Breast Cancer Screening, Diagnosis, and Surgery during the Pre- and Peri-pandemic: Experience of Patients in a Statewide Health Information Exchange.

BACKGROUND: Measures taken to address the COVID-19 pandemic interrupted routine diagnosis and care for breast cancer. The aim of this study was to characterize the effects of the pandemic on breast cancer care in a statewide cohort. PATIENTS AND METHODS: Using data from a large health information exchange, we retrospectively analyzed the timing of breast cancer screening, and identified a cohort of newly diagnosed patients with any stage of breast cancer to further access the information available about their surgical treatments. We compared data for four subgroups: pre-lockdown (preLD) 25 March to 16 June 2019; lockdown (LD) 23 March to 3 May 2020; reopening (RO) 4 May to 14 June 2020; and post-lockdown (postLD) 22 March to 13 June 2021. RESULTS: During LD and RO, screening mammograms in the cohort decreased by 96.3% and 36.2%, respectively. The overall breast cancer diagnosis and surgery volumes decreased up to 38.7%, and the median time to surgery was prolonged from 1.5 months to 2.4 for LD and 1.8 months for RO. Interestingly, higher mean DCIS diagnosis (5.0 per week vs. 3.1 per week, p < 0.05) and surgery volume (14.8 vs. 10.5, p < 0.05) were found for postLD compared with preLD, while median time to surgery was shorter (1.2 months vs. 1.5 months, p < 0.0001). However, the postLD average weekly screening and diagnostic mammogram did not fully recover to preLD levels (2055.3 vs. 2326.2, p < 0.05; 574.2 vs. 624.1, p < 0.05). CONCLUSIONS: Breast cancer diagnosis and treatment patterns were interrupted during the lockdown and still altered 1 year after. Screening in primary care should be expanded to mitigate possible longer-term effects of these interruptions.

The no-vertical scar technique for oncoplastic breast reconstruction.

INTRODUCTION: Oncoplastic reconstruction can optimize breast conserving therapy. Nipple loss is a concern in patients with significant ptosis and breast hypertrophy particularly with pedicle undermining during tumor resection. The modified Robertson technique (No-Vertical Scar reduction) has been previously described for breast reduction in large, ptotic patients using a wide, bell-shaped inferior pedicle with only inframammary fold and peri­areolar incisions. The purpose of this study was to evaluate the No-Vertical Scar (NVS) technique applied to oncoplastic reconstruction. METHODS: Women undergoing oncoplastic breast reduction using a NVS, Wise, or Vertical method were assessed. Predictive variables included patient demographics, comorbidities, and sternal notch to nipple (SNN) distance. Outcome variables were delayed wound healing, surgical site infection, seroma, fat necrosis, nipple necrosis, use of a free nipple graft, and time between surgery and adjuvant radiation. RESULTS: Fifty patients met inclusion criteria using NVS (N = 15), Wise (N = 16), and Vertical (N = 19) methods. The NVS group had a significantly higher BMI (p=.009), greater sternal notch to nipple distance (p=<0.001) and increased resection volume (p=<0.001) as compared to Wise and Vertical groups. There was no significant difference in complications (p=.25). No nipple necrosis occurred, and no free nipple grafts were required. CONCLUSION: The NVS approach is a useful technique for oncoplastic reconstruction in select patients with macromastia and severe Grade II or Grade III ptosis. The wide, bell-shaped pedicle is versatile for obliterating a lumpectomy cavity and optimizing nipple perfusion if pedicle undermining occurs during resection.

Optimizing tissue expander breast reconstruction in nicotine users: An algorithmic approach.

INTRODUCTION: Smoking is a risk factor for post-operative complications following breast reconstruction. Abruptly refraining from all nicotine products may be difficult for patients with a new cancer diagnosis. The goal of this study is to assess complications following a distinct approach to tissue expander reconstruction in nicotine users. METHODS: Patients who underwent tissue expander reconstruction after mastectomy were retrospectively reviewed. The approach to optimize outcomes in smokers was to delay reconstruction at least 7 days after the mastectomy and place the expander submuscularly (Group I). The other patients underwent standard immediate reconstruction on the day of mastectomy and were divided into Group II (active smokers) and Group III (non-smokers). Group III was considered the control group. RESULTS: There was a total of 195 patients (323 breast reconstructions): Group I (10 patients, 19 expanders); Group II (11 patients, 19 expanders) and Group III (174 patients, 285 expanders). In Group I, n = 1/19 breasts had wound dehiscence requiring surgical management, compared to n = 18/285 in Group III (p = 1.0). Group II exhibited more wound dehiscence (n = 6/19) compared to Group III (p = 0.002). There was no significant difference when comparing wound dehiscence in prepectoral expander placement (7.0%) versus submuscular placement (4.8%) in Group III (p = 0.60). CONCLUSION: Nicotine users who are offered tissue expander breast reconstruction 1) at least 7 days after the mastectomy (to allow for vascular delay and demarcation) and 2) in the submuscular plane can normalize their risk of skin necrosis to that of non-smokers who have standard (prepectoral or submuscular) reconstruction on the day of mastectomy.

Advantages of the Delayed-Immediate Microsurgical Breast Reconstruction: Extending the Choice.

BACKGROUND: Deep inferior epigastric perforator (DIEP) reconstruction can be performed in an immediate (at time of mastectomy), delayed-immediate (immediate tissue expander followed by staged DIEP), or delayed timing following mastectomy. Avoiding flap radiation is a known benefit of the delayed-immediate approach. The purpose of this study is to evaluate patients who chose DIEP flap as the reconstructive method during initial consultation and compared characteristics of surgery in relation to their final reconstructive choice. METHODS: Consecutive patients having breast reconstruction from 2017 to 2019 were divided into three groups: immediate DIEP after mastectomy (Group I); delayed-immediate DIEP with tissue expander first followed by DIEP (Group II); and patients who initially chose delayed-immediate DIEP but later decided on implants for the second stage of reconstruction (Group III). Exclusion criteria were patients that had delayed DIEP (no immediate reconstruction) or had initially chose implant-based reconstruction. RESULTS: The study included 59 patients. Unilateral free flaps in Group II had shorter operative times (318 minutes) compared with Group I unilateral free flaps (488 minutes) (p = 0.024). Eleven patients (30.6%) had prophylactic mastectomies in Group I compared with none in Group II (p = 0.004). Patients who had immediate tissue expansion frequently changed their mind from DIEP to implant for second stage reconstruction frequently (52.2%). CONCLUSION: Delayed-immediate DIEP reconstruction has several advantages over immediate DIEP flap including shorter free flap operative times. Patients commonly alter their preference for second stage reconstruction. A patient-centered advantage of delayed-immediate reconstruction is prolonging the time for patients to make their choice for the final reconstruction.

Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108).

PURPOSE: Distant metastases are present in 6% or more of patients with newly diagnosed breast cancer. In this context, locoregional therapy for the intact primary tumor has been hypothesized to improve overall survival (OS), but clinical trials have reported conflicting results. METHODS: Women presenting with metastatic breast cancer and an intact primary tumor received systemic therapy for 4-8 months; if no disease progression occurred, they were randomly assigned to locoregional therapy for the primary site (surgery and radiotherapy per standards for nonmetastatic disease) or continuing sysmetic therapy. The primary end point was OS; locoregional control and quality of life were secondary end points. The trial design provided 85% power to detect a 19.3% absolute difference in the 3-year OS rate in randomly assigned patients. The stratified log-rank test and Cox proportional hazards model were used to compare OS between arms. Cumulative incidence of locoregional progression was compared using Gray's test. Quality-of-life assessment used standard instruments. RESULTS: Of 390 participants enrolled, 256 were randomly assigned: 131 to continued systemic therapy and 125 to early locoregional therapy. The 3-year OS was 67.9% without and 68.4% with early locoregional therapy (hazard ratio = 1.11; 90% CI, 0.82 to 1.52; P = .57). The median OS was 53.1 months (95% CI, 47.9 to not estimable) in the systemic therapy arm and 54.9 months (95% CI, 46.7 to not estimable) in the locoregional therapy arm. Locoregional progression was less frequent in those randomly assigned to locoregional therapy (3-year rate: 16.3% v 39.8%; P < .001). Quality-of-life measures were largely similar between arms. CONCLUSION: Early locoregional therapy for the primary site did not improve survival in patients presenting with metastatic breast cancer. Although it was associated with improved locoregional control, this had no overall impact on quality of life.

Immediate Lymphatic Reconstruction to Prevent Breast Cancer-Related Lymphedema: A Systematic Review.

Significance: Lymphedema is chronic limb swelling from lymphatic dysfunction. The condition affects up to 250 million people worldwide. In breast cancer patients, lymphedema occurs in 30% who undergo axillary lymph node dissection (ALND). Recent Advances: Immediate lymphatic reconstruction (ILR), also termed Lymphatic Microsurgical Preventing Healing Approach (LyMPHA), is a method to decrease the risk of lymphedema by performing prophylactic lymphovenous anastomoses at the time of ALND. The objective of this study is to assess the risk reduction of ILR in preventing lymphedema. Critical Issues: Lymphedema has significant effects on the quality of life and morbidity of patients. Several techniques have been described to manage lymphedema after development, but prophylactic treatment of lymphedema with ILR may decrease risk of development to 6.6%. Future Directions: Long-term studies that demonstrate efficacy of ILR may allow for prophylactic management of lymphedema in the patient undergoing lymph node dissection.

Risk factors for the presence of residual disease in women after partial mastectomy for invasive breast cancer: A single institution experience.

BACKGROUND: We hypothesize that in addition to specimen margin widths other clinical variables may help predict the presence of residual disease in the lumpectomy bed. METHODS: Patients with Stage I-III invasive breast cancer (BC) who underwent partial mastectomy (PM) and re-excision from July 2010-June 2015 were retrospectively reviewed. Bivariate analyses were conducted using two-sample t-tests for continuous variables and Fisher's Exact tests for categorical variables. A multivariate logistic regression was then performed on significant bivariate analyses variables. RESULTS: ne-hundred and eighty-four patients were included in our analysis; 47% had residual disease on re-excision, while 53% had no residual disease. Tumor and nodal stage, operation type, type of disease present at margin, and number of positive margins were significantly associated with residual disease. On multivariate logistic regression, DCIS alone at the margin (p = 0.02), operation type (PM with cavity margins) (p = 0.003), and number of positive margins (3 or more) (p < 0.001) remained predictive of residual disease at re-excision. CONCLUSION: Based on a more comprehensive review of the initial pathology, there are additional factors that can help predict the likelihood of finding residual disease and help guide the surgeon in the decision for re-excision.

Bankruptcy among insured surgical patients with breast cancer: Who is at risk?

BACKGROUND: The rising cost of cancer treatment has been linked to higher bankruptcy rates and worse mortality among patients with cancer. The objective of this study was to identify the characteristics of insured patients with breast cancer who underwent surgery and filed for bankruptcy. METHODS: Insured patients with breast cancer who underwent surgery were identified in the Indiana State Cancer Registry (ISCR) from January 1, 2008 to December 31, 2014. Patients who filed for Chapter 7 or 13 bankruptcy in the Public Access to Courts Electronic Records (PACER) database were linked to patients in the ISCR. The cohort was divided into 2 groups: no bankruptcy (NB) and bankruptcy after diagnosis (BAD). Bivariate analysis and a logistic regression model were used to identify patients who were at increased risk of filing for bankruptcy after their diagnosis. RESULTS: Of 23,012 patients, 207 (0.9%) filed for bankruptcy after diagnosis and 22,805 (99.1%) did not file for bankruptcy. The patients who filed for bankruptcy after diagnosis were younger (BAD vs NB: median age, 53 years [interquartile range (IQR), 46-61 years] vs 62 years [IQR, 52-71 years], non-White (BAD vs NB, 20.5% vs 8.5%), and lived in lower income neighborhoods (BAD vs NB: median annual income, $50,869 [IQR, $41,051-$61,150] vs $52,522 [IQR, $41,356-$64,915]). On multivariable analysis, younger age (aged ≤40 years: odds ratio [OR], 5.41; 95% CI, 2.8-12.31; aged 41-64 years: OR, 2.65; 95% CI, 1.33-5.12; aged ≥65 years, reference category) and non-White race (non-White: OR, 2.43; 95% CI, 1.54-3.83; White, reference category) were associated with filing for bankruptcy after diagnosis CONCLUSIONS: Younger age and non-White race are associated with an increased risk of filing for bankruptcy after diagnosis among insured patients who undergo surgery for breast cancer. Additional steps should be taken to screen and address the financial vulnerability of these patients at treatment initiation.

Regenerative tissue filler for breast conserving surgery and other soft tissue restoration and reconstruction needs.

Complete removal of cancerous tissue and preservation of breast cosmesis with a single breast conserving surgery (BCS) is essential for surgeons. New and better options would allow them to more consistently achieve this goal and expand the number of women that receive this preferred therapy, while minimizing the need for re-excision and revision procedures or more aggressive surgical approaches (i.e., mastectomy). We have developed and evaluated a regenerative tissue filler that is applied as a liquid to defects during BCS prior to transitioning to a fibrillar collagen scaffold with soft tissue consistency. Using a porcine simulated BCS model, the collagen filler was shown to induce a regenerative healing response, characterized by rapid cellularization, vascularization, and progressive breast tissue neogenesis, including adipose tissue and mammary glands and ducts. Unlike conventional biomaterials, no foreign body response or inflammatory-mediated "active" biodegradation was observed. The collagen filler also did not compromise simulated surgical re-excision, radiography, or ultrasonography procedures, features that are important for clinical translation. When post-BCS radiation was applied, the collagen filler and its associated tissue response were largely similar to non-irradiated conditions; however, as expected, healing was modestly slower. This in situ scaffold-forming collagen is easy to apply, conforms to patient-specific defects, and regenerates complex soft tissues in the absence of inflammation. It has significant translational potential as the first regenerative tissue filler for BCS as well as other soft tissue restoration and reconstruction needs.

Immediate Lymphatic Reconstruction after Axillary Lymphadenectomy: A Single-Institution Early Experience.

PURPOSE: Lymphedema is progressive arm swelling from lymphatic dysfunction which can occur in 30% patients undergoing axillary dissection/radiation for breast cancer. Immediate lymphatic reconstruction (ILR) is performed in an attempt decrease the risk of lymphedema in patients undergoing axillary lymph node dissection (ALND). The purpose of this study was to assess the efficacy of ILR in preventing lymphedema rates in ALND patients. METHODS: An institutional review board-approved retrospective review was performed of all patients who underwent ILR from 2017 to 2019. Patient demographics, comorbidities, operative and pathologic findings, number of LVAs, limb measurements, complications, and follow-up were recorded and analyzed. Student's sample t-test, Fisher's exact test, and ANOVA were used to analyze data; significance was set at p < 0.05. RESULTS: Thirty-three patients were included in this analysis. Three patients (9.1%) developed persistent lymphedema, and two patients (6.1%) developed transient arm edema that resolved with compression and massage therapy. A significant effect was found for body mass index and the number of lymph nodes taken on the development of lymphedema (p < 0.01). CONCLUSIONS: The rate of lymphedema in this series was 9.1%, which is an improvement from historical rates of lymphedema. Our findings support ILR as a technique that potentially decreases the incidence of lymphedema after axillary lymphadenectomy. Obesity and number of lymph nodes removed were significant predictive variables for the development of lymphedema following LVA.

Breast Cancer Presentation, Surgical Management and Mortality Across the Rural-Urban Continuum in the National Cancer Database.

OBJECTIVE: The purpose of this study was to examine differences in presentation, surgical management, and mortality among breast cancer patients in the National Cancer Database (NCDB) based on area of residence. METHODS: The NCDB was queried for women with a diagnosis of breast cancer from 1 January 2004-31 December 2015. The data were divided by metropolitan (large, medium, small) and non-metropolitan (urban, rural) status. RESULTS: Cancer stage increased with rurality (p < 0.0001). Residency in a large metropolitan area was associated with increased breast reconstruction rates (odds ratio [OR] 1.25, 95% confidence interval [CI] 1.19-1.30) and reduced overall mortality (hazard ratio 0.92, 95% CI 0.89-0.95) compared with rural areas. There was no difference in mastectomy use among small metropolitan (OR 1.03, 95% CI 1.01-1.04), urban (OR 0.99, 95% CI 0.98-1), and rural areas (OR 1.05, 95% CI 1.01-1.07) compared with large metropolitan areas. CONCLUSIONS: Across the rural-urban continuum in the NCDB, stage of cancer presentation increased with rurality. Conversely, residency in a large metropolitan area was associated with higher reconstruction rates and a reduction in overall mortality. Future studies should evaluate factors contributing to advanced disease presentation and lower reconstruction rates among rural breast cancer patients.

The Landmark Series: Axillary Management in Breast Cancer.

The evolution in axillary management for patients with breast cancer has resulted in multiple dramatic changes over the past several decades. The end result has been an overall deescalation of surgery in the axilla. Landmark trials that have formed the basis for the current treatment guidelines are reviewed herein.

A cost-utility analysis comparing large volume displacement oncoplastic surgery to mastectomy with free flap reconstruction in the treatment of breast cancer.

PURPOSE: Breast cancer surgical treatment may include large volume displacement oncoplastic surgery (LVOS) or mastectomy with free flap reconstruction (MFFR). We investigated the cost-utility between LVOS versus MFFR to determine which approach was most cost-effective. METHODS: A literature review was performed to calculate probabilities for clinical outcomes for each surgical option (LVOS versus MFFR), and to obtain utility scores that were converted into quality adjusted life years (QALYs) as measures for clinical effectiveness. Average Medicare payments were surrogates for cost. A decision tree was constructed and an incremental cost-utility ratio (ICUR) was used to calculate cost-effectiveness. RESULTS: The decision tree demonstrates associated QALYs and costs with probabilities used to calculate the ICUR of $3699/QALY with gain of 2.7 QALY at an additional cost of $9987 proving that LVOS is a cost-effective surgical option. One-way sensitivity analysis showed that LVOS became cost-ineffective when its clinical effectiveness had a QALY of less than 30.187. Tornado Diagram Analysis and Monte-Carlo simulation supported our conclusion. CONCLUSION: LVOS is cost-effective when compared to MFFR for the appropriate breast cancer patient. CLINICAL QUESTION/LEVEL OF EVIDENCE: II.

A Systematic Review of Utility Score Assessments in the Breast Surgery Cost-Analysis Literature.

BACKGROUND: Surgery for breast cancer can have significant impact on patient quality-of-life. Cost-utility analysis provides a way to analyze the economic impact of a surgical procedure with the change in a patient's quality of life. Utility scores are used in these analyses to quantify the impact on quality of life. We undertook a systematic review of the literature on breast cancer surgical procedures to compile a repository of utility scores and to assess gaps in the current literature. METHODS: Following PRISMA guidelines, a systematic review was performed for studies reporting utility scores for breast surgery and breast reconstruction. The health states and utility scores were extracted and grouped into seven procedural categories based on oncologic and reconstructive methods. Mean utility score and ranges were calculated and reported for each procedural category. RESULTS: Nineteen articles met the inclusion criteria assessing 118 health states. Most utility scores were obtained from healthcare professionals. Breast-conserving therapy yielded the highest mean utility score at 0.79, whereas mastectomy yielded a mean utility score of 0.75. Among reconstruction health states, implant reconstruction had a lower score than autologous reconstruction (0.64 implant vs. latissimus dorsi 0.69 and TRAM/DIEP 0.71). No utility scores were found associated with oncoplasty or nipple-sparing mastectomy procedures. CONCLUSIONS: A reliable body of utility scores is important in enabling future cost-utility and value-based analysis comparisons for breast surgical oncology. Additional work is needed to obtain health state assessments from the patient perspective, as well as assessment of more modern surgical and reconstructive approaches.

The implications of insurance status on presentation, surgical management, and mortality among nonmetastatic breast cancer patients in Indiana.

BACKGROUND: The National Breast and Cervical Cancer Early Detection Program seeks to reduce health care disparities by providing uninsured and underinsured women access to screening mammograms. The objective of this study is to identify the differences in presentation, surgical management, and mortality among nonmetastatic uninsured patients diagnosed through Indiana's Breast and Cervical Cancer Program compared with patients with private and government (Medicare or Medicaid) insurance. METHODS: Study data were obtained using the Indiana state cancer registry and Indiana's Breast and Cervical Cancer Program. Women aged 50 to 64 with an index diagnosis of stage 0 to III breast cancer from January 1, 2006 to December 31, 2013, were included in the study. Bivariate intergroup analysis was conducted. Kaplan-Meier estimates between insurance types were compared using the log rank test. All-cause mortality was evaluated using a mixed effects model. RESULTS: The groups differed significantly for sociodemographic and clinical variables. Uninsured Indiana Breast and Cervical Cancer Program patients presented with later disease stage (P < .001) and had the highest overall mortality (hazard ratio 2.2, P = .003). Surgical management only differed among stage III patients (P = .012). CONCLUSION: To improve insurance-based disparities in Indiana, implementation of the Breast and Cervical Cancer Program in conjunction with expansion of insurance coverage to vulnerable low-income populations need to be optimized.

Quality of life and sexual well-being after nipple sparing mastectomy: A matched comparison of patients using the breast Q.

BACKGROUND: Nipple sparing mastectomy (NSM) is considered safe for select patients. Our objective was to examine quality of life (QOL) and satisfaction for NSM compared with skin sparing mastectomy (SSM). We aimed to evaluate these using the BREAST-Q. METHODS: After IRB approval, we analyzed patients who underwent NSM and reconstruction between July 2010-June 2015. NSM patients were matched with those after SSM based on age, race, and body mass index. Telephone interviews were prospectively conducted using the BREAST-Q Mastectomy Postoperative Module. Bivariate analysis and a paired samples t-test were performed. RESULTS: We identified 43 patients meeting our inclusion criteria with a response rate 60% (N = 26). NSM and SSM patients were matched well in age (P = 1.00), race (P = 1.00), and Body Mass Index (P = 0.99). There were no significant differences in stage, estrogen and progesterone status, HER2 expression, reconstruction type and radiation. Mean BREAST-Q scores did not vary between NSM and SSM in regards to satisfaction with breasts (P = 0.604), psychosocial well-being (P = 0.146), physical well-being (P = 0.121), and satisfaction with surgeon (P = 0.170). Sexual well-being was significantly higher in NSM patients (P = 0.011). CONCLUSION: NSM provides patients with favorable results in psychosocial, sexual, and physical well-being and overall satisfaction. Sexual well-being showed significant improvement for NSM.