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BREAST试验中关于自体脂肪移植(AFT)用于全乳重建的肿瘤学安全性的初步数据。

Preliminary data on the oncological safety of autologous fat transfer (AFT) for total breast reconstruction from the BREAST trial.

作者信息

Rijkx M E P, van der Venne W B W, Hommes J E, Kuijlaars Z M A, van Kuijk S M J, Moossdorff M, Heuts E M, Piatkowski A

机构信息

Department of Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Center+, P.O. Box 5800, 6202 AZ Maastricht, the Netherlands; NUTRIM School for Nutrition, and Translational Research in Metabolism, Maastricht University, P.O. Box 616, Universiteitssingel 40, 6229 ER Maastricht, the Netherlands.

NUTRIM School for Nutrition, and Translational Research in Metabolism, Maastricht University, P.O. Box 616, Universiteitssingel 40, 6229 ER Maastricht, the Netherlands; Department of Plastic, Reconstructive, and Hand Surgery, Haaglanden Medisch Centrum (HMC), Lijnbaan 32, 2512 HH Den Haag, the Netherlands.

出版信息

J Plast Reconstr Aesthet Surg. 2025 Aug;107:228-237. doi: 10.1016/j.bjps.2025.06.002. Epub 2025 Jun 13.

Abstract

BACKGROUND

Total breast reconstruction via autologous fat transfer (AFT) improves the quality of life compared to implant-based reconstruction (IBR). Hypotheses are that AFT may affect oncologic outcomes. As predetermined in the study protocol, we present the loco-regional recurrence data from the BREAST trial.

METHODS

This prospective cohort study is based on participants from the BREAST trial, comparing AFT to IBR after mastectomy. Patients were randomised 1:1 to AFT or IBR. Oncological follow-up, including clinical exams and imaging, was conducted annually for five years post-reconstruction in the intervention group. Data on demographics, tumour characteristics, and treatment details of the first tumour were collected from medical records and national pathology databases. Primary outcome for analysis was loco-regional breast cancer recurrence (LRR).

RESULTS

In total, 77 patients were included in the AFT arm and 86 in the control arm. Time from breast cancer diagnosis to first AFT exposure was considered control time to minimise immortal time bias. Eight patients in the AFT group and 5 in the control group experienced loco-regional recurrence. This was not significantly different (hazard ratio 1.74 (95% CI: 0.56 - 5.44, p = 0.341) in comparison to control. After adjustment for confounders, the difference remained non-significant.

CONCLUSION

Per study protocol, loco-regional recurrence in the BREAST trial was analysed: no significant difference was observed between AFT-reconstruction and IBR-reconstruction. This study was underpowered for oncological endpoints, the population was too heterogeneous, and not all participants received recommended oncological care.

摘要

背景

与基于植入物的乳房重建(IBR)相比,通过自体脂肪移植(AFT)进行全乳房重建可提高生活质量。有假设认为AFT可能会影响肿瘤学结局。按照研究方案的预先规定,我们展示了BREAST试验中的局部区域复发数据。

方法

这项前瞻性队列研究基于BREAST试验的参与者,比较了乳房切除术后AFT与IBR的效果。患者按1:1随机分为AFT组或IBR组。干预组在重建后的五年内每年进行包括临床检查和影像学检查在内的肿瘤学随访。从医疗记录和国家病理数据库中收集了有关人口统计学、肿瘤特征和首个肿瘤治疗细节的数据。分析的主要结局是局部区域乳腺癌复发(LRR)。

结果

AFT组共纳入77例患者,对照组纳入86例。将从乳腺癌诊断到首次接受AFT的时间视为对照时间,以尽量减少永生时间偏倚。AFT组有8例患者发生局部区域复发,对照组有5例。与对照组相比,这一差异无统计学意义(风险比1.74(95%CI:0.56 - 5.44,p = 0.341))。在对混杂因素进行调整后,差异仍然不显著。

结论

按照研究方案,对BREAST试验中的局部区域复发情况进行了分析:AFT重建与IBR重建之间未观察到显著差异。本研究在肿瘤学终点方面的效能不足,人群异质性过高,且并非所有参与者都接受了推荐的肿瘤学护理。

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