Piroth Marc D, Strnad Vratislav, Krug David, Fastner Gerd, Baumann René, Combs Stephanie E, Duma Marciana Nona, Dunst Jürgen, Feyer Petra, Fietkau Rainer, Haase Wulf, Harms Wolfgang, Hehr Thomas, Sedlmayer Felix, Souchon Rainer, Budach Wilfried
Department of Radiation Oncology, Helios University Hospital Wuppertal, Witten/Herdecke University, Wuppertal, Germany.
Department of Radiation Oncology, University Hospital, Erlangen, Germany.
Breast Care (Basel). 2022 Feb;17(1):81-84. doi: 10.1159/000515386. Epub 2021 Apr 6.
During the last decade, partial breast irradiation (PBI) has gained traction as a relevant treatment option for patients with early-stage low-risk breast cancer after breast-conserving surgery. The TARGIT-A prospective randomized trial compared a "risk-adapted" intraoperative radiotherapy (IORT) approach with 50-kv X-rays (INTRABEAM®) as the PBI followed by optional whole-breast irradiation (WBI) and conventional adjuvant WBI in terms of observed 5-year in-breast recurrence rates. Recently, long-term data were published. Since the first publication of the TARGIT-A trial, a broad debate has been emerged regarding several uncertainties and limitations associated with data analysis and interpretation. Our main objective was to summarize the data, with an emphasis on the updated report and the resulting implications.
From our point of view, the previously unresolved questions still remain and more have been added, especially with regard to the study design, a change in the primary outcome measure, the significant number of patients lost to follow-up, and the lack of a subgroup analysis according to risk factors and treatment specifications.
Taking into account the abovementioned limitations of the recently published long-term results of the TARGIT-A trial, the German Society of Radiation Oncology (DEGRO) Breast Cancer Expert Panel adheres to its recently published recommendations on PBI: "the 50-kV system (INTRABEAM) cannot be recommended for routine adjuvant PBI treatment after breast-conserving surgery."
在过去十年中，部分乳腺照射（PBI）作为保乳手术后早期低风险乳腺癌患者的一种相关治疗选择而受到关注。TARGIT-A前瞻性随机试验比较了一种“风险适应性”术中放疗（IORT）方法（采用50千伏X射线（INTRABEAM®）作为PBI）与可选的全乳照射（WBI）以及传统辅助WBI在观察到的5年乳腺内复发率方面的差异。最近，公布了长期数据。自TARGIT-A试验首次发表以来，围绕数据分析和解释相关的若干不确定性和局限性出现了广泛的争论。我们的主要目标是总结数据，重点关注更新后的报告及其产生的影响。
在我们看来，之前未解决的问题仍然存在，并且又增加了更多问题，特别是在研究设计、主要结局指标的变化、大量失访患者以及缺乏根据风险因素和治疗规范进行的亚组分析方面。
考虑到TARGIT-A试验最近公布的长期结果存在上述局限性，德国放射肿瘤学会（DEGRO）乳腺癌专家小组坚持其最近发布的关于PBI的建议：“不推荐将50千伏系统（INTRABEAM）用于保乳手术后的常规辅助PBI治疗。”
