Рандомизированное исследование: лечение пациенток с раком молочной железы стадий I–IIA, IIB (pT1-2 N0-1) после кожесохраняющих/сосоксохраняющих мастэктомий с реконструкцией имплантатами после лучевой терапии

Treatment of patients with breast cancer stage I–II A, B (pT1-2 N0-1) after skin sparing/nipple sparing mastectomies with implant reconstruction after radiation therapy: a randomized trial

Background. Currently, the necessity for radiotherapy after skin-sparing/subcutaneous mastectomy with immediate reconstruction in stage I–II breast cancer remains debatable, especially in the presence of favorable subtypes or complete clinical regression after neoadjuvant polychemotherapy. Material and methods. Retrospective non-randomized examination was conducted on 1135 breast cancer patients who were operated in P.A. Herzen Moscow oncology research institute from 2014 to 2023. All the patients underwent subcutaneous/skin-sparing mastectomies with immediate reconstruction. The patients were divided into two groups – with and without radiotherapy. Results. Recurrence rates were compared between groups based on clinical and morphological tumor characteristics, with a close scrutiny of the obtained data. Conclusion. In the case of stage I–II A, B breast cancer patients undergoing subcutaneous/skin-sparing mastectomy with reconstruction, the risk of recurrence rate in 5 years was 4.3±0.1%. Among radiotherapy and non-radiotherapy group recurrence rate was 2.5±0.6% and 6.9±1.2% (p<0.05), respectively indicating that radiotherapy has 4.4% less risk for recurrence. Our study identified the following criteria for postoperative radiotherapy indication: R1 resection margin, HER2-positive luminal/non-luminal subtype, and pN1 status. © 2025, Geotar Media Publishing Group. All rights reserved.