Expanded Indications for Nipple-Sparing Mastectomy and Immediate Breast Reconstruction in Patients Older Than 60 Years.

INTRODUCTION: Although nipple-sparing mastectomy (NSM) and immediate breast reconstruction (IBR) have long been praised for excellent cosmetic results and the resultant psychosocial benefits, the feasibility and safety of these procedures in patients older than 60 years have yet to be demonstrated in a large population. METHODS: Patients undergoing NSM with or without IBR at the MedStar Georgetown University Hospital between 1998 and 2017 were included. Patient demographics, surgical intervention, and complication and recurrence events were retrieved from electronic medical records. Primary outcomes were recurrence and complication rates by age groups older and younger than 60 years. RESULTS: There were 673 breasts from 397 patients; 58 (8.6%) older than 60 years and 615 (91.4%) younger than 60 years with mean follow-up of 5.43 (0.12) years. The mean age for those older than 60 was 63.9 (3.3) years, whereas that for those younger than 60 was 43.1 (7.9) years (P < 0.001). The older than 60 group had significantly higher prevalence of diabetes, rates of therapeutic (vs prophylactic) and unilateral (vs bilateral) NSM, and mastectomy weight. However, there were no significant differences by age group in complication rates or increased risk of locoregional or distant recurrence with age. CONCLUSIONS: Based on similar complication profiles in both age groups, we demonstrate safety and feasibility of both NSM and IBR in the aging population. Despite increased age and comorbidity status, appropriately selected older women were able to achieve similar outcomes to younger women undergoing NSM with or without IBR.

Nipple-Sparing Mastectomy With Immediate Reconstruction After Breast-Conserving Therapy and Radiation: Complications and Oncologic Safety.

INTRODUCTION: Nipple-sparing mastectomy (NSM) offers improved, patient-centered outcomes with demonstrated oncologic safety ( Ann Surg Oncol 2020;27:344-351). Indications for NSM continue to expand to patients outside of the traditional eligibility criteria, including those with prior breast-conserving therapy (BCT) with radiotherapy. Currently, limited data exist evaluating both short- and long-term outcomes in patients proceeding to NSM after prior BCT. METHODS: All patients undergoing bilateral NSM in a single institution from 2002 through 2017 with history of prior BCT were included in the final cohort, without exclusions. A retrospective chart review was performed to identify patient demographics, operative details, and complications. Outcomes assessed included early complications (<30 days from NSM), late complications (>30 days), rates of prosthetic failure, unplanned reoperations, and reconstructive failures, as well as oncologic safety. Student t , χ 2 , and Fisher exact tests were used to analyze outcomes of paired (BCT vs non-BCT) breasts within each patient. RESULTS: A total of 17 patients undergoing 34 NSMs were included. Each had a history of BCT and either ipsilateral breast recurrence (64.7%), risk-reducing NSM (23.5%), or a new contralateral primary cancer (11.8%). The cohort had a mean age of 51.1 years. With regard to acute complications (ischemia, infection, nipple-areolar complex or flap ischemia or necrosis, and wound dehiscence), there was no significant difference noted between breasts with prior BCT versus no prior BCT overall (41.2% vs 35.3%, respectively; P = 0.724). Complications occurring after 30 days postoperatively (capsular contracture, contour abnormality, animation deformity, bottoming out, rotation, and rippling) in prior BCT breasts versus no prior BCT had no significant differences overall (58.8% vs 41.2% respectively; P = 0.303). The mean follow-up was 5.5 years, during which no patients had a reported locoregional or distant recurrence in either breast. CONCLUSIONS: No significant differences in early or late complications were identified between breasts in patients undergoing bilateral NSM with a history of unilateral BCT and XRT. In the 5.5 years of follow-up, there were no recurrences, lending support to NSM for management of recurrent disease in addition to National Comprehensive Cancer Network-recommended total mastectomy. We propose that NSM should not be contraindicated in patients exposed to radiation with BCT.

A Critical Appraisal of Late Complications of Prepectoral versus Subpectoral Breast Reconstruction Following Nipple-Sparing Mastectomy.

BACKGROUND: Nipple-sparing mastectomy (NSM) offers improved aesthetics without compromising oncologic safety. Subpectoral breast reconstruction has long been standard practice, although prepectoral reconstruction has recently resurged in popularity. Due to this recent paradigm shift, studies comparing long-term outcomes by reconstructive plane are lacking. METHODS: A retrospective review was conducted on consecutive NSMs with implant-based reconstruction in either the prepectoral or subpectoral plane from 2014 to 2018. Patient demographics, implant specifications, and operative details were collected to evaluate primary outcomes of prosthetic failure and unplanned reoperations by reconstructive plane. Secondary outcomes included animation deformity, capsular contracture, rippling, plane change, and minor revisions, including fat grafting. Bivariate and multivariate analyses were performed to assess outcomes. RESULTS: Overall, 405 NSMs were performed on 228 women (subpectoral = 202, prepectoral = 203), with a mean follow-up of 2.1 years (standard deviation 1.1). During the study period (2014-2018), a shift from subpectoral to predominantly prepectoral mastectomies occurred in 2017. Prepectoral reconstructions were more often direct-to-implant (DTI) compared with subpectoral (73.9% vs. 33.2%, p < 0.001). Prepectoral reconstruction demonstrated significantly reduced prosthetic failure (odds ratio [OR] 0.30, 95% confidence interval [CI] 0.14-0.65) and unplanned reoperations (OR 0.43, 95% CI 0.24-0.77) compared with subpectoral reconstruction after controlling for implant characteristics and other possible confounders. Prepectoral patients experienced decreased animation deformity overall (19.7% vs. 0.0%, p < 0.001), with plane changes seen in 10.6% of subpectoral reconstructions for animation deformity correction. Prepectoral patients experienced an increase in rippling (15.3% vs. 6.1%, p = 0.003) without a significant increase in fat grafting (subpectoral = 11.6% vs. prepectoral = 12.3%, p = 0.829). CONCLUSIONS: This single-institution experience compares late complications of prepectoral and subpectoral implant-based reconstruction following NSM. Prepectoral reconstruction can be safely performed with improved understanding of mastectomy planes, readily affords DTI reconstruction, and reduces animation deformity at the expense of rippling.

TARGIT-R (Retrospective): 5-Year Follow-Up Evaluation of Intraoperative Radiation Therapy (IORT) for Breast Cancer Performed in North America.

BACKGROUND: Intraoperative radiation therapy (IORT) has been investigated for patients with low-risk, early-stage breast cancer. The The North American experience was evaluated by TARGIT-R (retrospective) to provide outcomes for patients treated in "real-world" clinical practice with breast IORT. This analysis presents a 5-year follow-up assessment. METHODS: TARGIT-R is a multi-institutional retrospective registry of patients who underwent lumpectomy and IORT between the years 2007 and 2013. The primary outcome of the evaluation was ipsilateral breast tumor recurrence (IBTR). RESULTS: The evaluation included 667 patients with a median follow-up period of 5.1 years. Primary IORT (IORT at the time of lumpectomy) was performed for 72%, delayed IORT (after lumpectomy) for 3%, intended boost for 8%, and unintended boost (primary IORT followed by whole-breast radiation) for 17% of the patients. At 5 years, IBTR was 6.6% for all the patients, with 8% for the primary IORT cohort and 1.7% for the unintended-boost cohort. No recurrences were identified in the delayed IORT or intended-boost cohorts. Noncompliance with endocrine therapy (ET) was associated with higher IBTR risk (hazard ratio [HR], 3.67). Patients treated with primary IORT who were complaint with ET had a 5-year IBTR rate of 3.9%. CONCLUSION: The local recurrence rates in this series differ slightly from recent results of randomized IORT trials and are notably higher than in previous published studies using whole-breast radiotherapy for similar patients with early-stage breast cancer. Understanding differences in this retrospective series and the prospective trials will be critical to optimizing patient selection and outcomes going forward.

Delivery of nipple-sparing mastectomy within a single healthcare system: The impact of provider preferences.

Nipple-sparing mastectomy (NSM) offers superior esthetic outcomes without sacrificing oncologic safety for select patients requiring mastectomy. While disparities in oncologic care are well established, no study to date has investigated equitable delivery of the various mastectomy types. The objective of this study is to examine multilevel factors related to the distribution of NSM. Patients undergoing mastectomy between 2014 and 2018 across eight hospitals in a single healthcare system were retrospectively reviewed. Patients were categorized by mastectomy type-NSM or other mastectomy (OM). Patient information such as age, race, comorbidities, and median income by ZIP code was collected. Disease characteristics, such as mastectomy weight, breast cancer stage, and treatment history, were identified. Provider and system-level variables, such as specific provider, hospital of operation, and insurance status, were determined. Bivariate analysis was used to identify variables for inclusion in a backward multivariable model. A cohort of 1202 mastectomy patients was identified, with 388 receiving NSM. The average age was 55.8 years (NSM: 48.8, OM: 59.1, P < .001). 39.8% of white patients (n = 242) and 20.0% of African American patients (n = 88) received NSM (P < .001). Average mastectomy weight was 384.3 (SD 195.7) in the NSM group, compared to 839.4 (SD 521.1) in the OM group (P < .001). 41.4% (n = 359) of patients treated at academic centers, and 6.9% (n = 21) of patients treated at community centers received NSM (P < .001). In the multivariate model, the factor with the largest impact on NSM was specific provider. Odds of NSM decreased by 76%-88% for certain surgeons, while odds increased by 63 times for one surgeon. This study utilizes a large multi-institutional database to highlight disparities in NSM delivery. Expectedly, younger, relatively healthy patients, with smaller breast size were more likely to undergo NSM, in accordance with surgical guidelines. However, when all other factors were controlled, provider preferences played the most significant role in NSM delivery rates. These findings demonstrate the need for practice reexamination to ensure equitable access to NSM.

Critical evaluation of factors contributing to time to mastectomy within a single health care system.

Increased time to mastectomy (TTM) has significant implications for mortality, well-being, and satisfaction. However, certain populations are subject to disparities that increase TTM. This study examines vulnerable populations and the patient-, disease-, provider-, and system-level factors related to treatment delays. Patients undergoing mastectomy for breast cancer from 2014 to 2018 across 8 hospitals in a single health care system were retrospectively reviewed. Demographics, disease characteristics, and provider- and system-level information were collected. Time from biopsy-proven diagnosis to mastectomy was calculated. Univariate analysis identified variables for inclusion in the multivariable model. One thousand, three hundred thirty patients met inclusion. Median TTM was 55.0 days. Factors from all levels-patient, disease, provider, and systemic-were significantly related to disparities. African-American patients had 11.6% longer TTM compared to white patients (69.0 vs 56.0 days, P < .0001). TTM was 15.5% longer for low-income patients when compared to high-income patients (65.0 vs 49.0 days, P = .0014). Preoperative plastic surgery visits led to 19.3% longer TTM (P = .0012); oncologic appointments for neo-adjuvant chemotherapy led to a 231.0% increase (P < .0001). Average time from last neo-adjuvant treatment to mastectomy was 44.4 days (SD 26.5); average TTM from diagnosis for patients not receiving neo-adjuvant chemotherapy was 58.5 days (SD 13.3). Patients with Medicaid waited 14.5% longer compared to patients with commercial insurance (94.0 vs 62.0 days, P = .0005). In our review of care across a large health care system, we identified multiple levels contributing to disparities in TTM. Identification of these disparities offers valuable insight into process improvement and intervention.

Opioid-free anesthesia for patients undergoing mastectomy: A matched comparison.

Opioid-free anesthesia (OFA) is being implemented in breast surgery due to increased awareness of adverse effects and the national opioid crisis. The objective of this study was to examine the effect of OFA on postoperative pain and postoperative nausea and vomiting (PONV) in mastectomy patients. A single-institution matched-cohort study was conducted from 2014 to 2017 on 48 women undergoing mastectomy, with the majority also undergoing immediate prosthetic-based reconstruction. Patients received either conventional anesthesia (CA) or a novel OFA regimen. Primary outcomes included postoperative pain scores, opioid use, and need for antiemetics that were evaluated both in the PACU and on the hospital floors. No significant differences were found in PACU opioid or antiemetic use between OFA and CA. Pain scores in PACU and on POD0 were not significantly different. There was a significant but modest decrease on POD1 in OFA patients (3.9 vs. 5.1, P = .046). Additionally, patients with higher intraoperative opioid regimens experienced significantly increased PONV (P = .023). This study demonstrated the efficacy of OFA in controlling postoperative pain and nausea compared to a traditional opioid-based regimen. Regardless of intraoperative opioids, patients experienced similar postoperative opioid requirements and PONV with decreased pain scores. Thus, OFA is feasible in mastectomy patients and should be further evaluated in select patients.

Neoadjuvant Chemotherapy and Nipple-Sparing Mastectomy: Timing and Postoperative Complications.

BACKGROUND: As the demand for nipple-sparing mastectomy (NSM) increases and surgeons expand the eligibility criteria, a subset of patients may become candidates following neoadjuvant chemotherapy (NACT). However, the impact of NACT on postoperative complications remains unclear as the current literature is discordant. METHODS: A single-institution, retrospective chart review was performed on patients undergoing NSM from 1989 to 2017. Patient demographics, surgical intervention, systemic treatment, and complication rates were collected. Primary outcomes were 30-day postoperative complications, including nipple-areolar necrosis, skin flap necrosis, infection, wound dehiscence, hematoma, and seroma. Secondary outcomes included characterization of the timing between chemotherapy and surgical intervention, and the impact on complication rates. Each breast was considered independently for analysis, and breasts undergoing either NACT or primary surgery (PS) were compared. RESULTS: Of the 832 breasts included, 88 (10.6%) received NACT and 744 (89.4%) underwent PS. Baseline complication rates were not significantly different between the NACT group and the PS group (5.7% vs. 10.6%; p = 0.119). When controlling for age, body mass index (BMI), smoking, and prior radiation, NACT was not a predictor of complications. Time from completion of NACT to PS occurred at a median of 40.5 days (interquartile range 31.3-55.3), and decreased intervals were not associated with increased complication rates. CONCLUSIONS: Postoperative complications following NSM in patients completing NACT are comparable with those receiving PS. Patients undergoing NACT do not have a significantly increased risk of necrosis, unintended reoperations, or nipple loss. NACT should not be considered a contraindication for NSM.

Positive Nipple Margin After Nipple-Sparing Mastectomy: An Alternative and Oncologically Safe Approach to Preserving the Nipple-Areolar Complex.

BACKGROUND: The aim of this study is to describe a less aggressive approach to management of positive nipple margin following nipple-sparing mastectomy (NSM), allowing for preservation of the nipple-areolar complex (NAC). STUDY DESIGN: A single-institution retrospective chart review was performed for patients undergoing NSM from 1989 to 2017. Positive nipple margin was defined as any residual invasive carcinoma or ductal carcinoma in situ (DCIS) within the additional nipple margin. Management included complete NAC removal, subareolar shave biopsy, or observation alone. Primary outcomes included rates of positive nipple margin and local recurrence. RESULTS: A total of 819 breasts underwent NSM, yielding a total of 32 breasts (3.9%) with positive nipple margin. Management included 11 (34.4%) subareolar shave biopsies, 15 (46.9%) complete NAC excisions, and 5 (15.6%) with observation alone, plus 1 (3.1%) lost to follow-up. Final pathology after subareolar shave biopsy did not reveal any residual disease, and no patients developed NAC necrosis or required NAC removal. Final pathology after NAC excision revealed 3 of 15 with additional disease (1 invasive ductal carcinoma, 2 DCIS). Of the five patients who had no subsequent intervention, tumor pathology was DCIS in all cases. One patient received adjuvant radiation therapy. Mean time to intervention was 3.7 ± 1.9 with mean follow-up of 2.9 years. CONCLUSIONS: Management of positive nipple margin after NSM with subareolar shave biopsy is a safe alternative to preserve the NAC.

Timing of radiation therapy in nipple-sparing mastectomy influences outcomes and patient-reported quality of life.

The aim of this study is to assess the complication profile and impact on patient-reported quality of life in those undergoing nipple-sparing mastectomy (NSM) with immediate breast reconstruction and subsequent prosthetic reconstruction in patients with prior breast radiation therapy (pRT) vs those receiving adjuvant post-mastectomy radiation therapy (PMRT). An IRB-approved, retrospective analysis was performed from 2002 to 2014 to identify NSM patients that underwent pRT or PMRT. A 22-item Likert scale questionnaire was administered by a third party to register patient-reported quality of life. Forty patients met criteria for outcomes analysis, and 30 patients answered the questionnaire. Mean age was 45.6 years old and mean follow-up was 3.8 years. Complication rates for the PMRT cohort were 61.9% vs 31.6% in the pRT cohort, P = .067, and those requiring operative intervention were PMRT 38.1% vs pRT 5.3%, P = .021. Nipple-areolar complex survival was 100% in the pRT vs 85.7% in the PMRT, P = .233. Breast-related quality of life scores were superior in the pRT group within multiple domains. Patients are more likely to develop complications requiring an operative intervention and have decreased breast-related quality of life when undergoing NSM with PMRT compared to patients undergoing NSM having received pRT.

New Breast Cancer Radiotherapy Technology Confers Higher Complications and Costs Before Effectiveness Proven: A Medicare Data Analysis.

A new breast cancer treatment, brachytherapy-based accelerated partial breast radiotherapy (RT), was adopted before long-term effectiveness evidence, potentially increasing morbidity and costs compared with whole breast RT. The aim of this study was to estimate complication rates and RT-specific and 1-year costs for a cohort of female Medicare beneficiaries diagnosed with breast cancer (N = 47 969). We analyzed 2005-2007 Medicare claims using multivariable logistic regression for complications and generalized linear models (log link, gamma distribution) for costs. Overall, 11% (n = 5296) underwent brachytherapy-based RT; 9.4% had complications. Odds of any complication were higher (odds ratio [OR]: 1.62; 95% confidence interval [CI]: 1.49-1.76) for brachytherapy versus whole breast RT, similarly to seroma (OR: 2.85; 95% CI: 1.97-4.13), wound complication/infection (OR: 1.72; 95% CI: 1.52-1.95), cellulitis (OR: 1.48; 95% CI: 1.27-1.73), and necrosis (OR: 2.07; 95% CI: 1.55-2.75). Mean RT-specific and 1-year total costs for whole breast RT were $6375, and $19 917, $4886, and $4803 lower than brachytherapy ( P < .0001). Multivariable analyses indicated brachytherapy yielded 76% higher RT costs (risk ratio: 1.76; 95% CI: 1.74-1.78, P < .0001) compared with whole breast RT. Brachytherapy had higher complications and costs before long-term evidence proved its effectiveness. Policies should require treatment registries with reimbursement incentives to capture surveillance data for new technologies.

Oncologic Outcomes After Nipple-Sparing Mastectomy.

BACKGROUND: Nipple-sparing mastectomy (NSM) is increasingly used as an alternative to traditional mastectomy because it provides improved aesthetic results. The data on its oncologic safety are limited. The authors' institution has performed NSM during the past 10 years for both oncologic and prophylactic indications. This study aimed to examine oncologic outcomes after NSM for breast cancer. METHODS: The study retrospectively examined all NSM cases managed between July 2007 and July 2013. Descriptive statistics were used to characterize the study cohort. Kaplan-Meier survival analysis was performed to estimate recurrence-free survival, specifically the 36-month recurrence-free survival proportion. RESULTS: A total of 721 nipple-sparing mastectomies were performed for 413 patients: 45 (10.9 %) to reduce risk and 368 (89.1 %) for breast cancer. In the breast cancer group, 29.8 % of the patients had ductal carcinoma in situ, and 70.2 % had invasive cancer. The mean follow-up time was 32 months (range 0.01-90.2 months). In the breast cancer group, the Kaplan-Meier 3-year recurrence-free survival rate was 93.6 % (95 % confidence interval, 89.9-96.0 %). Eight patients (2.2 %) had locoregional recurrences, including one in the nipple. Nine patients (2.4 %) had distant recurrence, and six patients (1.6 %) had a diagnosis of both local and distant recurrences. CONCLUSIONS: The findings showed a locoregional recurrence rate of 2.2 %, with an overall recurrence rate of 6.3 % for patients undergoing NSM for the treatment of breast cancer. The majority of these recurrences were distant, with one recurrence at the nipple. These results are promising, but a longer follow-up evaluation of this cohort is necessary.

TARGIT-R (Retrospective): North American Experience with Intraoperative Radiation Using Low-Kilovoltage X-Rays for Breast Cancer.

BACKGROUND: Single-dose intraoperative radiotherapy (IORT) is an emerging treatment for women with early stage breast cancer. The objective of this study was to define the frequency of IORT use, patient selection, and outcomes of patients treated in North America. METHODS: A multi-institutional retrospective registry was created, and 19 institutions using low-kilovoltage IORT for the treatment of breast cancer entered data on patients treated at their institution before July 31, 2013. Patient selection, IORT treatment details, complications, and recurrences were analyzed. RESULTS: From 2007 to July 31, 2013, a total of 935 women were identified and treated with lumpectomy and IORT. A total of 822 patients had at least 6 months' follow-up documented and were included in the analysis. The number of IORT cases performed increased significantly over time (p < 0.001). The median patient age was 66.8 years. Most patients had disease that was <2 cm in size (90 %) and was estrogen positive (91 %); most patients had invasive ductal cancer (68 %). Of those who had a sentinel lymph node procedure performed, 89 % had negative sentinel lymph nodes. The types of IORT performed were primary IORT in 79 %, secondary IORT in 7 %, or planned boost in 14 %. Complications were low. At a median follow-up of 23.3 months, crude in-breast recurrence was 2.3 % for all patients treated. CONCLUSIONS: IORT use for the treatment of breast cancer is significantly increasing in North America, and physicians are selecting low-risk patients for this treatment option. Low complication and local recurrence rates support IORT as a treatment option for selected women with early stage breast cancer.

Diffusion of accelerated partial breast radiotherapy in the United States: physician-level and patient-level analyses.

PURPOSE: To evaluate diffusion of brachytherapy-based accelerated partial breast radiotherapy (RT) in the United States, a new breast cancer treatment requiring 5 days twice daily, rather than daily treatment for 6-7 weeks. It has limited long-term effectiveness data compared with standard whole breast RT. DATA AND METHODS: We used 2005-2008 Medicare claims for female Medicare beneficiaries receiving RT after breast-conserving surgery merged with physician and area-based data (n=74,254 patient-subjects; n=1901 physicians), applying logistic regression to estimate: (1) proportion of patients for whom the radiation oncologist used brachytherapy-based accelerated RT, and (2) probability a patient received brachytherapy-based accelerated RT, clustering on physician. RESULTS: Use of accelerated partial breast RT increased over time (8% in 2005 to 17% in 2008). Physician-level analysis indicates rural physicians were less likely to perform accelerated RT [odds ratio (OR): 0.35-0.49; P<0.002)]; as were those licensed 20+years [OR: 0.54; 95% confidence interval (CI), 0.39-0.74]. Overall, 11.7% of patients received accelerated RT. Treatment post 2005 was associated with increasing odds of receiving accelerated RT (P<0.0001). Older age was associated with lower odds of receiving accelerated RT (reference, 66-69 years old, OR: 0.90, P<0.006), as was black (OR: 0.73;95% CI, 0.63-0.85) or other race (OR: 0.80; 95% CI, 0.65-1.00), living in rural areas (OR: 0.8; P<0.0001), or seeing an older physician [20+years postgraduation (OR: 0.7; 95% CI, 0.5-0.9)]. Patients living in counties with more hospitals with advanced RT facilities were more likely to undergo accelerated RT (OR: 1.4; 95% CI, 1.1-1.8). DISCUSSION: This new technology appears to be in the early phase of diffusion across the United States and is more rapidly being taken up in younger, white patients living in urban and suburban areas with availability of advanced RT facilities. Rural and older patient populations are not tending to undergo the treatment.

Literature review and guide for optimal position in implant-based breast reconstruction.

Background and Objective: Identification of ideal candidates for prepectoral versus retropectoral implant-based breast reconstruction relies on careful preoperative risk assessment and intraoperative flap evaluation. Few guidelines exist to guide the surgeon's decision-making process when evaluating the preferred plane for implant placement. Methods: A literature review was performed to develop clinical decision-making algorithms for direct-to-implant (DTI) reconstruction with acellular dermal matrix (ADM) for patients undergoing prophylactic or therapeutic nipple-sparing mastectomy (NSM) based on patient characteristics, surgical techniques, and outcomes. Key Content and Findings: Prepectoral reconstruction is most suitable for patients with small breasts or macromastia with desire for breast reduction, low-grade ptosis, smaller implant sizes, those undergoing PMRT, and for those who aim to mitigate animation deformity and capsular contracture. Retropectoral reconstruction may be recommended for patients with larger breasts with no desire for size change requiring additional prosthesis support, and in patients who aim to reduce likelihood of rippling and need for subsequent fat grafting procedures to address contour abnormalities. Conclusions: Careful preoperative and intraoperative assessment of reconstruction options for patients undergoing implant-based breast reconstruction is necessary to mitigate complications and produce superior aesthetic outcomes. Decision algorithms may be used to determine ideal surgical techniques based on patient factors, like radiation history and planning, breast size and ptosis, and patient preferences.

Direct-to-Implant versus Immediate Free Flap Reconstruction after Nipple-Sparing Mastectomy: A Propensity Score-Matched Analysis.

BACKGROUND: Both direct-to-implant (DTI) and immediate free flap (FF) breast reconstruction following nipple-sparing mastectomy (NSM) have been described in the literature. However, there is a paucity of comparative studies between these two techniques. Furthermore, existing studies do not control for factors influencing ischemic complications. METHODS: A retrospective review of all NSMs performed at a single institution between January of 2014 and January of 2020 was performed. Immediate FF reconstructions were propensity score matched using probit regression to identify a comparable DTI cohort based on mastectomy weight, smoking, age, and history of radiotherapy. Primary outcomes of interest were 30-day ischemic complications. RESULTS: One hundred eight NSMs performed in 79 patients were included. Average age was 45.7 ± 10.5 years and mean body mass index was 27.1 ± 4.8 kg/m 2 . There were 54 breasts in both the DTI group and the immediate FF group. Median mastectomy weight in the DTI group was 508 g (interquartile range, 264 g) as compared with 473 g (interquartile range, 303 g) in the FF group ( P = 0.792). There was no significant difference in the rate of partial nipple-areola complex necrosis in the DTI and FF groups (5.6% versus 3.7%, respectively; P = 0.500) or mastectomy flap necrosis (5.6% versus 11.1%; P = 0.297). Both the DTI and FF groups had a total nipple-areola complex necrosis rate of 1.9% ( P = 0.752). CONCLUSION: Both DTI and immediate FF reconstruction can be safely offered to patients undergoing NSM while providing the benefit of a single reconstructive procedure. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Review of Autologous Fat Grafting in Postmastectomy Reconstruction Patients: Nonroutine Diagnostics and Oncologic Safety.

Autologous fat grafting (FG) is increasingly used as an adjunctive reconstruction technique to augment volume, achieve symmetry, and improve contour deformities. This study aims to characterize the oncologic and surgical safety of FG in women undergoing autologous breast reconstruction (ABR) or implant-based reconstruction (IBR). Methods: A retrospective chart review was performed for all patients undergoing FG at a multi-site single health system between 2015 to 2018. A total of 228 eligible breasts from 155 patients were identified using Current Procedural Terminology codes. Patients were divided by reconstructive technique. Bivariate analyses compared baseline characteristics and post-FG outcomes. Results: Mean age for patients undergoing ABR (129 breasts) was 52.8 years compared to 48.6 years for those undergoing IBR (99 breasts; P = 0.002). A heavier volume of fat was grafted per ABR breast (143.8mL) than per IBR breast (102.2mL; P = 0.002). Forty-seven (20.6%) breasts required FG revision, more frequently in ABR breasts (31.0%) than IBR breasts (7.1%; P < 0.001). Following FG, 17.5% of patients experienced a palpable mass, and 18.9% of breasts underwent nonroutine diagnostics or procedures, with no difference between ABR and IBR groups. Most biopsies noted benign findings such as fat necrosis (2.2%) or a benign mass (0.9%), with recurrence only noted in two patients (0.9%). Mean follow-up was 20.4 months. Conclusion: FG is a safe, surgically simple procedure more commonly performed in ABR breasts. FG use in ABR and IBR breasts is oncologically safe, with no impairment in breast surveillance and low rates of locoregional recurrence, but possibly increased incidence of nonroutine imaging and biopsies.

Association of Residual Ductal Carcinoma In Situ With Breast Cancer Recurrence in the Neoadjuvant I-SPY2 Trial.

Importance: Pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC) in breast cancer strongly correlates with overall survival and has become the standard end point in neoadjuvant trials. However, there is controversy regarding whether the definition of pCR should exclude or permit the presence of residual ductal carcinoma in situ (DCIS). Objective: To examine the association of residual DCIS in surgical specimens after neoadjuvant chemotherapy for breast cancer with survival end points to inform standards for the assessment of pathologic complete response. Design, Setting, and Participants: The study team analyzed the association of residual DCIS after NAC with 3-year event-free survival (EFS), distant recurrence-free survival (DRFS), and local-regional recurrence (LRR) in the I-SPY2 trial, an adaptive neoadjuvant platform trial for patients with breast cancer at high risk of recurrence. This is a retrospective analysis of clinical specimens and data from the ongoing I-SPY2 adaptive platform trial of novel therapeutics on a background of standard of care for early breast cancer. I-SPY2 participants are adult women diagnosed with stage II/III breast cancer at high risk of recurrence. Interventions: Participants were randomized to receive taxane and anthracycline-based neoadjuvant therapy with or without 1 of 10 investigational agents, followed by definitive surgery. Main Outcomes and Measures: The presence of DCIS and EFS, DRFS, and LRR. Results: The study team identified 933 I-SPY2 participants (aged 24 to 77 years) with complete pathology and follow-up data. Median follow-up time was 3.9 years; 337 participants (36%) had no residual invasive disease (residual cancer burden 0, or pCR). Of the 337 participants with pCR, 70 (21%) had residual DCIS, which varied significantly by tumor-receptor subtype; residual DCIS was present in 8.5% of triple negative tumors, 15.6% of hormone-receptor positive tumors, and 36.6% of ERBB2-positive tumors. Among those participants with pCR, there was no significant difference in EFS, DRFS, or LRR based on presence or absence of residual DCIS. Conclusions and Relevance: The analysis supports the definition of pCR as the absence of invasive disease after NAC regardless of the presence or absence of DCIS. Trial Registration: ClinicalTrials.gov Identifier NCT01042379.