A Prospective Study of Sentinel Node Biopsy Omission in Women Age ≥ 65 Years with ER+ Breast Cancer.

BACKGROUND: National guidelines recommend omitting SNB in older patients with favorable invasive breast cancer. However, there is a lack of prospective data specifically addressing this issue. This study evaluates recurrence and survival in estrogen receptor-positive/Her2- (ER+) breast cancer patients, aged ≥ 65 years who have breast-conserving surgery (BCS) without SNB. METHODS: This is a prospective, observational study at a single institution where 125 patients aged ≥ 65 years with clinical T1-2N0 ER+ invasive breast cancer undergoing BCS were enrolled. Patients were treated with BCS without SNB. Primary outcome measure was axillary recurrence. Secondary outcome measures include recurrence-free survival (RFS), disease-free survival (DFS), breast cancer-specific survival (BCSS), and overall survival (OS). RESULTS: From January 2016 to July 2022, 125 patients were enrolled with median follow-up of 36.7 months [95% confidence interval (CI) 35.0-38.0]. Median age was 77.0 years (range 65-93). Median tumor size was 1 cm (range 0.1-5.0). Most tumors were ductal (95/124, 77.0%), intermediate grade (60/116, 51.7%), and PR-positive (117/123, 91.7%). Radiation therapy was performed in 37 of 125 (29.6%). Only 60 of 125 (48.0%) who were recommended hormonal therapy were compliant at 2 years. Chemotherapy was administered to six of 125 (4.8%) patients. There were two of 125 (1.6%) axillary recurrences. Estimated 3-years rates of regional RFS, DFS, and OS were 98.2%, 91.2%, and 94.8%, respectively. Univariate Cox regression identified hormonal therapy noncompliance to be significantly associated with recurrence (p = 0.02). CONCLUSIONS: Axillary recurrence rates were extremely low in this cohort. These results provide prospective data to support omission of SNB in this patient population TRIAL REGISTRATION: ClinicalTrials.gov ID NCT02564848.

Second primary malignancies in women with breast cancer.

BACKGROUND: Increased screening and treatment advancements have resulted in improved survival rates in women with breast cancer (BC). However, recent data suggests these women have elevated risk of developing a second primary malignancy (SPM) compared to the general population. Limited data exists on factors associated with BC patients developing a SPM. METHOD: A retrospective review of a prospective single institution database (1990-2016) identified 782 patients with a history of BC. One hundred and ninety-four BC patients developed a SPM. Clinicopathologic and treatment characteristics were analyzed. RESULTS: Of the 194 patients (24.8%) who developed a SPM, 56 (28.9%) BC patients were <50 years old (range: 24-87 years). Two-thirds (64.9%) had at least one first or second degree relative with a malignancy (no relatives-35.1%; ≥1 relative-62.9%). Most patients had invasive ductal carcinoma (n = 117, 60.3%) or ductal carcinoma in situ (n = 39, 20.1%). Twenty-two patients (11.3%) had pathogenic genetic mutations. Mean time to developing a SPM was 8.9 years (range: 4 months-50 years). Eighty (47.6%) patients received chemotherapy with 91 (54.5%) completing radiation. The most common SPMs were breast (22%), melanoma (17.8%), gynecologic (14.1%), colorectal (12.6%), hematologic (8.9%), and sarcoma (6.5%). Most breast tumors were estrogen receptor (ER) (n = 99, 78.0%) or progesterone receptor (PR) positive (n = 87, 73.1%) but not HER2-neu positive (n = 13, 14.0%). CONCLUSION: Most BC patients who developed a SPM had ER/PR positive tumors and a family history of malignancy, with most <50 years old. Although chemotherapy and radiation increase cancer risk, there were an equal number of patients with SPMs who did or did not receive either treatment. Most SPMs were breast, soft tissue, gynecologic, hematologic, or colorectal. BC patients should be followed closely given an elevated propensity for developing SPMs.

De-Implementation of Low-Value Care for Women 70 Years of Age or Older with Low-Risk Breast Cancer During the COVID-19 Pandemic.

BACKGROUND: Older women with early-stage estrogen receptor-positive (ER+) invasive breast cancer (IBC) are at risk for overtreatment. Guidelines allow for sentinel lymph node biopsy (SLNB) and radiotherapy omission after breast-conserving surgery (BCS) for women 70 years of age or older with T1, clinical node negativity (cN0), and ER+ IBC. The study objective was to evaluate radiotherapy and SLNB de-implementation in older women with low-risk IBC after the resource limitations of the COVID-19 pandemic. METHODS: An institutional database was analyzed to identify women 70 years of age or older who received BCS for IBC from 2012 to 2022. The patients were divided into two cohorts: (1) patients with low-risk IBC (pT1, cN0, and ER+/HER2-) who were eligible for radiotherapy and SLNB omission and (2) patients with high-risk IBC (pT2-T4, cN+, ER-, or HER2+) who were ineligible for therapy omission. Clinicopathologic variables in both cohorts were analyzed. RESULTS: The study enrolled 881 patients. For the patients with low-risk IBC, the annual rates of radiotherapy were stable from 2012 to 2019. However, radiotherapy utilization decreased significantly from 2020 to 2022 (58% in 2012 vs 36% in 2022; p = 0.04). In contrast, radiotherapy usage among the patients with high-risk IBC was stable from 2012 to 2022 (79% in 2012 vs 79% in 2022; p = 0.95). Among the patients with low-risk IBC, SLNB rates decreased from 86% in 2012 to 56% in 2022, but this trend predated those in 2020. The factors significantly associated with SLNB and receipt of radiotherapy among the patients with low-risk IBC were younger age, larger tumors, grade 3 disease, and involved nodal status (p < 0.01). CONCLUSION: This study demonstrated appropriate and sustained de-escalation of radiotherapy in older women with low-risk IBC after the COVID-19 pandemic.

Impact of Postoperative Antibiotic Prophylaxis on Surgical Site Infections Rates After Mastectomy with Drains but Without Immediate Reconstruction: A Multicenter, Double-Blinded, Randomized Control Superiority Trial.

BACKGROUND: There is no consensus on the use of postoperative antibiotic prophylaxis (PAP) after mastectomy with indwelling drains. We explored the utility of continued PAP in reducing surgical site infection (SSI) rates after mastectomy without immediate reconstruction and with indwelling drains. PATIENTS AND METHODS: A multicenter, two-armed, randomized control superiority trial was conducted in Pakistan. We enrolled all consenting adult patients undergoing mastectomy without immediate reconstruction. All patients received a single preoperative dose of cephalexin within 60 min of incision, and postoperatively were randomized to receive either continued PAP using cephalexin (intervention) or a placebo (control) for the duration of indwelling, closed-suction drains. The primary outcome was the development of SSI within 30 days and 90 days postoperatively. Secondary outcomes included study-drug-associated adverse events. Intention-to-treat analysis was performed using multivariable Cox regression. RESULTS: A total of 369 patients, 180 (48.8%) in the intervention group and 189 (51.2%) in the control group, were included in the final analysis. Overall cumulative SSI rates were 3.5% at 30 days and 4.6% at 90 days postoperatively. PAP was not associated with SSI reduction at 30 (hazard ratio, HR 1.666 [95% confidence interval CI 0.515-5.385]) or 90 (1.575 [0.558-4.448]) days postoperatively, or with study-drug-associated adverse effects (0.529 [0.196-1.428]). CONCLUSIONS: Continuing antibiotic prophylaxis for the duration of indwelling drains after mastectomy without immediate reconstruction offers no additional benefit in terms of SSI reduction. There is a need to update existing guidelines to provide clearer recommendations regarding use of postoperative antibiotic prophylaxis after mastectomy in the setting of indwelling drains.

Practice Patterns of Antibiotic Prophylaxis in Patients Undergoing Mastectomy: A Survey of Members of the American Society of Breast Surgeons.

BACKGROUND: Surgical site infections after breast surgery range from 1 to 16%. Both the American Society of Breast Surgeons (ASBrS) and the American Association of Plastic Surgeons guidelines lack clarity on postoperative antibiotic prophylaxis (AP) after mastectomy. We surveyed the ASBrS membership to understand their practice patterns of AP after mastectomy and familiarity with ASBrS guidelines. METHODS: A self-designed, 19-question survey was emailed to all 2934 ASBrS members. Information was obtained on the participants' training, familiarity with ASBrS guidelines, and practices of prescribing perioperative AP after mastectomy with/without reconstruction and with indwelling drains. RESULTS: In total, 556 (19%) responses were analyzed. Half were fellowship-trained breast surgeons/surgical oncologists (50.2%), with 55.6% having practiced for > 15 years and 66.9% in community/private practice. Only 53.6% reported familiarity with ASBrS guidelines for perioperative AP. Most (> 90%) surgeons reported "always" placing drains after mastectomy and "always" prescribing preoperative AP. Postoperatively, preference for continuing AP in cases with drains in place varied by procedure: 7.7% when no reconstruction, 29.1% when autologous-only, and 52.5% when implant reconstruction. Academic surgeons were less likely than surgeons in community/private practice to continue postoperative AP, whether for the duration of indwelling drains (5.1% versus 9.4%) or even till 7 days postoperatively (0.6% versus 3.2%) (p < 0.05). CONCLUSIONS: Surgeons uniformly adhere to ASBrS guidelines for preoperative AP. However, there is wide variation in AP postoperatively in patients with/without reconstruction and with indwelling drains. Our results highlight the need for high-quality evidence based on which guidelines must be updated, and the need to familiarize surgeons with current guidelines.

Upstaging of Fibroepithelial Lesions: A Single-Institution Experience.

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.

Breast cancer surveillance following ovarian cancer in BRCA mutation carriers.

OBJECTIVES: BRCA 1 or 2 mutation carriers have increased risk of developing breast cancer (BC) and serous epithelial ovarian cancer (EOC). The incidence of BC over time after EOC is unknown. Optimal BC surveillance for BRCA mutation carriers following EOC has not been defined. METHODS: A multi-institutional retrospective chart review was performed. Patients with BRCA -associated EOC diagnosed between 1996 and 2016 were followed for an average of 80 months. Women with previous bilateral mastectomy were excluded; women with prior BC and an intact breast were included. Descriptive statistics, Chi Square, and univariate survival analysis were performed. RESULTS: 184 patients with BRCA -associated EOC were identified. Eighteen (10%) were diagnosed with BC a median of 48 months following EOC. Two (1%) with prior BC developed contralateral BC and 16 (9%) developed primary BC. The majority of BC (55%) was diagnosed 3 years following EOC. The 3-, 5- and 10-year incidence of BC was 5.6%, 9.5% and 33.3%. Annual mammography was performed in 43% and MRI in 34%. Twenty-eight (15%) women underwent risk-reducing mastectomy (RRM). There was no statistically significant difference in BC screening between women with, and without, a prior BC. BC was most commonly detected on mammogram. Three (17%) women had occult BC at the time of RRM. Nine (50%) had DCIS, and 8 (44%) had stage I/II BC. Median 5- and 10-year survival was 68% and 43% and was comparable between groups. CONCLUSIONS: Ten percent of women developed BC after EOC. The incidence of BC following EOC in BRCA carriers increases over time, and surveillance is recommended given their enhanced survival of EOC. Timely genetic testing for women with EOC is imperative to better triage BC screening resources and treatment.

Contemporary Cancer Program Practice Profile Report (CP3R) Compliance Rates for Breast Cancer: A National Cancer Database Analysis.

INTRODUCTION: The Commission on Cancer (CoC) issues Cancer Program Practice Profile Reports (CP3R) that set standards for high-quality care. Three metrics for breast cancer include radiation within 1 year for women < 70 years of age receiving breast-conserving surgery, radiation within 1 year after mastectomy for women with four or more positive lymph nodes (MASTRT), and hormonal therapy within 1 year of a stage IB-III hormone receptor-positive breast cancer (HT). Our study evaluates national trends in quality metric compliance. METHODS: The National Cancer Database was queried from 2004 to 2014 to identify patients who met the criteria for the three quality metrics. National trends in compliance were compared. RESULTS: Overall, 1,094,264 patients qualified for BCSRT (n = 534,147), MASTRT (n = 66,291), or HT (n = 493,826). In 2014, 91.1% of patients met BCSRT, 88.4% met MASTRT, and 90.7% met HT. BCSRT, MASTRT, and HT compliance rates were lower in community hospitals compared with Integrated Network Cancer Programs (INCP) (BCSRT: 89.0% vs. 92.8%, p < 0.01; MASTRT: 85.5% vs. 90.6%, p < 0.01; HT: 87.3% vs. 93.7%, p < 0.01). On multivariate analysis, patients receiving care at an INCP facility [odds ratio (OR) 1.47, 95% confidence interval (CI) 1.37-1.58] and insured patients (OR 1.70, 95% CI 1.54-1.87) had higher odds of BCSRT compliance, and minorities (OR 0.76, 95% CI 0.73-0.80) had lower odds. Similar results were seen for MASTRT and HT. CONCLUSION: In more recent years, overall compliance rates for breast cancer quality metrics of BCSRT and HT by Comprehensive Community Cancer Programs, Academic/Research Programs, and INCPs have increased to meet the 90% CoC standards, while MASTRT has regressed. Community programs were least compliant with meeting the CoC standards.

Comparison of Multiple Wire, Radioactive Seed, and Savi Scout® Radar Localizations for Management of Surgical Breast Disease.

BACKGROUND: Radioactive seed localization (RSL) and the Savi Scout® radar (SSR) are newer alternatives to wire-guided localization (WL) for nonpalpable breast lesions. OBJECTIVE: The aim of this study was to compare three localization devices when multiple devices were used for preoperative localization for breast surgery. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Alterations in Breast Cancer Biomarkers Following Neoadjuvant Therapy.

INTRODUCTION: Biomarker changes in patients with residual disease (RD) after neoadjuvant systemic therapy (NAT) have unclear consequences. This study examined the prevalence of biomarker [hormone receptor (HR) and HER2] change and its effect on disease-free survival (DFS) and overall survival (OS). PATIENTS AND METHODS: A total of 303 patients treated with NAT from 2008 to 2016 were identified from a prospective database. Biomarker status at diagnosis was determined and retested after NAT in patients with RD. DFS and OS were compared among three groups: no biomarker change, clinically insignificant change in either ER or PR without alteration in HR status, and clinically significant change in at least one biomarker with resultant change in HR or HER2 status. Subgroups with no change and HR change were examined [HR+HER2- no change, triple negative (TN) no change, HR+HER2- to TN, TN to HR+HER2]. RESULTS: Overall, 61.4% of patients had RD. Of these, 32.8% had changes in at least one biomarker. At median follow up of 5.48 years, no biomarker change was associated with improved DFS compared with changes in HR or HER2 status (p = 0.043). In addition, no biomarker change (p = 0.005) and clinically insignificant changes in biomarker status (p = 0.019) were associated with improved OS compared with clinically significant changes in HR or HER2 status. Among subgroups, HR+HER2- to TN was associated with worse DFS (p = 0.029) and OS (p = 0.008) compared with HR+HER2- no change. CONCLUSIONS: Among those with RD, biomarker status change was common and impacted survival in subgroups of HR+ or TN disease. Retesting biomarkers after NAT has prognostic implications.

Changes in utilization of axillary dissection in women with invasive breast cancer and sentinel node metastasis after the ACOSOG Z0011 trial.

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.

Incidental radiologic findings in breast cancer patients who undergo staging prior to neo-adjuvant chemotherapy.

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.

Adjuvant endocrine therapy is associated with improved overall survival in elderly hormone receptor-positive breast cancer patients.

PURPOSE: 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. METHODS: 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. RESULTS: 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 < 0.001), had positive LNs (25.5 vs 9.8%, p = 0.008), and received radiation (XRT, 76 vs 43%, p < 0.001). After adjusting for ASA score, age, LN status, tumor grade, and XRT, receipt of ET was associated with improved OS (HR 0.44; 95% CI 0.25-0.77; p = 0.004) and DFS (HR 0.42; 95% CI 0.28-0.64; p < 0.01). Receipt of ET was associated with improved LRR on univariate analysis (HR 0.25; 95% CI 0.09-0.70; p = 0.008); however, after adjusting for grade and XRT, this was not statistically significant on multivariable analysis (HR 0.38; 95% CI 0.13-1.08; p = 0.069) and was not associated with BCSS (HR 0.59; 95% CI 0.16-2.16; p = 0.43). CONCLUSIONS: ET was associated with significant improvements in OS and DFS, regardless of clinicopathological features; however, receipt of ET did not impact LRR and BCSS.

Treatment at Academic Centers Increases Likelihood of Reconstruction After Mastectomy for Breast Cancer Patients.

BACKGROUND: Mastectomy rates continue to increase in women diagnosed with breast cancer (BC). There are limited data regarding reconstruction rates at academic centers (AC) versus community hospitals (CH). We aim to determine the effect of facility type on reconstruction rates. MATERIALS AND METHODS: The National Cancer Database was queried for BC patients treated with mastectomy from 2004 to 2014. Clinical characteristics and type of reconstruction were compared between treatment at AC or CH. RESULTS: A total of 860,509 patients were included. Patients treated at AC were younger (58.7 ± 12 y AC versus 61.6 ± 13 y CH; P < 0.001) and traveled farther to their treatment center (33.1 ± 122.8 miles AC versus 20 ± 75.3 miles CH; P < 0.001). Patients undergoing surgery at AC were more likely to have reconstruction than those at CH (43.7% AC versus 32.5% CH; P < 0.001). This trend remained across all reconstruction types including expander/implant-based reconstruction (immediate breast reconstruction) (14.4% AC versus 9.9% CH), autologous reconstruction (14.9% AC versus 11.7% CH), mixed reconstruction (5.2% AC versus 3.6% CH), and other reconstructions (9.2% AC versus 7.3% CH) (all P < 0.001). Patients in all age categories, across insurance statuses, and with comorbidities were more likely to receive reconstruction if treated at AC compared with CH. In multivariate analysis, having a mastectomy at AC was an independent predictor of reconstruction (adjusted odds ratio, 1.51; 95% confidence interval, 1.49-1.51; P < 0.001). CONCLUSIONS: Undergoing mastectomy at AC results in higher rate of reconstruction compared with CH.

Impact of the extent of pathologic complete response on outcomes after neoadjuvant chemotherapy.

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.

Comparison of wire localization, radioactive seed, and Savi scout® radar for management of surgical breast disease.

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 < .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. CONCLUSION: Nonwire localization devices are associated with reduced overall perioperative time compared to wire localization, with few complications.

Flat epithelial atypia on core needle biopsy does not always mandate excisional biopsy.

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.

Overuse of Preoperative Staging of Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer.

BACKGROUND: Guidelines of the American Society of Clinical Oncology (ASCO), the National Comprehensive Cancer Network (NCCN), and the European Society for Medical Oncology (ESMO) discourage the use of imaging to stage newly diagnosed early breast cancer (stages 1 and 2). This study aimed to evaluate preoperative staging imaging rates among patients with stage 1 or 2 breast cancer treated with neoadjuvant chemotherapy (NAC). METHODS: From a prospectively maintained database, 303 patients with stage 1 or 2 breast cancer who had NAC from 2008 to 2016 were identified. The main outcome measures were the rate and outcomes of staging imaging performed. RESULTS: The mean age of the 303 patients with stage 1 or 2 breast cancer was 51 years (range, 26-87 years). Of these 303 patients, 278 (92.4%) had invasive ductal cancer. 90 (30.2%) had estrogen receptor (ER)-positive disease, 79 (26.5%) had triple-negative disease, and 127 (42.6%) had human epidermal growth factor receptor 2 (HER2)-positive disease. Staging positron emission tomography (PET) or computed tomography (CT) scan was performed for 258 patients (85.2%), brain imaging for 94 patients (31%), bone scans for 117 patients (38.6%), and all three for 48 patients (15.8%). As a result, 15 patients (4.9%) with a positive PET/CT scan were upstaged to stage 4 breast cancer. No difference was observed among the ER-positive (p = 1.000), HER2-positive (p = 0.259), or triple-negative (p = 0.369) receptor profiles of the patients upstaged to stage 4 disease. One patient (1.1%) had positive brain imaging. Five patients (4.3%) had a positive bone scan, and three of these patients (60%) had bone metastasis also shown on the PET/CT scan. CONCLUSION: Despite guideline recommendations, a high rate of preoperative staging imaging is completed for patients with clinical stage 1 or 2 breast cancer who receive NAC, with few positive results.

Prognostic factors influencing survival in small bowel neuroendocrine tumor with liver metastases.

BACKGROUND: Resection of liver metastasis in small bowel neuroendocrine tumors (SBNET) may improve survival, however, factors influencing prognosis are unclear. We evaluated how the extent of resection influences outcomes. METHODS: Patients with SBNET with liver metastasis from 1990 to 2013 who underwent resection of the primary tumor were identified. Outcomes among patients undergoing complete resection (CR), partial resection (PR), or no resection (NR) of liver metastases with resection of the primary tumor only were compared. RESULTS: One hundred eleven patients met the criteria. The median number of liver lesions was seven and median lesions resected was one. Fifty (45%) patients had NR, 41 (36.9%) underwent CR, and 20 (18.1%) underwent PR. The 5-year overall survival (OS) was 79.4% for NR, 84.7% for PR, and 100% for CR, demonstrating a trend that CR was best, followed by PR then NR (P = .02). 10-year OS showed no significant differences (72.7% NR; 84.7% PR; 82.5% CR; P = .10). Greater than 10 liver lesions (hazard ratio [HR] 3.6; P = 0.04) or receiving chemotherapy (HR 3.7; P = .03) were negative predictors of survival. CONCLUSION: The extent of resection of liver disease in SBNET influenced survival at 5 years but not at 10 years. In addition, more than 10 liver lesions and chemotherapy were predictors of mortality.

Outcomes in patients with small node-negative invasive breast cancer.

PURPOSE: There is controversy whether systemic therapy is warranted in patients with small node-negative tumors, especially among those with HER2+ and triple negative breast cancers (TNBC). In this study we sought to compare survival and recurrence rates (RR) in patients with T1mi,a,bN0M0 breast cancer by tumor type. METHODS: Review of a prospectively maintained data base between January 1, 2000 through December 31, 2013 identified 71 patients with HER2+ tumors, 545 with hormone receptor (HR)+ /HER2- tumors, and 45 with TNBC. The three groups were compared with respect to RR, disease-free survival (DFS), and overall survival (OS). Patients with HER2+ disease and TNBC who received chemotherapy were compared to those who did not. RESULTS: At mean follow-up of 4.9 years, the 5-year OS was 95% and 5-year DFS was 98%. RR for HER2+ , HR+ /HER2- , and TNBC was 7.0%, 3.7%, and 4.4% respectively (P = 0.2). There was no significant difference in OS (P = 0.9) and DFS (P = 0.4) amongst the three groups. On multivariable analysis, use of adjuvant chemotherapy was not associated with improvement in DFS or OS. When patients with HER2+ breast cancer and TNBC who received chemotherapy were compared to those who did not, there was no difference in death rates (P = 0.3). CONCLUSIONS: Patients with T1mi,a,bN0M0 invasive breast cancer have an excellent prognosis. The three molecular subtypes differed significantly in age, tumor size, and tumor grade, but had similar RR, DFS, and OS. Chemotherapy was not associated with improved survival. Tumor subtype may not influence recurrence and survival in such small early stage tumors.