Mastectomy with or without immediate implant reconstruction has similar 30-day perioperative outcomes

invasion, which apparently increase this predictive power. As a result of this article, clearly useful information has become available that can be applied in routine practice. An important finding is regarding the triple-negative group. Triple-negative tumors are high grade tumors and behave aggressively but have a lower incidence of axillary nodal involvement than the other groups, and thus patients with triplenegative tumors may be spared axillary nodal dissection even when 2 SNs show metastatic involvement. However, some clarifications are in order. Using estrogen receptor/ progesterone receptor/human epidermal growth factor receptor 2 results as the basis for determining molecular signature is inaccurate; it would be better to designate the groups simply by their immunohistochemical characteristics with regard to the recep-

tors. It is not clear what purpose such co-opted molecular terminology offers over categorization of tumors merely by their immunohistochemical profile for tumor markers. Tumor grade is an important biological characteristic of breast cancer. Future studies should include grade in conjunction with other clinicopathologic variables, including receptor status. This may offer a better resolution particularly in the estrogen receptor-positive subgroup, which comprises low-, intermediate-, and high-grade tumors. Although the cases reported in this article had 1-2 positive SNs on hematoxylin and eosin-stained sections, we do not know whether any of these were micro-metastases or isolated tumor cells. Also, the article did not reveal whether the additional positive axillary lymph nodes were all macro-metastases or included micro-

metastases/isolated tumor cells. This information is obviously of clinical importance. Similarly, with regard to extracapsular extension, it would be interesting to know if the extension was minimal or significant. A cutoff at 2 mm for extent of extracapsular extension may be expedient, as this cutoff is already being used at some centers in deciding on postmastectomy radiation therapy in patients with invasive breast cancer with limited axillary nodal disease. In summary, this is an important article that provides further insight to help resolve the dilemma facing breast surgeons when it comes to deciding whether to offer axillary nodal dissection to patients with 1-2 positive SNs. D. Giri, MD

COSMETIC AND RECONSTRUCTIVE SURGERY Mastectomy with or without immediate implant reconstruction has similar 30day perioperative outcomes Fischer JP, Wes AM, Tuggle CT, et al (Hosp of the Univ of Pennsylvania, Philadelphia; Yale Univ School of Medicine, New Haven, CT; et al) J Plast Reconstr Aesthetic Surg 67:1515-1522, 2014

Background.dImmediate breast reconstruction (IBR) using implants

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remains a favorable reconstructive option in breast cancer. Understanding the added risk associated with IBR continues to enhance the risk counseling process and management of these patients. Methods.dWomen undergoing mastectomy alone and mastectomy with tissue expander (TE) were identified in the ACS-NSQIP datasets. Specific complications examined included any, wound, medical complications, and deep infections. Bivariate and multivariate analyses were performed to identify predictors of outcomes, and

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propensity-matching was used to compare cohorts. Results.dA total of 42,823 patients who underwent either mastectomy alone (N ¼ 30,440) or mastectomy with immediate TE placement (N ¼ 12,383) were identified. Notable independently associated perioperative differences between mastectomy and TE patients included: race (P < 0.001), comorbidity burden (P < 0.001), year of surgery (P < 0.001), ASA physical status (P < 0.001), functional status (P < 0.001), inpatient procedures (P < 0.001), bilateral procedures

(P < 0.001), BMI (P < 0.001), age (P < 0.001), and lymphadenectomy (P < 0.001). IBR using TE was not found to be associated with greater risk of wound (3.3% vs. 3.2%, P ¼ 0.855), medical (1.7% vs. 1.6%, P ¼ 0.751), or overall (9.6% vs. 10.0%, P ¼ 0.430) complications. TE placement was associated with higher rates of deep wound infections (2.0% vs. 1.0%, P < 0.001) and unplanned reoperations (6.9% vs. 6.1%, P ¼ 0.025). Additionally, the rate of 30-day device loss was 0.8% in patients receiving reconstruction. Multivariate conditional (fixed-effects) logistic regression analysis failed to demonstrate significantly associated independent risk of wound, medical, or overall complications with the addition of TE. Conclusions.dUndergoing IBR with TE placement does not confer added risk of wound, medical, or overall morbidity relative to mastectomy alone based upon propensity-matched 30-day complication rates in 15,238 patients from the 2005e2011 ACSNSQIP datasets. These findings further confirm the safety profile of prostheticbased IBR. Level of Evidence.dPrognostic/ risk category, level II. As reported in this article, Fischer and colleagues assessed perioperative outcomes after mastectomy alone versus mastectomy with IBR using implants. The authors evaluated the American College of Surgeons National Surgical Quality Improvement Program database from 2005 to 2011 to identify all female patients who underwent mastectomy. A total of 42 823 patients were found, with 30 440 patients undergoing mastectomy alone and 12 383 patients undergoing mastectomy with immediate TE breast reconstruction. Thirtyday perioperative wound and medical

complication rates were studied. Younger patients and white patients were more likely to undergo TE reconstruction. In addition, TE patients had a lower comorbidity rate (P < .001) and lower body mass index (P < .001) preoperatively. Patients who underwent mastectomy alone were found to have higher rates of wound complications (P ¼ .025) and medical complications (P < .001), while the presence of any complication (P ¼ .017), unplanned reoperations (P < .001), and deep wound infections (P < .001) were more common in the TE cohort. There was a device failure rate of 0.8% in the TE group. Propensity matching based on preoperative differences was performed to control for selection bias, as the use of TEs was nonrandomized. A cohort of 15 238 patients were split between mastectomy alone (N ¼ 7619) and TE placement (N ¼ 7619). In this analysis, the TE group was older (P < .001) and less likely to smoke (P < .001). Not surprisingly, immediate TE placement was associated with increased operative time (P < .0001). Bivariate analysis showed that superficial infection was more common in the mastectomy-alone group (P ¼ .005), while deep wound infections (P < .001), unplanned reoperations (P ¼ .025), deep venous thrombosis (P ¼ .011), and pulmonary embolism (P ¼ .032) were more common in TE patients. Similar to other cohort studies,1-3 multivariate logistic regression analysis identified smoking as a factor associated with any postoperative complication (P < .001), wound complications (P < .001), and deep wound infections (P ¼ .05). Several large, retrospective, single-institution cohort studies have evaluated risk factors and complications associated with TE placement

immediately after mastectomy; however, this is the only study of IBR to use a prospectively collected, validated national database that is generalizable to a large population. Complications such as deep wound infections, unplanned reoperations, and thromboembolic events were higher in the TE group but may also be associated with the expected longer operative times in these cases. In addition, smoking alone is an independent risk factor for an increase in perioperative morbidity, as has been confirmed by several previous studies.1-3 Unfortunately, owing to the nature of this study and the database, late complications, which are relevant to TE placement, were not captured, as modality-specific complications such as capsular contracture or device failure are often delayed findings. In addition, other factors influencing reconstructive selection, reoperation rates, and conversion to autologous tissue reconstruction were not addressed, including surgeon experience, practice setting, initial cancer staging or prophylaxis, and postmastectomy radiation therapy. IBR offers a psychosocial benefit to our patients and greatly improves patient satisfaction and quality of life. Given that the rates of TE or implant-based reconstruction after mastectomy continue to rise in the United States, prospectively collected data regarding preoperative risk and perioperative complications are useful for surgeons counseling patients for IBR. Fischer and colleagues effectively demonstrated that IBR with TE placement showed rates of 30-day wound and medical complications similar to those of mastectomy alone, although, as with any reconstructive efforts, patient selection and long-term expectations must be clearly managed. Long-term, prospective-outcome studies in breast

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reconstruction will complement shortterm quality improvement studies such as the one reviewed here. N. Gangopadhyay, MD S. E. Hanson, MD, PhD

References 1. Reish RG, Damjanovic B, Austen WG Jr, et al. Infection

following implant-based reconstruction in 1952 consecutive breast reconstructions: salvage rates and predictors of success. Plast Reconstr Surg. 2013;131:1223-1230. 2. McCarthy CM, Mehrara BJ, Riedel E, et al. Predicting complications following expander/implant breast reconstruction: an outcomes analysis based on preoperative clinical risk. Plast Reconstr Surg. 2008;121: 1886-1892.

3. Woerdeman LA, Hage JJ, Hofland MM, Rutgers EJ. A prospective assessment of surgical risk factors in 400 cases of skinsparing mastectomy and immediate breast reconstructions with implants to establish selection criteria. Plast Reconstr Surg. 2007;119:455-463.

RADIATION THERAPY Accelerated partial breast irradiation using intensitymodulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial Livi L, Meattini I, Marrazzo L, et al (Univ of Florence, Italy) Eur J Cancer 51:451-463, 2015

Background.dAccelerated partial breast irradiation (APBI) has been introduced as an alternative treatment method for selected patients with early stage breast cancer (BC). Intensitymodulated radiotherapy (IMRT) has the theoretical advantage of a further increase in dose conformity compared with three-dimensional techniques, with more normal tissue sparing. The aim of this randomised trial is to compare the local recurrence and survival of APBI using the IMRT technique after breast-conserving surgery to conventional whole-breast irradiation (WBI) in early stage BC.

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Methods.dThis study was performed at the University of Florence (Florence, Italy). Women aged more than 40 years affected by early BC, with a maximum pathological tumour size of 25 mm, were randomly assigned in a 1:1 ratio to receive either WBI or APBI using IMRT. Patients in the APBI arm received a total dose of 30 Gy to the tumour bed in five daily fractions. The WBI arm received 50 Gy in 25 fractions, followed by a boost on the tumour bed of 10 Gy in five fractions. The primary end-point was occurrence of ipsilateral breast tumour recurrences (IBTRs); the main analysis was by intention-to-treat. This trial is registered with ClinicalTrials. gov, number NCT02104895. Findings.dA total of 520 patients were randomised (260 to external WBI and 260 to APBI with IMRT) between March 2005 and June 2013. At a median follow-up of 5.0 years (Interquartile Range (IQR) 3.4e7.0), the IBTR rate was 1.5% (three cases) in the APBI group (95% confidence interval (CI) 0.1e3.0) and in the WBI group

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(three cases; 95% CI 0.0e2.8). No significant difference emerged between the two groups (log rank test p ¼ 0.86). We identified seven deaths in the WBI group and only one in the APBI group (p ¼ 0.057). The 5-year overall survival was 96.6% for the WBI group and 99.4% for the APBI group. The APBI group presented significantly better results considering acute (p ¼ 0.0001), late (p ¼ 0.004), and cosmetic outcome (p ¼ 0.045). Interpretation.dTo our knowledge, this is the first randomised study using the IMRT technique for APBI delivery. No significant difference in terms of IBTR and overall survival was observed between the two arms. APBI displayed a significantly better toxicity profile. This article by Livi and colleagues reports a small but wellexecuted randomized trial that compared conventional WBI to a highly conformal noninvasive external-beam technique for APBI. The conformal APBI technique