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.
在乳腺癌治疗优化的背景下，本研究前瞻性探讨了针对高风险患者，采用术中放疗（IORT）作为推量放疗联合标准外照射放疗（EBRT）的可行性与临床结局。不同指南建议，对于具有局部乳腺癌复发风险因素的患者，在全乳EBRT基础上应增加瘤床推量照射。TARGIT BQR研究（NCT01440010）是一项前瞻性、多中心注册研究，旨在确保临床结果的质量。该研究首次提供了来自大规模队列的数据，详细评估了使用低能X射线进行IORT推量后的急性及长期毒性反应。纳入标准包括肿瘤最大径≤3.5 cm且术前有推量放疗指征。IORT推量在肿瘤切除后立即实施，单次剂量为20 Gy。EBRT及全身治疗方案遵循当地肿瘤委员会的建议。毒性评估（依据LENT SOMA标准：纤维化、毛细血管扩张、挛缩、疼痛、乳房水肿、淋巴水肿、色素沉着、溃疡）在术前、EBRT后6周至90天、IORT后6个月及之后每年进行，采用标准化病例报告表（CRFs）记录。2011年至2020年间，来自10个中心的1133例患者术前入组。其中90%按计划接受了IORT推量，97%接受了EBRT。中位随访时间为32个月（范围1-120个月，失访率20.4%），患者中位年龄为61岁（范围30-90岁）。未观察到急性3级或4级毒性反应。急性副作用包括1级或2级红斑（4.4%）、可触及血清肿（9.1%）、穿刺抽吸血清肿（0.3%）及伤口愈合障碍（2.1%）。总体而言，任何级别的慢性毛细血管扩张发生率为16.2%，≥2级纤维化为14.3%，≥2级疼痛为3.4%，色素沉着为1.1%。综上所述，采用低能X射线进行IORT瘤床推量是一种快速可行的方法，联合全乳照射时表现出较低的急性及长期毒性发生率。
肿瘤(癌症)患者之家