Kostova-Lefterova Desislava, Vasileva-Slaveva Mariela, Maslyankov Svilen, Konsoulova Assia, Atanasova Margarita, Paycheva Tsvetelina, Vlahova Alexandrina, Genadieva-Yordanova Marusya, Prodanova Ginka, Zahariev Zahari, Pavlov Vasil, Todorov Georgi, Vasilev Boris, Angelov Kostadin, Deliyski Tashko, Petrova Ivelina, Hitova Desislava, Petrov Ivo
Department of Medical Diagnostic Activities, Medical University-Pleven, 1 Saint Kliment Ohridski Str., 5800 Pleven, Bulgaria.
Department of Surgery, University Hospital Acibadem City Clinic Sofia, 66A Tsarigradsko Shose Str., 1784 Sofia, Bulgaria.
Curr Oncol. 2021 Oct 3;28(5):3932-3944. doi: 10.3390/curroncol28050335.
(1) Background: We aimed to analyze currently available studies with intraoperative radiotherapy (IORT) as a choice of treatment where the Xoft Axxent electronic brachytherapy (eBx) system was used as a single-dose irradiation and an exclusive radiotherapy approach at the time of surgery in patients with early breast cancer (EBC). We also compared the results of the systematic review to the Bulgarian experience. (2) Methods and Materials: We performed a systematic review of the studies published before February 2021, which investigate the application of a single-fraction 20 Gy radiation treatment, delivered at the time of lumpectomy in EBC patients with the Xoft Axxent eBx System. A systematic search in PubMed, Scopus, and ScienceDirect was performed. The results are reported following the PRISMA guidelines. The criteria on patients' selection for IORT (the additional need for EBRT), cosmetic outcomes, and recurrence rate from the eligible studies are compared to the treatment results in Bulgarian patients. (3) Results: We searched through 1032 results to find 17 eligible studies. There are no published outcomes from randomized trials. When reported, the cosmetic outcomes in most of the studies are defined as excellent. The observed recurrence rate is low (1-5.8%). Still, the number of patients additionally referred to postoperative external breast radiotherapy (EBRT) is up to 31%. Amongst the 20 patients treated in Bulgaria, the cosmetic outcomes are also evaluated as excellent, five of which (25%) are referred for EBRT. Within median follow-up of 39 months, there was one local and one distal recurrence. (4) Conclusions: Current evidence demonstrates the Xoft Axxent eBx system as a safe and feasible technique for IORT delivery in EBC patients. There are no randomized controlled trials conducted at this time point to prove its long-term effectiveness. Better patient selection and a reimbursement strategy have to be proposed to extend the application of this technique in Bulgaria.
(1) 背景:我们旨在分析目前可用的研究,这些研究将术中放疗(IORT)作为一种治疗选择,其中Xoft Axxent电子近距离放疗(eBx)系统在早期乳腺癌(EBC)患者手术时用作单次照射和唯一的放疗方法。我们还将系统评价的结果与保加利亚的经验进行了比较。(2) 方法和材料:我们对2021年2月之前发表的研究进行了系统评价,这些研究调查了使用Xoft Axxent eBx系统在EBC患者乳房肿块切除时进行单次20 Gy放射治疗的应用情况。在PubMed、Scopus和ScienceDirect上进行了系统检索。结果按照PRISMA指南报告。将符合条件的研究中IORT患者选择标准(额外需要外照射放疗[EBRT])、美容效果和复发率与保加利亚患者的治疗结果进行比较。(3) 结果:我们在1032个结果中进行筛选,以找到17项符合条件的研究。尚无随机试验的已发表结果。在有报告的情况下,大多数研究中的美容效果被定义为优秀。观察到的复发率较低(1%-5.8%)。然而,额外接受术后乳房外照射放疗(EBRT)的患者数量高达31%。在保加利亚接受治疗的20名患者中,美容效果也被评估为优秀,其中5名(25%)接受了EBRT。在中位随访39个月时,有1例局部复发和1例远处复发。(4) 结论:目前的证据表明,Xoft Axxent eBx系统是EBC患者IORT的一种安全可行的技术。目前尚无随机对照试验来证明其长期有效性。必须提出更好的患者选择和报销策略,以扩大该技术在保加利亚的应用。
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