From the Division of Radiation Oncology, Division of Epidemiology and Biostatistics, Unit of Medical Physics, Division of Plastic and Reconstructive Surgery, Division of Breast Surgery, and the Scientific Directorate, IEO, European Institute of Oncology IRCCS; and the Department of Oncology and Hemato-oncology, University of Milan.
Plast Reconstr Surg. 2020 Feb;145(2):317-327. doi: 10.1097/PRS.0000000000006441.
This study investigated the risk of reconstruction failure after mastectomy, immediate breast reconstruction, and radiotherapy to either a temporary tissue expander or permanent implant.
Records of women treated at a single institution between June of 1997 and December of 2011 were reviewed. Two patient groups were identified based on type of immediate breast reconstruction: tissue expander followed by exchange with a permanent implant and permanent implant. The study endpoint was rate of reconstruction failure, defined as a replacement, loss of the implant, or conversion to flap.
The tissue expander/permanent implant and the permanent implant groups consisted of 63 and 75 patients, respectively. The groups were well balanced for clinical and treatment characteristics. With a median follow-up of 116 months, eight implant losses, 50 implant replacements, and four flap conversions were recorded. Reconstruction failure occurred in 22 of 63 patients in the expander/implant group and in 40 of 75 patients in the permanent implant group. A traditional proportional hazards model showed a higher risk of reconstruction failure for the expander/implant group (hazard ratio, 2.01) and a significantly shorter time to reconstruction failure compared with the permanent implant group (109.2 months versus 157.7 months; p = 0.03); however, according to a competing risk model, the between-groups cumulative incidences were not significantly different (hazard ratio, 1.09).
Radiotherapy to either a tissue expander or a permanent implant presented a fairly large risk of reconstruction failure over time. The expander/implant group was not more likely to develop reconstruction failure compared to permanent implant group, but the timing of onset was shorter. More complex techniques should be investigated to lower the risk of reconstruction failure.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
本研究调查了乳房切除术后、即刻乳房重建以及放疗对临时组织扩张器或永久性植入物的重建失败风险。
回顾了 1997 年 6 月至 2011 年 12 月在一家机构接受治疗的女性患者的记录。根据即刻乳房重建的类型确定了两组患者：组织扩张器随后用永久性植入物置换和永久性植入物。研究终点为重建失败率，定义为置换、植入物丢失或转换为皮瓣。
组织扩张器/永久性植入物组和永久性植入物组分别包含 63 例和 75 例患者。两组在临床和治疗特征方面平衡良好。中位随访 116 个月，记录了 8 例植入物丢失、50 例植入物置换和 4 例皮瓣转换。在扩张器/植入物组中，有 22 例患者发生重建失败，在永久性植入物组中，有 40 例患者发生重建失败。传统的比例风险模型显示，扩张器/植入物组的重建失败风险更高（风险比为 2.01），且与永久性植入物组相比，重建失败的时间明显缩短（109.2 个月与 157.7 个月；p = 0.03）；然而，根据竞争风险模型，两组之间的累积发生率并无显著差异（风险比为 1.09）。
放疗对组织扩张器或永久性植入物都存在较大的重建失败风险。与永久性植入物组相比，扩张器/植入物组发生重建失败的可能性并没有增加，但发病时间更短。应研究更复杂的技术以降低重建失败的风险。
临床问题/证据水平：治疗性，III 级。
