Importance:Randomized trials established the safety of omitting axillary lymph node dissection (ALND) among patients with clinically node-negative breast cancer and less than 3 positive sentinel lymph nodes (+SLNs) having upfront surgery and adjuvant radiation. Patients with palpable mobile level I/II axillary adenopathy (cN1) were not eligible for these studies. Presently, more than 80% of patients with HR+/HER2- cN1 disease undergo ALND either at upfront surgery or after neoadjuvant therapy, despite evidence that 50% to 60% will have only 1 or 2 positive nodes. Objective:To determine upfront sentinel lymph node biopsy (SLNB) feasibility and evaluate ALND rate among patients with HR+/HER2- cN1 breast cancer selected with axillary ultrasound (AUS). Design, Setting, and Participants:This nonrandomized clinical trial involved patients with cTx/cT1-2 cN1 HR+/HER2- breast cancer with 3 or fewer morphologically abnormal nodes on AUS at 4 centers. The trial began on April 20, 2021, and the database for this report was frozen on September 26, 2024. Interventions:Patients underwent upfront lumpectomy/mastectomy and SLNB, with single/dual-tracer mapping. ALND was indicated for 3 or more positive SLNs. Main Outcomes and Measures:The primary outcome was ALND rate. Secondary outcomes were frequency of palpable nodes being radioactive/blue and locoregional recurrence. Results:Among 78 enrolled patients, the median (IQR) age was 58 (49.0-66.5) years. Most tumors were cT1 (37 [47%]) or cT2 (40 [51%]), 56 patients (72%) had ductal histology, and 59 tumors (76%) were moderately differentiated. On AUS, 39 patients (50%) had 1 abnormal-appearing node, 33 (42%) had 2, and 6 (8%) had 3. Median (IQR) pathologic tumor size was 2.3 (1.6-3.3) cm, 50 patients (64%) had lymphovascular invasion, and 54 (69%) had extracapsular extension. SLNB was performed with dual tracer in 68 (87%), and 3 or more SLNs were retrieved in 75 (96%). The palpable diseased nodes were blue and/or radioactive in 107 of 161 instances (66.5%). Overall, 24 patients (31%) had 1 +SLN, 30 patients (38%) had 2 +SLNs, and 24 patients (31%) had 3 or more +SLNs. SLNB alone was performed in 59 patients (76%), while 19 (24%) had ALND; indicated ALND was deferred in 5 cases. Among those with 12 months or more follow-up (n = 68; median, 25 months), there have been no isolated axillary or locoregional recurrences. Conclusions and Relevance:This study found that SLNB is feasible among patients with cN1 HR+/HER2- disease and that resection of palpable nodes is necessary to minimize false-negative rates. This approach affords the opportunity to omit ALND and minimize morbidity among patients with cN1 cancer and limited nodal burden. Trial Registration:ClinicalTrials.gov Identifier: NCT04854005.

This nonrandomized clinical trial analyzes data for patients who underwent upfront surgery to determine the feasibility of upfront sentinel lymph node biopsy and evaluate the rate of axillary lymph node dissection. QuestionWhat is the feasibility of upfront sentinel lymph node biopsy (SLNB) and the rate of axillary lymph node dissection (ALND) among patients with HR+/HER2- cN1 breast cancer selected with axillary ultrasound?FindingsIn this nonrandomized clinical trial including 78 consecutive patients with cTx/cT1-2 cN1 HR+/HER2- breast cancer with palpable, biopsy-proven nodal metastases, SLNB was feasible among patients with cN1 HR+/HER2- disease, with 3 or more SLNs retrieved in 96% of cases, and nearly 70% of patients meeting criteria for SLNB alone and able to avoid ALND.MeaningThis approach affords the opportunity to omit ALND and minimize morbidity among cN1 patients with limited nodal disease burden. ImportanceRandomized trials established the safety of omitting axillary lymph node dissection (ALND) among patients with clinically node-negative breast cancer and less than 3 positive sentinel lymph nodes (+SLNs) having upfront surgery and adjuvant radiation. Patients with palpable mobile level I/II axillary adenopathy (cN1) were not eligible for these studies. Presently, more than 80% of patients with HR+/HER2- cN1 disease undergo ALND either at upfront surgery or after neoadjuvant therapy, despite evidence that 50% to 60% will have only 1 or 2 positive nodes.ObjectiveTo determine upfront sentinel lymph node biopsy (SLNB) feasibility and evaluate ALND rate among patients with HR+/HER2- cN1 breast cancer selected with axillary ultrasound (AUS).Design, Setting, and ParticipantsThis nonrandomized clinical trial involved patients with cTx/cT1-2 cN1 HR+/HER2- breast cancer with 3 or fewer morphologically abnormal nodes on AUS at 4 centers. The trial began on April 20, 2021, and the database for this report was frozen on September 26, 2024.InterventionsPatients underwent upfront lumpectomy/mastectomy and SLNB, with single/dual-tracer mapping. ALND was indicated for 3 or more positive SLNs.Main Outcomes and MeasuresThe primary outcome was ALND rate. Secondary outcomes were frequency of palpable nodes being radioactive/blue and locoregional recurrence.ResultsAmong 78 enrolled patients, the median (IQR) age was 58 (49.0-66.5) years. Most tumors were cT1 (37 [47%]) or cT2 (40 [51%]), 56 patients (72%) had ductal histology, and 59 tumors (76%) were moderately differentiated. On AUS, 39 patients (50%) had 1 abnormal-appearing node, 33 (42%) had 2, and 6 (8%) had 3. Median (IQR) pathologic tumor size was 2.3 (1.6-3.3) cm, 50 patients (64%) had lymphovascular invasion, and 54 (69%) had extracapsular extension. SLNB was performed with dual tracer in 68 (87%), and 3 or more SLNs were retrieved in 75 (96%). The palpable diseased nodes were blue and/or radioactive in 107 of 161 instances (66.5%). Overall, 24 patients (31%) had 1 +SLN, 30 patients (38%) had 2 +SLNs, and 24 patients (31%) had 3 or more +SLNs. SLNB alone was performed in 59 patients (76%), while 19 (24%) had ALND; indicated ALND was deferred in 5 cases. Among those with 12 months or more follow-up (n = 68; median, 25 months), there have been no isolated axillary or locoregional recurrences.Conclusions and RelevanceThis study found that SLNB is feasible among patients with cN1 HR+/HER2- disease and that resection of palpable nodes is necessary to minimize false-negative rates. This approach affords the opportunity to omit ALND and minimize morbidity among patients with cN1 cancer and limited nodal burden.Trial RegistrationClinicalTrials.gov Identifier: NCT04854005

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.

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.

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 (median [IQR] age, 49 [40-58] years), 555 (91%) converted to cN0 and underwent SLNB; 234 (42%) had 3 or more negative SLNs and had SLNB alone. Median age was 49 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. This cohort study examines nodal recurrence rates in patients with clinically node-positive cancer treated with sentinel lymph node biopsy alone after neoadjuvant chemotherapy. Question What is the nodal recurrence rate in patients with clinically node-positive (cN1) breast cancer treated with sentinel lymph node biopsy (SLNB) alone after neoadjuvant chemotherapy (NAC)? Findings In this cohort study of 610 patients with cN1 breast cancer, among 234 consecutive patients whose cancer was rendered cN0 with NAC treated with SLNB alone with 3 or more negative SLNs retrieved, rates of axillary failure at a median follow-up of 40 months were low (0.4%), without routine nodal clipping. Meaning These data support potential omission of axillary lymph node dissection in patients with cN1 breast cancer who achieve nodal pathologic complete response with NAC and are treated with SLNB alone.

In the ACOSOG (American College of Surgeons Oncology Group) Z0011 trial and the AMAROS (After Mapping of the Axilla: Radiotherapy or Surgery?) trial, matted nodes with gross extracapsular extension (ECE), a risk factor for locoregional recurrence, were an indication for axillary lymph node dissection (ALND), but the effect of microscopic ECE (mECE) in the sentinel lymph nodes (SLNs) on recurrence was not examined. Between 2010 and 2017, 811 patients with cT1-2N0 breast cancer and SLN metastasis were prospectively managed according to Z0011 criteria, with ALND for those with more than two positive SLNs or gross ECE. Management of mECE was not specified. In this study, we compare outcomes of patients with one to two positive SLNs with and without mECE, treated with SLN biopsy alone (n = 685). Median patient age was 58 years, and median tumor size was 1.7 cm. mECE was identified in 210 (31%) patients. Patients with mECE were older, had larger tumors, and were more likely to be hormone receptor positive and HER2 negative, have two positive SLNs, and receive nodal radiation. At a median follow-up of 41 months, no isolated axillary failures were observed. There were 11 nodal recurrences; two supraclavicular ± axillary, four synchronous with breast, and five with distant failure. The five-year rate of any nodal recurrence was 1.6% and did not differ by mECE (2.3% vs. 1.3%; p = 0.84). No differences were observed in local (p = 0.08) or distant (p = 0.31) recurrence rates by mECE status. In Z0011-eligible patients, nodal recurrence rates in patients with mECE are low after treatment with SLN biopsy alone, even in the absence of routine nodal radiation. The presence of mECE should not be considered a routine indication for ALND.

OBJECTIVE:To determine rates of axillary dissection (ALND) and nodal recurrence in patients eligible for ACOSOG Z0011.BACKGROUND:Z0011 demonstrated that patients with cT1-2N0 breast cancers and 1 to 2 involved sentinel lymph nodes (SLNs) having breast-conserving therapy had no difference in locoregional recurrence or survival after SLN biopsy alone or ALND. The generalizability of the results and importance of nodal radiotherapy (RT) is unclear.METHODS:Patients eligible for Z0011 had SLN biopsy alone. Prospectively defined indications for ALND were metastases in ≥3 SLNs or gross extracapsular extension. Axillary imaging was not routine. SLN and ALND groups and radiation fields were compared with chi-square and t tests. Cumulative incidence of recurrences was estimated with competing risk analysis.RESULTS:From August 2010 to December 2016, 793 patients met Z0011 eligibility criteria and had SLN metastases. Among them, 130 (16%) had ALND; ALND did not vary based on age, estrogen receptor, progesterone receptor, or HER2 status. Five-year event-free survival after SLN alone was 93% with no isolated axillary recurrences. Cumulative 5-year rates of breast + nodal and nodal + distant recurrence were each 0.7%. In 484 SLN-only patients with known RT fields (103 prone, 280 supine tangent, 101 breast + nodes) and follow-up ≥12 months, the 5-year cumulative nodal recurrence rate was 1% and did not differ significantly by RT fields.CONCLUSIONS:We confirm that even without preoperative axillary imaging or routine use of nodal RT, ALND can be avoided in a large majority of Z0011-eligible patients with excellent regional control. This approach has the potential to spare substantial numbers of women the morbidity of ALND.

Introduction: Nipple sparing mastectomy (NSM) is now performed with increasing frequency in both therapeutic and prophylactic breast surgery. The role of NSM in BRCA1 and BRCA2 mutation carriers has not been well described. The aim of this study was to review our experience with NSM in this high-risk population. Methods: A review of the breast database was performed to identify all patients with documented BRCA mutations who underwent NSM at Memorial Sloan Kettering Cancer Center. Data extracted from the database included patient demographics, type of mutation, indication for surgery, type of reconstruction, and complications. For patients undergoing therapeutic mastectomy, data on disease stage, axillary procedures, and follow-up were also extracted. Results: 177 NSMs (88 bilateral, 1 unilateral) were performed in 89 female patients with a documented BRCA mutation between September 2005 and December 2013. There were 56 patients with BRCA1 mutation, 26 with BRCA2 mutation, and 7 with genetic variants of uncertain significance. 26 patients had a therapeutic NSM for breast cancer (stage 0: n=6; stage 1: n=15; stage 2: n=5) and concurrent contralateral prophylactic mastectomy (CPM). The mean tumor size was 1.46cm (range, 0.1-3.5cm), and all were node negative following sentinel lymph node biopsy. 63 patients had NSM for prophylaxis. The mean age of patients undergoing therapeutic NSM was 41 years (range, 26-59) and prophylactic NSM was 39 years (25-59). There was an incidental diagnosis of ductal carcinoma in situ (DCIS) in 4 women undergoing CPM and 4 patients undergoing prophylactic NSM, including 1 patient diagnosed with bilateral DCIS, and an incidental diagnosis of atypia in 8 patients undergoing prophylactic NSM. In 26 patients undergoing therapeutic NSM, at median follow-up of 2.34 years (range, 0.45-6.06) there were no local or regional recurrences. One patient developed distant metastases and subsequently died from her disease, and 1 other patient died from metastatic ovarian cancer. In 63 patients undergoing prophylactic NSM, at median follow-up of 2.15 years (range, 0.11-8.14) there were no newly diagnosed breast cancers or deaths. Following NSM, 5 patients (5.6%) required subsequent excision of the nipple-areolar complex (3 cases for close or positive DCIS on final histology, 1 case for infection with necrosis, and 1 case for ongoing nipple discharge). All 89 patients had immediate breast reconstruction (tissue expander: n=80; permanent implant: n=8; autologous (DIEP) flap: n=1). Postoperative complications are shown in Table 1. Conclusion: NSM is an acceptable choice for patients with BRCA gene mutations undergoing therapeutic or prophylactic mastectomy with no evidence of compromise to oncological safety. This report shows an acceptable complication rate, and patients rarely required subsequent excision of the nipple-areolar complex. Citation Format: Aidan T Manning, Andrea Pusic, Caitlin Wood, Anne Eaton, Michelle Stempel, Deborah Capko, Virgilio Sacchini. Nipple sparing mastectomy in patients with BRCA1 and BRCA2 mutations [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P2-13-02.

BACKGROUND:Nipple-sparing mastectomy (NSM) is associated with improved cosmesis and is being performed increasingly. Its role in BRCA mutation carriers has not been well described. This was a study of the indications for, and outcomes of, NSM in BRCA mutation carriers.METHODS:BRCA mutation carriers who underwent NSM were identified. Details of patient demographics, surgical procedures, complications, and relevant disease stage and follow-up were recorded.RESULTS:A total of 177 NSMs were performed in 89 BRCA mutation carriers between September 2005 and December 2013. Twenty-six patients of median age 41 years had NSM for early-stage breast cancer and a contralateral prophylactic mastectomy. Mean tumour size was 1·4 (range 0·1-3·5) cm. Sixty-three patients of median age 39 years had prophylactic NSM, eight of whom had an incidental diagnosis of ductal carcinoma in situ. There were no local or regional recurrences in the 26 patients with breast cancer at a median follow-up of 28 (i.q.r. 15-43) months. There were no newly diagnosed breast cancers in the 63 patients undergoing prophylactic NSM at a median follow-up of 26 (11-42) months. All patients had immediate breast reconstruction. Five patients (6 per cent) required subsequent excision of the nipple-areola complex for oncological or other reasons. Skin desquamation occurred in 68 (38·4 per cent) of the 177 breasts, and most resolved without intervention. Debridement was required in 13 (7·3 per cent) of the 177 breasts, and tissue-expander or implant removal was necessary in six instances (3·4 per cent).CONCLUSION:NSM is an acceptable choice for patients with BRCA mutations, with no evidence of compromise to oncological safety at short-term follow-up. Complication rates were acceptable, and subsequent excision of the nipple-areola complex was rarely required.

Background Rates of mastectomy with immediate reconstruction are rising. Skin flap necrosis after this procedure is a recognized complication that can have an impact on cosmetic outcomes and patient satisfaction, and in worst cases can potentially delay adjuvant therapies. Many retrospective studies of this complication have identified variable event rates and inconsistent associated factors. Methods A prospective study was designed to capture the rate of skin flap necrosis as well as pre-, intra-, and postoperative variables, with follow-up assessment to 8 weeks postoperatively. Uni- and multivariate analyses were performed for factors associated with skin flap necrosis. Results Of 606 consecutive procedures, 85 (14 %) had some level of skin flap necrosis: 46 mild (8 %), 6 moderate (1 %), 31 severe (5 %), and 2 uncategorized (0.3 %). Univariate analysis for any necrosis showed smoking, history of breast augmentation, nipple-sparing mastectomy, and time from incision to specimen removal to be significant. In multivariate models, nipple-sparing, time from incision to specimen removal, sharp dissection, and previous breast reduction were significant for any necrosis. Univariate analysis of only moderate or severe necrosis showed body mass index, diabetes, nipple-sparing mastectomy, specimen size, and expander size to be significant. Multivariate analysis showed nipple-sparing mastectomy and specimen size to be significant. Nipple-sparing mastectomy was associated with higher rates of necrosis at every level of severity. Conclusions Rates of skin flap necrosis are likely higher than reported in retrospective series. Modifiable technical variables have limited the impact on rates of necrosis. Patients with multiple risk factors should be counseled about the risks, especially if they are contemplating nipple-sparing mastectomy.

Abstract Introduction: Nipple sparing mastectomy (NSM) is now performed with increasing frequency in both therapeutic and prophylactic breast surgery. The role of NSM in BRCA1 and BRCA2 mutation carriers has not been well described. The aim of this study was to review our experience with NSM in this high-risk population. Methods: A review of the breast database was performed to identify all patients with documented BRCA mutations who underwent NSM at Memorial Sloan Kettering Cancer Center. Data extracted from the database included patient demographics, type of mutation, indication for surgery, type of reconstruction, and complications. For patients undergoing therapeutic mastectomy, data on disease stage, axillary procedures, and follow-up were also extracted. Results: 177 NSMs (88 bilateral, 1 unilateral) were performed in 89 female patients with a documented BRCA mutation between September 2005 and December 2013. There were 56 patients with BRCA1 mutation, 26 with BRCA2 mutation, and 7 with genetic variants of uncertain significance. 26 patients had a therapeutic NSM for breast cancer (stage 0: n=6; stage 1: n=15; stage 2: n=5) and concurrent contralateral prophylactic mastectomy (CPM). The mean tumor size was 1.46cm (range, 0.1-3.5cm), and all were node negative following sentinel lymph node biopsy. 63 patients had NSM for prophylaxis. The mean age of patients undergoing therapeutic NSM was 41 years (range, 26-59) and prophylactic NSM was 39 years (25-59). There was an incidental diagnosis of ductal carcinoma in situ (DCIS) in 4 women undergoing CPM and 4 patients undergoing prophylactic NSM, including 1 patient diagnosed with bilateral DCIS, and an incidental diagnosis of atypia in 8 patients undergoing prophylactic NSM. In 26 patients undergoing therapeutic NSM, at median follow-up of 2.34 years (range, 0.45-6.06) there were no local or regional recurrences. One patient developed distant metastases and subsequently died from her disease, and 1 other patient died from metastatic ovarian cancer. In 63 patients undergoing prophylactic NSM, at median follow-up of 2.15 years (range, 0.11-8.14) there were no newly diagnosed breast cancers or deaths. Following NSM, 5 patients (5.6%) required subsequent excision of the nipple-areolar complex (3 cases for close or positive DCIS on final histology, 1 case for infection with necrosis, and 1 case for ongoing nipple discharge). All 89 patients had immediate breast reconstruction (tissue expander: n=80; permanent implant: n=8; autologous (DIEP) flap: n=1). Postoperative complications are shown in Table 1. Postoperative complications following 177 nipple sparing mastectomies performed in 89 patients with BRCA mutations No. of Breasts; n (%)No. of Patients; n (%)Skin desquamation68 (38.4)40 (44.9)Necrosis requiring debridement18 (10.2)13 (14.6)Infection7 (4.0)7 (7.9)Hematoma3 (1.69)3 (3.4)Complication requiring implant or tissue expander removal6 (3.4)6 (6.7) Conclusion: NSM is an acceptable choice for patients with BRCA gene mutations undergoing therapeutic or prophylactic mastectomy with no evidence of compromise to oncological safety. This report shows an acceptable complication rate, and patients rarely required subsequent excision of the nipple-areolar complex. Citation Format: Aidan T Manning, Andrea Pusic, Caitlin Wood, Anne Eaton, Michelle Stempel, Deborah Capko, Virgilio Sacchini. Nipple sparing mastectomy in patients with BRCA1 and BRCA2 mutations [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P2-13-02.

The extent to which ACOSOG Z0011 findings are applicable to patients undergoing breast-conserving therapy (BCT) is uncertain. We prospectively assessed how often axillary dissection (ALND) was avoided in an unselected, consecutive patient cohort meeting Z0011 eligibility criteria and whether subgroups requiring ALND could be identified preoperatively.

1019 Background: Whether ECE mandates ALND in patients with ≤2 positive sentinel nodes (SN) is controversial. ACOSOG Z11 excluded patients with matted nodes, but did not comment on microscopic ECE. In a prospective, consecutive series of patients, we sought to determine if ECE correlates with the number of positive axillary lymph nodes (LN) and if ECE ≤2mm clinically differs from ECE >2mm. Methods: In 8/2010 an institutional treatment algorithm based on the Z11 results was prospectively applied to consecutive patients having BCS. ALND was performed for ≥3 +SNs. The approach to ECE was not specified. Characteristics of patients with and without ECE were compared with Fisher’s exact test and the Wilcoxon rank sum test. Results: From 8/10-11/12, 2157 invasive breast cancer patients had BCS; 381 had LN metastasis, 287 met Z11 selection criteria, and ALND was avoided in 242 (84%). ECE was present in 111 (39%), of whom 23% had ≥3 +SNs (vs 2% without ECE; p<0.0001) and 35% had ALND (vs 3% without ECE; p<0.0001). The presence of ECE was associated with tumor size (1.9cm vs 1.6; p=.01) but not with age, grade, or receptor status. The degree of ECE was associated with age, grade, number of +SNs, and performance of ALND (Table). In 45 cases, ALND was advised for ≥3 +SNs (n=29) or <3 +SNs with ECE (n=16). 39 patients had ALND and 34 of these had ECE. Additional +LNs were seen in 5/9 patients with ≤2mm ECE and 20/25 with >2mm ECE; median of 1 additional +LN in each group. Seven or more additional +LNs were seen in 6 patients with >2mm ECE; 1 patient with ≤2mm ECE had 6 additional +LNs, the remainder had ≤3. Conclusions: The presence of ECE was associated with ≥3 +SNs and the need for ALND. Only a minority of patients with ≤2mm of ECE had ≥3 +SNs, and nodal disease at ALND in this group was limited, suggesting that ≤2mm ECE may not be an indication for ALND. [Table: see text]

Background Nipple-sparing mastectomy (NSM) has been gathering increased recognition as an alternative to more traditional mastectomy approaches. Initially, questions concerning its oncologic safety limited the use of NSM. Nevertheless, mounting evidence supporting the practice of NSM for both prophylactic and oncologic purposes is leading to its more widespread use and broadened indications. Methods Using a prospectively maintained database, we reviewed our experience of 353 NSM procedures performed in 200 patients over the past 10 years. Results The indications for surgery were: 196 prophylactic risk-reduction (55.5%), 74 ductal carcinoma in situ (DCIS) (20.8%), 82 invasive cancer (23.2%), and 1 phyllodes tumor (0.5%). The nipple areolar complex (NAC) was entirely preserved in 341 mastectomies (96.7%). There were 11 patients (3.1%) who were found to have cancer at the nipple margin, warranting further excision. A total of 69 breasts (19.5%) had some degree of skin desquamation or necrosis, but only 12 (3.3%) required operative debridement, of which 3 breasts (1%) necessitated removal of a breast implant. Also, 6 patients (2%) were treated for infection. Of the 196 prophylactic NSMs, 11 specimens (5.6%) were found to harbor occult cancer (8 DCIS and 3 invasive cancers). One patient who underwent NSM for invasive ductal carcinoma in 2006 developed metastatic disease to her brain. No other recurrences are attributable to the 353 NSMs. Conclusions The trends demonstrate the increasing acceptance of NSM as a prophylactic procedure as well as for therapeutic purposes. Although NSM is not standard, our experience supports the selective use of NSM in both prophylactic and malignant settings.

Background: No conclusive evidence exists concerning the effectiveness of follow-up programs after curative surgery for colorectal cancer, and presently cost-benefit analyses have not indicated that follow-up strategies increase survival or quality of life.