PDF(Pubmed)
Abstract：
In the context of breast cancer treatment optimization, this study prospectively examines the feasibility and outcomes of utilizing intraoperative radiotherapy (IORT) as a boost in combination with standard external beam radiotherapy (EBRT) for high-risk patients. Different guidelines recommend such a tumor bed boost in addition to whole breast irradiation with EBRT for patients with risk factors for local breast cancer recurrence. The TARGIT BQR (NCT01440010) is a prospective, multicenter registry study aimed at ensuring the quality of clinical outcomes. It provides, for the first time, data from a large cohort with a detailed assessment of acute and long-term toxicity following an IORT boost using low-energy X-rays. Inclusion criteria encompassed tumors up to 3.5 cm in size and preoperative indications for a boost. The IORT boost, administered immediately after tumor resection, delivered a single dose of 20 Gy. EBRT and systemic therapy adhered to local tumor board recommendations. Follow-up for toxicity assessment (LENT SOMA criteria: fibrosis, teleangiectasia, retraction, pain, breast edema, lymphedema, hyperpigmentation, ulceration) took place before surgery, 6 weeks to 90 days after EBRT, 6 months after IORT, and then annually using standardized case report forms (CRFs). Between 2011 and 2020, 1133 patients from 10 centers were preoperatively enrolled. The planned IORT boost was conducted in 90%, and EBRT in 97% of cases. Median follow-up was 32 months (range 1-120, 20.4% dropped out), with a median age of 61 years (range 30-90). No acute grade 3 or 4 toxicities were observed. Acute side effects included erythema grade 1 or 2 in 4.4%, palpable seroma in 9.1%, punctured seroma in 0.3%, and wound healing disorders in 2.1%. Overall, chronic teleangiectasia of any grade occurred in 16.2%, fibrosis grade ≥ 2 in 14.3%, pain grade ≥ 2 in 3.4%, and hyperpigmentation in 1.1%. In conclusion, a tumor bed boost through IORT using low-energy X-rays is a swift and feasible method that demonstrates low rates in terms of acute or long-term toxicity profiles in combination with whole breast irradiation.
摘要：
在乳腺癌治疗优化的背景下，本研究前瞻性研究了术中放疗(IORT)联合标准外束放疗(EBRT)用于高危患者的可行性和结果.对于有局部乳腺癌复发危险因素的患者，除了使用EBRT进行全乳照射外，不同的指南还建议进行这种肿瘤床增强。TARGITBQR(NCT01440010)是一个有前景的，旨在确保临床结果质量的多中心注册研究。它提供了,第一次,数据来自一个大型队列，详细评估了使用低能量X射线进行IORT增强后的急性和长期毒性。纳入标准包括大小达3.5cm的肿瘤和术前增强适应症。IORT的提升，肿瘤切除后立即给药，单剂量20Gy.EBRT和全身治疗符合当地肿瘤委员会的建议。毒性评估的随访（LENTSOMA标准：纤维化，毛细血管扩张症,撤回,疼痛,乳房水肿,淋巴水肿,色素沉着过度,溃疡)发生在手术前，EBRT后6周至90天，IORT后6个月，然后每年使用标准化病例报告表(CRF)。在2011年至2020年之间，来自10个中心的1133名患者在术前登记。计划中的IORT提高了90%，和EBRT在97%的病例中。中位随访32个月（范围1-120，20.4%退出），年龄中位数为61岁（30-90岁）。没有观察到急性3级或4级毒性。急性副作用包括4.4%的红斑1级或2级，可触及的血清肿占9.1%，穿刺血清肿0.3%，伤口愈合障碍占2.1%。总的来说,任何级别的慢性血管扩张发生在16.2%，纤维化等级≥2，占14.3%，疼痛等级≥2的3.4%，和色素沉着过度在1.1%。总之,使用低能量X射线通过IORT进行肿瘤床增强是一种快速可行的方法,在联合全乳照射的急性或长期毒性方面显示出较低的发生率.
