Routine Axillary Ultrasound for Patients with T1-T2 Breast Cancer Does Not Increase the Rate of Axillary Lymph Node Dissection Based on Predictive Modeling.

BACKGROUND: Since publication of the American College of Surgeons Oncology Group Z0011 trial results, demonstrating that many patients with nonpalpable axillary lymph nodes and one or two positive sentinel nodes do not require axillary lymph node dissection (ALND), preoperative axillary ultrasound (AUS) has become controversial. Clinicians are concerned that AUS may lead to unnecessary ALND. The authors developed an algorithm (Algorithm 1) in which the number of AUS-suspicious nodes and tumor biology direct management. For estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer with a single AUS-suspicious node and a positive lymph node needle biopsy (LNNB), sentinel lymph node biopsy (SLNB) is performed with a specimen X-ray documenting retrieval of the clipped node. Other patients with positive LNNB receive neoadjuvant chemotherapy. The authors hypothesized that routine AUS and this algorithm could decrease ALND compared with a strategy of no preoperative AUS. METHODS: Decision-tree analysis and Monte Carlo simulation were used to assess the expected number of ALNDs under two strategies (routine AUS vs no AUS). Probabilities were drawn from a literature review and an institutional database. The authors assumed nodal pathologic complete response rates as reported in the literature. Four additional algorithms were created to assess whether any other treatment model could decrease the rate of ALND. RESULTS: Using the routine AUS and the authors' algorithm, the predicted ALND rate was 9%, versus 10% for a strategy of no AUS, with overlapping uncertainty intervals. The remaining treatment algorithms showed similar results. DISCUSSION: Use of AUS may help to tailor patient care without leading to overutilization of ALND, as long as neoadjuvant chemotherapy is administered when appropriate.

Benchmarking the American Society of Breast Surgeon Member Performance for More Than a Million Quality Measure-Patient Encounters.

BACKGROUND: Nine breast cancer quality measures (QM) were selected by the American Society of Breast Surgeons (ASBrS) for the Centers for Medicare and Medicaid Services (CMS) Quality Payment Programs (QPP) and other performance improvement programs. We report member performance. STUDY DESIGN: Surgeons entered QM data into an electronic registry. For each QM, aggregate "performance met" (PM) was reported (median, range and percentiles) and benchmarks (target goals) were calculated by CMS methodology, specifically, the Achievable Benchmark of Care™ (ABC) method. RESULTS: A total of 1,286,011 QM encounters were captured from 2011-2015. For 7 QM, first and last PM rates were as follows: (1) needle biopsy (95.8, 98.5%), (2) specimen imaging (97.9, 98.8%), (3) specimen orientation (98.5, 98.3%), (4) sentinel node use (95.1, 93.4%), (5) antibiotic selection (98.0, 99.4%), (6) antibiotic duration (99.0, 99.8%), and (7) no surgical site infection (98.8, 98.9%); all p values < 0.001 for trends. Variability and reasons for noncompliance by surgeon for each QM were identified. The CMS-calculated target goals (ABC™ benchmarks) for PM for 6 QM were 100%, suggesting that not meeting performance is a "never should occur" event. CONCLUSIONS: Surgeons self-reported a large number of specialty-specific patient-measure encounters into a registry for self-assessment and participation in QPP. Despite high levels of performance demonstrated initially in 2011 with minimal subsequent change, the ASBrS concluded "perfect" performance was not a realistic goal for QPP. Thus, after review of our normative performance data, the ASBrS recommended different benchmarks than CMS for each QM.

Select Choices in Benign Breast Disease: An Initiative of the American Society of Breast Surgeons for the American Board of Internal Medicine Choosing Wisely® Campaign.

BACKGROUND: Up to 50% of all women encounter benign breast problems. In contrast to breast cancer, high-level evidence is not available to guide treatment. Management is therefore largely based on individual physician experience/training. The American board of internal medicine (ABIM) initiated its Choosing Wisely® campaign to promote conversations between patients and physicians about challenging the use of tests or procedures which may not be necessary. The American society of breast surgeons (ASBrS) Patient safety and quality committee (PSQC) chose to participate in this campaign in regard to the management of benign breast disease. METHODS: The PSQC solicited initial candidate measures. PSQC surgeons represent a wide variety of practices. The resulting measures were ranked by modified Delphi appropriateness methodology in two rounds. The final list was approved by ASBrS and endorsed by the ABIM. RESULTS: The final five measures are as follows. (1) Don't routinely excise areas of pseuodoangiomatous stromal hyperplasia (PASH) of the breast in patients who are not having symptoms from it. (2) Don't routinely surgically excise biopsy-proven fibroadenomas that are < 2 cm. (3) Don't routinely operate for a breast abscess without an initial attempt to percutaneously aspirate. (4) Don't perform screening mammography in asymptomatic patients with normal exams who have less than a 5-years life expectancy. (5) Don't routinely drain nonpainful, fluid-filled cysts. CONCLUSIONS: The ASBrS Choosing Wisely® measures that address benign breast disease management are easily accessible to patients via the internet. Consensus was reached by PSQC regarding these recommendations. These measures provide guidance for shared decision-making.

The American Society of Breast Surgeons and Quality Payment Programs: Ranking, Defining, and Benchmarking More Than 1 Million Patient Quality Measure Encounters.

BACKGROUND: To identify and remediate gaps in the quality of surgical care, the American Society of Breast Surgeons (ASBrS) developed surgeon-specific quality measures (QMs), built a patient registry, and nominated itself to become a Center for Medicare and Medicaid Services (CMS) Qualified Clinical Data Registry (QCDR), thereby linking surgical performance to potential reimbursement and public reporting. This report provides a summary of the program development. METHODS: Using a modified Delphi process, more than 100 measures of care quality were ranked. In compliance with CMS rules, selected QMs were specified with inclusion, exclusion, and exception criteria, then incorporated into an electronic patient registry. After surgeons entered QM data into the registry, the ASBrS provided real-time peer performance comparisons. RESULTS: After ranking, 9 of 144 measures of quality were chosen, submitted, and subsequently accepted by CMS as a QCDR in 2014. The measures selected were diagnosis of cancer by needle biopsy, surgical-site infection, mastectomy reoperation rate, and appropriateness of specimen imaging, intraoperative specimen orientation, sentinel node use, hereditary assessment, antibiotic choice, and antibiotic duration. More than 1 million patient-measure encounters were captured from 2010 to 2015. Benchmarking functionality with peer performance comparison was successful. In 2016, the ASBrS provided public transparency on its website for the 2015 performance reported by our surgeon participants. CONCLUSIONS: In an effort to improve quality of care and to participate in CMS quality payment programs, the ASBrS defined QMs, tracked compliance, provided benchmarking, and reported breast-specific QMs to the public.

Prospective Study Comparing Surgeons' Pain and Fatigue Associated with Nipple-Sparing versus Skin-Sparing Mastectomy.

BACKGROUND: Nipple-sparing mastectomy (NSM) is more technically challenging than skin-sparing mastectomy (SSM) but offers quality-of-life and cosmetic advantages. However, surgeon physical symptoms related to NSM workload have not been documented. METHODS: This was a prospective study using questionnaires to compare surgeon-reported physical symptoms before, during, and after NSM versus SSM. Surgeons also answered general questions about each mastectomy. Bilateral cases were performed simultaneously by two surgeons, who completed independent questionnaires. RESULTS: Questionnaires were completed after 82 SSMs and 44 NSMs. On a 0-10 scale, surgeons reported NSM was more physically demanding than SSM (7.0 vs. 4.5, p < 0.001). Mean visualization was more difficult (5.7 vs. 3.2, p < 0.001) and mean fatigue score was greater (5.6 vs. 3.1, p < 0.001) after NSM than SSM. The mean increase in neck pain (on a 0-4 scale) was greater for NSM than SSM, both from before-to-during surgery (0.8 vs. 0.2, p = 0.003) and before-to-after surgery (0.9 vs. 0.2, p = 0.002). The mean increase in lower back pain was greater for NSM than SSM, both from before-to-during surgery (0.7 vs. 0.2, p = 0.008) and before-to-after surgery (0.9 vs. 0.2, p = 0.003). Surgeons reported that NSM was more mentally demanding (p < 0.001), complex (p = 0.01), and difficult (p < 0.001) than SSM. CONCLUSION: Surgeons experienced greater physical symptoms, mental strain, and fatigue with NSM than SSM. This raises concern that mild but repetitive pain over the course of a breast surgeon's career may lead to repetitive stress injury.

Measures of Appropriateness and Value for Breast Surgeons and Their Patients: The American Society of Breast Surgeons Choosing Wisely (®) Initiative.

BACKGROUND: Current breast cancer care is based on high-level evidence from randomized, controlled trials. Despite these data, there continues to be variability of breast cancer care, including overutilization of some tests and operations. To reduce overutilization, the American Board of Internal Medicine Choosing Wisely (®) Campaign recommends that professional organizations provide patients and providers with a list of care practices that may not be necessary. Shared decision making regarding these services is encouraged. METHODS: The Patient Safety and Quality Committee of the American Society of Breast Surgeons (ASBrS) solicited candidate measures for the Choosing Wisely (®) Campaign. The resulting list of "appropriateness" measures of care was ranked by a modified Delphi appropriateness methodology. The highest-ranked measures were submitted to and later approved by the ASBrS Board of Directors. They are listed below. RESULTS: (1) Don't routinely order breast magnetic resonance imaging in new breast cancer patients. (2) Don't routinely excise all the lymph nodes beneath the arm in patients having lumpectomy for breast cancer. (3) Don't routinely order specialized tumor gene testing in all new breast cancer patients. (4) Don't routinely reoperate on patients with invasive cancer if the cancer is close to the edge of the excised lumpectomy tissue. (5) Don't routinely perform a double mastectomy in patients who have a single breast with cancer. CONCLUSIONS: The ASBrS list for the Choosing Wisely (®) campaign is easily accessible to breast cancer patients online. These measures provide surgeons and their patients with a starting point for shared decision making regarding potentially unnecessary testing and operations.

A prediction model for the presence of axillary lymph node involvement in women with invasive breast cancer: a focus on older women.

Axillary lymph node (ALN) status at diagnosis is the most powerful prognostic indicator for patients with breast cancer. Our aim is to examine the contribution of variables that lead to ALN metastases in a large dataset with a high proportion of patients greater than 70 years old. Using the data from two multicenter prospective studies, a retrospective review was performed on 2,812 patients diagnosed with clinically node-negative invasive breast cancer from 1996 to 2005 and who underwent ALN sampling. Univariate and multivariate logistic regression were used to identify variables that were strongly associated with axillary metastases, and an equation was developed to estimate risk of ALN metastases. Of the 2,812 patients with invasive breast cancer, 18% had ALN metastases at diagnosis. Based on univariate analysis, tumor size, lymphovascular invasion (LVI), tumor grade, age at diagnosis, menopausal status, race, tumor location, tumor type, and estrogen and progesterone receptor status were statistically significant. The relationship between age and involvement of axillary metastases was nonlinear. In multivariate analysis, LVI, tumor size and menopausal status were the most significant factors associated with ALN metastases. Age, however, was not a significant contributing factor for axillary metastases. Tumor size, LVI, and menopausal status are strongly associated with ALN metastases. We believe that age may have been a strong factor in previous analyses because there was not an adequate representation of women in older age groups and because of the violation of the assumption of linearity in their multivariate analyses.

Increasing national mastectomy rates for the treatment of early stage breast cancer.

BACKGROUND: To study national trends in the mastectomy rate for treatment of early stage breast cancer. METHODS: We analyzed data from the Surveillance, Epidemiology, and End Results database, including 256,081 women diagnosed with T1-2 N0-3 M0 breast cancer from 2000 to 2008. We evaluated therapeutic mastectomy rates by the year of diagnosis and performed a multivariable logistic regression analyses to determine predictors of mastectomy as the treatment choice. RESULTS: The proportion of women treated with mastectomy decreased from 40.1 to 35.6 % between 2000 and 2005. Subsequently, the mastectomy rate increased to 38.4 % in 2008 (p < 0.0001). Simple logistic regression models demonstrated that mastectomy rates between 2005 and 2008 were moderated by age (p < 0.0001), marital status (p = 0.0230), and geographic location (p < 0.0001). Multivariate logistic regression analysis found that age, race, marital status, geographic location, involvement of multiple regions of the breast, lobular histology, increasing T stage, lymph node positivity, increasing grade, and negative hormone receptor status were independent predictors of mastectomy. Additionally, multivariate analysis confirmed that women diagnosed in 2008 were more likely to undergo mastectomy than women diagnosed in 2005 (odds ratio 1.17, 95 % confidence interval 1.13 to 1.21, p < 0.0001). CONCLUSIONS: There is evidence of a reversal in the previously declining national mastectomy rates, with the mastectomy rate reaching a nadir in 2005 and subsequently rising. Further follow-up to confirm this trend and investigation to determine the underlying cause of this trend and its effect on outcomes may be warranted.

Does breast tumor heterogeneity necessitate further immunohistochemical staining on surgical specimens?

BACKGROUND: Prognostic and predictive tumor markers in breast cancer are most commonly performed on core needle biopsies (CNB) of the primary tumor. Because treatment recommendations are influenced by these markers, it is imperative to verify strong concordance between tumor markers on CNB specimens and the corresponding surgical specimens (SS). STUDY DESIGN: A prospective study was performed on 165 women (205 samples) with breast cancer diagnosed from January 2009 to July 2011. Tumor type, grade, estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor 2 (HER2), and Ki67 expression by immunohistochemical (IHC) testing were retrospectively analyzed in the CNB and SS. Contingency tables and agreement modeling were performed. RESULTS: There was substantial agreement between the CNB and SS for PR% and HER2; moderate agreement for tumor type, grade, and ER%; and fair agreement for Ki67%. In 8% of patients (n = 13), tumor heterogeneity was seen. In heterogeneous tumors the overall concordance between the CNB and SS was worse, especially for HER2. Six of these patients had areas of tumor that were positive for HER2, which were not detected in their CNBs. Nine patients had multiple distinct molecular subtypes within their tumor(s). CONCLUSIONS: The heterogeneous distribution of antigens in breast cancer tumors raises concern that the CNB may not adequately represent the true biologic profile in all patients. There is strong concordance for tumor type, ER, and PR between CNB and SS (although a quantitative decline was noted from CNB to SS); however, HER2 activity does not appear to be adequately detected on CNB in patients with heterogeneous tumors. These data suggest that IHC testing on the CNB alone may not be adequate to tailor targeted therapy in all patients.

Preoperative radiation therapy significantly increases patient eligibility for accelerated partial breast irradiation using 3D-conformal radiotherapy.

INTRODUCTION: Three-dimensional-conformal radiation (3D-CRT) is the most common approach used in National Surgical Adjuvant Breast and Bowel Project (NSABP) B-39 for accelerated partial breast irradiation (APBI). Administration of APBI-3D-CRT in the preoperative (preop) setting has been shown to decrease the planning target volume. The impact of this decrease on patient eligibility for APBI has not been evaluated in a comparative manner. MATERIALS AND METHODS: Forty patients with 41 previously treated breast cancers (≤4 cm) were analyzed. A spherical preop tumor volume was created using the largest reported radiographic dimension and centered within the contoured lumpectomy cavity. Plans were created and optimized using the preop tumor volume and postoperative lumpectomy cavity using NSABP B-39 guidelines. The primary end point was to evaluate for differences in patient eligibility and normal tissue exposure. RESULTS: Thirty-five tumors (85%) in the preop versus 19 tumors (46%) in the postoperative setting were eligible for 3D-CRT-APBI using NSABP B-39 criteria (P=0.0002). The most common reason for ineligibility was due to >60% of the ipsilateral breast volume receiving 50% of the dose. Other reasons included dose to the contralateral breast, heart, and ipsilateral lung. Preop 3D-CRT-APBI was associated with statistically significant improvements in dose sparing to the heart, ipsilateral normal breast tissue, contralateral breast, chest wall, ipsilateral lung, and skin. CONCLUSIONS: Dosimetrically, the use of preop radiation would increase patient eligibility for 3D-CRT-APBI and decrease dose to normal tissues, which will potentially decrease toxicity and improve cosmesis. These results provide the basis for a recently activated prospective study of preop 3D-CRT-APBI.

Similar survival with breast conservation therapy or mastectomy in the management of young women with early-stage breast cancer.

PURPOSE: To evaluate survival outcomes of young women with early-stage breast cancer treated with breast conservation therapy (BCT) or mastectomy, using a large, population-based database. METHODS AND MATERIALS: Using the Surveillance, Epidemiology, and End Results (SEER) database, information was obtained for all female patients, ages 20 to 39 years old, diagnosed with T1-2 N0-1 M0 breast cancer between 1990 and 2007, who underwent either BCT (lumpectomy and radiation treatment) or mastectomy. Multivariable and matched pair analyses were performed to compare overall survival (OS) and cause-specific survival (CSS) of patients undergoing BCT and mastectomy. RESULTS: A total of 14,764 women were identified, of whom 45% received BCT and 55% received mastectomy. Median follow-up was 5.7 years (range, 0.5-17.9 years). After we accounted for all patient and tumor characteristics, multivariable analysis found that BCT resulted in OS (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.83-1.04; p = 0.16) and CSS (HR, 0.93; CI, 0.83-1.05; p = 0.26) similar to that of mastectomy. Matched pair analysis, including 4,644 BCT and mastectomy patients, confirmed no difference in OS or CSS: the 5-, 10-, and 15-year OS rates for BCT and mastectomy were 92.5%, 83.5%, and 77.0% and 91.9%, 83.6%, and 79.1%, respectively (p = 0.99), and the 5-, 10-, and 15-year CSS rates for BCT and mastectomy were 93.3%, 85.5%, and 79.9% and 92.5%, 85.5%, and 81.9%, respectively (p = 0.88). CONCLUSIONS: Our analysis of this population-based database suggests that young women with early-stage breast cancer have similar survival rates whether treated with BCT or mastectomy. These patients should be counseled appropriately regarding their treatment options and should not choose a mastectomy based on the assumption of improved survival.

Accelerated partial breast irradiation via brachytherapy: a patterns-of-care analysis with ASTRO consensus statement groupings.

PURPOSE: The 2002 Food and Drug Administration approval of the MammoSite catheter (Hologic, Inc., Beford, MA) led to a surge of interest in accelerated partial breast irradiation (APBI). Until recently, guidelines as to the optimal candidates for this treatment were unavailable. We performed a patterns-of-care analysis for patients undergoing breast brachytherapy and compared these results with the American Society for Radiation Oncology (ASTRO) consensus statement. METHODS AND MATERIALS: The Surveillance, Epidemiology, and End Results database was used to examine female breast cancer patients treated with brachytherapy between 2002 and 2007. The patients were then categorized into suitable, cautionary, and unsuitable groups based on the ASTRO guidelines. RESULTS: We identified 4172 female breast cancer patients treated within the stated years. The number of brachytherapy cases increased nearly 10-fold over the time period studied from 163 in 2002 to 1427 in 2007 (p<0.0001). Patients with data missing were excluded, leaving a total of 3593 patients available for analysis. The mean patient age was 64 years. Most patients had small (<2cm in 80.9%) estrogen receptor-positive (86.7%) invasive (88.6%) tumors. The percentage of patients treated for ductal carcinoma in situ increased with time (p<0.001), whereas the percentage of patients treated with positive lymph nodes decreased with time (p<0.001). Using the data available, 1369 (38.1%), 1563 (43.5%), and 661 (18.3%) patients were characterized as suitable, cautionary, and unsuitable, respectively. CONCLUSIONS: More than 60% of patients who received APBI via brachytherapy would fall into the ASTRO cautionary or unsuitable groupings. This is the largest patterns-of-care analysis for APBI patients and serves as a baseline for future comparison.