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IOERT versus external beam electrons for boost radiotherapy in stage I/II breast cancer: 10-year results of a phase III randomized study
Breast Cancer Research ( IF 6.1 ) Pub Date : 2021-04-13 , DOI: 10.1186/s13058-021-01424-9
Antonella Ciabattoni , Fabiana Gregucci , Gerd Fastner , Silvio Cavuto , Antonio Spera , Stefano Drago , Ingrid Ziegler , Maria Alessandra Mirri , Rita Consorti , Felix Sedlmayer

Intraoperative radiotherapy with electrons (IOERT) boost could be not inferior to external beam radiotherapy (EBRT) boost in terms of local control and tissue tolerance. The aim of the study is to present the long-term follow-up results on local control, esthetic evaluation, and toxicity of a prospective study on early-stage breast cancer patients treated with breast-conserving surgery with an IOERT boost of 10 Gy (experimental group) versus 5 × 2 Gy EBRT boost (standard arm). Both arms received whole-breast irradiation (WBI) with 50 Gy (2 Gy single dose). A single-institution phase III randomized study to compare IOERT versus EBRT boost in early-stage breast cancer was conducted as a non-inferiority trial. Primary endpoints were the evaluation of in-breast true recurrences (IBTR) and out-field local recurrences (LR) as well as toxicity and cosmetic results. Secondary endpoints were overall survival (OS), disease-free survival (DFS), and patient’s grade of satisfaction with cosmetic outcomes. Between 1999 and 2004, 245 patients were randomized: 133 for IOERT and 112 for EBRT. The median follow-up was 12 years (range 10–16 years). The cumulative risk of IBTR at 5–10 years was 0.8% and 4.3% after IOERT, compared to 4.2% and 5.3% after EBRT boost (p = 0.709). The cumulative risk of out-field LR at 5–10 years was 4.7% and 7.9% for IOERT versus 5.2% and 10.3% for EBRT (p = 0.762). All of the IOERT arm recurrences were observed at > 100 months’ follow-up, whereas the mean time to recurrence in the EBRT group was earlier (55.2 months) (p < 0.05). No late complications associated with IOERT were observed. The overall cosmetic results were scored as good or excellent in physician and patient evaluations for both IOERT and EBRT. There were significantly better scores for IOERT at all time points in physician and patient evaluations with the greatest difference at the end of EBRT (p = 0.006 objective and p = 0.0004 subjective) and most narrow difference at 12 months after the end of EBRT (p = 0.08 objective and p = 0.04 subjective analysis). A 10-Gy IOERT boost during breast-conserving surgery provides high local control rates without significant morbidity. Although not significantly superior to external beam boosts, the median time to local recurrences after IOERT is prolonged by more than 4 years.

中文翻译:

IOERT与外部电子束在I / II期乳腺癌中加强放射治疗:III期随机研究的10年结果

就局部控制和组织耐受性而言,术中电子增强放疗(IOERT)可能不逊于外部电子束放疗(EBRT)增强。这项研究的目的是,对一项长期研究进行长期随访研究,该研究针对以IOERT提高10 Gy进行保乳手术的早期乳腺癌患者进行的前瞻性研究,该研究涉及局部控制,美学评估和毒性研究。实验组)与5×2 Gy EBRT增强(标准组)相比。两只手臂均接受50 Gy(单剂量2 Gy)的全乳照射(WBI)。作为一项非劣效性试验,进行了一项单机构的III期随机研究,以比较IOERT与EBRT增强对早期乳腺癌的影响。主要终点是评估乳房内真实复发率(IBTR)和外场局部复发率(LR)以及毒性和美容效果。次要终点是总体生存期(OS),无病生存期(DFS)和患者对美容结局的满意程度。在1999年至2004年之间,共有245例患者被随机分组​​:IOERT为133例,EBRT为112例。中位随访时间为12年(范围10-16年)。IOERT后5-10年的IBTR累积风险分别为0.8%和4.3%,而EBRT增强后为4.2%和5.3%(p = 0.709)。IOERT在5-10年时的累积LR累积风险分别为4.7%和7.9%,而EBRT为5.2%和10.3%(p = 0.762)。随访> 100个月观察到所有IOERT臂复发,而EBRT组的平均复发时间更早(55.2个月)(p <0.05)。没有观察到与IOERT相关的晚期并发症。在IOERT和EBRT的医师和患者评估中,整体美容结果均被评为“好”或“优秀”。在医师和患者评估中,所有时间点的IOERT得分均明显更高,在EBRT结束时差异最大(p = 0.006客观,p = 0.0004主观),在EBRT结束后12个月差异最窄(p = 0.08个目标,p = 0.04个主观分析)。在保乳手术中增加10Gy的IOERT可以提供较高的局部控制率,而没有明显的发病率。尽管不能显着优于外部束增强,但是IOERT后局部复发的中位时间延长了4年以上。在IOERT和EBRT的医师和患者评估中,整体美容结果均被评为“好”或“优秀”。在医师和患者评估中,所有时间点的IOERT得分均明显更高,在EBRT结束时差异最大(p = 0.006客观,p = 0.0004主观),在EBRT结束后12个月差异最窄(p = 0.08个目标,p = 0.04个主观分析)。在保乳手术中增加10Gy的IOERT可以提供较高的局部控制率,而没有明显的发病率。尽管不能显着优于外部束增强,但是IOERT后局部复发的中位时间延长了4年以上。在IOERT和EBRT的医师和患者评估中,整体美容结果均被评为“好”或“优秀”。在医师和患者评估中,所有时间点的IOERT得分均明显更高,在EBRT结束时差异最大(p = 0.006客观,p = 0.0004主观),在EBRT结束后12个月差异最窄(p = 0.08个目标,p = 0.04个主观分析)。在保乳手术中增加10Gy的IOERT可以提供较高的局部控制率,而没有明显的发病率。尽管不能显着优于外部束增强,但是IOERT后局部复发的中位时间延长了4年以上。在医师和患者评估中,所有时间点的IOERT得分均明显更高,在EBRT结束时差异最大(p = 0.006客观,p = 0.0004主观),在EBRT结束后12个月差异最窄(p = 0.08个目标,p = 0.04个主观分析)。在保乳手术中增加10Gy的IOERT可以提供较高的局部控制率,而没有明显的发病率。尽管不能显着优于外部束增强,但是IOERT后局部复发的中位时间延长了4年以上。在医师和患者评估中,所有时间点的IOERT得分均明显更高,在EBRT结束时差异最大(p = 0.006客观,p = 0.0004主观),在EBRT结束后12个月差异最窄(p = 0.08个目标,p = 0.04个主观分析)。在保乳手术中增加10Gy的IOERT可提供较高的局部控制率,而无明显的发病率。尽管不能显着优于外部束增强,但是IOERT后局部复发的中位时间延长了4年以上。在保乳手术中增加10Gy的IOERT可以提供较高的局部控制率,而没有明显的发病率。尽管不能显着优于外部束增强,但是IOERT后局部复发的中位时间延长了4年以上。在保乳手术中增加10Gy的IOERT可以提供较高的局部控制率,而没有明显的发病率。尽管不能显着优于外部束增强,但是IOERT后局部复发的中位时间延长了4年以上。
更新日期:2021-04-13
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