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Background: Mastectomy skin flap necrosis (SFN) is common following nipple-sparing mastectomy (NSM), but studies on its quality-of-life (QOL) impact are limited. We examined patient-reported QOL and satisfaction after NSM with/without SFN utilizing the BREAST-Q patient-reported outcome measure (PROM) survey., Patients and Methods: Patients undergoing NSM between April 2018 and July 2021 at our institution were examined; the BREAST-Q PROM was administered preoperatively, and at 6 months and 1 year postoperatively. SFN extent/severity was documented at 2-3 weeks postoperatively; QOL and satisfaction domains were compared between patients with/without SFN., Results: A total of 573 NSMs in 333 patients were included, and 135 breasts in 82 patients developed SFN (24% superficial, 56% partial thickness, 16% full thickness). Patients with SFN reported significantly lower scores in the satisfaction with breasts (p = 0.032) and psychosocial QOL domains (p = 0.009) at 6 months versus those without SFN, with scores returning to baseline at 1 year in both domains. In the "physical well-being-of-the-chest" domain, there was an overall decline in scores among all patients; however, there were no significant differences at any time point between patients with or without SFN. Sexual well-being scores declined for patients with SFN compared with those without at 6 months and also at 1 year, but this did not reach significance (p = 0.13, p = 0.2, respectively)., Conclusions: Patients undergoing NSM who developed SFN reported significantly lower satisfaction and psychosocial well-being scores at 6 months, which returned to baseline by 1 year. Physical well-being of the chest significantly declines after NSM regardless of SFN. Future studies with larger sample sizes and longer follow-up are needed to determine SFN's impact on long-term QOL., (© 2024. Society of Surgical Oncology.)

Background: Performing large randomized trials in anesthesiology is often challenging and costly. The clinically integrated randomized trial is characterized by simplified logistics embedded into routine clinical practice, enabling ease and efficiency of recruitment, offering an opportunity for clinicians to conduct large, high-quality randomized trials under low cost. Our aims were to (1) demonstrate the feasibility of the clinically integrated trial design in a high-volume anesthesiology practice and (2) assess whether trial quality improvement interventions led to more balanced accrual among study arms and improved trial compliance over time., Methods: This is an interim analysis of recruitment to a cluster-randomized trial investigating three nerve block approaches for mastectomy with immediate implant-based reconstruction: paravertebral block (arm 1), paravertebral plus interpectoral plane blocks (arm 2), and serratus anterior plane plus interpectoral plane blocks (arm 3). We monitored accrual and consent rates, clinician compliance with the randomized treatment, and availability of outcome data. Assessment after the initial year of implementation showed a slight imbalance in study arms suggesting areas for improvement in trial compliance. Specific improvement interventions included increasing the frequency of communication with the consenting staff and providing direct feedback to clinician investigators about their individual recruitment patterns. We assessed overall accrual rates and tested for differences in accrual, consent, and compliance rates pre- and post-improvement interventions., Results: Overall recruitment was extremely high, accruing close to 90% of the eligible population. In the pre-intervention period, there was evidence of bias in the proportion of patients being accrued and receiving the monthly block, with higher rates in arm 3 (90%) compared to arms 1 (81%) and 2 (79%, p = 0.021). In contrast, in the post-intervention period, there was no statistically significant difference between groups (p = 0.8). Eligible for randomization rate increased from 89% in the pre-intervention period to 95% in the post-intervention period (difference 5.7%; 95% confidence interval = 2.2%-9.4%, p = 0.002). Consent rate increased from 95% to 98% (difference of 3.7%; 95% confidence interval = 1.1%-6.3%; p = 0.004). Compliance with the randomized nerve block approach was maintained at close to 100% and availability of primary outcome data was 100%., Conclusion: The clinically integrated randomized trial design enables rapid trial accrual with a high participant compliance rate in a high-volume anesthesiology practice. Continuous monitoring of accrual, consent, and compliance rates is necessary to maintain and improve trial conduct and reduce potential biases. This trial methodology serves as a template for the implementation of other large, low-cost randomized trials in anesthesiology., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Recent data suggest disparities in receipt of regional anesthesia prior to breast reconstruction. We aimed to understand factors associated with block receipt for mastectomy with immediate tissue expander (TE) reconstruction in a high-volume ambulatory surgery practice with standardized regional anesthesia pathways., Patients and Methods: Patients who underwent mastectomy with immediate TE reconstruction from 2017 to 2022 were included. All patients were considered eligible for and were offered preoperative nerve blocks as part of routine anesthesia care. Interpreters were used for non-English speaking patients. Patients who declined a block were compared with those who opted for the procedure., Results: Of 4213 patients who underwent mastectomy with immediate TE reconstruction, 91% accepted and 9% declined a nerve block. On univariate analyses, patients with the lowest rate of block refusal were white, non-Hispanic, English speakers, patients with commercial insurance, and patients undergoing bilateral reconstruction. The rate of block refusal went down from 12 in 2017 to 6% in 2022. Multivariable logistic regression demonstrated that older age (p = 0.011), Hispanic ethnicity (versus non-Hispanic; p = 0.049), Medicaid status (versus commercial insurance; p < 0.001), unilateral surgery (versus bilateral; p = 0.045), and reconstruction in earlier study years (versus 2022; 2017, p < 0.001; 2018, p < 0.001; 2019, p = 0.001; 2020, p = 0.006) were associated with block refusal., Conclusions: An established preoperative regional anesthesia program with blocks offered to all patients undergoing mastectomy with TE reconstruction can result in decreased racial disparities. However, continued differences in age, ethnicity, and insurance status justify future efforts to enhance preoperative educational efforts that address patient hesitancies in these subpopulations., (© 2024. Society of Surgical Oncology.)

Purpose: Several data sets have demonstrated a correlation between lymphovascular invasion (LVI) and locoregional recurrence (LRR). Whether the observation of "extensive LVI" is a further and incremental determinant of LRR risk is unknown. We describe clinical outcomes in women with invasive breast cancer stratified by (1) absence of LVI (neg), (2) LVI focal or suspicious (FS-LVI), (3) usual (nonextensive) LVI (LVI), and (4) extensive LVI (E-LVI)., Methods and Materials: Between December 2009 and August 2021, 8837 patients with early-stage breast cancer were treated with curative intent and were evaluable. Clinical-pathologic details were abstracted by retrospective review. The description of LVI was abstracted from pathology reports. Recurrence and survival outcomes were compared based on the extent of LVI. A matched propensity score analysis compared outcomes between patients with LVI versus E-LVI., Results: Of the 8837 patients studied, 5584 were negative, 461 had FS-LVI, 2315 had LVI, and 477 had E-LVI. Patients with E-LVI had an adverse risk profile compared with the other groups. The 5- and 10-year LRR cumulative incidence estimates in patients with E-LVI were 9.6% (95% CI, 7.1-13) and 13% (95% CI, 10-17), respectively, which were significantly higher than those observed in the usual LVI group (6.8% [5.7-7.9] and 10% [8.8-12], respectively). A statistically significant difference in LRR was demonstrated in univariable (HR, 1.4; 95% CI, 1.03-1.89; P = .029) and multivariable regression analysis (HR, 1.62; 95% CI, 1.15-2.27; P = .005) compared with nonextensive LVI. In an alternative approach, we performed a 2:1 propensity score matching analysis comparing patients with LVI to those with E-LVI. The hazard ratio for LRR (HR, 1.47; CI 1.02-2.14; P = .041) was suggestive of a higher risk associated with E-LVI., Conclusions: Our work suggests that patients with E-LVI are at a higher risk for LRR than those with usual LVI. For patients who are borderline candidates for regional nodal irradiation or post-mastectomy radiation therapy, the finding of E-LVI might be decisive in favor of intensified treatment., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background and Objectives: We investigated whether age, body mass index (BMI), and tissue expander placement were related to postoperative opioid requirement for patients undergoing therapeutic versus prophylactic breast surgery., Methods: Postoperative opioid consumption was evaluated for patients who underwent bilateral mastectomy with immediate implant-based reconstruction at a freestanding ambulatory cancer surgery center between 2016 and 2021. Ordinal regression tested whether surgical indication was associated with increased postoperative opioid requirements after adjusting for age, BMI, and tissue expander placement., Results: Of 2447 patients, 6% underwent prophylactic surgeries. Therapeutic mastectomy patients had lower postoperative opioid requirement (OR = 0.67; 95% CI: 0.50-0.91; p = 0.030), but this was not significant after adjusting for covariates (OR = 0.75; 95% CI: 0.53-1.07; p = 0.2). Opioid use increased with higher BMI (OR = 1.06; 95% CI: 1.05-1.08; p < 0.001) and decreased with age (OR = 0.97; 95% CI: 0.96-0.98; p < 0.001) with therapeutic mastectomy patients being older (median 46 vs. 39). The subpectoral tissue expander group had nearly double the postoperative opioid requirement compared to prepectoral placement (OR = 1.86; 95% CI: 1.55-2.23; p < 0.001)., Conclusions: Increased postoperative opioid requirement in women undergoing prophylactic procedures is best explained by age. Mastectomy patients should be counseled similarly about postoperative pain irrespective of indication. A larger prophylactic mastectomy sample is required to provide more precise estimates., (© 2023 Wiley Periodicals LLC.)

Background: Nipple-sparing mastectomy is associated with a higher risk of mastectomy skin-flap necrosis than conventional skin-sparing mastectomy. There are limited prospective data examining modifiable intraoperative factors that contribute to skin-flap necrosis after nipple-sparing mastectomy., Methods: Data on consecutive patients undergoing nipple-sparing mastectomy between April 2018 and December 2020 were recorded prospectively. Relevant intraoperative variables were documented by both breast and plastic surgeons at the time of surgery. The presence and extent of nipple and/or skin-flap necrosis was documented at the first postoperative visit. Necrosis treatment and outcome was documented at 8-10 weeks after surgery. The association of clinical and intraoperative variables with nipple and skin-flap necrosis was analysed, and significant variables were included in a multivariable logistic regression analysis with backward selection., Results: Some 299 patients underwent 515 nipple-sparing mastectomies (54.8 per cent (282 of 515) prophylactic, 45.2 per cent therapeutic). Overall, 23.3 per cent of breasts (120 of 515) developed nipple or skin-flap necrosis; 45.8 per cent of these (55 of 120) had nipple necrosis only. Among 120 breasts with necrosis, 22.5 per cent had superficial, 60.8 per cent had partial, and 16.7 per cent had full-thickness necrosis. On multivariable logistic regression analysis, significant modifiable intraoperative predictors of necrosis included sacrificing the second intercostal perforator (P = 0.006), greater tissue expander fill volume (P < 0.001), and non-lateral inframammary fold incision placement (P = 0.003)., Conclusion: Modifiable intraoperative factors that may decrease the likelihood of necrosis after nipple-sparing mastectomy include incision placement in the lateral inframammary fold, preserving the second intercostal perforating vessel, and minimizing tissue expander fill volume., (© The Author(s) 2023. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: Receipt of chemotherapy is associated with decreased satisfaction after breast surgery, but whether timing as adjuvant versus neoadjuvant (NAC) affects patient-reported outcomes (PROs) is unclear. We examined associations between chemotherapy timing and PROs after breast-conserving surgery (BCS) and mastectomy with immediate reconstruction (M-IR)., Methods: In this retrospective cohort study of patients with stage I-III breast cancer undergoing chemotherapy between January 2017 and December 2019, we compared satisfaction with breasts (SABTR) and chest physical well-being (PWB-CHEST) between chemotherapy groups in BCS and M-IR cohorts. Median SABTR and PWB-CHEST scores (scale 0-100) were compared between chemotherapy groups at baseline and for 3 years postoperatively. Factors associated with SABTR and PWB-CHEST at 1 and 2 years were assessed with multivariable linear regression., Results: Overall, 640 patients had BCS and 602 had M-IR; 210 (33%) BCS patients and 294 (49%) M-IR patients had NAC. Following BCS, SABTR was higher than baseline at all postoperative timepoints, whereas 3-year SABTR remained similar to baseline following M-IR, independent of chemotherapy timing. In both surgical cohorts, PWB-CHEST was lowest after NAC at 6 months compared with baseline but was similar to adjuvant counterparts by 3 years. NAC was not a statistically significant predictor of SABTR or PWB-CHEST in either surgical cohort on multivariable analysis., Conclusions: For patients with breast cancer who require chemotherapy, neoadjuvant versus adjuvant timing does not impact long-term PROs in this study. These findings may inform shared decision making regarding the sequence of treatment in patients with operable disease., (© 2023. Society of Surgical Oncology.)

Background: The paravertebral block (PVB) is an adjunctive perioperative pain control method for patients undergoing breast reconstruction that may improve perioperative pain control and reduce narcotic use. This study determined the efficacy of preoperative PVBs for perioperative pain management in patients undergoing tissue expander breast reconstruction., Methods: A retrospective review was performed of patients who underwent tissue expander breast reconstruction from December of 2017 to September of 2019. Two patients with PVBs were matched using propensity scoring to one no-block patient. Perioperative analgesic use, pain severity scores on days 2 to 10 after discharge, and BREAST-Q Physical Well-Being scores before surgery and at 2 weeks, 6 weeks, and 3 months after surgery were compared between the two groups., Results: The propensity-matched cohort consisted of 471 patients (314 PVB and 157 no block). The PVB group used significantly fewer morphine milligram equivalents than the no-block group (53.7 versus 69.8; P < 0.001). Average daily postoperative pain severity scores were comparable, with a maximum difference of 0.3 points on a 0-point to 4-point scale. BREAST-Q Physical Well-Being scores were significantly higher for the PVB group than the no-block group at 6 weeks after surgery (60.6 versus 51.0; P = 0.015) but did not differ significantly at 2 weeks or 3 months after surgery., Conclusions: PVBs may help reduce perioperative opioid requirements but did not reduce pain scores after discharge when used as part of an expander-based reconstruction perioperative pain management protocol. Continued research should examine additional or alternative regional block procedures as well as financial cost and potential long-term impact of PVBs., Clinical Question/level of Evidence: Therapeutic, III., Competing Interests: Disclosure:Dr. Mehrara is the recipient of investigator-initiated research awards from Regeneron Corp. and Pfizer and royalty payments from PureTech, and is a consultant for Mediflix Corp. The remaining authors have no conflicts of interest or financial interests to declare., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Background: Patients with clinical T4M0 breast cancer are recommended to undergo neoadjuvant chemotherapy, modified radical mastectomy, and postmastectomy radiotherapy. This study determined whether BREAST-Q scores differ by decision to pursue reconstruction or timing of reconstruction., Methods: This retrospective, single-institutional study analyzed cT4 breast cancer patients from 2014 to 2021 without evidence of distant metastatic disease undergoing mastectomy with or without reconstruction. As routine care, BREAST-Q was administered preoperatively, then 6 months, 1 year, and 2 years postoperatively. Satisfaction and quality-of-life domains were compared between mastectomy with no reconstruction (NR), immediate reconstruction (IR), and delayed reconstruction (DR) groups., Results: Of the 144 patients eligible for this study, 71 (49%) had NR, 36 (25%) had DR, and 37 (26%) had IR. The patients undergoing reconstruction were younger and more likely to elect contralateral prophylactic mastectomy. Timing of reconstruction was not associated with significant differences in satisfaction with breasts (SATBR) at any time point. For the patients who had DR, breast satisfaction increased over time after reconstructive surgery. Physical well-being of the chest (PWB-CHEST) did not significantly differ among IR, DR, and NR at any time point. The patients who underwent DR experienced improvement in PWB-CHEST scores from preoperative scores. The patients with IR and NR experienced PWB-CHEST decline over time. Psychosocial well-being (PSWB) did not differ significantly across time or by subgroup., Conclusions: The patients with T4 breast cancer who elected reconstruction did not differ in patient-reported outcomes based on timing of reconstruction. In the DR cohort, SATBR significantly improved after reconstructive surgery. These data can help inform breast reconstructive decision-making for patients facing the choice among DR, IR, and NR., (© 2022. Society of Surgical Oncology.)

Introduction: Patient-reported outcome measures (PROM) are used to assess value-based care. Little is known as to whether PROM response in breast cancer reflects the diverse patient population. The BREAST-Q, a validated measure of satisfaction and quality of life, and Recovery Tracker, a postoperative assessment tool, are PROM routinely delivered to all patients undergoing breast surgery at our institution. Here we determine whether response to PROM differs by age, race, language, or disease stage., Methods: All patients who had a breast operation between January 2020 and July 2021 were requested to complete the BREAST-Q and Recovery Tracker. Non-responders did not complete the PROM at any timepoint; responders completed 1 or more. Primary outcomes included rates of non-response versus response overall., Results: Of 6374 patients identified, 5653 (88.7%) responded to either PROM [4366/4751 (91.9%) BREAST-Q; 2746/3384 (81.1%) Recovery Tracker]. On univariate analysis, non-responders were older (60 years versus 55 years, p < 0.001) and more often non-English speaking (p < 0.001), Hispanic ethnicity (p = 0.031), and Black race (p < 0.001), versus responders. On multivariate analysis, non-responders were significantly more often Black race and non-English speaking (p < 0.001). Non-English speakers were significantly less responsive among all ethnicities and races except Black race. Although breast cancer stage did not reach significance for response, patients with malignant disease and those receiving neoadjuvant chemotherapy responded more often., Conclusions: Our findings demonstrate high patient engagement using 2 different PROM following breast surgery, but suggest that PROM results may not reflect the experience of the entire breast cancer population. Care process changes based solely on PROM should consider these findings to ensure that the views of the entire spectrum of patients with breast cancer are represented., (© 2022. Society of Surgical Oncology.)

Background: Although it is intuitive that nipple-sparing mastectomy in selected patients would result in excellent cosmetic outcomes and high patient satisfaction, studies of clinical outcomes and health-related quality of life are limited and show mixed results. This study aimed to use a propensity score-matching analysis to compare satisfaction and health-related quality-of-life outcomes in patients who underwent implant-based reconstruction following bilateral nipple-sparing mastectomy or skin-sparing mastectomy., Methods: A propensity score-matching analysis (1:1 matching, no replacement) was performed comparing patients undergoing nipple-sparing or skin-sparing mastectomy with immediate bilateral implant-based breast reconstruction. Patients with a history of any radiation therapy were excluded. Matched covariates included age, body mass index, race, smoking history, neoadjuvant chemotherapy, bra size, and history of psychiatric diagnosis. Outcomes of interest included BREAST-Q scores and complications., Results: The authors examined 1371 patients for matching and included 460 patients (nipple-sparing mastectomy, n = 230; skin-sparing mastectomy, n = 230) in the final analyses. The authors found no significant differences in baseline, cancer, and surgical characteristics between matched nipple-sparing and skin-sparing mastectomy patients, who also had similar profiles for surgical complications. Interestingly, the authors found that postoperative Satisfaction with Breasts scores and all other health-related quality-of-life domains were stable over a 3-year period and did not differ significantly between the two groups., Conclusions: Compared with skin-sparing mastectomy, bilateral nipple-sparing mastectomy did not improve patient-reported or clinical outcomes when combined with immediate implant-based reconstruction. The impact that nipple-sparing mastectomy may have on breast aesthetics and the ability of the BREAST-Q to gauge an aesthetic result following nipple-sparing mastectomy warrant further investigation., Clinical Question/level of Evidence: Therapeutic, III., (Copyright © 2022 by the American Society of Plastic Surgeons.)

Introduction: Acute postoperative pain affects time to opioid cessation and quality of life, and is associated with chronic pain. Effective screening tools are needed to identify patients at increased risk of experiencing more severe acute postoperative pain, and who may benefit from multimodal analgesia and early pain management referral. In this study, we develop a nomogram to preoperatively identify patients at high risk of moderate-severe pain following mastectomy., Methods: Demographic, psychosocial, and clinical variables were retrospectively assessed in 1195 consecutive patients who underwent mastectomy from January 2019 to December 2020 and had pain scores available from a post-discharge questionnaire. We examined pain severity on postoperative days 1-5, with moderate-severe pain as the outcome of interest. Multivariable logistic regression was performed to identify variables associated with moderate-severe pain in a training cohort of 956 patients. The final model was determined using the Akaike information criterion. A nomogram was constructed using this model, which also included a priori selected clinically relevant variables. Internal validation was performed in the remaining cohort of 239 patients., Results: In the training cohort, 297 patients reported no-mild pain and 659 reported moderate-severe pain. High body mass index (p = 0.042), preoperative Distress Thermometer score ≥4 (p = 0.012), and bilateral surgery (p = 0.003) predicted moderate-severe pain. The resulting nomogram accurately predicted moderate-severe pain in the validation cohort (AUC =  0.735)., Conclusions: This nomogram incorporates eight preoperative variables to provide a risk estimate of acute moderate-severe pain following mastectomy. Preoperative risk stratification can identify patients who may benefit from individually tailored perioperative pain management strategies and early postoperative interventions to treat pain and assist with opioid tapering., (© 2022. Society of Surgical Oncology.)

Background: Post-mastectomy radiation therapy (PMRT) in women with pathologic stage T1-2N1M0 breast cancer is controversial., Methods: Data from five North American institutions including women undergoing mastectomy without neoadjuvant therapy with pT1-2N1M0 breast cancer treated from 2006 to 2015 were pooled for analysis. Competing-risks regression was performed to identify factors associated with locoregional recurrence (LRR), distant metastasis (DM), overall recurrence (OR), and breast cancer mortality (BCM)., Results: A total of 3532 patients were included for analysis with a median follow-up time among survivors of 6.8 years (interquartile range [IQR], 4.5-9.5 years). The 2154 (61%) patients who received PMRT had significantly more adverse risk factors than those patients not receiving PMRT: younger age, larger tumors, more positive lymph nodes, lymphovascular invasion, extracapsular extension, and positive margins (p < .05 for all). On competing risk regression analysis, receipt of PMRT was significantly associated with a decreased risk of LRR (hazard ratio [HR], 0.21; 95% confidence interval [CI], 0.14-0.31; p < .001) and OR (HR, 0.76; 95% CI, 0.62-0.94; p = .011). Model performance metrics for each end point showed good discrimination and calibration. An online prediction model to estimate predicted risks for each outcome based on individual patient and tumor characteristics was created from the model., Conclusions: In a large multi-institutional cohort of patients, PMRT for T1-2N1 breast cancer was associated with a significant reduction in locoregional and overall recurrence after accounting for known prognostic factors. An online calculator was developed to aid in personalized decision-making regarding PMRT in this population., (© 2022 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.)

Although pectoralis (PECS) blocks are commonly used for breast surgery, recommendations regarding the efficacy of these blocks have thus far not been developed by any professional anesthesia society. Given the potential impact of PECS blocks on analgesia after outpatient breast surgery, The Society for Ambulatory Anesthesia (SAMBA) convened a task force to develop a practice advisory on the use of this analgesic technique. In this practice advisory, we compare the efficacy of PECS blocks with systemic analgesia, local infiltration anesthesia, and paravertebral blockade. Our objectives were to advise on two clinical questions. (1) Does PECS-1 and/or -2 blockade provide more effective analgesia for breast-conserving surgery than either systemic analgesics or surgeon-provided local infiltration anesthesia? (2) Does PECS-1 and/or -2 blockade provide equivalent analgesia for mastectomy compared with a paravertebral block (PVB)? Among patients undergoing breast-conserving surgery, PECS blocks moderately reduce postoperative opioid use, prolong time to analgesic rescue, and decrease postoperative pain scores when compared with systemic analgesics. SAMBA recommends the use of a PECS-1 or -2 blockade in the absence of systemic analgesia (Strength of Recommendation A). No evidence currently exists that strongly favors the use of PECS blocks over surgeon-performed local infiltration in this surgical population. SAMBA cannot recommend PECS blocks over surgical infiltration (Strength of Recommendation C). For patients undergoing a mastectomy, a PECS block may provide an opioid-sparing effect similar to that achieved with PVB; SAMBA recommends the use of a PECS block if a patient is unable to receive a PVB (Strength of Recommendation A)., (© 2022. Society of Surgical Oncology.)

Background: Multimodal analgesia (MMA) during breast surgery reduces postoperative pain and opioid requirements, but the relative contribution of local anesthetic dosing as a component of MMA is not well defined among patients undergoing lumpectomy and sentinel lymph node biopsy (SLNB)., Patients and Methods: We identified consecutive patients who underwent lumpectomy and SLNB with MMA from 1/2019 to 4/2020. Univariable and multivariable linear and logistic regression were used to examine associations between local anesthetics, opioid requirements in the post-anesthesia care unit (PACU), and pain scores in the PACU and on postoperative day (POD) 1., Results: In total, 1603 patients [median tumor size, 14 mm (interquartile range 8-20 mm)] were included. The median PACU opioid requirement was 0 morphine milligram equivalents (interquartile range 0-5). PACU maximum pain was none or mild in 58% of patients and moderate to severe in 42%; among 420 survey respondents, 56% reported no or mild pain and 44% reported moderate to severe pain on POD 1. On multivariable analysis that adjusted for routine components of MMA, increasing doses of 0.5% bupivacaine were associated with reduced PACU opioid requirements (β -0.04, 95% confidence interval -0.07 to -0.01, p = 0.011) and lower odds of moderate to severe pain (odds ratio 0.98, 95% confidence interval 0.97-0.99, p < 0.001). Local anesthetics were not associated with pain scores on POD 1., Conclusions: Higher amounts of local anesthetics reduce acute postoperative pain and opioid requirement after lumpectomy and SLNB. Maximizing dosing within weight-based limits is a low-risk, cost-effective pain control strategy that can be used in diverse practice settings., (© 2021. Society of Surgical Oncology.)

Importance: Prospective trials have demonstrated sentinel lymph node (SLN) false-negative rates of less than 10% when 3 or more SLNs are retrieved in patients with clinically node-positive breast cancer rendered clinically node-negative with neoadjuvant chemotherapy (NAC). However, rates of nodal recurrence in such patients treated with SLN biopsy (SLNB) alone are unknown because axillary lymph node dissection (ALND) was performed in all patients, limiting adoption of this approach., Objective: To evaluate nodal recurrence rates in a consecutive cohort of patients with clinically node-positive (cN1) breast cancer receiving NAC, followed by a negative SLNB using a standardized technique, and no further axillary surgery., Design, Setting, and Participants: From November 2013 to February 2019, a cohort of consecutively identified patients with cT1 to cT3 biopsy-proven N1 breast cancer rendered cN0 by NAC underwent SLNB with dual tracer mapping and omission of ALND if 3 or more SLNs were identified and all were pathologically negative. Metastatic nodes were not routinely clipped, and localization of clipped nodes was not performed. The study was performed in a single tertiary cancer center., Intervention: Omission of ALND in patients with cN1 breast cancer after NAC if 3 or more SLNs were pathologically negative., Main Outcome and Measures: The primary outcome was the rate of nodal recurrence among patients with cN1 breast cancer treated with SLNB alone after NAC., Results: Of 610 patients with cN1 breast cancer treated with NAC, 555 (91%) converted to cN0 and underwent SLNB; 234 (42%) had 3 or more negative SLNs and had SLNB alone. The median (IQR) age of these 234 patients was 49 (40-58) years; median tumor size was 3 cm; 144 (62%) were ERBB2 (formerly HER2)-positive, and 43 (18%) were triple negative. Most (212 [91%]) received doxorubicin-based NAC; 205 (88%) received adjuvant radiotherapy (RT), and 164 (70%) also received nodal RT. At a median follow-up of 40 months, there was 1 axillary nodal recurrence synchronous with local recurrence in a patient who refused RT. Among patients who received RT (n = 205), there were no nodal recurrences., Conclusions and Relevance: This cohort study found that in patients with cN1 disease rendered cN0 with NAC, with 3 or more negative SLNs with SLNB alone, nodal recurrence rates were low, without routine nodal clipping. These findings potentially support omitting ALND in such patients.

Peripheral blood mononuclear cells (PBMCs) respond to altered physiological conditions to alleviate the threat. Production of the 70 kDa heat shock protein (HSP70) is up-regulated to protect proteins from degradation. Sequestosome-1 (p62) binds to altered proteins and the p62-protein complex is degraded by autophagy. P62 is also a regulator of intracellular kinase activity and cell differentiation. We hypothesized that the PBMC response to a malignant breast mass involves elevated production of HSP70 and a decrease in intracellular p62. In this study 46 women had their breast mass excised. PBMCs were isolated and intracellular levels of HSP70 and p62 were quantitated by ELISA. Differences between women with a benign or malignant breast mass were determined. A breast malignancy was diagnosed in 38 women (82.6%) while 8 had a benign lesion. Mean intracellular HSP70 levels were 79.3 ng/ml in PBMCs from women with a malignant lesion as opposed to 44.2 ng/ml in controls (p = 0.04). The mean PBMC p62 level was 2.3 ng/ml in women with a benign breast lesion as opposed to 0.6 ng/ml in those with breast cancer (p < 0.001). Mean p62 levels were lowest in women with invasive carcinoma and a positive lymph node biopsy when compared to those with in-situ carcinoma or absence of lymphadenopathy, respectively. Intracellular HSP70 and p62 levels in PBMCs differ between women with a malignant or benign breast lesion. These measurements may be of value in the preoperative triage of women with a breast mass., (© 2021. The Author(s).)

Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are increasingly used in ambulatory breast surgery. The risk of hematoma associated with intraoperative ketorolac is low, but whether concomitant routine discharge with NSAIDs increases the risk of hematoma is unclear., Methods: We retrospectively identified patients who underwent lumpectomy and sentinel lymph node biopsy (SLNB), and compared the 30-day risk of hematoma between patients discharged with opioids (opioid period: January 2018-August 2018) and patients discharged with NSAIDs with or without opioids (NSAID period: January 2019-April 2020). The association between study period and hematoma risk was assessed using multivariable models. Covariates included intraoperative ketorolac, home aspirin, and race/ethnicity. During the NSAID period, a survey was used to assess analgesic consumption on postoperative days 1-5., Results: In total, 2724 patients were identified: 858 (31%) in the opioid period and 1866 (69%) in the NSAID period. In the NSAID period, 867 (46%) received NSAIDs and opioids, and 999 (54%) received NSAIDs only. Receipt of intraoperative ketorolac was higher in the NSAID period (78 vs. 64%, P < 0.001). The risks of any hematoma (4.1 vs. 3.6%, P = 0.6) and reoperation for bleeding (0.5 vs. 0.6%, P = 0.8) were similar between groups. Study period was not associated with hematoma risk (odds ratio 0.87, 95% confidence interval 0.56-1.35, P = 0.5). Among survey respondents (41%), nonopioid analgesic consumption did not increase after opioids were removed from the discharge regimen (median, 6 pills/group, P = 0.06)., Conclusions: NSAIDs are associated with a low risk of hematoma after lumpectomy and SLNB, and should be prescribed instead of opioids, unless contraindicated., (© 2021. Society of Surgical Oncology.)

Background: As neoadjuvant chemotherapy (NAC) for breast cancer has become more widely used, so has nipple-sparing mastectomy. A common criterion for eligibility is a 1 cm tumor-to-nipple distance (TND), but its suitability after NAC is unclear. In this study, we examined factors predictive of negative nipple pathologic status (NS-) in women undergoing total mastectomy after NAC., Methods: Women with invasive breast cancer treated with NAC and total mastectomy from August 2014 to April 2018 at our institution were retrospectively identified. Following review of pre- and post-NAC magnetic resonance imaging (MRI) and mammograms, the association of clinicopathologic and imaging variables with NS- was examined and the accuracy of 1 cm TND on imaging for predicting NS- was determined., Results: Among 175 women undergoing 179 mastectomies, 74% of tumors were cT1-T2 and 67% were cN+ on pre-NAC staging; 10% (18/179) had invasive or in situ carcinoma in the nipple on final pathology. On multivariable analysis, after adjusting for age, grade, and tumor stage, three factors, namely number of positive nodes, pre-NAC nipple-areolar complex retraction, and decreasing TND, were significant predictors of nipple involvement (p < 0.05). The likelihood of NS- was higher with increasing TND on pre- and post-NAC imaging (p < 0.05). TND ≥ 1 cm predicted NS- in 97% and 95% of breasts on pre- and post-NAC imaging, respectively., Conclusions: Increasing TND was associated with a higher likelihood of NS-. A TND ≥ 1 cm on pre- or post-NAC imaging is highly predictive of NS- and could be used to determine eligibility for nipple-sparing mastectomy after NAC., (© 2021. Society of Surgical Oncology.)

Background: In patients with a positive sentinel lymph node (SLN) after neoadjuvant chemotherapy (NAC), the likelihood of residual nodal disease at axillary dissection (ALND) is high. Whether non-SLN metastasis frequency varies based on tumor subtype and SLN metastasis size is uncertain. We examined the association between tumor subtype and frequency of non-SLN metastases in patients with SLN micro- vs macrometastases after NAC., Methods: Patients with invasive breast cancer and a positive SLN biopsy after NAC between July 2008 and July 2019 were identified. Associations between tumor subtype, SLN disease volume, and frequency of non-SLN metastases were examined., Results: Among 273 patients with ≥ 1 positive SLN and a completion ALND, mean age was 51 years, 87% of tumors were ductal, 80% were clinically node-positive at presentation, and 85% were cT2-3. The frequency of non-SLN metastases was non-significantly higher in HR+/HER2- (61%) vs. HER2+ (52%) and triple negative tumors (45%) (p = 0.09). Frequency of SLN micrometastasis was 9% for triple negative tumors compared with 17% for HR+/HER2- and 34% for HER2+ tumors (p = 0.015). Size of SLN metastasis (micro- vs. macrometastases) was not associated with non-SLN metastasis frequency or number within any subtype., Conclusions: In patients with a positive SLN after NAC, the likelihood of non-SLN metastasis at ALND was high across all tumor subtypes and did not vary significantly for SLN micro- versus macrometastases. ALND is recommended for SLN micro- and macrometastases after NAC, irrespective of tumor subtype., (© 2021. Society of Surgical Oncology.)

Context.—: It is unclear whether HER2+ tumors expressing both estrogen receptor (ER) and progesterone receptor (PR), that is, triple-positive breast carcinomas (TPBCs), show unique morphologic and clinical features and response to neoadjuvant chemotherapy (NAC)., Objective.—: To study the morphologic and immunohistochemical features of TPBCs from patients who underwent NAC., Design.—: We retrospectively reviewed core biopsy and post-NAC slides of 85 TPBCs. H-scores were calculated for ER and PR. HER2 slides and fluorescence in situ hybridization (FISH) reports were reviewed. Residual cancer burden was calculated for post-NAC specimens., Results.—: Eighty-one of the 85 tumors (95.3%) showed ductal histology, 3 (3.5%) were invasive lobular carcinomas, and 1 (1.2%) showed mixed ductal and lobular features. A subset showed mucinous (n = 7, 8.2%), apocrine (n = 5, 5.9%), and/or micropapillary (n = 4, 4.7%) differentiation. Fifty-four TPBCs (63.5%) showed high ER expression (H-score >200), including 27 (31.8%) with high expression of ER and PR. Fifty-two tumors (61.1%) showed HER2 3+ staining. Mean HER2/CEP17 ratio by FISH was 3.6 (range, 2-12.2) and mean HER2 signals per cell was 8 (range, 3.7-30.4). Pathologic complete response (pCR) rate was 35.3% (30 of 85). HER2 3+ staining was the only significant predictor of pCR on multivariate analysis (odds ratio = 9.215; 95% CI, 2.401-35.371; P < .001). The ER/PR expression did not correlate with response to therapy., Conclusions.—: TPBCs are heterogeneous with some showing mucinous, lobular, or micropapillary differentiation. The pCR rate of TPBCs is similar to that reported for ER+/PR-/HER2+ tumors. HER2 overexpression by IHC was associated with significantly better response to therapy and may help select patients for treatment in the neoadjuvant setting.

Background: Opioid analgesics are overprescribed after surgery. In August 2018, the authors replaced routine discharge opioid prescription with a nonsteroidal anti-inflammatory drug (NSAID) for patients who had a lumpectomy or excisional biopsy (lump/ex). This study compared patient-reported post-discharge pain scores for patients treated before and after the change in routine discharge medication., Methods: Patients were categorized based on treatment before and after a change in discharge medication as follows: study period 1 (routine opioids), study period 2 (routine NSAID). Pain severity was assessed with an electronic survey on postoperative days (PODs) 1 to 5. Multivariable generalized estimating equations tested the association between pain severity and discharge in the first versus the second study period., Results: Lump/ex was performed for 1606 patients between December 2017 and June 2019. Of these patients, 789 (49%) reported pain scores and were analyzed (328 in study period 1, 461 in study period 2). Opioid prescription at discharge decreased from 96% in period 1 to 14% (95% confidence interval [CI], 11-18%) in period 2. Only 1% of the patients discharged with NSAID were later prescribed an opioid. The maximum reported pain score on any POD for all the patients was severe for 30 patients (3.8%), moderate for 217 patients (28%), mild for 430 patients (54%), and none for 112 patients (14%). The estimated risk for moderate or greater pain on POD 1 was 36% for period 1 and 34% for period 2. The proportion of patients reporting moderate or greater pain was nonsignificantly lower for the patients treated in period 2 (odds ratio [OR], 0.91; 95% CI 0.67-1.22; P = 0.5)., Conclusions: For patients undergoing lump/ex, a clinically meaningful difference in reported post-discharge pain scores can be excluded with a change to routine NSAID at discharge. Patients undergoing lump/ex should not be routinely discharged with opioids.

Background: Whether routinely prescribed opioids are necessary for pain control after discharge among lumpectomy/sentinel node biopsy (Lump/SLNB) patients is unclear. We hypothesize that Lump/SLNB patients could be discharged without opioids, with a failure rate < 10%. This study prospectively examines outcomes after changing standard discharge prescription from an opioid/non-steroidal anti-inflammatory drug (NSAID) to NSAID/acetaminophen., Patients and Methods: Standard discharge pain medication orders included opioids in the first 3-month study period and were changed to NSAID/acetaminophen in the second 3-month period. Patient-reported medication consumption and pain scores were collected by post-discharge survey. Frequency of discharge with opioid, NSAID/acetaminophen failure rate, opioid use, and pain scores were examined., Results: From May to October 2019, 663 patients had Lump/SLNB: 371 in the opioid study period and 292 in the NSAID period. In the opioid period, 92% (342/371) of patients were prescribed an opioid at discharge; of 142 patients who documented opioid use on the survey, 86 (61%) used zero tablets. Among 56 (39%) patients who used opioids, the median number taken by POD 5 was 4. After the change to NSAID/acetaminophen, rates of opioid prescription decreased to 14% (41/292). The NSAID/acetaminophen failure rate was 2% (5/251). Among survey respondents, there was no significant difference in the maximum reported pain scores (POD 1-5) between the opioid period and the NSAID period (p = 0.7)., Conclusions: In Lump/SLNB patients, a change to default discharge with NSAID/acetaminophen resulted in a 78% absolute reduction in opioid prescription, with a failure rate of 2% and no difference in patient-reported pain scores. Most Lump/SLNB patients can be discharged with NSAID/acetaminophen.

Purpose: Cosmetic outcomes and rate of implant loss are poorly characterized among patients with breast cancer with previous breast augmentation (BA) who undergo breast-conservation therapy (BCT). Here we determine capsular contracture and implant loss frequency after BCT among patients receiving contemporary whole-breast radiation therapy (RT)., Methods and Materials: Patients with breast cancer with a history of BA presenting to our institution from January 2006 to January 2017 who elected for BCT were included. Seventy-one breast cancers in 70 patients with a history of BA electing for BCT were retrospectively identified. Clinicopathologic, treatment, and outcome variables were examined. Whole-breast RT included conventional and hypofractionated schedules with and without a boost. Rates of implant loss and cosmetic outcomes among patients who did and did not develop a new/worse contracture based on physician assessment were compared., Results: In the study, 54.9% of patients received radiation using hypofractionated whole-breast tangents; 81.7% received a boost. In addition, 18 out of 71 cases (25.4%) developed a new/worse contracture after BCT with a mean follow-up of 1.9 years. Furthermore, 9 out of 71 cases (12.7%) were referred to a plastic surgeon for revisional surgery. There were no implant-loss cases. On univariate analysis, implant location, time from implant placement to diagnosis, RT type, RT boost, body mass index, and tumor size were not associated with new/worse contracture. Of 12 patients with existing contracture, only 2 developed worsening contracture. Physician assessment of cosmetic outcome after BCT was noted to be excellent or good for 87.4% of patients., Conclusions: BCT for breast cancer patients with prior history of BA has a low risk of implant loss. Hypofractionated RT does not adversely affect implant outcomes. Patients should be counseled regarding risk for capsular contracture, but the majority have good/excellent outcome; BA does not represent a contraindication to BCT., (Copyright © 2020 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.)

Background: Nipple-sparing mastectomy (NSM) is being performed increasingly for risk reduction in high-risk groups. There are limited data regarding complications and oncological outcomes in women undergoing bilateral prophylactic NSM. This study reviewed institutional experience with prophylactic NSM, and examined the indications, rates of postoperative complications, incidence of occult malignant disease and subsequent breast cancer diagnosis., Methods: Women who had bilateral prophylactic NSM between 2000 and 2016 were identified from a prospectively maintained database. Rates of postoperative complications, incidental breast cancer, recurrence and overall survival were evaluated., Results: A total of 192 women underwent 384 prophylactic NSMs. Indications included BRCA1 or BRCA2 mutations in 117 patients (60·9 per cent), family history of breast cancer in 35 (18·2 per cent), lobular carcinoma in situ in 29 (15·1 per cent) and other reasons in 11 (5·7 per cent). Immediate breast reconstruction was performed in 191 patients. Of 384 NSMs, 116 breasts (30·2 per cent) had some evidence of skin necrosis at follow-up, which resolved spontaneously in most; only 24 breasts (6·3 per cent) required debridement. Overall, there was at least one complication in 129 breasts (33·6 per cent); 3·6 and 1·6 per cent had incidental findings of ductal carcinoma in situ and invasive breast cancer respectively. The nipple-areola complex was preserved entirely in 378 mastectomies. After a median follow-up of 36·8 months, there had been no deaths and no new breast cancer diagnoses., Conclusion: These findings support the use of prophylactic NSM in high-risk patients. The nipples could be preserved in the majority of patients, postoperative complication rates were low, and, with limited follow-up, there were no new breast cancers., (© 2020 BJS Society Ltd Published by John Wiley & Sons Ltd.)

Purpose: Axillary treatment strategies for the young woman with early-stage, clinically node-negative breast cancer undergoing upfront surgery found to have 1-3 positive sentinel lymph nodes (SLNs) differ significantly after BCT and mastectomy. Here we compare axillary lymph node dissection (ALND) and regional nodal irradiation (NRI) rates between women electing breast-conservation therapy (BCT) versus mastectomy., Methods: From 2010 to 2016, women age < 50 years with clinical T1-T2N0 breast cancer having upfront surgery and found to have a positive SLN were identified. ALND and/or NRI receipt were compared between groups., Results: 192 women undergoing BCT and 165 undergoing mastectomy were identified (median age: 44 years). 5.2% (10/192) of women undergoing BCT had an ALND versus 87% (144/165) of women undergoing mastectomy (p < 0.01). NRI was given to 48% (78/165) of mastectomy patients compared to 30% (57/192) of BCT patients (p < 0.01). Of the 75 mastectomy patients with 1-2 total positive lymph nodes after completion ALND, 44% received NRI. Women undergoing mastectomy were significantly more likely to receive both ALND and NRI than women undergoing BCS (45% vs 6%, p < 0.01)., Conclusion: Young cT1-2N0 breast cancer patients found to have 1-3 SLN metastases received ALND, NRI, and combined ALND/NRI more frequently if they elected mastectomy over BCT. Use of both ALND and postmastectomy radiotherapy (PMRT) in this population could be reduced in the future by omitting ALND in patients for whom the need for PMRT is clear with the finding of 1-2 SLN metastases.

Background: Nipple-sparing mastectomy (NSM) is increasingly performed for invasive breast cancer. Growing evidence supporting the oncologic safety of NSM has led to its widespread use and broadened indications. In this study, we examine the indications, complications, and long-term outcomes of therapeutic NSM., Methods: From 2003 to 2016, women undergoing NSM for invasive cancer or ductal carcinoma in situ (DCIS) were identified from a prospectively maintained database. Patient and disease characteristics were compared by procedure year, while complications were compared by procedure year using generalized mixed-effects models accounting for a random surgeon effect. Overall survival and time to recurrence were examined., Results: Of the 467 therapeutic NSMs, 337 (72%) were invasive cancer, 126 (27%) were DCIS, and 4 (1%) were phyllodes tumors. Median age was 45 years (range 24-75) and median follow-up among survivors was 39.4 months. Three hundred and fifty-seven (76.4%) cases were performed in 2011 or after. When comparing NSMs performed before and after 2011, there was a significant increase in NSMs performed for invasive tumors (58% vs. 77%; p < 0.001). There was no difference in family history, genetic mutations, smoking status, neoadjuvant chemotherapy, prior radiation, nodal involvement, or tumor subtype. Twenty-one (4.5%) nipple excisions were performed, of which 14 were performed for cancer at the nipple margin. Forty-four breasts (9.4%) had complications that required re-operation. Fifteen patients had locoregional recurrence or distant metastasis., Conclusions: NSM use for invasive carcinoma has doubled at our institution since 2011, while postoperative complications and recurrence rates remain low. Our experience supports the selective use of NSM in the malignant setting with careful patient selection.

Background: The National Comprehensive Cancer Network (NCCN) endorses sentinel lymph node biopsy (SLNB) in patients with clinically positive axillary nodes who downstage after neoadjuvant chemotherapy (NAC). In this study, we compared the accuracy of post-NAC MRI to clinical exam alone in predicting pathologic status of sentinel lymph nodes in cN1 patients., Methods: We identified patients with T0-3, N1 breast cancer who underwent NAC and subsequent SLNB from March 2014 to July 2017. Patients were grouped based on whether a post-NAC MRI was done. MRI accuracy in predicting SLN status was assessed versus clinical exam alone., Results: A total of 450 patients met initial study criteria; 269 were analyzed after excluding patients without biopsy-confirmed nodal disease, palpable disease after NAC, and failed SLN mapping. Median age was 49 years. Post-NAC MRI was done in 68% (182/269). Patients undergoing lumpectomy vs mastectomy more frequently received a post-NAC MRI (88 vs 54%, p < 0.001). All other clinicopathologic parameters were comparable between those who did and did not have a post-NAC MRI. Thirty percent (55/182) had abnormal lymph nodes on MRI. Among these, 58% (32/55) had a positive SLN on final pathology versus 42% (53/127) of patients with no abnormal lymph nodes on MRI and 52% (45/87) of patients who had clinical exam alone (p = 0.09). MRI sensitivity was 38%, specificity was 76%, and overall SLN status prediction accuracy was 58%., Conclusions: Post-NAC MRI is no more accurate than clinical exam alone in predicting SLN pathology in patients presenting with cN1 disease. Abnormal lymph nodes on MRI should not preclude SLNB.

False-negative (FN) intraoperative frozen section (FS) results of sentinel lymph nodes (SLN) have been reported to be more common after neoadjuvant chemotherapy (NAC) in the primary surgical setting. We evaluated SLN FS assessment in breast cancer patients treated with NAC to determine the FN rate and the histomorphologic factors associated with FN results. Patients who had FS SLN assessment following NAC from July 2008 to July 2017 were identified. Of the 711 SLN FS cases, 522 were negative, 181 positive, and 8 deferred. The FN rate was 5.4% (28/522). There were no false-positive results. Of the 8 deferred cases, 5 were positive on permanent section and 3 were negative. There was a higher frequency of micrometastasis and isolated tumor cells in FN cases (P<0.001). There was a significant increase in tissue surface area present on permanent section slides compared with FS slides (P<0.001), highlighting the inherent technical limitations of FS and histologic under-sampling of tissue which leads to most FN results. The majority (25/28, 89%) of FN cases had metastatic foci identified exclusively on permanent sections and were not due to a true diagnostic interpretation error. FN cases were more frequently estrogen receptor positive (P<0.001), progesterone receptor positive (P=0.001), human epidermal growth factor receptor-2 negative (P=0.009) and histologic grade 1 (P=0.015), which most likely reflects the lower rates of pathologic complete response in these tumors. Despite its limitations, FS is a reliable modality to assess the presence of SLN metastases in NAC treated patients.

Background/objective: Guidelines concur that postmastectomy radiation therapy (PMRT) in T1-2 tumors with one to three positive (+) lymph nodes (LNs) decreases locoregional recurrence (LRR) but advise limiting PMRT to patients at highest risk to balance against potential harms. In this study, we identify the risks of LRR after mastectomy in patients with T1-2N1 disease, treated with modern chemotherapy, and identify predictors of LRR when omitting PMRT., Methods: Patients with T1-2N1 breast cancer undergoing mastectomy between 1995 and 2006 were categorized by receipt of PMRT. The Chi square test compared the clinicopathologic features between both groups, and Kaplan-Meier and Cox regression analysis was used to determine the rates of LRR, recurrence-free survival (RFS), and overall survival (OS)., Results: Overall, 1087 patients (924 no PMRT, 163 PMRT) were included in the study, with a median follow-up of 10.8 years (range 0-21). We identified 63 LRRs (56 no PMRT, 7 PMRT), and 10-year rates of LRR with and without PMRT were 4.0% and 7.0%, respectively. Patients receiving PMRT were younger (p = 0.019), had larger tumors (p = 0.0013), higher histologic grade (p = 0.029), more positive LNs (p < 0.0001), lymphovascular invasion (LVI) (p < 0.0001), extracapsular nodal extension (p < 0.0001), and macroscopic LN metastases (p < 0.0001). There was no difference in LRR, RFS, or OS between groups. On multivariate analysis, age < 40 years (p < 0.0001) and LVI (p < 0.0001) were associated with LRR in those not receiving PMRT., Conclusion: Consistent with the guidelines, 85% of patients with T1-2N1 were spared PMRT at our center, while maintaining low LRR. Age < 40 years and the presence of LVI are significantly associated with LRR in those not receiving PMRT.

Breast cancer treatment is multidisciplinary. Most women with early stage breast cancer are candidates for breast-conserving surgery with radiotherapy or mastectomy. The risk of local recurrence and the chance of survival does not differ with these approaches. Sentinel node biopsy is used for axillary staging, and individualized approaches are minimizing the need for axillary dissection in women with positive sentinel nodes. Adjuvant systemic therapy is used in most women based on proven survival benefit, and molecular profiling to individualize treatment based on risk is now a clinical reality for patients with hormone receptor-positive cancers., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background/objective: Intraoperative evaluation of sentinel lymph nodes (SLNs) after neoadjuvant chemotherapy (NAC) has a higher false-negative rate than in the primary surgical setting, particularly for small tumor deposits. Additional tumor burden seen with isolated tumor cells (ITCs) and micrometastases following primary surgery is low; however, it is unknown whether the same is true after NAC. We examined the false-negative rate of intraoperative frozen section (FS) after NAC, and the association between SLN metastasis size and residual disease at axillary lymph node dissection (ALND)., Methods: Patients undergoing SLN biopsy after NAC were identified. The association between SLN metastasis size and residual axillary disease was examined., Results: From July 2008 to July 2017, 702 patients (711 cancers) had SLN biopsy after NAC. On FS, 181 had metastases, 530 were negative; 33 negative cases were positive on final pathology (false-negative rate 6.2%). Among patients with a positive FS, 3 (2%) had ITCs and no further disease on ALND; 41 (23%) had micrometastases and 125 (69%) had macrometastases. Fifty-nine percent of patients with micrometastases and 63% with macrometastases had one or more additional positive nodes at ALND. Among those with a false-negative result, 10 (30%) had ITCs, 15 (46%) had micrometastases, and 8 (24%) had macrometastases; 17 had ALND and 59% had one or more additional positive lymph nodes. Overall, 1/6 (17%) patients with ITCs and 28/44 (64%) patients with micrometastases had additional nodal metastases at ALND., Conclusion: Low-volume SLN disease after NAC is not an indicator of a low risk of additional positive axillary nodes and remains an indication for ALND, even when not detected on intraoperative FS.

Background: This study provides an updated description of diversity along the academic surgical pipeline to determine what progress has been made., Methods: Data was extracted from a variety of publically available data sources to determine proportions of minorities in medical school, general surgery training, and academic surgery leadership., Results: In 2014-2015, Blacks represented 12.4% of the U.S. population, but only 5.7% graduating medical students, 6.2% general surgery trainees, 3.8% assistant professors, 2.5% associate professors and 2.0% full professors. From 2005-2015, representation among Black associate professors has gotten worse (-0.07%/year, p < 0.01). Similarly, in 2014-2015, Hispanics represented 17.4% of the U.S. population but only 4.5% graduating medical students, 8.5% general surgery trainees, 5.0% assistant professors, 5.0% associate professors and 4.0% full professors. There has been modest improvement in Hispanic representation among general surgery trainees (0.2%/year, p < 0.01), associate (0.12%/year, p < 0.01) and full professors (0.13%/year, p < 0.01)., Conclusion: Despite efforts to promote diversity in surgery, Blacks and Hispanics remain underrepresented. A multi-level national focus is imperative to elucidate effective mechanisms to make academic surgery more reflective of the US population., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Breast cancer is the leading cause of cancer death in women younger than 40 years. Triple-negative breast cancer (TNBC) and human epidermal growth factor receptor-2 (HER2) positive subtypes have a particularly poor prognosis in this age group. The purpose of this study was to compare rates of recurrence among breast cancer subtypes in young patients treated with modern adjuvant systemic therapy. A retrospective review of breast cancer patients managed at a major academic breast center between May 2000 and November 2014 was performed. We included 239 women with breast cancer who were diagnosed and treated at age ≤40 years. Clinical, pathological, therapeutic, and outcome data were recorded. Patients were classified into the following molecular subtypes: luminal A/B (estrogen receptor [ER] positive and/or progesterone receptor [PR] positive, and HER2 negative), luminal/HER2 (ER positive and/or PR positive, and HER2 positive), HER2- enriched (ER negative, PR negative, and HER2 positive) and TNBC (ER negative, PR negative, and HER2 negative). Descriptive statistics were used to characterize the study cohort. Kaplan-Meier survival analysis was performed to estimate recurrence-free survival (RFS). Median follow-up time was 29 months. Mean age was 34.5 years. Among all patients, 193 (80.8%) were diagnosed with Invasive breast cancer and 46 (19.2%) with ductal carcinoma in situ with or without microinvasion. Subclassification into molecular subtypes was complete for 199 patients among which, 50.7% were classified as luminal A/B, 21.1% luminal/HER2, 12.1% HER2-enriched and 16.1% TNBC. Of the 199 patients, 25.1% received neo-adjuvant chemotherapy and 59.2% received adjuvant chemotherapy. Among HER2-positive patients, 81.3% received HER2 directed therapy. Twenty-eight patients (11.7%) had recurrences (13 loco-regional, seven distant, and eight both). At 3 years, the HER2 subtype had the highest RFS 100%, compared to 91.1% in luminal A/B, 85.6% in luminal/HER2 and 81.9% in TNBC. In comparing outcomes among subtypes, the HER2 positive subtype was associated with improved RFS, likely reflecting the impact of HER2 directed therapy. Those young patients with triple-negative subtype continued to have the poorest outcomes., (Published 2017. This article is a U.S. Government work and is in the public domain in the USA.)

Background: Approximately 4% of women age 70 will develop breast cancer during the next ten years. Reconstruction has become a standard option for young women undergoing mastectomy for breast cancer, however may not be offered to older women due to the presence of co-morbidities. There is limited data on the outcomes of mastectomy with reconstruction in patient's ≥ 70. This study examines comorbidities and 30-day complication rates in patients ≥70 undergoing mastectomy for breast cancer., Methods: The American College of Surgeons National Surgery Quality Improvement Program database was used to examine co-morbidities and 30-day complication rates in breast cancer patients undergoing mastectomy from 2007 to 2012. Patients were grouped based on age and procedure. Complication rates were characterized using descriptive statistics and Wilcoxon rank sum-test. Variable frequencies were compared using Chi-square or Fisher's exact test., Results: 54,821 patients underwent mastectomy. Among patients ≥70, 11,927 did not have reconstruction, 109 had reconstruction. Among patients <70, 40,755 did not have reconstruction and 2040 had reconstruction. Patients without reconstruction had a significantly higher number of co-morbidities compared to those having reconstruction (P = 0.001). The 30-day complication rate for patients without reconstruction was 4.2% in patients ≥70 compared to 4.4% for those <70 (p = 0.4). In patients with reconstruction, the 30-day complication rate was 6.4% in patients ≥70 compared to 5.6% for those <70 (p = 0.7)., Conclusion: There was no difference in 30-day complication rate between patients ≥70 and < 70 having mastectomy with and without reconstruction. Similar outcomes among women ≥70 years and younger patients undergoing reconstruction may reflect patient selection based on co-morbidities. With appropriate risk stratification, breast reconstruction may be a safe surgical option for women ≥70 year patients undergoing treatment for breast cancer., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Breast lesions not sampled prior to surgery or initially diagnosed as fibroepithelial lesions on core biopsy may have a diagnosis of phyllodes tumor (PT) on excision. Historically, re-excision for close or positive margins has been the standard of care. We examined the rate of re-excision for close or positive margins in patients with benign phyllodes and compared recurrence rates among those undergoing re-excision versus observation., Methods: We identified all patients with phyllodes tumor diagnosed between 2003 and 2013. Operative and surgical pathology reports were reviewed for clinical, pathologic, and follow-up data., Results: Among 246 cases, 216 (88%) were benign PT and 30 (12%) borderline/malignant tumors. In the group of benign PT (n = 216), margins were negative in 64 patients (29.6%), 50 (23%) were close, and 102 (47%) were positive. Of those with close margins, 22 (44%) underwent reexcision and residual benign PT was found in 2 (9%). In patients with positive margins, 45 (44%) had re-excision and residual benign PT was detected in 4 (8.8%). After a median follow-up of 35.5 months, there were 4 (1.9%) recurrences among patients with benign PT. There was no difference in recurrence among patients who had re-excision for positive or close margins versus observation (p = 0.7 and 0.21, respectively)., Conclusions: Among patients with close or positive margins, there was no significant difference in disease recurrence between patients who underwent reexcision and those who were observed. Based on these results, it may be reasonable to manage these patients conservatively with close follow-up.

Residual carcinoma confined to lymphovascular spaces following neoadjuvant chemotherapy (NAC) for invasive breast carcinoma is an uncommon finding. We studied pathologic features and outcome for patients with pure intralymphatic carcinoma (PIC) following NAC, a pattern of residual disease reported to have a poor outcome in the only previously published series of this entity. Six of 284 (2.1%) patients treated with NAC were studied. All 6 patients had axillary lymph node involvement before NAC. Tumors were triple-negative (n=3) and HER2+ (n=3: 2 ER+, 1 ER-). Two patients presented with clinical findings of inflammatory carcinoma. Three of 5 pre-NAC core biopsies showed lymphovascular invasion. Three patients showed complete clinical response to NAC, and 3 showed partial response. Post-NAC surgical specimens showed foci of intralymphatic carcinoma in the breast spanning an extent of 0.5 mm to 0.5 cm. Residual ductal carcinoma in situ was present in 2 cases. Four of 6 patients converted to node-negative following NAC. One patient had distant metastasis at presentation and 1 patient died of pulmonary embolism 2 months after surgery. Three of the 4 remaining patients developed distant metastasis, of which 2 first recurred locally (in mean follow-up of 46.5 mo). Patients with PIC had significant greater risk for relapse (hazard ratio, 10.18 [1.97, 52.58]; P=0.006) compared with other NAC-treated patients, after controlling for residual lymph node involvement, tumor size, tumor subtype, histologic grade, and age. Residual PIC following NAC is associated with poor outcome, including in patients that are node-negative following NAC.

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.