Individualizing Breast Cancer Risk Assessment in Clinical Practice.

Multiple tools exist to assess a patient's breast cancer risk. The choice of risk model depends on the patient's risk factors and how the calculation will impact care. High-risk patients-those with a lifetime breast cancer risk of ≥20%-are, for instance, eligible for supplemental screening with breast magnetic resonance imaging. Those with an elevated short-term breast cancer risk (frequently defined as a 5-year risk ≥1.66%) should be offered endocrine prophylaxis. High-risk patients should also receive guidance on modification of lifestyle factors that affect breast cancer risk.

Impact of consensus guidelines for breast-conserving surgery in patients with ductal carcinoma in situ.

BACKGROUND: Consensus guidelines published in 2016 recommended a 2 mm free margin as the standard for negative margins in patients undergoing breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). The goal of the guideline recommendation was standardization of re-excision practices. AIMS: To evaluate the impact of this consensus guideline on our institutional practices. METHODS: We identified all patients at our institution with pure DCIS who were initially treated with BCS from September 2014 to August 2018 using a prospectively-maintained institutional database. A retrospective chart review was performed to determine margin status and re-excision rates during the 2 years before and the 2 years after the guideline was published in order to determine the effect on our re-excision rates. Close margins were defined as <2 mm. RESULTS: In the 2 years before the consensus guideline was published, 184 patients with DCIS underwent BCS. Twenty-six patients had positive margins and 24 underwent re-excision, including three who had completion mastectomy. Of the remaining 159 patients, 76 had ≥2 mm (negative) margins. The remaining 82 patients had close margins and 48 of these patients (58.5%) underwent re-excision, including one who had a completion mastectomy. Excluding the patients with positive margins, our re-excision rate was 30.4% prior to the guideline. In the 2 years after the consensus guideline was published, 192 patients with DCIS underwent initial BCS. Twenty-four patients had positive margins and 22 underwent re-excision, including three who had completion mastectomy. Of the remaining 168 patients, 95 patients had ≥2 mm (negative) margins. The remaining 73 patients had close margins and 45 of those patients (61.6%) underwent re-excision, including six who had completion mastectomy. Excluding the patients with positive margins, our re-excision rate was 26.8% after the guideline. CONCLUSIONS: Our institution's re-excision rate did not change significantly during the 2 years before and after the publication of the consensus guideline on adequate margins for patients undergoing BCT for DCIS. Our overall re-excision rate decreased slightly. However, of the patients who had close margins, a larger proportion underwent re-excision after the guideline was published. The guideline publication appears to have affected our institutional practices slightly, but not dramatically as many of our surgeons' practices were comparable to the guideline recommendations prior to 2016. We continue to use clinical judgment based on patient and tumor characteristics in deciding which patients will benefit from margin re-excision.

An absence of equipoise: Examining surgeons' decision talk during encounters with women considering breast cancer surgery.

Shared decision-making is recommended for decisions with multiple reasonable options, yet clinicians often subtly or explicitly guide choices. Using purposive sampling, we performed a secondary analysis of 142 audio-recorded encounters between 13 surgeons and women eligible for breast-conserving surgery with radiation or mastectomy. We trained 9 surgeons in shared decision-making and provided them one of two conversation aids; 4 surgeons practiced as usual. Based on a published taxonomy of treatment recommendations (pronouncements, suggestions, proposals, offers, assertions), we examined how surgeons framed choices with patients. Many surgeons made assertions providing information and advice (usual care 71% vs. intervention 66%; p = 0.54). Some made strong pronouncements (usual care 51% vs. intervention 36%; p = .09). Few made proposals and offers, leaving the door open for deliberation (proposals usual care 21% vs. intervention 26%; p = 0.51; offers usual care 40% vs. intervention 40%; p = 0.98). Surgeons were significantly more likely to describe options as comparable when using a conversation aid, mentioning this in all intervention group encounters (usual care 64% vs. intervention 100%; p<0.001). Conversation aids can facilitate offers of comparable options, but other conversational actions can inhibit aspects of shared decision-making.

What matters most: Randomized controlled trial of breast cancer surgery conversation aids across socioeconomic strata.

BACKGROUND: Women of lower socioeconomic status (SES) with early-stage breast cancer are more likely to report poorer physician-patient communication, lower satisfaction with surgery, lower involvement in decision making, and higher decision regret compared to women of higher SES. The objective of this study was to understand how to support women across socioeconomic strata in making breast cancer surgery choices. METHODS: We conducted a 3-arm (Option Grid, Picture Option Grid, and usual care), multisite, randomized controlled superiority trial with surgeon-level randomization. The Option Grid (text only) and Picture Option Grid (pictures plus text) conversation aids were evidence-based summaries of available breast cancer surgery options on paper. Decision quality (primary outcome), treatment choice, treatment intention, shared decision making (SDM), anxiety, quality of life, decision regret, and coordination of care were measured from T0 (pre-consultation) to T5 (1-year after surgery. RESULTS: Sixteen surgeons saw 571 of 622 consented patients. Patients in the Picture Option Grid arm (n = 248) had higher knowledge (immediately after the visit [T2] and 1 week after surgery or within 2 weeks of the first postoperative visit [T3]), an improved decision process (T2 and T3), lower decision regret (T3), and more SDM (observed and self-reported) compared to usual care (n = 257). Patients in the Option Grid arm (n = 66) had higher decision process scores (T2 and T3), better coordination of care (12 weeks after surgery or within 2 weeks of the second postoperative visit [T4]), and more observed SDM (during the surgical visit [T1]) compared to usual care arm. Subgroup analyses suggested that the Picture Option Grid had more impact among women of lower SES and health literacy. Neither intervention affected concordance, treatment choice, or anxiety. CONCLUSIONS: Paper-based conversation aids improved key outcomes over usual care. The Picture Option Grid had more impact among disadvantaged patients. LAY SUMMARY: The objective of this study was to understand how to help women with lower incomes or less formal education to make breast cancer surgery choices. Compared with usual care, a conversation aid with pictures and text led to higher knowledge. It improved the decision process and shared decision making (SDM) and lowered decision regret. A text-only conversation aid led to an improved decision process, more coordinated care, and higher SDM compared to usual care. The conversation aid with pictures was more helpful for women with lower income or less formal education. Conversation aids with pictures and text helped women make better breast cancer surgery choices.

A prospective cohort study to analyze the interaction of tumor-to-breast volume in breast conservation therapy versus mastectomy with reconstruction.

PURPOSE: We explored the impact of the relative volume of a tumor versus the entire breast on outcomes in patients undergoing breast conservation therapy (BCT) versus mastectomy and reconstruction (M + R). We hypothesized that there would be a threshold tumor:breast ratio (TBR) below which patient-reported outcomes (PRO) would favor BCT and above which would favor M + R. METHODS: We conducted a prospective cohort study of patients with ductal carcinoma in situ (DCIS) or invasive breast cancers undergoing BCT or M + R. A prerequisite for inclusion, analysis of tumor and breast volumes was conducted from three-dimensional magnetic resonance imaging reconstructions to calculate the TBR. Three-dimensional photography was utilized to calculate pre- and postoperative volumes and assess symmetry. Oncologic, surgical, and patient-reported outcome data were obtained from relevant BREAST-Q modules administered pre- and postoperatively. RESULTS: The BCT cohort had significantly smaller tumor volumes (p = 0.001) and lower TBRs (p = 0.001) than patients undergoing M + R overall. The M + R group, however, comprised a broader range of TBRs, characterized at lower values by patients opting for contralateral prophylactic mastectomy. Postoperative satisfaction with breasts, psychosocial, and sexual well-being scores were significantly higher in the BCT cohort, while physical well-being significantly favored the M + R cohort 480.2 ± 286.3 and 453.1 ± 392.7 days later, respectively. CONCLUSIONS: Relative to BCT, M + R was used to manage a broad range of TBRs. The relative importance of oncologic and surgical risk reduction, symmetry, and number of procedures can vary considerably and may limit the utility of TBR as a guide for deciding between BCT and M + R. Clinical Trial StatementThis study was registered with clinicaltrials.gov as "A Prospective Trial to Assess Tumor:Breast Ratio and Patient Satisfaction Following Lumpectomy Versus Mastectomy With Reconstruction", Identifier: NCT02216136.

Single-Institution Phase 1/2 Prospective Clinical Trial of Single-Fraction, High-Gradient Adjuvant Partial-Breast Irradiation for Hormone Sensitive Stage 0-I Breast Cancer.

PURPOSE: We sought to evaluate the feasibility and tolerability of a novel accelerated partial breast irradiation regimen delivered in a single fraction postoperatively. METHODS AND MATERIALS: We enrolled 50 patients with low-risk, hormone-sensitive breast cancer from 2015 to 2018 on a prospective phase 1/2 trial to receive single-fraction, high-gradient partial-breast irradiation (SFHGPBI) 2 to 8 weeks after lumpectomy for node-negative, invasive, or in situ breast cancer. The high gradient was achieved by prescribing 20 Gy to the surgical bed and 5 Gy to the breast tissue within 1 cm of the surgical bed simultaneously in 1 fraction using external beam. RESULTS: The median age was 65 (range, 52-84). Ten patients (20%) had small-volume ductal carcinoma in situ while the remainder had stage I disease. At a median follow-up of 25 months, we evaluated toxicity, patient- and physician-reported cosmesis, patient-reported quality of life (QOL), and initial tumor control. There was no Common Terminology Criteria for Adverse Events v4.0 grade 3+ toxicity. Only 34% of patients experienced grade 1 erythema. Good-to-excellent pretreatment cosmesis was present in 100% and 98% per physicians and patients, respectively, and did not change post-SFHGPBI. Quantitative cosmesis by percentage of breast retraction assessment significantly improved over time during the post-SFHGPBI period per mixed repeated measures modeling (P = .0026). QOL per European Organization for Research and Treatment of Cancer QOL Questionnaires C30 and BR-23 did not decline other than temporarily in the systemic therapy effects and hair loss domains, both of which returned to pretreatment values. There was 1 noninvasive in-breast recurrence in a separate untreated quadrant 18 months post-SFHGPBI and 1 isolated axillary recurrence 30 months post-SFHGPBI, both salvaged successfully. There were no distant recurrences or cancer-related deaths observed. CONCLUSIONS: Accelerated partial-breast irradiation delivered in a single fraction postoperatively using external beam techniques is a novel, feasible, well-tolerated regimen. SFHGPBI does not adversely affect cosmesis or QOL as reported by both physicians and patients. Initial tumor control rates are excellent, with longer follow-up required to confirm efficacy.

Oncologic Safety and Outcomes in Patients Undergoing Nipple-Sparing Mastectomy.

BACKGROUND: Nipple-sparing mastectomy (NSM) is an alternative to skin-sparing mastectomy in appropriately selected patients. The aim of this study was to review our experience with NSM and to evaluate for oncologic safety. STUDY DESIGN: Patients who underwent NSM at our institution from September 2008 through August 2017 were identified after IRB approval. Data included patient age, tobacco use, tumor size, hormone receptor status, lymph node status, radiation and chemotherapy use, incision type, and reconstruction type. Statistical analyses were performed using ANOVA and chi-square tests. RESULTS: There were 322 patients who underwent 588 NSM (83% bilateral, 17% unilateral), including 399 (68%) for malignancy (Stage 0 [27%], I [44%], II [25%] and III [4%]). The overall rate of wound complication was 18.9%. Tobacco use increased complication (37.5% vs 16.3%, p < 0.001), as did adjuvant radiation therapy (31.4% vs 17.4%, p = 0.014). Patients with lymph node involvement and larger tumor size had a higher rate of complication (31.3% vs 17.2%, p = 0.016). Patients undergoing circumareolar incisions had a higher rate of complication than those undergoing lateral radial, inframammary fold, or curvilinear incisions (43.5% vs 17.4% vs 17.4% vs 14.3%, respectively, p = 0.018). Six (1%) local chest wall recurrences occurred during the follow-up period, none of which involved the nipple-areolar complex. Four patients (1%) suffered a distant recurrence. CONCLUSIONS: Most NSM performed at our institution are in patients with malignancy. The oncologic safety is confirmed by the low locoregional recurrence rate. Tobacco use and adjuvant radiation therapy remain the most significant risk factors for complication, highlighting the need for careful patient selection and patient counseling regarding modifiable risk factors and expected outcomes.

Long-Term Outcomes with 3-Dimensional Conformal External Beam Accelerated Partial Breast Irradiation.

PURPOSE: Long-term tumor control and cosmetic outcomes for accelerated partial breast radiation (APBI) delivered with 3-dimensional conformal external beam radiation (3D-CRT) remain limited. We seek to address these concerns by reporting our experience of 3D-CRT APBI with extended follow-up. METHODS AND MATERIALS: All patients treated with APBI delivered with 3D-CRT from January 2006 through December 2012 at a single institution were identified. Those with more than a year of follow-up were analyzed for ipsilateral breast tumor recurrence (IBTR), progression-free survival (PFS), cosmesis, and pain. Disease outcomes were analyzed by margin status (<2 mm, ≥2 mm), total radiation dose prescribed, presence of invasive disease, and American Society for Radiation Oncology (ASTRO) 2016 updated consensus groupings (suitable, cautionary, and unsuitable). RESULTS: Two hundred ninety-three patients were identified, of whom 266 had >1 year of follow-up. Median follow-up was 87 months (range, 13-156). Of the 266, 162 (60.9%) were ASTRO "suitable," 87 (32.7%) were "cautionary," and 17 (6.4%) were "unsuitable." Seven-year rates of IBTR and PFS were 1.8% and 95.2%, respectively. Margin status, invasive versus in situ disease, prescribed dose, and ASTRO grouping were not prognostic for either IBTR or PFS on univariate analysis. Cosmesis was good to excellent in 75.2%. Two patients (0.8%) had subsequent plastic surgery owing to poor cosmesis. Narcotic medication for treatment site pain was needed by 6 (2.3%). CONCLUSIONS: External beam APBI results in excellent long-term disease control. Good to excellent cosmetic outcomes are achieved in most patients, although increasing dose per fraction and greater percentage of irradiated breast were predictive of adverse posttreatment cosmetic outcomes. Select patients in "cautionary" and "unsuitable" consensus groupings do not appear to have inferior outcomes.

Predictors of Locoregional Recurrence After Failure to Achieve Pathologic Complete Response to Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer.

BACKGROUND: This study evaluated factors predictive of locoregional recurrence (LRR) in women with triple-negative breast cancer (TNBC) treated with neoadjuvant chemotherapy who do not experience pathologic complete response (pCR). METHODS: This is a single-institution retrospective review of women with TNBC treated with neoadjuvant chemotherapy, surgery, and radiation therapy in 2000 through 2013. LRR was estimated between patients with and without pCR using the Kaplan-Meier method. Patient-, tumor-, and treatment-specific factors in patients without pCR were analyzed using the Cox proportional hazards method to evaluate factors predictive of LRR. Log-rank statistics were then used to compare LRR among these risk factors. RESULTS: A total of 153 patients with a median follow-up of 48.6 months were included. The 4-year overall survival and LRR were 70% and 15%, respectively, and the 4-year LRR in patients with pCR was 0% versus 22.0% in those without (P<.001). In patients without pCR, lymphovascular space invasion (LVSI; hazard ratio, 3.92; 95% CI, 1.64-9.38; P=.002) and extranodal extension (ENE; hazard ratio, 3.32; 95% CI, 1.35-8.15; P=.009) were significant predictors of LRR in multivariable analysis. In these patients, the 4-year LRR with LVSI was 39.8% versus 15.0% without (P<.001). Similarly, the 4-year LRR was 48.1% with ENE versus 16.1% without (P=.002). In patients without pCR, the presence of both LVSI and ENE were associated with an even further increased risk of LRR compared with patients with either LVSI or ENE alone and those with neither LVSI nor ENE in the residual tumor (P<.001). CONCLUSIONS: In patients without pCR, the presence of LVSI and ENE increases the risk of LRR in TNBC. The risk of LRR is compounded when both LVSI and ENE are present in the same patient. Future clinical trials are warranted to lower the risk of LRR in these high-risk patients.

Treatment response as predictor for brain metastasis in triple negative breast cancer: A score-based model.

BACKGROUND: Triple negative breast cancer (TNBC) has worse prognosis than other subtypes of breast cancer, and many patients develop brain metastasis (BM). We developed a simple predictive model to stratify the risk of BM in TNBC patients receiving neo-adjuvant chemotherapy (NAC), surgery, and radiation therapy (RT). METHODS: Patients with TNBC who received NAC, surgery, and RT were included. Cox proportional hazards method was used to evaluate factors associated with BM. Significant factors predictive for BM on multivariate analysis (MVA) were used to develop a risk score. Patients were divided into three risk groups: low, intermediate, and high. A receiver operating characteristic (ROC) curve was drawn to evaluate the value of the risk group in predicting BM. This predictive model was externally validated. RESULTS: A total of 160 patients were included. The median follow-up was 47.4 months. The median age at diagnosis was 49.9 years. The 2-year freedom from BM was 90.5%. Persistent lymph node positivity, HR 8.75 (1.76-43.52, P = 0.01), and lack of downstaging, HR 3.46 (1.03-11.62, P = 0.04), were significant predictors for BM. The 2-year rate of BM was 0%, 10.7%, and 30.3% (P < 0.001) in patients belonging to low-, intermediate-, and high-risk groups, respectively. Area under the ROC curve was 0.81 (P < 0.001). This model was externally validated (C-index = 0.79). CONCLUSIONS: Lack of downstaging and persistent lymph node positivity after NAC are associated with development of BM in TNBC. This model can be used by the clinicians to stratify patients into the three risk groups to identify those at increased risk of developing BM and potentially impact surveillance strategies.

Nipple-Sparing Mastectomy Incisions for Cancer Extirpation Prospective Cohort Trial: Perfusion, Complications, and Patient Outcomes.

BACKGROUND: Nipple-sparing mastectomy offers several advantages for women seeking postmastectomy breast reconstruction, but compromised skin and nipple perfusion may lead to skin and nipple necrosis. It is unclear whether the incisional approach contributes to these complications; therefore, the purpose of this study was to compare the impact of incision type on outcomes in patients undergoing nipple-sparing mastectomy. METHODS: This is a prospective cohort study of patients undergoing nipple-sparing mastectomy with prosthetic breast reconstruction through an inframammary fold versus a lateral radial incision. Skin and nipple perfusion as represented by fluorescence intensity, mammometric parameters, patient-reported outcomes, and clinical outcomes were analyzed and compared for the two cohorts, and multivariable logistic regression models were performed to evaluate the effects of covariates on outcomes. RESULTS: Seventy-nine patients were studied: 55 in the inframammary fold cohort and 24 in the lateral radial cohort. The inframammary fold group had significantly less fluorescence intensity to the inferior (21.9 percent versus 36.9 percent; p = 0.001) and lateral portions of breast skin (23.1 percent versus 40.7 percent; p = 0.003) after reconstruction. Decreased fluorescence intensity was associated with smoking, decreased mean arterial pressure, and greater specimen weight. Postreconstruction breast volumes were increased over preoperative volumes in the inframammary fold group (38.3 percent) versus the lateral radial (31.2 percent) group; however, patients with a lateral radial incision had a greater increase in satisfaction with their breasts and psychosocial well-being. CONCLUSIONS: There are significant differences in patient-reported outcomes and final breast volumes based on the incisional approach to nipple-sparing mastectomy. These data can be used to guide providers and counsel patients considering nipple-sparing mastectomy with prosthetic reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Breast Cancer, Version 4.2017, NCCN Clinical Practice Guidelines in Oncology.

Ductal carcinoma in situ (DCIS) of the breast represents a heterogeneous group of neoplastic lesions in the breast ducts. The goal for management of DCIS is to prevent the development of invasive breast cancer. This manuscript focuses on the NCCN Guidelines Panel recommendations for the workup, primary treatment, risk reduction strategies, and surveillance specific to DCIS.

Long-term outcomes of APBI via multicatheter interstitial HDR brachytherapy: Results of a prospective single-institutional registry.

PURPOSE: Long-term outcome reports of accelerated partial-breast irradiation (APBI) are limited. Here, we report the 10-year outcomes of APBI delivered using multicatheter interstitial implant (ISI) brachytherapy. METHODS AND MATERIALS: Patients with early-stage breast cancer treated with APBI via ISI brachytherapy were enrolled in a prospective registry. Selection criteria included age ≥40 years, ductal carcinoma in situ or invasive tumor ≤3 cm, negative margins (≥2 mm), and negative axillary nodes. 34 Gy in 10 twice-daily fractions was administered to 2 cm of breast tissue surrounding the surgical bed. Toxicity and cosmetic outcomes were collected prospectively. RESULTS: A total of 175 patients were included. The median followup time was 10.0 years. Ten-year ipsilateral breast tumor control, regional control, freedom from distant metastasis, breast cancer-specific survival, and overall survival were 92.1%, 96.9%, 97.4%, 97.1%, and 81.2%, respectively. High-grade disease was correlated with increase in the rate of ipsilateral breast tumor recurrence. Grade 1 or 2 skin toxicity was present in 44 patients, and Grade 3 skin toxicity was present in only 1 patient. There were no Grade 4 or higher toxicities observed. Thirty-seven patients developed fat necrosis. Dose Homogeneity Index of ≤0.85 and integrated reference air-kerma of >3400 cGycm2/h correlated with higher rates of fat necrosis. There were 115 (66%), 51 (29%), 8 (5%), and 0 (0%) patients having excellent, good, fair, and poor cosmetic outcomes, respectively. CONCLUSIONS: APBI using ISI brachytherapy offers excellent clinical outcomes in appropriately selected patients with excellent cosmetic outcomes and low rates of toxicities such as symptomatic fat necrosis.

Overuse of Chest CT in Patients With Stage I and II Breast Cancer: An Opportunity to Increase Guidelines Compliance at an NCCN Member Institution.

Background: The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) recommend that patients with clinical stage I/II breast cancer undergo advanced imaging for staging only when symptomatic. Regardless, many asymptomatic patients undergo chest CT. The goal of this study was to assess the use and results of chest CT in these patients at an NCCN Member Institution. Methods: Patients with breast cancer diagnosed between 1998 and 2012 were identified in a prospectively maintained database. All patients with clinical stage I/II disease who did not receive neoadjuvant chemotherapy were included. Data collected included demographics, tumor size, node status, chest CT within 6 months of diagnosis, imaging findings, need for additional workup, and identification of metastatic disease. Appropriate statistical tests were used for analysis. Results: From 1998 to 2012, 3,321 patients were diagnosed with early-stage breast cancer. Of these, 2,062 (62.1%) had clinical stage I breast cancer at diagnosis and 1,259 (37.9%) had stage II; 227 patients (11%) with stage I and 456 (36.2%) with stage II breast cancer received staging chest CT. Of patients undergoing CT, 184 (26.9%) were found to have pulmonary nodules, which measured ≤5 mm for 128 patients (69.6%), 5 to 10 mm for 46 patients (25.0%), 11 to 20 mm for 6 patients (3.2%), and ≥20 mm for 4 patients (2.2%). Patients undergoing chest CT for staging subsequently underwent a mean of 2.34 (range, 0-16) additional CTs in follow-up. Of all patients undergoing chest CT for staging, only 9 (1.3%) were ultimately diagnosed with pulmonary metastases at an average of 25 months (range, 0-97) after initial staging chest CT. Conclusions: A significant percentage of patients with stage I/II breast cancer underwent unnecessary chest CT as part of their initial workup. Nearly one-third of these patients were found to have pulmonary nodules, but only 1.3% were ever diagnosed with pulmonary metastases. Adherence to NCCN Guidelines will reduce the excessive use of CT chest imaging.

Nipple-sparing mastectomies: Clinical outcomes from a single academic institution.

Nipple-sparing mastectomies (NSMs) are increasingly used in the surgical treatment of patients with breast cancer and for prevention of breast cancer. The present study was performed to review the outcomes of patients undergoing NSMs at a single large university setting. A retrospective chart review was performed on all patients undergoing NSMs from 2008-2014. Charts were reviewed for demographic data and patient characteristics. Tumor and breast size, cancer recurrence and complications were also evaluated. Descriptive statistics were utilized to summarize the findings. From 2008-2014, 110 patients underwent 197 NSMs. The mean patient age was 44.4 years (range, 20-77). The average body mass index was 24 (range, 18-47). Breast weight was available for 106 specimens, with a mean weight of 475.5 g (range, 124.1-1,625.0 g). Seventy-three NSMs were performed for cancer and 124 were performed prophylactically. The mean tumor width was 1.38 cm (range, 0-6.0 cm), with an average nipple to tumor distance of 5.87 cm (range, 2.93-10.0 cm). Three (4%) patients required removal of the nipple areolar complex (NAC) due to pathological extension of the tumor. A total of 34 (17.2%) complications occurred, including infections, hematomas and nipple necrosis, with 9 requiring removal of the NAC and 13 requiring removal of the tissue expander or implant. Smokers had a 36.0% (9/25) complication rate, compared with 14.5% (25/172) of nonsmokers (P<0.05). During follow-up, one recurrence was noted, located on the chest wall. There were no recurrences in the NAC group. Therefore, NSMs may safely be performed without compromising oncologic outcomes or increasing complication rates in properly selected patients.