The Oncological Safety of Nipple-Sparing Mastectomy: A Systematic Review of the Literature with a Pooled Analysis of 12,358 Procedures

Abstract

Nipple-sparing mastectomy (NSM) is increasingly popular as a procedure for the treatment of breast cancer and as a prophylactic procedure for those at high risk of developing the disease. However, it remains a controversial option due to questions regarding its oncological safety and concerns regarding locoregional recurrence. This systematic review with a pooled analysis examines the current literature regarding NSM, including locoregional recurrence and complication rates. Systematic electronic searches were conducted using the PubMed database and the Ovid database for studies reporting the indications for NSM and the subsequent outcomes. Studies between January 1970 and January 2015 (inclusive) were analysed if they met the inclusion criteria. Pooled descriptive statistics were performed. Seventy-three studies that met the inclusion criteria were included in the analysis, yielding 12,358 procedures. After a mean follow up of 38 months (range, 7.4–156 months), the overall pooled locoregional recurrence rate was 2.38%, the overall complication rate was 22.3%, and the overall incidence of nipple necrosis, either partial or total, was 5.9%. Significant heterogeneity was found among the published studies and patient selection was affected by tumour characteristics. We concluded that NSM appears to be an oncologically safe option for appropriately selected patients, with low rates of locoregional recurrence. For NSM to be performed, tumours should be peripherally located, smaller than 5 cm in diameter, located more than 2 cm away from the nipple margin, and human epidermal growth factor 2-negative. A separate histopathological examination of the subareolar tissue and exclusion of malignancy at this site is essential for safe oncological practice. Long-term follow-up studies and prospective cohort studies are required in order to determine the best reconstructive methods.

Determinants of short and long term outcomes in patients undergoing immediate breast reconstruction following neoadjuvant chemotherapy

“…A number of studies have addressed the risk of nipple areola complex or skin recurrence in patients undergoing SSM and NSM. Rates of LRR in patients with smaller tumors have been reported to be between 2% and 12% and in patients with LABC, LRR rates of 2‐14% have been reported . Our study results demonstrate a low LRR recurrence rate of 3.2% in a cohort of patients who received NAC prior to NSM/SSM with IR, supporting the procedure's oncologic safety.…”

“…In a systematic review which included 3331 NSMs, the rate of partial nipple necrosis was reported in 9.1%, complete necrosis in 2.0% (range, 0‐10), skin flap necrosis in 9.5%, and overall expander‐implant loss in 3.9% . A more recent systematic review of 12 358 patients demonstrated an overall complication rate of 22.3% and an overall incidence of partial or total nipple necrosis of 5.9% . A study using the ACS‐NSQIP database showed that 6.8% of patients undergoing mastectomy with IR experienced a return to the operating room for a complication within 30‐days of operation .…”

Nipple-sparing and skin-sparing mastectomy: Review of aims, oncological safety and contraindications

“…Headon et al [20] conducted a pooled analysis of 12,358 NSMs to assess complications (and oncological safety). The overall complication rate was 22.3% and the nipple necrosis rate was 5.9%.…”

Hereditary lobular breast cancer with an emphasis on E-cadherin genetic defect

“…A recent meta-analysis of nipple-sparing mastectomy (NSM) reported an overall complication rate of 22% and a nipple necrosis rate of 5.9% 91. On the other hand, the aesthetic outcome can be significantly improved by conserving the NAC 92 93…”