prospectively enrolled. Mean age was 53 years. Median follow-up was 32 months. DTCs were identified in 109 patients (30%). Ten percent of patients with DTCs (11/109) and 3% of patients without DTCs (8/257) died (p = 0.009). Overall survival (OS) in patients with DTCs was 30 months vs. 31 months in those without DTCs. DTCs did not predict relapse free survival (P=NS). On multivariate analysis the presence of DTCs was an independent predictor of worse overall survival (p < 0.0001). No correlation was observed between the presence of DTCs and lymph node metastases and/or other clinicopathologic variables. Conclusions: The presence of DTCs was an independent predictor of worse OS in patients with stage I-III breast cancer. Consideration should be given to the utilization of DTCs as predictors of outcome in clinical practice.

150 Background: Sentinel lymph node biopsy (SLNB) has been shown to be an accurate predictor of axillary lymph node involvement in breast cancer patients treated with neoadjuvant chemotherapy (NAC). A predictive model of SLN positivity in clinically node negative patients who completed NAC can assist in preoperative multidisciplinary treatment decision making, such as planning for postmastectomy radiation therapy and breast reconstruction. Methods: We reviewed our prospective database to identifyclinically node negative patients with invasive breast cancer who underwent NAC and SLNB from 1998-2011. Clincopathologic factors including age, tumor location, histology, nuclear grade, tumor size, decrease in tumor size with therapy, multifocality, nodal appearance on preoperative ultrasound, hormone receptor status, and lymphovascular invasion (LVI) were analyzed. A nomogram to predict SLN metastasis was developed using multivariate logistic regression analysis. Results: A total of 836 patients were treated with NAC followed by SLNB. Of these, 160 patients (19.1%) had a positive SLN. All factors were significant predictors of SLN positivity on univariate analysis except tumor location and nodal appearance on preoperative ultrasound. Multivariate analysis showed that young age, invasive lobular histology, tumor size, multifocality, and LVI were independent positive predictors of SLN positivity whereas high grade, response to chemotherapy, and triple negative hormone receptor status were negative predictors. Favorable histologies were strongly associated with a lower rate of SLN positivity but were excluded from the nomogram due to small numbers of patients (N=14). Discrimination of the nomogram to correctly predict SLN positivity was measured using the area under the receiver operating characteristic curve (AUC). The unadjusted AUC was 75.9, while the internally validated 2000 bootstrap sample-adjusted AUC was 74.2. Conclusions: Neoadjuvant chemotherapy is known to decrease the incidence of positive nodes in breast cancer patients. Use of our nomogram preoperatively can assist in decisions regarding multidisciplinary treatment planning.

1102 Background: Inflammatory breast cancer (IBC) is a rare and aggressive form of breast cancer typically presenting with early metastasis. Optimal outcomes are achieved with multimodality treatment strategies in the non-metastatic setting. Data is limited, however, on the benefit of surgery in patients with metastatic IBC. We evaluated the effect of primary tumor resection on outcomes in patients with newly diagnosed stage IV IBC. Methods: We reviewed records of 172 patients with metastatic IBC treated at our institution from 1994 - 2009. All patients received systemic therapy with or without locoregional therapy (LRT). Patient demographics, receptor (ER) and HER2-neu status, grade, histology, presence of lymphovascular invasion, margin status, number of distant disease sites, pathologic response of primary tumor and clinical response to systemic therapy (CRS) at distant disease sites were recorded. Overall survival (OS), distant progression-free survival (DPFS), and chest/skin involvement at last follow-up were evaluated. Kaplan-Meier survival analyses, univariate (UV) and multivariate (MV) logistic regression models were used. Chest/skin involvement was compared between groups using Kruskal-Wallis test. Results: Seventy-nine (45%) patients underwent primary tumor resection. Average age was 51 (22-78). Median live-patient follow-up was 33 months. OS and DPFS were significantly better for patients who underwent LRT versus none (p

1130 Background: Recent data from large cooperative group trials have questioned the relevance of small volume metastases identified in the sentinel lymph nodes (SLN) of early stage breast cancer patients. The 7th ed. of the AJCC staging system differentiates node negative patients (stage IA) from those with micrometastases (stage IB) or macrometastases (stage II or III). This study was undertaken to determine the utility of the stage IB designation. Methods: Review of a prospectively maintained database identified 3474 patients who underwent SLN biopsy between 1993 and 2007. Clinicopathologic and outcomes data were recorded and patients staged according to the 7th ed. AJCC system. Recurrence-free (RFS), disease-specific (DSS) and overall survival (OS) were determined using the Kaplan-Meier method and compared using the log-rank test. Results: AJCC stage distribution included: 2246 (65%) stage IA, 207 (6%) stage IB, 685 (20%) stage IIA, 209 (6%) stage IIB, and 127 (3%) stage III. For patients with stage IB disease, SLN micrometastasis was identified by H&E in 173 (84%) and immunohistochemistry (IHC) in 34 (16%); suggesting that 16% would have been staged IA if enhanced evaluation had not been performed. Median follow-up was 6.1 yrs (range 0-17.2). The 5-yr RFS,DSS and OS rates for patients with stage IB disease were 98.0%, 99.5%, and 95.9% respectively, which did not differ significantly from patients with stage IA disease who had 5-year RFS,DSS and OS rates of (97.5%, p=.9), (98.8%, p=.7) and (96.2%, p=.8). When all stage I patients (IA and IB) were evaluated by ER status or grade (grade 1 vs 2 vs 3), these biologic factors were able to significantly discriminate patients with respect to RFS, DSS and OS. Conclusions: Differentiating patients with micrometastases from node negative patients does not stratify patients with respect to survival. Biologic factors (ER status and grade) are better discriminants of survival than the presence of small volume nodal metastases in patients with early stage disease. These data do not support routine use of IHC or alterations in adjuvant therapy decisions based on identification of SLN micrometastases.

TPS10631 Background: Evaluation of HER2 in circulating (CTCs) and disseminated (DTC) tumor cells may aid therapy in breast cancer. We report here the discordance in HER2 status in CTCs and DTCs in early stage breast cancer by fluorescence in situ hybridization (FISH) using a microfluidic cell platform (OncoCEE). Methods: Blood (10ml) and BM (1-2ml) from patients with Stage T1 and T2 breast cancer was collected in OncoCEE-Sure collection tubes. Mononuclear cells were recovered using a Percoll density gradient method, incubated with a mixture of 10 primary capture antibodies (Abs), and introduced into streptavidin coated OncoCEE microchannels for tumor cell capture. For blood samples, captured cells were stained with anti cytokeratin (CK) and CD45 Abs for CTC enumeration followed by FISH using probes specific to centromere 17 and HER2. For BM samples, captured cells were subjected to HER2 FISH analysis. The ratio of HER2:CEP17>2.0 in any CK+/ CD45- and CK-/CD45- cell was regarded as positive for HER2. Results: Blood and BM from 68 patients (68 Blood, 54 BM; 54 matched blood and BM) with stage T1N0 (41), T1N1 (6), T2N0 (11), T2N1(2), T2N2 (1), T2N3 (2) with HER2+ (n=7) and HER2- (n=61) breast cancers were studied. The 7 patients with HER2 + primary tumor had HER2+ DTCs in 3/7 (43 %) and HER2 + CTCs in 1/6 (17 %) patients. HER2 + DTCs and HER2 + CTCs occurred in 10/47 (21%) and in 4/57 (7%) patients with HER2- primary breast tumors. The discordance of HER2 status was observed in 14% in CTCs and in 22% in DTCs. Conclusion: 1. The cell enrichment and extraction microfluidic platform (OncoCEE) provides a sensitive approach for evaluation of HER2 in CTCs and DTCs. 2. CTCs and DTCs acquired HER2 gene amplification in 21% and 7% of patients with HER2 negative early stage primary breast cancer. 3. CTCs and DTCs lost HER2 gene amplified status in 57% and 83% of patients with HER2 positive early stage primary breast cancer. 4. The clinical significance of alterations in HER2 status among CTCs and DTCs in early stage breast cancer needs further investigation.

1549 Background: Patients with DCIS are at increased risk for developing contralateral breast cancer (CBC). Therefore, an increasing number of women with DCIS are electing for contralateral prophylactic mastectomy (CPM). In a previous study involving 2072 women with DCIS, 13.5% chose CPM. In this study, we aimed to evaluate factors associated with CPM in patients with DCIS who underwent genetic counseling for BRCA. Methods: 165 women with pure DCIS, who underwent genetic counseling, were included in the study. Patients’ characteristics were obtained from a prospectively maintained research database at UT M.D. Anderson Cancer Center. Univariate and multivaraite logistic regression analysis were used to determine predictive factors associated with CPM. Patients’ characteristics included age, marital and educational status, tumor markers, nuclear grade, family history with breast (BC) and ovarian cancer (OC), race, Ashkenazi Jewish ancestry, and BRCA genetic test results. Results: Out of 165 patients, 17(10.3%) were found to have a BRCA deleterious mutation. 44(26.7%) underwent CPM. Younger patients (median ≤ 45 yr) were more likely to elect for CPM than older patients (p= 0.0098). Patients who tested positive for a BRCA mutation were more likely to elect for CPM than those who tested negative or were not tested (p= 0.0001). Patients who had a family history of OC (15 (57.7%) were more likely to choose CPM than those who did not (p= 0.0004). These three factors remained significant in the multivariate model (p

1028 Background: Recent studies have reported increased mastectomy rates for the treatment of early stage breast cancer during the last decade. The aims of this study were to examine trends in mastectomy rates at a single institution and in a population-based database and to compare differences between the two cohorts. Methods: Patients with stage 0-II breast cancer diagnosed from 2000 to 2008 were identified from our cancer center institutional database (CC cohort, n=8,915) and the Surveillance, Epidemiology and End Results database (SEER cohort, n=359,572). Patients without primary surgery or unknown surgery type were excluded. Mastectomy rates by the year of diagnosis were evaluated and multivariable logistic regression models were built to identify clinicopathologic factors that predicted mastectomy as the treatment choice. Results: The proportion of patients treated with mastectomy decreased from 44.5% to 37.8% between 2000 and 2005 in the CC cohort (P=0.003) and from 42.8% to 36.6% in the SEER cohort (P

1528 Background: Women with breast cancer have an increased risk of developing contralateral breast cancer in their lifetime. Thus increasing numbers of women have been electing to undergo contralateral prophylactic mastectomy (CPM) at the time of their initial breast cancer treatment. The objective of this study was to identify factors that determine the decision for CPM in patients at a major cancer center. Methods: 2,544 women with Stage 0-III unilateral primary breast cancer who underwent surgery to the breast at our institution from January 2000 to August 2006 were identified from a prospectively maintained database. Patient and tumor characteristics were evaluated and comparisons were made between patients who did or did not undergo CPM using logistic regression. Results: Of the 2,544 patients, 1254 (49.3%) underwent total mastectomy for their known cancer; 282 (22.5%) of these patients underwent immediate or delayed CPM. Overall, 171 patients (6.7%) had genetic testing; and the use of testing increased in the latter years of the study (3.% in 2000–2002 vs. 8.2% in 2003–2006, p [Table: see text] No significant financial relationships to disclose.

598 Background: Limited data exists regarding optimal local therapy for patients who present with stage IV breast cancer with an intact primary tumor. Two retrospective series, from the National Cancer Data Base and the Geneva Cancer Registry, showed that surgery may improve overall survival in these patients. Our institutional experience demonstrated improved metastatic progression-free survival after a median follow-up of 32.1 months but did not show a survival benefit at short term follow-up. We evaluated the impact of local control on overall (OS) and disease-specific survival (DSS) in this population after a longer follow-up interval to determine if a survival benefit could be demonstrated from local surgical treatment for selected patients with stage IV breast cancer. Methods: We reviewed the records of all patients at our institution who presented from 1997–2002 with stage IV disease with an intact primary tumor. OS and DSS were estimated by the Kaplan-Meier method. The log-rank test was used to compare the difference in survival between surgical and non-surgical patients. Multivariate statistical analysis was performed using the Cox proportional hazards model. Results: Of 220 patients identified with stage IV disease with an intact primary tumor, 80 (36%) underwent surgical resection of the primary tumor; 39 (49%) had segmental mastectomy and 41 (51%) had a total mastectomy. There were 140 (64%) patients who did not undergo surgery. The median follow-up duration from time of presentation to our institution was 58.6 months and the median OS time after presentation was 45.8 months. After adjustment for covariates, surgery was associated with improved OS (p=0.03) and DSS (p=0.04) compared to the non-surgical group. Conclusions: With a median follow-up time of 58.6 months, patients who presented with stage IV breast cancer with an intact primary tumor treated surgically had significantly improved OS and DSS compared to patients who did not undergo surgery. Our findings may be limited by a selection bias. Therefore, we feel that the issue of surgical intervention for the primary tumor in stage IV breast cancer patients deserves to be carefully studied in a well-designed, prospective, multi-center trial. No significant financial relationships to disclose.

529 Background: This report presents 2-year data on treatment efficacy and cosmesis for patients enrolled on the ASBS sponsored MammoSite Registry trial. Methods: 1449 patients were treated with the MammoSite device to deliver APBI. 924 patients have been followed ≥ 12 months, 586 ≥ 18 months, 316 ≥ 24 months and 52 ≥ 36 months. Median follow-up for surviving patients was 14 months. Results: Eleven patients (0.8%) developed an ipsilateral breast tumor recurrence (IBTR) as some component of their initial failure (prior to distant metastases [DM]) for a 2-yr actuarial rate of 1.2%. The 2-yr actuarial rate of isolated IBTR was 0.8% (n=8). Six patients (0.4%) developed an axillary failure (AF) as some component of their initial failure (prior to DM) for a 2-yr actuarial rate of 1.0%. The 2-yr actuarial rate of isolated AF was 0.6% (n=3). The only variable associated with the development of an isolated IBTR (n=8) included an extensive intraductal component (p=0.073) (patient age, margin status, grade, histology, tumor size, nodal status, use of systemic therapy and method of device placement were not associated with IBTR). The only variable associated with the development of all IBTRs (n=11) was tumor location (inner quadrant, p=0.079). The percentage of patients with good/excellent cosmetic results at 6, 12, 18, 24 and 36 months were as follows: 95.1% (n=769 patients), 93.7% (n=621 patients), 91.3% (n=344 patients), 93.5% (n=248 patients), and 90.4% (n=52 patients) (p=NS). For the 174 patients with both a 12-month and 24 month cosmetic assessment, the rate of good/excellent cosmetic results was 94% at 12 and 24 months. At 24 months (n=248 patients), factors associated with good/excellent cosmetic results included increased skin spacing as a categorical variable (94.8% versus 86.1%, p=0.064), no infection (94.8% versus 85.7%, p=0.057), and no systemic chemotherapy treatment (95.3% versus 82.4%, p=0.012). Conclusions: Treatment efficacy and cosmesis 2 years after treatment with APBI using the MammoSite device are excellent and appear similar to those reported with standard whole breast RT. No significant financial relationships to disclose.

598 Background: Excisional biopsy (ExB) and percutaneous needle biopsy (PB) are both accurate methods for diagnosing breast cancer. However, comprehensive breast cancer staging requires surgical assessment of the primary tumor and regional nodes. This study was designed to examine surgical and financial implications for breast cancer patients undergoing either ExB or PB. Methods: We evaluated 2,459 women with invasive breast cancer enrolled in a comprehensive database from 2000 to 2005. Clinical and treatment factors were compared for patients who had ExB versus PB. Total costs, facility fees (operating rooms, radiology suites, and pathology processing), and professional fees were estimated. A multivariate logistic regression was performed to determine factors associated with biopsy type. Results: PB was utilized in 1817 (74%) patients and ExB in 642 (26%). Of ExB patients, 86% were performed prior to referral. Patients undergoing ExB required a greater number of surgical procedures for margin control and lymph node assessment compared to PB (median 2.0 vs. 1.0, respectively). ExB exacted a cost increase 1.7 times that of PB, with a difference of >$3400 at our institution. After adjusting for age, tumor size and year of diagnosis, ExB was significantly associated with an increased number of surgical procedures required for definitive treatment compared to PB (OR = 166.7, p < 0.001). Conclusions: Excisional biopsy for breast cancer diagnosis results in an increased need for return trips to the operating room and higher cost of care. Percutaneous biopsy should be considered as the preferred approach in the diagnosis of breast cancer. No significant financial relationships to disclose.

602 Background: The predictive utility of sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy is similar to that for patients treated initially with surgery. We hypothesized that patients with positive SLNs after chemotherapy would have unique clinical and pathologic factors predictive of additional non-SLN positivity. Methods: From 1993 - 2005, 104 patients were identified from a prospective database who responded to neoadjuvant therapy, had a positive SLNB, and underwent axillary dissection. At presentation, 66 patients had clinically negative nodes (CN) by ultrasound, and 38 patients had positive nodes by fine needle aspirate (Pos). Univariate and multivariate assessments of 17 predictive factors for additional non-SLN disease were performed using chi-square and logistical regression analysis with a bootstrapped backwards elimination procedure. Results: Patients with CN nodes (47%) were less likely to have additional non-SLNs positive when compared to patients with FNA Pos nodes at presentation (71%) (p=0.017). In additional univariate analysis, method of SLN metastasis detection, lymphovascular invasion (LVI), multicentricity, LN response to neoadjuvant therapy, nuclear grade, number of SLNs positive, and size of SLN metastasis were predictive for additional positive non-SLNs (p ≤ 0.05). In multivariate analysis, LVI, method of SLN metastasis detection, multicentricity, axillary node status at presentation, and pathologic tumor size retained grouped significance with a bootstrap adjusted AUC of 0.762. A nomogram for predicting non-SLN metastasis was created incorporating these variables. Multifocality, ER, nuclear grade, and number of negative or positive SLNs did not add statistical predictive power to our model. Conclusions: Patients treated with neoadjuvant therapy who have positive SLNs are at high risk of having additional non-SLN disease; use of a nomogram may help to risk-stratify this patient population. We have identified unique predictive variables for these patients, including multicentricity and nodal status at presentation, that indicate additional non-SLN disease when the SLN is positive. We plan to validate the predictive ability of the multivariate results for this patient population prospectively. No significant financial relationships to disclose.

PURPOSE: To assess patient and tumor characteristics associated with a complete pathologic response (pCR) in both the breast and axillary lymph node specimens and the outcome of patients found to have a pCR after neoadjuvant chemotherapy for locally advanced breast cancer (LABC). PATIENTS AND METHODS: Three hundred seventy-two LABC patients received treatment in two prospective neoadjuvant trials using four cycles of doxorubicin-containing chemotherapy. Patients had a total mastectomy with axillary dissection or segmental mastectomy and axillary dissection followed by four or more cycles of additional chemotherapy. Patients then received irradiation treatment of the chest-wall or breast and regional lymphatics. Median follow-up was 58 months (range, 8 to 99 months). RESULTS: The initial nodal status, age, and stage distribution of patients with a pCR were not significantly different from those of patients with less than a pCR (P > .05). Patients with a pCR had initial tumors that were more likely to be estrogen receptor (ER)–negative (P CONCLUSION: Neoadjuvant chemotherapy has the capacity to completely clear the breast and axillary lymph nodes of invasive tumor before surgery. Patients with LABC who have a pCR in the breast and axillary nodes have a significantly improved disease-free survival rate. However, a pCR does not entirely eliminate recurrence. Further efforts should focus on elucidating the molecular mechanisms associated with this response.