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Significant weight loss due to cardiac cachexia is an independent predictor of mortality in many heart failure (HF) clinical trials. The impact of significant weight loss while on the waitlist for heart transplant (HT) has yet to be studied with respect to post-transplant survival.Adult HT recipients from 2010 to 2021 were identified in the UNOS registry. Patients who experienced an absolute weight change from the time of listing to transplant were included and classified into two groups by percent weight loss from time of listing to time of transplant using a cut-off of 10%. The primary endpoint was 1-year survival following HT.5951 patients were included in the analysis, of whom 763 (13%) experienced ≥10% weight loss from the time of listing to transplant. Weight loss ≥ 10% was associated with reduced 1-year post-transplant survival (86.9% vs. 91.0%, long-rank p = .0003). Additionally, weight loss ≥ 10% was an independent predictor of 1-year mortality in a multivariable model adjusting for significant risk factors (adjusted HR 1.23, 95% CI 1.04-1.46). In secondary analyses, weight loss ≥ 10% was associated with reduced 1-year survival independent of hospitalized status at time of transplant as well as obesity status at listing (i.e., body mass index [BMI] 30 kg/mPreoperative weight loss ≥ 10% is associated with reduced survival in patients listed for HT. Nutrition interventions prior to transplant may prove beneficial in this population.

Objective To determine if increasing paternal age has an adverse effect on pregnancy outcomes in paired donor egg recipients who received oocytes from the same donor in the same stimulation cycle. Design Retrospective cohort study. Setting Reproductive Medicine Center. Patient(s) The study included 154 recipients who received oocytes from a split donor oocyte cycle and received sperm from men in discrepant age groups (group A: Intervention(s) None. Main Outcome Measure(s) Implantation rate, pregnancy loss rate, pregnancy rate, and live birth rate. Result(s) The median paternal age was 41 years old for group A and 48 years old for group B. The pregnancy rate was 81% in group A compared with 69% in group B. The live birth rate was 65% in group A compared with 53% in group B. The rate of pregnancy loss was 19% in group A and 23% in group B. The implantation rate was 69% in group A compared with 66% in group B. The adjusted odds of pregnancy were found to be 65% lower for patients in the older partner age group (95% confidence interval [CI], 0.13, 0.95). The adjusted odds of live birth rate (odds ratio [OR], 0.45; 95% CI, 0.20, 1.00), implantation rate (OR, 0.91; 95% CI, 0.43, 1.92), and rate of pregnancy loss (OR, 1.5; 95% CI, 0.5, 4.5) favored the younger partner age group; however, these results were not statistically significant. Conclusion(s) In this model that controlled for oocyte quality to the greatest degree possible by using paired recipients from the same donor from the same stimulation cycle, we found that increased paternal age had a negative effect on pregnancy rates.

Introduction Breast surveillance in patients with BRCA mutations include mammography (MMG) and MRI. Patients may elect to undergo risk-reducing bilateral prophylactic mastectomies (BPM). Sentinel lymph node biopsies (SLNB) are frequently performed and associated with increased morbidity. This study sought to determine the correlation between preoperative imaging and the final pathology and evaluate the role of SLNB in these high-risk patients. Methods A prospective database identified BRCA patients who underwent BPM between 2006 and 2022. Imaging, pathology, and operative reports were reviewed. Results 170 patients with BRCA 1/2 mutations were identified. 162 (95.3%) had imaging within one year of BPM. Of these, 28 (17.3%) patients had a MMG/ultrasound, 53 (32.7%) had an MRI, and 81 (50%) had both; 21/162 (13.0%) patients had abnormal imaging. Bilateral SLNB were performed in 31 (18.2%) patients, of which 7 had abnormal imaging; unilateral SLNB were performed in 4 (2.4%) patients, of which 3 had abnormal imaging. 11/170 (6.4%) patients had a malignancy and only one (9%) of these patients had imaging abnormalities. 1/170 (0.6%) patient had an invasive carcinoma requiring an axillary lymph node dissection (ALND), and 10/170 (5.9%) patients had ductal carcinoma in situ (DCIS). 25/170 (14.7%) had ADH/ALH. Only 7/170 (4.1%) patients had imaging abnormalities and abnormal pathology. All SLNB and ALND performed demonstrated no metastatic disease. Discussion There is a high rate of discordance between preoperative imaging prior to surgery in BRCA patients undergoing prophylactic mastectomies and final pathology. This study does not support routine SLNB at the time of BPM.

Background: Pembrolizumab (pembro)-mediated checkpoint blockade has shown only modest efficacy in triple negative breast cancer (TNBC). Pathologic complete response (pCR) rates in TNBC are 34-55% with neoadjuvant chemotherapy and 26% with neoadjuvant stereotactic radiation therapy (RT) alone. However, because RT induces immune-mediated cell death that can generate a rich supply of tumor antigens and trigger anti-tumor immunity, the addition of pembro to RT can generate robust anti-tumor immune responses as demonstrated in metastatic TNBC. If administered in the pre-operative setting, immune therapy plus RT could induce long-term tumor-specific memory, and ultimately, improve cure rates. This study aimed to establish the safety of pre-operative pembro plus RT in 20 TNBC patients for whom lumpectomy and adjuvant RT were planned and to explore predictive biomarkers (NCT03366844). Methods: Women planning breast conserving surgery for operable, stage II/III, TNBC were enrolled in this single-institution pilot study. Study treatment consisted of pre-operative pembro (200mg IV) followed 3 weeks later by pembro (200mg IV) plus RT (24 Gy/3 fractions) to the primary breast tumor followed 3-5 weeks later by standard-of-care (SOC) neoadjuvant chemotherapy. Adjuvant RT was administered per SOC after surgery, but without a boost dose. Research blood and tumor biopsies were obtained at baseline, at week 4 prior to pembro/RT, and at week 6-8 prior to chemotherapy initiation. Co-primary endpoints were: safety/tolerability (defined by the number of patients who do not necessitate a delay in SOC chemotherapy or surgery) and change in tumor infiltrating lymphocyte (TIL) score. Secondary endpoints include safety/toxicity up to 19 weeks after study enrollment and pathologic complete response (pCR) rate. Results: 20 patients were enrolled and completed all treatment (pembro, RT, chemotherapy and surgery) as of July 2020. The median age is 55y (range 33-70y). The stage distribution is IIA (11), IIB (6), IIIA (2) and IIIC (1) with biopsy proven nodal involvement in 55%. All patients received a taxane containing regimen, 12/20 (60%) received carboplatin and 15/20 (75%) received an anthracycline. Three patients did not complete the planned course of chemotherapy, two of whom had residual disease. None of the patients experienced significant delay (>2 weeks) in receiving SOC treatment. There were no observed grade 3 or 4 toxicities observed during the pembro +/- RT treatment. Grade 4 colitis in 2/20 was reported during SOC chemotherapy and was attributed to pembro. The most frequent grade 1/2 toxicities were nausea (4/20), arthralgia (15/20), fatigue (16/20), maculopapular rash (1/20), diarrhea (1/20) and mucositis (1/20). At the time of surgery, 12/20 (60%) were ypT0N0 and 13/20 (65%) were ypT0/Tis. 15/20 (75%) achieved an RCB 0/1, 4/20 (20%) were RCB 2 and 1/20 (5%) was RCB 3. Of the 11 patients with node-positive disease at diagnosis, 9/11 (82%) became ypN0, 1/11 (9%) became ypN1mic and 1/11 (9%) became ypN1a. No patients progressed during treatment. Change in TILs after pembro or pembro-RT did not correlate with treatment response, however baseline TIL count ≥10% in the initial biopsy was associated with pCR (p = 0.005). Further profiling of the immune cells in the biopsies revealed that RCB 0/1 patients were strongly associated with increased numbers of CD8+ T cells and lower numbers of CD11b+ myeloid cells following the combination of pembro and RT. Conclusions: Neoadjuvant pembro plus RT prior to SOC chemotherapy is safe/feasible and may increase pCR rates and clearance of nodal metastases beyond chemotherapy alone. A phase 2 study of checkpoint blockade + RT expansion of this trial (n=50) is currently accruing. Citation Format: Heather McArthur, Stephen Shiao, Scott Karlan, Reva Basho, Farin Amersi, Brittany Arnold, Michele Burnison, Alice Chung, Cathie Chung, Catherine Dang, Armando Giuliano, Nimmi Kapoor, Negin Habibi Khameneh, Simon Knott, Cynthia Martin, Philomena McAndrew, Monica Mita, Dorothy Park, Christina DiLauro Abaya, Alice Ho. Pre-operative pembrolizumab (Pembro) with radiation therapy (RT) in patients with operable triple-negative breast cancer (TNBC) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS12-09.

The American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial demonstrated no survival advantage for women with clinical T1-T2 invasive breast cancer with 1-2 positive sentinel lymph nodes (SLN) who received whole-breast radiation, and no further axillary surgery when compared to women who did undergo axillary lymph node dissection (ALND). We used the National Cancer Database (NCDB) to study changes in utilization of ALND after the publication of this trial. NCDB was queried for female patients from 2012 to 2015 who met Z0011 criteria. Patients were divided into four groups based on Commission on Cancer facility accreditation. Outcome measures include the rate of ALND (nonadherence to Z0011) and the average number of nodes retrieved with ALND. 27,635 patients were identified, with no significant differences in T stage and receptor profiles between groups. Overall rate of ALND decreased from 34.0% in 2012 to 22.7% in 2015. Nonadherence was lowest in Academic Programs (decreasing from 30.1% in 2012 to 20.5% in 2015) and was highest in Community Cancer Programs (41.2% in 2012 to 29.1% in 2015). Median number of positive SLN did not differ between groups (p = .563). Median number of nodes retrieved on ALND decreased from 9 (IQR 5-14) in 2012 to 7 (IQR 4-12) in 2015 (p < .001). In patients who met the ACOSOG Z11 trial guidelines, rates of ALND have decreased over time. However, rates of nonadherence to Z0011 are significantly higher in Community Cancer Programs compared to Academic Programs.

What is the impact of low body mass index (BMI) on live birth rates and obstetric outcomes in infertile women treated with IVF and fresh embryo transfer?This was a retrospective cohort study of infertile patients in an academic hospital setting who underwent their first oocyte retrieval with planned autologous fresh embryo transfer between 1 January 2012 and 31 December 2018. The primary study outcome was live birth rate. Secondary outcomes were IVF treatment and delivery outcomes. Underweight patients were stratified into a significantly underweight group (body mass index [BMI]17.5 kg/mA total of 5229 patients were included (significantly underweight, 76; mildly underweight, 231; normal weight, 4922), resulting in 4798 embryo transfers. After oocyte retrieval, there were no significant differences between groups for total oocytes, mature oocyte yield and number of supernumerary blastocysts cryopreserved. Among women who had an embryo transfer, there were no significant differences in the live birth rates in significantly (31.0%, odds ratio [OR] 0.67, confidence interval [0.95, CI] 0.40-1.13) and mildly (37.7%, OR 0.95, CI 0.73-1.33) underweight patients compared with normal-weight patients (35.9%). Additionally, there were no statistically significant increased risks of preterm delivery, Caesarean delivery or a low birthweight (2500 g) neonate.Mildly and significantly underweight infertile women have similar pregnancy and live birth rates to normal-weight patients after IVF treatment. In addition, underweight patients do not have an increased risk of preterm delivery (37 weeks), Caesarean delivery or a low birthweight neonate.

OBJECTIVE: Assess the effect of class III (body mass index [BMI, kg/m(2)] 40–49.9) and class IV obesity (≥ 50) on clinical pregnancy and live birth outcomes after first oocyte retrieval and fresh embryo transfer cycle. DESIGN: Cohort study SETTING: Academic center PATIENTS: Patients undergoing their first oocyte retrieval with planned fresh embryo transfer in our clinic between 01/01/2012 and 12/31/2018. Patients were stratified by BMI: 18.5–24.9 (n = 4913), 25–29.9 (n = 1566) 30–34.9 (n = 559), 35–39.9 (n = 218), and ≥ 40 (n = 114). INTERVENTION: None MAIN OUTCOME MEASURE: Live birth rate RESULTS: Following embryo transfer, there were no differences in pregnancy rates across all BMI groups (p value, linear trend = 0.86). However among pregnant patients, as BMI increased, a significant trend of a decreased live birth rate was observed (p value, test for linear trend = 0.004). Additionally, as BMI increased, a significant trend of an increased miscarriage rate was observed (p value, linear trend = < 0.001). Compared to the normal-weight cohort, women with a BMI ≥ 40 had a significantly higher rate of cancelled fresh transfers after retrieval (18.4% vs. 8.2%, OR 2.51; 95%CI 1.55–4.08). Among singleton deliveries, a significant trend of an increased c-section rate was identified as the BMI increased (p value, linear trend = 40 have worse IVF treatment outcomes compared to normal-weight patients. After embryo transfer, their pregnancy rate is comparable to normal-weight women; however, their miscarriage rate is higher, leading to a lower live birth rate for pregnant women in this population. Patients with a BMI > 40 have a c-section rate that is 50% higher than normal-weight patients. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10815-020-02011-1.

Optimum tissue resection volume for patients with invasive breast cancer undergoing breast conserving surgery following neoadjuvant therapy (NAT) is not known. We compared positive margin and in-breast tumor recurrence (IBTR) between 2 groups that were created based on radiologic tumor size (RTS (cm3)) at diagnosis, RTS post-NAT, and volume of tissue resected (VTL): Pre-NAT group, patients with VTL closer to RTS at diagnosis, and post-NAT group, patients with VTL closer to post-NAT RTS. 82 patients with 84 breast cancers treated with NAT between 2007 and 2017 who had pre- and post-NAT imaging were identified from a prospectively maintained database. RTS at diagnosis, RTS post-NAT, and VTL were determined. Clinical and treatment characteristics, IBTR, and disease-free survival (DFS) were compared between pre-NAT (n = 51) and post-NAT (n = 33) groups. Compared to post-NAT patients, pre-NAT patients had smaller RTS at presentation (9.2 vs. 33.5 cm3, P < .001) and post-NAT (1.2 vs. 8.2 cm3, P = .024). At median follow-up of 4 years, there were no differences between groups in pathologic tumor size, positive margin rate, adjuvant therapy, IBTR, or DFS. Resection volumes that matched RTS on post-NAT imaging were not associated with increased positive margins or IBTR. It may be appropriate to use post-NAT imaging to guide lumpectomy volume.

Radioactive seed localization (RSL) and the Savi Scout® radar (SSR) are newer alternatives to wire-guided localization (WL) for nonpalpable breast lesions. The aim of this study was to compare three localization devices when multiple devices were used for preoperative localization for breast surgery. Between July 2017 and July 2018, 68 patients had a partial mastectomy (n = 54) or breast biopsy (n = 14) with preoperative image-guided localization using multiple wires or device placement for nonpalpable lesions. Operative timing, outcomes, and 30-day complications were evaluated. Overall, 41 patients (60%) had WL, 11 patients (16%) had RSL, and 16 patients (24%) had SSR localization. Fifty-four patients (79.4%) had localization of two lesions and 13 patients (19.1%) had localization of three lesions. Twenty-three patients (33.8%) had a lesion that was bracketed. There was no difference in retained biopsy clip among the groups (average 7.4%; p = 0.962). For operations performed in the hospital, there was no difference in operative time among the groups, with a median of 77.5 min (p = 0.705) or total perioperative time of 508 min (p = 0.210). Among operations with delayed start times, there was a longer average delay of 95.5 min in WL, compared with 42 min in SSR (p = 0.004). A greater volume of tissue was excised in the WL group (29.5 g WL vs. 15.9 g RSL vs. 12.1 g SSR; p = 0.022). There was no difference in positive margin rate and 30-day complications among groups. SSR and RSL can be used to localize multiple breast lesions, with no difference in positive margin rates or complications and less tissue excised compared with WL.

There is controversy regarding the survival benefit of endocrine therapy (ET) in elderly patients with early invasive hormone receptor-positive (HR+) breast cancer. In this study, we characterize a single institution’s practice patterns using adjuvant ET for these patients and evaluated the effect of ET on outcomes. A review of a prospectively maintained database identified 483 women ≥ 70 years old who underwent breast -conserving surgery (BCS) for stage I-III HR+ tumors from 2004–2013. We compared clinicopathologic characteristics, overall survival (OS), disease-free survival (DFS), locoregional recurrence (LRR), and breast cancer-specific survival (BCSS) in patients who did and did not receive ET. Compared to patients who did not get ET, patients who received ET were younger (median age 76 vs 78 years, p = 0.006), had larger tumors (median size 15 vs 14 mm, p = 0.016), underwent sentinel lymph node (LN) biopsy (83.7 vs 67.8%, p

Objective To determine whether a higher body mass index (BMI) adversely affects endometrial receptivity. Design Retrospective cohort study. Setting Academic medical center. Patient(s) All donor egg recipients (DERs) who received fresh sibling-oocytes (oocytes from a donor that were retrieved from a single controlled ovarian hyperstimulation [COH] cycle and split between two recipients) at our center over a 7-year period were included. Intervention(s) COH of a donor with fresh embryo transfer to recipients of differing BMI. The two recipients of the sibling-oocytes were paired and categorized based on BMI: group A (normal weight, BMI 18.5−24.9 kg/m2) and group B (overweight/obese, BMI >25.0 kg/m2). Main Outcome Measure(s) The primary outcome was implantation rate. Secondary outcomes were positive pregnancy rate and live birth rate. Result(s) A total of 408 patients had received oocytes from a split donor oocyte cycle. There were 71 pairs of patients (142 recipients) that had discrepant BMI categories and were analyzed. Implantation rates were similar for the two groups (54.5%±5.3% vs. 56.3%±4.8% for group A and B, respectively, P=0.72). The positive pregnancy rate (77.5% vs. 80.3%, P=0.28) and live birth rate (54.9% vs. 60.6%, P=0.33) for groups A and B were also found to be similar. Conclusion(s) In this idealized model that controls to the greatest degree possible for factors that would impact implantation, we found that a higher BMI did not reduce implantation, positive pregnancy, or delivery rates. These findings suggest that a higher BMI does not adversely affect uterine receptivity.

BACKGROUND Radioactive seed localization (RSL) and the Savi scout® radar (SSR) are newer alternatives to wire-guided localization (WL) for nonpalpable breast lesions. OBJECTIVE To compare three types of localization devices used in breast conserving surgery. METHODS A total of 293 patients had a partial mastectomy (n = 194) or breast biopsy (n = 99) with preoperative image-guided localization of a single nonpalpable lesion between July 2017 to July 2018. Lesions were localized by WL, RSL, or SSR. Although all operations performed were outpatient, due to workflow differences at our institution, operations performed in the hospital operating rooms were defined as "hospital setting." Operations performed at an outpatient surgery facility without the capacity to admit patients were defined as "ambulatory." Delay in operating room start times and total perioperative times in both the hospital and ambulatory setting, localization time, explant of localization device, positive margins, volume of tissue excised, and 30-day complications were evaluated. RESULTS A total of 126 patients (43%) had WL; 59 patients (20%) had RSL; and 108 patients (37%) had SSR localization. SSR localization took longer to perform with an average time of 19 minutes, compared with 15 minutes for WL and 14 minutes for RSL (P = .020). In 93.52% of cases, the first specimen contained both the clip and localization device, which was similar among groups (P = .073). There was no difference in retained biopsy clip among the groups (average 3.4%, P = .173). For operations performed in the hospital, the time from patient arrival to the preoperative area and incision was significantly longer in the WL group with a median of 233 minutes (range 56-486), 130 minutes (range 64-294) in RSL, and 108 minutes (range 59-240) for SSR (P

Background: Pembrolizumab (pembro)-mediated checkpoint blockade has shown modest efficacy in triple negative breast cancer (TNBC). Pathologic complete response (pCR) rates in TNBC are 34-55% with neoadjuvant chemotherapy (Cortazar Lancet 2014, Sharma Clin Cancer Res 2017) and 26% with neoadjuvant stereotactic radiation therapy (RT) alone (Riet Eur J Cancer 2017). However, because RT induces immune-mediated cell death that can generate a rich supply of tumor antigens and trigger anti-tumor immunity, the addition of pembro to RT can generate robust anti-tumor immune responses as demonstrated in metastatic TNBC (McArthur ASCO 2018). If administered in the pre-operative setting, immune therapy plus RT could induce long-term tumor-specific memory, and ultimately, improve cure rates. This study aimed to establish the safety of pre-operative pembro plus RT in 20 TNBC patients for whom lumpectomy and adjuvant RT were planned and to explore predictive biomarkers (NCT03366844). Methods: Women planning breast conserving surgery for operable, stage II/III, TNBC were enrolled in this single-institution pilot study. Study treatment consisted of pre-operative pembro (200mg IV) followed 3 weeks later by pembro (200mg IV) plus RT (24 Gy/3 fractions) to the primary breast tumor followed 3-5 weeks later by standard-of-care (SOC) neoadjuvant chemotherapy. Adjuvant RT was administered per SOC after surgery, but without a boost dose. Research blood and tumor biopsies were obtained at baseline, at week 4 prior to pembro/RT, and at week 6-8 prior to chemotherapy initiation. Co-primary endpoints were: safety/tolerability (defined by the number of patients who do not necessitate a delay in SOCchemotherapy or surgery) and change in tumor infiltrating lymphocyte (TIL) score. Secondary endpoints include safety/toxicity up to 19 weeks after study enrollment and pathologic complete response (pCR) rate. Results: As of 7/8/19, the accrual goal of 20 patients has been met. The median age is 53y (range 33-70y). The stage distribution is IIA (12), IIB (5), IIIA (2) and IIIC (1) with biopsy proven nodal involvement in 40%. To date, 18 patients have completed pembro/RT and 12 have completed chemotherapy and surgery. All patients received a taxane containing regimen, 8/12 (67%) received carboplatin and 10/12 (83%) received an anthracycline. Three patients did not complete the planned course of chemotherapy, two of whom had residual disease. None of the patients experienced significant delay (>2 weeks) in receiving SOC treatment. There were no observed grade 3 or 4 toxicities observed with pembro +/- RT. Grade 4 colitis in 1/18 was reported during SOC chemotherapy and was attributed to pembro. The most frequent grade 1/2 toxicities were nausea (3/18), arthralgia (12/18), fatigue (10/18), maculopapular rash (1/18), diarrhea (1/18) and mucositis (1/18). Of the 12 patients who completed surgery, 8/12 (67%) were ypT0N0, 9/12 (75%) were ypT0/Tis and 10/12 (83%) were ypN0. Of the 5 patients with node-positive disease at diagnosis, 3/5 (60%) became ypN0 and 1/5 (20%) became ypN1mic. Change in TILs after pembro or pembro-RT did not correlate with treatment response, however baseline TIL count ≥10% in the initial biopsy was associated with pCR (p = 0.01). Conclusions: Neoadjuvant pembro plus RT prior to SOC chemotherapy is safe/feasible and may increase pCR rates beyond chemotherapy alone. A randomized phase 2 study of checkpoint blockade +/- RT in a larger cohort is planned. Citation Format: Heather McArthur, Stephen Shiao, Scott Karlan, Farin Amersi, Brittany Arnold, Reva Basho, Michele Burnison, Alice Chung, Cathie Chung, Catherine Dang, Armando Giuliano, Negin Habibi Khameneh, Simon Knott, Cynthia Martin, Philomena McAndrew, Monica Mita, Dorothy Park, Christina Abaya, Alice Ho. Pre-operative pembrolizumab (pembro) with radiation therapy (RT) in patients with operable triple-negative breast cancer (TNBC) [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P3-09-09.

Objective Few studies examine the impact of surgical trainee involvement on tumor-free margins in breast conserving surgery (BCS). Our objective was to investigate the impact of resident and fellow involvement on positive margins rates following BCS for invasive breast cancer (BC). Design We identified female patients who had BCS for BC between January 2005 to December 2015. Setting Tertiary care hospital. Participants Around 1089 patients were identified from a prospectively maintained database. Results Of 1089 patients, mean age was 63 (range 43-99) years. Around 768 patients (70.1%) required preoperative localization, and 328 patients (29.9%) had a palpable cancer. Nonpalpable cancers had a smaller volume of specimen tissue excised (p = 0.0005) compared to palpable cancers, and no significant difference was observed in the positive margin rate between the nonpalpable group compared to the palpable group (24.7% nonpalpable vs. 25.3% palpable, p = 0.88). Nonpalpable cancer positive margin rates were 23.9% (n = 102/427) for cases performed by an attending surgeon, 25.0% (n = 15/60) with a junior resident (PGY 2-3), 28.6% (n = 8/28) with a senior resident (PGY 4-5), and 25.7% (n = 65/253) with a fellow, which were not statistically significant (p = 0.89). Palpable cancer positive margin rates were 27.6% (n = 47/170) for cases performed by an attending, 13.9% (n = 5/36) with an intern (PGY-1), 40.9% (n = 9/22) with a junior resident, 0% (n = 0/8) with a senior resident, and 23.9% (n = 22/92) with a fellow, which were also not significantly different (p = 0.07). Conclusion Resident and fellow participation in BCS for BC does not appear to impact the rate of positive margins.

Is household income or IVF insurance coverage associated with live birth outcomes in infertile women undertaking IVF?Retrospective cohort study in an academic hospital, including patients residing in New York State undergoing a frozen single embryo transfer at the study IVF centre between 1 January 2017 and 31 December 2018. Only the first embryo transfer per patient was included. Patients were stratified by tertiles of estimated income using home zip code census data:$85,888 (n = 348), $85,888-122,628 (n = 348) and$122,628 (n = 350). A second analysis stratified patients by IVF insurance coverage or no coverage. The primary outcome was live birth. Modified Poisson regression with robust error variance adjusted a priori for age, preimplantation genetic testing and previous fresh embryo transfer estimated the relative risk of outcomes with a 95% confidence interval.A total of 1046 patients were included. Live birth rate was similar among all three income tertiles. Secondarily, the pregnancy rate and pregnancy loss rate were also similar among all three tertiles. In the IVF insurance coverage analysis, live birth rate was similar between patients with and without IVF insurance coverage. Secondarily, the pregnancy rate and pregnancy loss rate were also similar among these two groups.Overall, neither median household income nor IVF insurance coverage of patients undergoing single frozen embryo transfer was associated with pregnancy, pregnancy loss or live birth outcomes. Lower income, relative to the patient cohort, and lack of insurance coverage are well-described barriers to accessing infertility evaluation and treatment. However, once treatment is initiated, the current results suggest that these variables do not influence pregnancy and live birth outcomes in infertile patients.

Inadequate pain control frequently extends length of stay (LOS) and costs for patients undergoing mastectomy with implant-based reconstruction (IBR). We sought to examine the effects of Paravertebral blocks (PVB) and liposomal bupivacaine (LB) and compare LOS, pain scores and costs of hospitalization.Prospective database review of patients undergoing mastectomy with IBR was performed.541 patients were identified. 51/491 (9.4%) received PVB and 50 (9.2%) received LB. LOS in the PVB group was significantly less than that of the no block (NB) group (1 [1-2] days PVB vs 3 [2-4] days NB (p 0.0001), but was not different from the LB group (1 [1-2] days LB, p = 0.23). PVB patients had lower PACU pain scores compared to NB patients (3.2 ± 2.9 PVB vs 5.7 ± 2.6 NB, p 0.0001), but similar PACU pain scores to LB patients (4.1 ± 2.3). Patients who received PVB had higher total costs compared to NB patients ($27148±$7053 PVB vs $23113 ± 6860 NB, p = 0.003) but similar to LB patients ($26183 ± $3761).PVB and LB are associated with shorter LOS and lower pain scores compared to NB.

Introduction Fibroepithelial lesions of the breast (FEL) are heterogeneous lesions ranging from fibroadenomas (FA) to phyllodes tumors (PT). FEL with cellular stroma are diagnostic challenges on core needle biopsy (CNB) as it is difficult to distinguish cellular FA from PT. The purpose of this study was to determine the features of FEL on CNB that may be predictive of PT, the upstage rate to PT after excision, and the outcomes of those who did not undergo excision. Methods Overall, 305 patients with FEL on CNB between 2009 and 2019 were identified from a prospectively maintained institutional database. Presentation, imaging, and pathology were evaluated. Results Mean age at diagnosis was 43.8 years. Pathology on CNB included 97 cases of FEL favoring FA, 19 cases of FEL favoring PT, 3 cases of FEL versus pseudoangiomatous stromal hyperplasia, and 186 cases of FEL not otherwise specified. Following CNB, 96 (31.5%) patients were observed, 158 (51.8%) patients had an excisional biopsy, 48 (15.7%) patients underwent segmental mastectomy, and 3 (1.0%) patients underwent a mastectomy. The upgrade rate from FEL on CNB to PT upon excision was 25.8%. PT on final pathology was more commonly seen when the CNB identified stromal overgrowth, necrosis, and diagnosis of FEL favoring PT. On multivariable analysis, a final diagnosis of PT was associated with age >50 years, larger tumor size >2 cm, stromal overgrowth, and ≥1 mitoses/10 high power fields (HPF) on CNB. Patients who were observed had smaller tumors compared with those who underwent excision. Conclusion In this 10-year single-institution experience of FEL, the upstage rate to PT was 25.8%. Excision of FEL is recommended. Furthermore, the observation of lesions appeared to be safe in select cases, specifically in patients with smaller tumor size.

Background: Immune checkpoint inhibition (ICI) is synergistic with HER2-directed therapy in pre-clinical models. Clinically, pembrolizumab (K)-mediated ICI plus HER2-directed therapy with trastuzumab (H) was safe and demonstrated modest activity in H-resistant HER2-positive (HER2+) metastatic breast cancer. Because ICI may confer more robust activity when administered earlier in the course of disease, HER2-directed therapy with ICI administered in the curative-intent, treatment-naive setting may allow for de-escalation of cytotoxic backbones; confer life-long, tumor-specific immunity; and ultimately, improve cure rates. Moreover, the synergy of H and K with paclitaxel (T) may overcome the need for dual HER2-blockade with H plus pertuzumab (P). In this randomized, multicenter, phase II, open-label trial, the efficacy and safety of neoadjuvant THP vs THP-K vs TH-K are being explored (NCT03747120). Methods: 174 patients (pts) ≥18years with previously untreated, clinical stage II-III, HER2+ breast cancer will be randomized 1:1:1 to one of 3 study arms, stratified by clinical nodal status (positive vs. negative) and hormone receptor status (positive vs. negative). In arm A, pts receive THP: T at 80 mg/m2 weekly for 12 weeks, H day 1 at 8 mg/Kg (loading dose) and then 6 mg/Kg every 3 weeks x 3 doses, P day 1 at 840 mg (loading dose) and then 420 mg/Kg every 3 weeks x 3 doses (THP). In arm B, pts receive THP plus K day 1 at 200mg (flat dose) and then every 3 weeks x 3 doses (THP-K). In arm C, pts receive TH-K. Definitive surgery is 3-6 weeks after the last dose of T. After surgery, pts are treated per the treating physician’s discretion including HER2-directed therapy, endocrine therapy and radiotherapy per local clinical standards. The primary endpoint is pathologic complete response (pCR) rate in the breast and axilla (ypT0/Tis ypN0). Secondary end points include pCR rate by ypT0ypN0 and ypT0/Tis, residual cancer burden index, event free survival, breast conserving surgery rate, safety and overall survival. Exploratory correlative studies will characterize potential immune biomarkers predictive of efficacy and/or toxicity. Citation Format: Heather McArthur, Jorge Leal, David Page, Christina DiLauro Abaya, Reva Basho, Lindsey Ristow, Hannah Coleman, Stephen Shiao, Simon Knott, Monica Mita, Mourad Tighiouart, Alice Chung, Farnaz Dadmanesh, Philomena McAndrew, Scott Karlan, Sunil Verma, Armando Giuliano. Neoadjuvant HER2-targeted therapy +/- immunotherapy with pembrolizumab (neoHIP): An open label randomized phase 2 trial [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT2-04-04.

Background: Anti-PD(L)1 in addition to neoadjuvant chemotherapy (NAC) can achieve pathologic complete response (pCR) rates of up to 65% in patients with early stage triple negative breast cancer (TNBC). However, patients with non-pCR can have dismal prognosis. Innovative strategies that render the tumor microenvironment more sensitive to anti-PD(L)1 may confer benefit. Preclinical studies have shown that hypofractionated radiation therapy (RT) delivered to an in-situ breast tumor, when combined with immune checkpoint blockade, stimulates anti-tumor immune responses and induces long-term, tumor-specific memory. Here, we report the first results of a phase II study that established the feasibility and efficacy of this approach in the pre-operative treatment setting for TNBC. Methods: Fifty patients with stage I-III TNBC, defined as ER4-week delay in initiating NAC after pembro C2 + RT; 2) change in tumor infiltrating lymphocyte (TIL) score. Secondary endpoints included pCR, defined as ypT0/TisypN0, in addition to toxicity and cosmesis evaluations. Results: To date, 50 patients are evaluable with a median follow up of 12 months (range 6-12). Median age of cohort is 55y (range 26-76). The majority (92%) were clinical stage II; 2% stage I and 6% stage III. 34% of the cohort had biopsy-proven, node positive disease. All patients received a taxane, 52% carboplatin and 74% anthracycline. 12% did not complete the planned course of NAC due to toxicities. No patients experienced a delay in initiating NAC. 50% received breast-conserving surgery and 50% mastectomy. Grade 1 or 2 toxicities consisted of fatigue (76%), nausea (66%), maculopapular rash (32%), diarrhea (38%), colitis (2%), hypothyroidism (8%) and peripheral neuropathy (40%). Four patients had grade 3 toxicities that were attributable to pembro: hyponatremia(1), colitis (1), adrenal insufficiency(1) and pneumonitis (1). Three patients had grade 4 neutropenia which were not attributable to pembro. The overall rate of pCR was 74% (37/50). Among the 13 patients with non-pCR, 0% were RCB 1, 16% RCB 2 and 10% RCB 3. Among the 17 N+ patients, 13 converted to ypN0, 1 ypN1mic and 3 ypN1a. No patients progressed during treatment. Changes in TIL count, PD-L1 and other biomarkers after pembro +/- RT and their association with treatment response, will be presented at the meeting. Conclusions: The novel combination of pre-operative pembro followed by the addition of RT to pembro prior to NAC is not only feasible, but also achieves pCR rates that are higher-than-expected compared to the pembro arm of KEYNOTE-522. AEs were consistent with known safety profiles of each agent. If confirmed by larger, randomized studies, this combination will be paradigm-changing for the treatment of TNBC. Citation Format: Heather L McArthur, Stephen Shiao, Scott Karlan, Reva Basho, Farin Amersi, Michele Burnison, Amin Mirhadi, Alice Chung, Cathie T Chung, Catherine Dang, Heather Richardson, Armando E Giuliano, Nimmi Kapoor, Brigid Larkin, Hector Godinez, Samantha A Dunn, Negin Habibi Khameneh, Simon Knott, Philomena McAndrew, Monica Mita, Dorothy J Park, Christina Abaya, Jonathan H Chen, Amy Ly, Veerle Bossuyt, Alice Ho. The PEARL trial: Pre-operative pembrolizumab with radiation therapy in early stage triple negative breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr PD10-01.

Background and objective With advances in systemic therapies for breast cancer, responses to neoadjuvant chemotherapy (NAC) have increased. Pathologic complete response (pCR) after NAC is an independent prognostic factor. We examined the impact of breast and/or lymph node (LN) pCR on survival. Methods From a prospectively maintained database, 202 women were identified with LN-positive breast cancer who underwent NAC then surgery. Clinicopathologic factors and survival were compared between four groups: breast/LNs pCR, node-only pCR, breast-only pCR, and residual disease (RD). Results Forty-eight (23.8%) patients had breast/LNs pCR, 43 (21.3%) node-only pCR, 5 (2.5%) breast-only pCR, and 106 (52.5%) had RD. There was no difference in age, stage, or breast operation between groups. With a median follow-up of 48.2 months, patients with any pCR had improved disease-free survival (DFS) (HR, 0.3; 95% CI, 0.157-0.572) and OS (HR, 0.192; 95% CI, 0.057-0.652) compared with RD patients. There were no significant differences in DFS (log-rank P = .18) and OS (log-rank P = 0.12) between patients with node-only pCR, breast-only pCR, and breast/LNs pCR. Conclusion In node-positive breast cancer patients receiving NAC, any pCR was associated with improved survival vs RD. The anatomic site of pCR did not impact survival. This suggests that any favorable response to NAC has prognostic value.

The American College of Surgeons Oncology Group (ACOSOG) Z1071 and Sentinel Neoadjuvant (SENTINA) trials of sentinel node biopsy for node-positive breast cancer treated with neoadjuvant chemotherapy (NAC) demonstrated false-negative rates that varied on the basis of surgical technique. This study evaluated trends in axillary operations before and after publication of these trials. This study analyzed patients from National Cancer Database (NCDB) with clinical T0 through T4, N1 and N2, M0 breast cancer who received NAC from 1 January 2012 to 31 December 2015 and sentinel lymph node biopsy (SNB) or axillary lymph node dissection (ALND). The patients were divided into the following groups: SNB, ALND, and (SNB + ALND). Of the 32,036 evaluable patients identified in this study. 5565 had SNB, 19,930 had ALND, and 6541 had SNB + ALND. Compared with the ALND group, the SNB group was younger, had more invasive ductal cancers, and had lower clinical T- and N-stage disease (p

Research question Do IVF-ICSI cycles using fresh and frozen ejaculated sperm result in similar pregnancy outcomes in couples with non-male factor infertility? Design In a retrospective cohort study, patients undergoing donor egg recipient cycles in which oocytes from a single controlled ovarian hyperstimulation were split between two recipients were reviewed. Two recipients of the single donor oocyte were paired and categorized based on the type of ejaculated sperm (fresh/frozen). Outcomes included live birth rate (LBR), implantation, pregnancy, pregnancy loss and fertilization rates. Results 408 patients received oocytes from a split donor oocyte cycle. 45 pairs of patients used discrepant types of ejaculated sperm. Fertilization rate was 74.8% in the fresh and 68.6% in the frozen sperm group (p=0.13). Pregnancy rate was 76% in the fresh and 67% in the frozen group. LBR was 69% in the fresh and 44% in the frozen group. Implantation rate was significantly higher at 64% in the fresh and 36% in the frozen group (p=0.04). Rate of pregnancy loss was significantly higher at 5.9% in the fresh and 33% in the frozen group (p = 0.013). Adjusted odds of LBR was 67% lower for patients in the frozen group (95% CI: 0.12, 0.89). Adjusted odds of pregnancy (OR 0.67, 95% CI: 0.20, 2.27) and implantation rates (OR 0.5, 95% CI: 0.12, 2.12) favored the fresh group. Conclusion In this model that controls for oocyte quality by using paired recipients from the same donor, we found that frozen ejaculated sperm resulted in lower live birth rates than those using fresh sperm.

Post-transplant diarrhea is a common complication after solid organ transplantation and is frequently attributed to the widely prescribed immunosuppressant mycophenolate mofetil (MMF). Given recent work identifying the relationship between MMF toxicity and gut bacterial β-glucuronidase activity, we evaluated the relationship between gut microbiota composition, fecal β-glucuronidase activity, and post-transplant diarrhea. We recruited 97 kidney transplant recipients and profiled the gut microbiota in 273 fecal specimens using 16S rRNA gene sequencing. We further characterized fecal β-glucuronidase activity in a subset of this cohort. Kidney transplant recipients with post-transplant diarrhea had decreased gut microbial diversity and decreased relative gut abundances of 12 genera when compared to those without post-transplant diarrhea (adjusted p value < .15, Wilcoxon rank sum test). Among the kidney transplant recipients with post-transplant diarrhea, those with higher fecal β-glucuronidase activity had a more prolonged course of diarrhea (≥7 days) compared to patients with lower fecal β-glucuronidase activity (91% vs 40%, p = .02, Fisher's exact test). Our data reveal post-transplant diarrhea as a complex phenomenon with decreased gut microbial diversity and commensal gut organisms. This study further links commensal bacterial metabolism with an important clinical outcome measure, suggesting fecal β-glucuronidase activity could be a novel biomarker for gastrointestinal-related MMF toxicity.

NCCN guidelines discourage the use of staging imaging for newly diagnosed patients with early breast cancer (BC). When performed, incidental radiologic findings of uncertain significance are often encountered. The purpose of this study was to compare incidental findings seen on staging imaging with distant recurrence in patients undergoing neo-adjuvant chemotherapy (NAC). 396 patients with BC who had NAC from 2008 to 2016 were identified from a prospectively maintained data base. Staging imaging was reviewed. Of 396 patients with BC treated with NAC, patients with a positive PET/CT for metastatic disease (n = 36, 9.1%), those that did not undergo staging imaging (n = 49, 12.4%), or those that did not have a reported incidental finding (n = 49, 12.4%) were excluded from analysis. Of the 262 patients who met criteria, mean age was 50 years (range: 26-88). 201 (76.7%) patients had stage I-II cancer, and 61 (23.3%) patients had stage III cancer. Overall, 146 (55.7%) patients had an incidental finding on imaging. 90 (34.4%) patients had one finding, 42 (16.0%) patients had two, and 14 (5.3%) patients had three or more findings. The majority of incidental findings were seen in the ovary/uterus (29.7%), followed by lung (18.4%), liver (10.3%), and bone (9.0%). 5 (3.4%) patients had additional imaging performed. At mean follow-up of 3.7 years (range: 0.7-10.8), 43 (15.6%) patients had a distant recurrence. Of these patients, only 5 (1.9%) patients had distant metastasis in the same organ that was initially thought to be an incidental finding. Our results suggest that breast cancer patients with incidental findings on preoperative staging imaging are unlikely to be indicative of sites for future metastasis.

Erectile dysfunction (ED) is defined as an inability to achieve or maintain penile erection sufficiently enough for sexual performance. Sexual function involves an interplay between psychological, vascular, neurological, endocrine functions; thus the various etiologies of ED can be divided into psychosocial or organic causes. Current mainstays of treatment for ED are centered around enhancing levels of nitric oxide at the nerve terminal with pharmacologic agents such as phosphodiesterase inhibitors, followed by more invasive therapies such as intracavernosal injections and penile prosthesis. The market for supplements for ED has been growing in popularity and has warranted further investigation into mechanisms of action and efficacy. This chapter discusses several supplements that have been marketed as therapies for ED, their efficacies in clinical trials, as well as their mechanism of action on the biochemical level, safety profiles, and adverse effects.

Background Invasive lobular carcinoma (ILC) is associated with high re-excision rates following breast-conserving surgery (BCS). The correlation between lesion size on different imaging modalities and final tumor size has not been well characterized. Methods A prospective database of patients with stage I-III breast cancer undergoing BCS between 2006 and 2016 was reviewed. Pearson correlation analysis was used to correlate tumor size on breast imaging to final pathology. Results Of these, 111 patients with ILC were identified. Mean lesion size was 1.93 cm for MMG, 1.61 cm for US, and 2.51 cm for MRI. Mean tumor size on surgical excision was 2.64 cm. The correlation coefficient between pathology and the different imaging modalities were as follows: MMG .17, US 0.37, and MRI .58. Actual tumor size was underestimated by 1 cm in 27.1% of MMGs, 50% of USs, and in 13.3% of MRIs. 38 patients (34.2%) underwent re-excision. No differences in re-excision rates were noted in patients with and without MRI, 30.3% vs 40.0%, respectively (P = .31). Conclusion While MRI provides a better estimate of tumor size than MMG and US, the size of the tumor on imaging only weakly correlated with pathology. The use of MRI does not decrease re-excision rates.

Due to the low incidence of male breast cancer (BC), there are few studies evaluating outcomes. We evaluated the clinicopathologic features and outcomes of male BC. Male patients with BC from January 2006 to December 2018 were identified. Of 49 patients, mean age was 64 (range 33-94) years. Of the 27 (55.1%) patients who had genetic testing, 9 (33.3%) had a Breast Cancer gene (BRCA) 1 or 2 mutation. The majority of patients had a mastectomy (n = 43/49, 87.8%) and had invasive ductal carcinoma (n = 47/49, 95.9%). 20 patients (n = 20/43, 46.5%) had positive lymph nodes. 41 (n = 41/47, 87.2%) patients had estrogen receptor positive disease. The majority of patients were pathologic stage 2 (n = 21/46, 45.7%), followed by stage 1 (n = 15/46, 32.6%), stage 3 (n = 6/46, 13.0%), and stage 4 (n = 4/46, 8.7%). Eight patients had the 21-gene recurrence score performed. Of patients with stage 1-3 BC, 10 (n = 10/43, 23.3%) patients had recurrence. With median follow-up of 4.1 (range .6-10.6) years, 5-year overall survival was 82.9% and 5-year disease-free survival was 65.9%. In conclusion, our cohort of patients with male BC had a high incidence of BRCA mutations and most commonly had high-grade estrogen positive stage 2 tumors. Breast conserving surgery was utilized in 4% of patients and genomic testing utilized in 55% of patients.

Radioactive seed localization (RSL) and the Savi ScoutThe aim of this study was to compare three localization devices when multiple devices were used for preoperative localization for breast surgery.Between July 2017 and July 2018, 68 patients had a partial mastectomy (n = 54) or breast biopsy (n = 14) with preoperative image-guided localization using multiple wires or device placement for nonpalpable lesions. Operative timing, outcomes, and 30-day complications were evaluated.Overall, 41 patients (60%) had WL, 11 patients (16%) had RSL, and 16 patients (24%) had SSR localization. Fifty-four patients (79.4%) had localization of two lesions and 13 patients (19.1%) had localization of three lesions. Twenty-three patients (33.8%) had a lesion that was bracketed. There was no difference in retained biopsy clip among the groups (average 7.4%; p = 0.962). For operations performed in the hospital, there was no difference in operative time among the groups, with a median of 77.5 min (p = 0.705) or total perioperative time of 508 min (p = 0.210). Among operations with delayed start times, there was a longer average delay of 95.5 min in WL, compared with 42 min in SSR (p = 0.004). A greater volume of tissue was excised in the WL group (29.5 g WL vs. 15.9 g RSL vs. 12.1 g SSR; p = 0.022). There was no difference in positive margin rate and 30-day complications among groups.SSR and RSL can be used to localize multiple breast lesions, with no difference in positive margin rates or complications and less tissue excised compared with WL.

Outcomes based on menopausal status of breast cancer (BC) patients who are BRCA mutations carriers (BRCAm) are not well known. A prospective database identified 88 BRCAm with BC from 2005 to 2015. Of the 88 patients, 68 (77.3%) women were premenopausal (Pre-M) and 20 (22.7%) were postmenopausal (Post-M). In the Pre-M group, 52.9 per cent of patients had triple-negative (TN) BC, whereas in the Post-M group, there were more estrogen receptor +(65%; P = 0.129) and less TN (25%; P = 0.041) tumors. Median tumor size was significantly larger in the Pre-M group compared with the Post-M group ( P

Surgical deserts (SDs) are defined as the geographic maldistribution of general surgeons of six or less per 100,000 population in underserved/rural counties. Disparities have been reported in breast cancer outcomes; however, the effect of SDs remains unknown. We sought to examine the effect of SDs on breast reconstruction (BR) after mastectomy and the differences between patients in both the cohorts.Using the Nationwide Inpatient Sample database years 2007-2011, we identified International Classification of Diseases 9th edition codes for breast cancer, mastectomy, and BR in California. SDs were identified using the American College of Surgeons Health Policy Research Institute workforce atlas. Data included patient demographics and socioeconomic status, and the primary outcome was the rates of BR.A total of 9325 mastectomy patients, with or without BR, were identified. Of this, 12.8% patients were in SDs, whereas 87.2% patients were in nonsurgical deserts (NSDs). Overall, 35.8% of patients received BR, whereas 64.2% did not. Of the patients in SDs, only 14% received BR, whereas in NSDs, 39% received BR. On multivariate analysis, SD patients were significantly less likely to receive BR than NSD patients (odds ratio [95% confidence interval], 0.29 [0.24-0.35]; P 0.001). SDs had higher rates of low household income, Medicare insurance, and comorbidities. NSDs had higher rates of high household income, Health Maintenance Organization/private insurance, and lower rates of comorbidities.Patients in SDs are significantly less likely to receive BR. This disparity may be magnified because of differences in demographics and income levels, and decreased access to reconstructive surgeons. Interventions aimed at decreasing disparities caused by SDs are needed.

The optimal management of lobular carcinoma in situ (LCIS) has largely been debated. This study evaluated practice patterns and outcomes in women diagnosed with LCIS at a single institution from 2000 to 2014. Patient characteristics, histology, method of diagnosis, and management were examined in relation to disease-free survival, and overall survival (OS). A total of 209 patients were identified. Surgical management in the majority of patients was excisional biopsy or local excision. Patients diagnosed with LCIS by core biopsy were less likely to have mastectomy as compared with other methods of initial diagnosis (P = 0.01). A total of 108 (90.8%) patients received chemoprevention (CP) counseling, and 47 (43.5%) used chemoprevention. Estimated five-year disease-free survival rate was 96.3 per cent (95% confidence interval (CI): 92.0–98.3%) and OS rate was 98.6 per cent (95% CI: 94.6–99.7%). Older age was associated with a higher risk of subsequent breast cancer (hazard ratio (HR): 1.04; 95% CI: 1.01–1.07; P = 0.01). Older age (HR: 1.06; 95% CI: 1.02–1.11; P = 0.004) and diagnosis in the earlier years of the study period (HR: 0.65; 95% CI: 0.48–0.89; P = 0.007) were significantly associated with worse OS in multivariate analysis. LCIS has a favorable prognosis and is most commonly managed conservatively.

Flat Epithelia Atypia (FEA) is a proliferative lesion of the breast where cells demonstrate columnar change and cytologic atypia. This lesion has been identified as distinct from the classic atypical hyperplasias (AH). While many patients undergo excisional biopsy, management of FEA identified on core needle biopsy (CNB) is controversial, and the rate of associated ductal carcinoma in situ (DCIS) or invasive cancer is not well defined. The aim of this study was to determine the upstage rate of FEA diagnosed by CNB. We identified patients from a prospectively maintained data base who had FEA diagnosed by CNB from 01/2010 to 07/2015. Patient variables collected included age at presentation, imaging findings, pathologic findings following surgical excision, and subsequent development of breast cancer. Of 132 patients, 62 (n = 62/132, 47.0%) patients had FEA associated with DCIS and invasive ductal carcinoma (IDC) on CNB and were excluded from analysis. Of the remaining 70 patients, median age was 52 (range 31-84) years. Thirty-two (45.7%) patients had FEA plus AH, 4 (5.7%) patients had FEA plus lobular carcinoma in situ (LCIS), and 34 (48.6%) patients had FEA alone or with another non-pathologic finding (pure FEA). Two (6.3%) patients with FEA plus AH had DCIS or IDC on subsequent excisional biopsy. Of the 34 patients with pure FEA who underwent excisional biopsy, only one (2.9%) was found to have IDC. Twenty-two (64.7%) patients with pure FEA who underwent excisional biopsy presented with calcifications on mammography. None of these patients had cancer on excisional biopsy, and 10 (45.5%) patients had AH (3 ADH, 3 ALH, and 4 both ALH and ADH). Twelve (n = 12/34, 35.3%) patients with pure FEA underwent CNB for a mass or asymmetry noted on imaging. Of these 12 patients, 9 (75.0%) had benign findings on excisional biopsy, two (16.7%) patients had AH, and one (8.3%) patient had IDC. Median follow-up was 4.6 years (IQR 3.1-6.5 years). Three (4.3%) patients subsequently developed IDC, two of which were in the contralateral breast. FEA is often found in combination with ADH and ALH as well as carcinoma on CNB. In our study, pure FEA was upstaged to cancer in only 2.9% of patients. Mammographic findings unlikely predict upstaging to malignancy. These findings suggest that excisional biopsy may not be warranted in patients with pure FEA and could be managed with close imaging surveillance.

Radioactive seed localization (RSL) and the Savi scoutTo compare three types of localization devices used in breast conserving surgery.A total of 293 patients had a partial mastectomy (n = 194) or breast biopsy (n = 99) with preoperative image-guided localization of a single nonpalpable lesion between July 2017 to July 2018. Lesions were localized by WL, RSL, or SSR. Although all operations performed were outpatient, due to workflow differences at our institution, operations performed in the hospital operating rooms were defined as "hospital setting." Operations performed at an outpatient surgery facility without the capacity to admit patients were defined as "ambulatory." Delay in operating room start times and total perioperative times in both the hospital and ambulatory setting, localization time, explant of localization device, positive margins, volume of tissue excised, and 30-day complications were evaluated.A total of 126 patients (43%) had WL; 59 patients (20%) had RSL; and 108 patients (37%) had SSR localization. SSR localization took longer to perform with an average time of 19 minutes, compared with 15 minutes for WL and 14 minutes for RSL (P = .020). In 93.52% of cases, the first specimen contained both the clip and localization device, which was similar among groups (P = .073). There was no difference in retained biopsy clip among the groups (average 3.4%, P = .173). For operations performed in the hospital, the time from patient arrival to the preoperative area and incision was significantly longer in the WL group with a median of 233 minutes (range 56-486), 130 minutes (range 64-294) in RSL, and 108 minutes (range 59-240) for SSR (P .001). There was no difference in operative time among the groups with a median of 51 minutes (range 17-122) (P = .108). There was, however, significantly longer perioperative time of 469 minutes (range 210-926) in the WL group compared with 399 minutes (range 240-871) for RSL and 381 minutes (range 232-711) for SSR (P ≤ .001). For the ambulatory setting, although there was no difference in operating time among the groups (median 50 minutes, range 18-127, P = .715), only the RSL showed a decreased perioperative time compared to WL (WL 356 vs RSL 275, P .001; SSR 279, p = NS). A total of 131 patients (44.7%) had same day localizations. Among operations with delayed start times, there was a longer average delay of 85 minutes (range 1-304) for WL group compared with 69 minutes (range 13-219) in RSL and 53 minutes (range 0-228) in SSR (P .001). There was no difference among the three groups in positive margin rate, volume of tissue excised, and 30-day complications.Nonwire localization devices are associated with reduced overall perioperative time compared to wire localization, with few complications.