Silverstein Melvin J, Kim Brian, Lin Kevin, Lloyd Shane, Snyder Lincoln, Khan Sadia, Hossino Deena, Chen Peter
Department of Surgery, Hoag Memorial Hospital Presbyterian, Newport Beach, CA, USA.
Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Ann Surg Oncol. 2025 May 31. doi: 10.1245/s10434-025-17546-9.
Intraoperative radiation therapy (IORT) delivers the full course of radiation therapy during the initial surgical excision. In the early 2000s, IORT was a promising method of breast cancer treatment de-escalation, offering many advantages. This technique should have succeeded in the USA, but several factors hindered its widespread adoption. We report the results of our 15-year IORT registry trial and our reasons for halting the trial.
Patients with early-stage breast cancer were entered into an institutional review board (IRB) approved registry. They were analyzed by intention to treat and by various subgroups, including those who received local treatment to the area of the primary tumor only versus those who received additional whole breast treatment.
A total of 1785 patients with 1828 early-stage breast cancers entered the registry. With a median follow-up of 85 months, the local recurrence rate (LRR) at 5-years for the entire cohort was 4.44%. Among 1527 who received local treatment only, the LRR at 5-years was 5.09% compared with 1.13% for 301 patients who received additional whole breast treatment (p = 0.001). For patients aged ≥ 65 with luminal A tumors ≤ 20mm, the 5-year LRR dropped to 2.32%.
IORT is extremely convenient for the patient and offers many advantages when compared with other methods of partial or whole breast treatment. Overall, the LRR for IORT is 4-5 times higher than many competing forms of whole or accelerated partial breast irradiation but still relatively low. A more select choice of patients for IORT can lower the LRR. Following the decision by ASTRO in 2024 not to recommend IORT, and considering a number of other factors, our group made the decision to discontinue our IORT program.
术中放射治疗（IORT）在初次手术切除时提供全程放射治疗。在21世纪初，IORT是一种有前景的乳腺癌降阶梯治疗方法，具有诸多优势。这项技术在美国本应取得成功，但一些因素阻碍了它的广泛应用。我们报告了我们15年的IORT注册试验结果以及停止该试验的原因。
早期乳腺癌患者进入经机构审查委员会（IRB）批准的注册研究。按意向性分析和不同亚组进行分析，包括仅对原发肿瘤部位进行局部治疗的患者与接受额外全乳治疗的患者。
共有1785例患者的1828例早期乳腺癌进入注册研究。中位随访85个月，整个队列5年局部复发率（LRR）为4.44%。在仅接受局部治疗的1527例患者中，5年LRR为5.09%，而接受额外全乳治疗的301例患者为1.13%（p = 0.001）。对于年龄≥65岁、管腔A型肿瘤≤20mm的患者，5年LRR降至2.32%。
IORT对患者极为方便，与其他部分或全乳治疗方法相比具有诸多优势。总体而言，IORT的LRR比许多全乳或加速部分乳腺照射的竞争形式高4至5倍，但仍相对较低。更有针对性地选择IORT患者可降低LRR。继美国放射肿瘤学会（ASTRO）在2024年决定不推荐IORT，并考虑到其他一些因素后，我们团队决定停止我们的IORT项目。
