Palacios-Eito Amalia, Moreno-Manzanaro María Del Carmen, Espinosa-Calvo María, Ginés-Santiago Fátima, Camús-Martínez Juan Adrián, Calvo-Tudela Ángel, Rioja-Torres Pilar, Romero-Martín Sara, Miñano-Herrero José Antonio, Sarria Gustavo R, García-Cabezas Sonia
Department of Radiation Oncology, Reina Sofia University Hospital. Avda. Menéndez Pidal s/n, 14004 Cordoba, Spain.
Department of Radiation Oncology, Virgen de la Victoria University Hospital. Campus de Teatinos s/n 29010, Málaga, Spain.
Clin Transl Radiat Oncol. 2025 Jun 22;54:100998. doi: 10.1016/j.ctro.2025.100998. eCollection 2025 Sep.
Treatment of early-stage, low-risk breast cancer (BC) has undergone significant de-escalation during the past years. The TARGIT-A trial provided information on intraoperative radiotherapy (IORT) as a convenient, single-fraction modality. Nevertheless, significant discussion regarding different aspects of the trial continues. This study reports on oncological outcomes in a real-world clinical setting and contributes to the understanding of its optimal indication.
Five-hundred patients planned for breast-conserving surgery (BCS) were screened for IORT between June 2017 and December 2023, within this prospective, observational, single-center. The treatment protocol replicated the experimental arm of the TARGIT-A trial, implementing stricter inclusion criteria and maintaining a risk-adapted approach. The primary endpoint was ipsilateral breast recurrence rates (IBR). Secondary endpoints included local recurrence-free survival, progression-free survival, overall survival, and patient-reported cosmesis. The Kaplan-Meier method was used to analyze survival and recurrence risk, and risk factors for IBR were assessed through Cox regression analysis.
After screening and recruiting, IORT was performed in 464 patients. The median follow-up was 45.3 (8-89) months. The estimated 5-year IBR risk in the entire cohort was 1.7 % (95 % CI: 0.7 %-2.8 %), decreasing to 1 % (95 % CI: 0.3 %-2.4 %) in the IORT + whole breast irradiation (WBI) cohort. In the IORT-only cohort, the risk was 2.1 % (95 % CI: 0.6 %-3.7 %). No significant differences were observed among the three subgroups. The 5-year overall survival and breast cancer-specific survival rates were 97.6 % (95 % CI: 96.0 %-99.1 %) and 99.5 % (95 % CI: 98.5 %-100 %), respectively. Two independent significant risk factors for IBR were identified: age < 50 years (HR = 0.138, 95 % CI: 0.032-0.597, p = 0.008) and close or affected surgical margins (HR = 5.8, 95 % CI: 1.5-22.5, p = 0.011). No grade 3-4 toxicity events were reported. Patient-reported cosmesis was excellent/good in 84 % of cases.
Local recurrence rates were low amongst all groups. Superior control outcomes could be obtained by applying more restrictive criteria than the TARGIT A trial. Longer follow-up is needed to confirm our findings.
在过去几年中，早期低风险乳腺癌（BC）的治疗已大幅降级。TARGIT-A试验提供了关于术中放疗（IORT）作为一种便捷的单次分割治疗方式的信息。然而，关于该试验不同方面的重要讨论仍在继续。本研究报告了真实临床环境中的肿瘤学结局，并有助于理解其最佳适应症。
在2017年6月至2023年12月期间，对本前瞻性、观察性、单中心计划进行保乳手术（BCS）的500例患者进行了IORT筛查。治疗方案复制了TARGIT-A试验的试验组，采用了更严格的纳入标准并维持风险适应性方法。主要终点是同侧乳腺复发率（IBR）。次要终点包括无局部复发生存率、无进展生存率、总生存率以及患者报告的美容效果。采用Kaplan-Meier方法分析生存和复发风险，并通过Cox回归分析评估IBR的危险因素。
经过筛查和招募，464例患者接受了IORT。中位随访时间为45.3（8 - 89）个月。整个队列中估计的5年IBR风险为1.7%（95%CI：0.7% - 2.8%），在IORT +全乳照射（WBI）队列中降至1%（95%CI：0.3% - 2.4%）。在仅接受IORT的队列中，风险为2.1%（95%CI：0.6% - 3.7%）。三个亚组之间未观察到显著差异。5年总生存率和乳腺癌特异性生存率分别为97.6%（95%CI：96.0% - 99.1%）和99.5%（95%CI：98.5% - 100%）。确定了两个独立的IBR显著危险因素：年龄<50岁（HR = 0.138，95%CI：0.032 - 0.597，p = 0.008）和手术切缘接近或受影响（HR = 5.8，95%CI：1.5 - 22.5，p = 0.011）。未报告3 - 4级毒性事件。84%的病例中患者报告的美容效果为优/良。
所有组的局部复发率都很低。通过应用比TARGIT A试验更严格的标准可以获得更好的控制效果。需要更长时间的随访来证实我们的发现。
