Investigation of the Current Situation of Nipple-Sparing Mastectomy: A Large Multicenter Study in China

Nipple-sparing mastectomy (NSM) has emerged as a significant advancement in breast surgery, aiming to preserve the nipple-areola complex (NAC) while ensuring oncologic safety. This study evaluates the real-world application of NSM across 28 centers in China, analyzing its feasibility, complications, and factors influencing surgical outcomes. The research provides critical insights into the current status of NSM in a large patient cohort, shedding light on surgical practices, patient selection criteria, and postoperative outcomes in the Chinese healthcare context.

Study Design and Patient Characteristics

The retrospective analysis included 615 patients (641 NSM procedures) treated between January 1 and December 31, 2018. The proportion of NSM among all breast surgeries in China was notably low at 2.67%, with significant variability across centers (range: 0.22%–14.21%). The cohort had a median age of 43 years (range: 22–79), with 74.2% aged 31–50 years. Women constituted 99.5% of participants, including three male cases (gynecomastia or male breast cancer). Malignant tumors dominated the indications for NSM (87.2%, 559/641), primarily invasive ductal carcinoma (63.2%), ductal carcinoma in situ (20.4%), and invasive lobular carcinoma (2.8%). Benign conditions accounted for 10.3% of cases, including intraductal papillomas, phyllodes tumors, and gynecomastia.

Surgical Techniques and Reconstruction Trends

A total of 475 patients (77.3%) underwent NSM combined with immediate reconstruction. Implant-based reconstruction was most prevalent (53.7%), followed by tissue expanders (12.2%) and autologous tissue reconstruction (8.7%). Reconstruction rates inversely correlated with age (P 55 years. Radial incisions were preferred overall (31.4%), while curvilinear incisions were more common in reconstruction cases (18.4%) and circumareolar incisions in non-reconstruction groups (19.1%). Inframammary incisions accounted for 11.9% of procedures.

Oncologic Safety and Pathologic Margins

Tumor characteristics revealed a mean size of 2.4 cm (range: 0.2–15 cm), with 49% ≤2 cm. The tumor-to-nipple distance (TND) significantly influenced outcomes: 12.5% had TND ≤2 cm, associated with higher complication rates (8.8% vs. 1.8% for TND >2 cm, P = 0.004). Multicentric breast cancer showed elevated recurrence (5.0% vs. 0.8% unifocal) and complication rates (5.0% vs. 2.7%). Axillary lymph node involvement correlated with increased metastasis risk (2.2% vs. 0.1% node-negative, P < 0.01). Negative deep nipple-areola margins were achieved in 90.9% of cases. Positive margins occurred in 3.0% (19/641), leading to NAC resection in 68.4% of these cases.

Complications and Recurrence Outcomes

Postoperative complications occurred in 2.93% of cases (18/615), including partial areolar necrosis (4 cases), skin flap necrosis (1 case), poor wound healing (9 cases), hematoma (1 case), and seroma (3 cases). Neither tumor size, location, molecular subtype, nor nipple discharge correlated with complications. At six-month median follow-up, seven patients (1.1%) experienced recurrence/metastasis: two local chest wall recurrences and five distant metastases (two visceral). All recurrence cases involved invasive ductal carcinoma without nipple discharge, with mean TND of 2.85 cm and tumor size of 3.58 cm.

Radiation Therapy and Adjuvant Treatment

Radiotherapy data showed a 13.3% complication rate in NAC-irradiated patients versus 3.1% in chest wall irradiation groups, though not statistically significant (P = 0.161). Systemic therapy included neoadjuvant chemotherapy (14.4%), adjuvant chemotherapy (43.5%), and targeted therapies like Herceptin. Notably, two patients with positive deep margins developed distant metastases despite adjuvant treatment, underscoring the importance of margin clearance.

Critical Discussion and Clinical Implications

This multicenter analysis highlights several key findings:

1. Low NSM Adoption: The 2.67% national rate reflects conservative surgical attitudes, potentially due to concerns about NAC involvement and technical complexity. However, centers performing higher volumes demonstrated feasibility and safety.
2. TND as Key Predictor: The strong association between TND ≤2 cm and complications (8.8% vs. 1.8%) reinforces existing guidelines recommending TND >2 cm for NSM eligibility.
3. Reconstruction Preferences: Younger patients disproportionately chose implant-based reconstruction, emphasizing the importance of aesthetic outcomes in this demographic.
4. Margin Control: The 90.9% negative margin rate supports NSM’s oncologic safety when combined with rigorous intraoperative pathologic assessment.
5. Recurrence Patterns: The 1.1% recurrence rate at six months aligns with global data, validating NSM as an oncologically sound option for appropriately selected patients.

Limitations and Future Directions

As a retrospective study, potential biases in patient selection and data collection exist. The short follow-up period (median six months) limits assessment of long-term recurrence and survival. Prospective studies with standardized surgical protocols and extended surveillance are needed to validate these findings. Additionally, factors like breast size, body mass index, and smoking history—not analyzed here—warrant investigation as potential modulators of complications.

Conclusion

This large-scale study demonstrates that NSM is a viable surgical option in China with acceptable complication rates when adhering to strict selection criteria, particularly maintaining TND >2 cm. The low national adoption rate suggests unmet potential for broader implementation in eligible patients. Future efforts should focus on standardizing surgical techniques, optimizing radiation strategies for margin-positive cases, and conducting long-term outcome studies to reinforce NSM’s role in modern breast oncology.

doi.org/10.1097/CM9.0000000000001350

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