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There are few large-scale studies that have examined outcomes for BRCA1/2 carriers who have undergone nipple-sparing mastectomy (NSM). The objective of our study was to examine incidental cancers, operative complications, and locoregional recurrences in BRCA1/2 mutation carriers who underwent NSM for both risk reduction and cancer treatment. This was a retrospective review of pathology results and outcomes of 201 BRCA1/2 carriers from two different institutions who underwent NSM from 2007 to 2014. NSM was performed in 397 breasts of 201 BRCA1/2 carriers. One hundred and twenty-five (62.2 %) patients had a BRCA1 mutation and 76 (37.8 %) had a BRCA2 mutation; 150 (74.6 %) patients underwent NSM for risk reduction and 51 (25.4 %) for cancer. Incidental cancers were found in four (2.7 %) of the 150 risk-reduction patients and two (3.9 %) of the 51 cancer patients. The nipple-areolar complex (NAC) was involved with cancer in three (5.8 %) patients. No prophylactic mastectomy had a positive NAC margin. There was loss of the NAC in seven breasts (1.8 %) and flap necrosis in ten (2.5 %) breasts. With a mean follow-up of 32.6 months (1–76 months), there have been four cancer events—three in cancer patients and one in a risk-reduction patient but none at the NAC. NSM in BRCA1/2 carriers is associated with a low rate of complications and locoregional recurrence but these patients require long-term follow-up in both the cancer and risk-reduction setting.

Background Young patients with breast cancer represent a unique cohort of patients who often have different treatment plans than older patients. We hypothesized that the rates of contralateral prophylactic mastectomy (CPM) were significantly higher and those of lumpectomy were significantly lower in young patients compared with older patients and that this trend persists when adjusting for patient, tumor, and facility factors. Study Design We used the National Cancer Data Base (NCDB) to study 553,593 patients from all ages with American Joint Committee on Cancer (AJCC) stage 0 to II breast tumors, who underwent lumpectomy, unilateral mastectomy, or CPM from 2003 to 2010. Results Over the entire cohort, lumpectomy rates decreased from 67.7% in 2003 to 66.4% in 2010 in contrast to women 45 years old or less, in whom the lumpectomy rates went from 61.3% in 2003 to 49.4% in 2010. Unilateral mastectomy went from 28.2% to 23.9% and CPM from 4.1% to 9.7% compared with women 45 years old or less, in whom unilateral mastectomy rates went from 29.3% to 26.4% and CPM rates from 9.3% to 26.4%. Age was the most significant factor related to increasing CPM rates: 19.7% of women between 41 and 45 years old underwent CPM vs 5.1% of women between 66 and 70 years old. There was substantial regional variation in surgical procedures for young women: lumpectomy rates were lowest in the West and CPM rates were highest in the Midwest. Multivariate logistic regression showed that women 45 years old or younger compared with women more than 45 years who underwent CPM were more likely to be Caucasian, treated at an academic/research institution, have larger tumors, higher grade, higher stage, and lobular histology. Conclusions The rate of CPM continues to increase, with one-quarter of younger women undergoing CPM. This trend persists across all patient, tumor, and facility characteristics.

Background: There has been a rapid increase in the use of new radiation techniques for postlumpectomy radiation, including partial breast irradiation via brachytherapy (APBI-b), 3-dimentional conformal radiotherapy (3D-CRT), and intensity modulated radiotherapy (IMRT) techniques. However, it is unknown if these new radiation techniques provide survival benefit equivalent to external beam whole-breast irradiation (WBI) in patients undergoing breast conservation. Additionally, compliance with the 2009 ASTRO guidelines for partial breast radiation has not been examined in a contemporary cohort of patients. Method: From the National Cancer Database, we identified 718,392 women diagnosed with AJCC stage 0-III breast cancer between 2003 and 2010, who underwent breast conserving surgery. Patients were classified into suitable, cautionary, or unsuitable for APBI-b according to ASTRO guidelines. Cox proportional hazard models were used to examine the effectiveness of the new irradiation modalities on overall survival in all eligible patients and within each ASTRO category. Results: Overall, 37,363 patients (6.4%) underwent APBI-b, 40,767 (5.7%) underwent IMRT, 45,721 (6.4%) underwent 3D-CRT, 421,497 (58.7%) underwent conventional WBI. The utilization of the three new radiation techniques increased over the study period, and 31.3% of all patients treated with radiotherapy after lumpectomy actually used one of the three new methods in 2010. Overall, 35% of patients receiving APBI-b fell in the suitable category, 47% in the cautionary category, and 18% in the unsuitable category. After publication of the ASTRO guideline, the proportion of patients receiving APBI-b in the suitable category has increased from 34% in 2008 to 40% in 2010. After a median follow up of 46 months, 52,099 patients died. In invasive breast cancer patients, we found patients undergoing APBI-b had a 38% reduction in the risk of death, compared to patients without radiotherapy (hazard ratio, HR = 0.62, 95% CI: 0.57-0.66, p Conclusions: In a large cohort of women with early stage breast cancer, radiotherapy using three new techniques (APBI-b, IMRT, and 3D-CRT) was found to be as effective in reducing mortality as conventional whole breast irradiation. Although this is promising, long-term follow-up studies and randomized clinical trials are warranted. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P5-14-09.

The use of contralateral prophylactic mastectomy (CPM) has been increasing despite questionable survival benefit. We examined the effect of CPM on survival using the National Cancer Data Base. We examined overall survival on 219,983 mastectomy patients diagnosed with unilateral AJCC Stage 1–III invasive breast cancer between 1998 and 2002 of which 14,994 (7 %) underwent CPM at the time of their index mastectomy. Median follow up time was 5 years. Neoadjuvant and locally advanced breast cancers were excluded. Approximately 4 % underwent CPM in 1998 compared to 9.4 % in 2002, an ~125 % increase. CPM patients were significantly younger than non-CPM patients, on managed care plans, and were treated at high volume centers. The unadjusted hazard ratio (HR) of death was 0.55 (95 % CI 0.52–0.57) for CPM compared to unilateral mastectomy. In a multivariable Cox model adjusting for age, race, stage, grade, histology, insurance, facility characteristics, use of adjuvant hormonal, chemotherapy, and radiotherapy, and year of diagnosis, the adjusted HR was 0.88 (95 % CI 0.83–0.93; p < 0.001) which translated into an absolute 5-year benefit of 2 %. There was a differential effect of CPM by stage and age: HR = 0.88 (95 % CI 0.82–0.94; p < 0.001) in women younger than 70 with stage I/II, and HR = 0.95 (95 % CI 0.88–1.04; p = 0.28) in women with stage III or older than age 69 which translated into an absolute 5-year benefit of 1.3 %. Utilization of hormonal therapy or chemotherapy had no effect on the HR. After adjusting for confounding, the overall survival benefit for CPM is minimal at best.

Although complete excision of breast cancer is accepted as the best means to reduce local recurrence and thereby improve survival, there is currently no standard margin width for breast conservation surgery. As a result, significant variability exists in the number of additional operations or repeat surgeries patients undergo to establish tumor-negative margins.To determine the patient, tumor, and facility factors that influence repeat surgery rates in US patients undergoing breast conservation surgery.Patients diagnosed as having breast cancer at a Commission on Cancer accredited center from January 1, 2004, through December 31, 2010, and identified via the National Cancer Data Base, a large observational database, were included in the analysis. A total of 316,114 patients with stage 0 to II breast cancer who underwent initial breast conservation surgery were studied. Patients who were neoadjuvantly treated or whose conditions were diagnosed by excisional biopsy were excluded.Patient, tumor, and facility factors associated with repeat surgeries.A total of 241,597 patients (76.4%) underwent a single lumpectomy, whereas 74,517 (23.6%) underwent at least 1 additional operation, of whom 46,250 (62.1%) underwent a completion lumpectomy and 28,267 (37.9%) underwent a mastectomy. The proportion of patients undergoing repeat surgery decreased slightly during the study period from 25.4% to 22.7% (P .001). Independent predictors of repeat surgeries were age, race, insurance status, comorbidities, histologic subtype, estrogen receptor status, pathologic tumor size, node status, tumor grade, facility type and location, and volume of breast cancer cases. Age was inversely associated with repeat surgery, decreasing from 38.5% in patients 18 to 29 years old to 16.5% in those older than 80 years (P .001). In contrast, larger tumor size was linearly associated with a higher repeat surgery rate (P .001). Repeat surgeries were most common at facilities located in the Northeast region (26.5%) compared with facilities in the Mountain region, where only 18.4% of patients underwent repeat surgery (P .001). Academic or research facilities had a 26.0% repeat surgery rate compared with a rate of 22.4% at community facilities (P .001).Approximately one-fourth of all patients who undergo initial breast conservation surgery for breast cancer will have a subsequent operative intervention. The rate of repeat surgeries varies by patient, tumor, and facility factors and has decreased slightly during the past 6 years.

Rates of bilateral mastectomy (BM) have increased, but the impact on length of stay (LOS), readmission rate, 30-day mortality, and time to adjuvant therapy is unknown. Using the National Cancer Data Base, we selected 390,712 non-neoadjuvant AJCC stage 0–III breast cancer patients who underwent either unilateral mastectomy (UM) or BM from 2003 to 2010 with and without reconstruction. We used chi-square and logistic regression models for the analysis. A total of 315,278 patients (81 %) had UM, and 75,437 (19 %) had BM; 97,031 (25 %) underwent reconstruction. The number of median days from diagnosis to UM increased from 19 days in 2003 to 28 days in 2010, and for BM, increased from 21 to 31 days (p

Data on recent trends and correlates of utilization for accelerated partial breast irradiation using brachytherapy (APBI-b) for ductal carcinoma in situ (DCIS) are lacking. This study included 113,841 DCIS patients from the National Cancer Data Base, of whom 8,709 (6.5 %) underwent APBI-b and 105,132 (93.5 %) underwent external beam irradiation after lumpectomy between 2003 and 2011. Trends in APBI-b use, American Society for Radiation Oncology (ASTRO) guideline concordance, and independent factors related to APBI-b use were examined. APBI-b use increased from 1.6 % in 2003 to 11.9 % in 2008 and then decreased to 9.1 % in 2011 (p

Randomized trials have not demonstrated a survival benefit for axillary dissection in the elderly, but the use of axillary staging for women 70 years of age and older remains controversial. We utilized the National Cancer Data Base to study the use of axillary staging from 2004 to 2010 on 102,026 clinically node-negative and estrogen receptor-positive cases of pT1N0 tumors. Chi-square and logistic regression models were used to determine the trends and factors related to axillary staging. Axillary nodes were examined in 88.9 % of the total cohort, and the trend significantly increased from 87.7 % in 2004 to 89.2 % in 2010. A total of 77.2 % of patients underwent lumpectomy and 22.8 % mastectomy, with 87.0 % of lumpectomy patients undergoing axillary staging compared to 95.5 % of mastectomy patients. Predictors of axillary staging examined were age, comorbidity, income, histology, grade, facility type, facility location, and population density. The strongest independent predictor of axillary staging was age: 96.0 % of women aged 70–75 years underwent axillary staging, versus 92.3 % of women 75–80 years old, 83.2 % of women 80–85 years old, 66.5 % of women 86–90 years old, and 45.6 % of women >90 years old. Patients treated at academic/research facilities were 18.5 % less likely (odds ratio 0.81, 95 % confidence interval 0.76–0.87) than community cancer programs to undergo axillary staging. There was significant regional variation among U.S. Census regions: patients treated in the Midwest were 3.8 times more likely to undergo axillary staging than those treated in the Northeast. Despite data indicating decreased utility, axillary staging remains overutilized in women with advancing age.

The purpose of this study was to determine if newly diagnosed breast cancer patients undergoing contralateral prophylactic mastectomy (CPM) experience more complications than patients undergoing unilateral mastectomy (UM). A total of 600 patients underwent either UM or CPM between January 2009 and March 2012 for unilateral breast cancer. Operative complications were classified as minor (aspirations, infection requiring antibiotics, partial flap and nipple necrosis, minor bleeding, delayed wound healing) or major (hematoma or seroma requiring operation, infection requiring rehospitalization, blood product transfusion, total flap or nipple loss, implant removal), mixed (both minor and major complications), or multiple. Chi-square and multivariate logistic regressions were used for the analysis. Of the 600 patients, 391 (65 %) underwent UM and 209 (35 %) underwent CPM. Across all complication groups, there were significantly more complications in the CPM group versus the UM group (41.6 vs. 28.6 %, p = 0.001). Major complications alone were significantly greater in the CPM versus the UM group (13.9 vs. 4.1 %, p

Although internal mammary chain (IMC) metastases are an independent predictor of prognosis, collecting IMC sentinel nodes (SN) remains controversial. We sought to determine predictors for IMC nodal positivity and the role positive IMC-SNs have on changing staging and management.We reviewed a prospectively collected database (1997-2012) to identify patients who had IMC drainage detected on lymphoscintigraphy and underwent biopsy. Chi square tests and logistic regression models were used to determine trends and factors associated with IMC node positivity.A total of 122 patients with cTis-T2cN0M0 breast cancer underwent IMC-SN biopsy. Mean age of the cohort was 53 years, and mean tumor size was 2.0 cm. Identification of IMC nodes was successful in 100% of the cases. There were no complications. Sentinel nodes mapped to the IMC alone in 14 of 122 (11%) patients. Overall, 26% of patients were node positive, with 12 of 122 (10%) patients having a positive IMC-SN. In patients with a positive axilla, IMC-SN was positive in 33% of patients, whereas in patients with a negative axilla, IMC-SN was positive in 3% of cases (P0.001). The number of positive axillary nodes was the only independent predictor of IMC positivity (1-3 positive axillary nodes odds ratio 16.9, 95% CI 3.1-91.1; ≥4 positive axillary nodes odds ratio 45.0, 95% CI 4.0-500.7). IMC-SN positivity led to a more advanced nodal category in all patients and more accurate staging in 4 of 12 (33%) patients.IMC-SN biopsy is predictable and safe. Identification of IMC metastases though IMC-SN biopsy has the potential to alter the stage and adjuvant therapy of breast cancer patients.

Withdrawn by Author Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P4-01-16.

1033 Background: The Cancer and Leukemia Group B (CALGB) 9343 trial published in 2004 showed no overall survival benefit from radiation in patients >70 years old with estrogen receptor (ER) positive, pT1 tumors with the use of tamoxifen. We tested the hypothesis that the use of radiotherapy decreased in this group of patients following publication of the trial, utilizing the National Cancer Data Base. Methods: 34,853 breast cancer patients 70 years or older with pT1N0/NX, ER positive tumors who underwent a lumpectomy between 2004 and 2007 were studied. Chi-square tests and logistic regression models were used to determine trends and factors related to the use of radiation. Results: The use of radiation decreased from 70.6% in 2004 to 66.4% in 2005, 66.6% in 2006, and 67.2% in 2007 (p

6040 Background: The use of accelerated partial breast irradiation using brachytherapy (APBI-b) for patients with invasive cancer is increasing but data for ductal carcinoma in situ (DCIS) cases are limited. The American Society of Radiation Oncology (ASTRO) guidelines suggest that APBI-b should be used only on a "cautionary" or "on trial" basis for women with DCIS. The purpose of this study was to examine utilization trends and correlates of APBI-b use for patients with DCIS. Methods: A total of 70,043 postlumpectomy patients from the National Cancer Database diagnosed with DCIS between 2002 and 2007 were studied. Chi-square tests and logistic regression models were used to determine trends and factors related to APBI-b use. Results: The use of APBI-b increased from 0.7% in 2002 to 10.0% in 2007 (p