2024 年 7 月 11 日（星期四）下午 4:00 - 5:30 BP01 演讲时间：下午 4:00

IF 1.7 4区医学 Q4 ONCOLOGY

Brachytherapy Pub Date : 2024-10-25 DOI:10.1016/j.brachy.2024.08.025

Vratislav Strnad Prof. MD , Csaba Polgar Prof. MD , Tibor Major PhD , Jose Luis Guinot MD , Cristina Gutierrez Miguelez MD , Kristina Lössl PD, MD , Bülent Polat PD, MD , Peter Niehoff Prof. MD , Christine Gall PhD , Wolfgang Uter Prof. MD

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引用次数: 0

摘要

目的评估GEC-ESTRO第3期非劣效性试验在根据GEC-ESTRO和ASTRO APBI患者选择标准定义的亚组患者中的疗效结果。方法年龄≥40岁、保乳手术后患低危浸润性乳腺癌或原位导管癌的患者被随机分配接受50 Gy WBI（肿瘤床增强10 Gy）或使用多导管近距离放射治疗的APBI。633/1184名患者随机接受了使用多导管近距离放射治疗的APBI。根据目前已有的 10 年随访后的完整结果，我们报告了对这后 633 例患者进行的补充子分析的结果，即根据 GEC-ESTRO 和 ASTRO 患者 APBI 选择标准分类的亚组的 10 年局部控制率、无病生存率和总生存率的比较结果。值得注意的是，在我们的患者队列中，有些标准将患者分别限定为低风险以上或值得警惕的患者，但根据设计，这些标准并未出现在我们的患者队列中（如纳入/排除标准）。该试验已在ClinicalTrials.gov上注册，编号为NCT00402519。结果APBI治疗组的10年局部复发率为3.5%（95% CI：2.0-5.0%）。在接受多导管近距离放射治疗的 633 名 APBI 患者中，根据 ASTRO 标准，共有 423 名患者（66.8%）被归类为 "适合"，195 名患者（30.8%）被归类为 "谨慎"，11 名患者（1.7%）被归类为 "不适合"；有 4 例患者无法进行 ASTRO 分类。在 "适合 "组和 "谨慎 "组中，10 年局部复发的累积发生率（95% CI）分别为 3.3% 和 5.0%（P=0.61）；差异为 1.7%（95% CI：-2.0 至 5.5%）。10年无病生存率分别为81.9%和83.6%（P=0.63）。根据 GEC-ESTRO 标准，430 名患者（68%）被列为 APBI 的良好候选者--"低风险组"，203 名患者（32%）被列为 APBI 的可能候选者--"中风险组"，没有患者属于 "高风险组"。根据 ESTRO 标准对患者进行分组，"低风险组 "和 "中风险组 "10 年的局部复发累积发生率分别为 3.5% 和 4.4%（P = 0.55）；差异为 0.9%（95%CI：-2.6 至 4.5%）。此外，"低危 "组和 "中危 "组的 10 年无病生存率分别为 81.0% 和 86.4%（P = 0.11）。结论：根据 GEC-ESTRO 标准，接受保乳手术后使用多导管近距离放射治疗进行 APBI 治疗的患者的 10 年结果在 "低危 "组和 "中危 "组之间以及根据 ASTRO 标准在 "合适 "组和 "谨慎 "组之间具有可比性。根据 APBI 目前的长期结果，应讨论完善现有的 APBI 患者选择标准建议，以便让更多患者在保乳手术后接受 APBI 治疗。

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Thursday, July 11, 20244:00 PM - 5:30 PM BP01 Presentation Time: 4:00 PM

Purpose

To evaluate efficacy results of the GEC-ESTRO phase 3 non-inferiority trial in subgroups of patients defined by the GEC-ESTRO and ASTRO patient selection criteria for APBI.

Methods

Patients aged ≥ 40 years with low risk invasive breast cancer or ductal carcinoma in-situ after breast conserving surgery were randomized to receive either 50 Gy WBI with tumor bed boost of 10 Gy or APBI using multicatheter brachytherapy. 633/1184 patients were randomized to APBI using multicatheter brachytherapy. In the context of the current available complete results after 10 years follow-up, we report results of a supplementary sub-analysis of these latter 633 patients regarding 10-year local control rates, disease-free and overall survival results comparing subgroups categorized according to the GEC-ESTRO and ASTRO patient selection criteria for APBI. Of note, some of these criteria qualifying patients as more than low risk or as cautionary, respectively, did not occur in our patient cohort by design (c.f. in-/exclusion criteria). The trial is registered with ClinicalTrials.gov, NCT00402519.

Results

The 10-year local recurrence rate in the APBI arm was 3.5% (95% CI: 2.0-5.0%). Among 633 patients treated with multicatheter brachytherapy for APBI, according to ASTRO criteria altogether 423 patients (66.8%) were classified as “suitable”, 195 (30.8%) as “cautionary” and 11 (1.7%) as “unsuitable”; in 4 cases no ASTRO categorization was possible. In the “suitable” and “cautionary” groups, the cumulative incidence (95% CI) of local recurrence at 10 years was 3.3% and 5.0% (p=0.61), respectively; difference 1.7% (95% CI: -2.0 to 5.5%). 10-year disease-free survival was 81.9% and 83.6% (p=0.63), respectively. According to GEC-ESTRO criteria, 430 patients (68%) were classified as good candidates for APBI - “low risk group”, 203 (32%) as possible candidates for APBI - “intermediate risk group”, with no patients being in the “high risk group”. Using ESTRO criteria for subgrouping of patients, the cumulative incidence of local recurrence at 10 years was 3.5% versus 4.4% (p = 0.55) in the “low risk group” and “intermediate risk group”, respectively; difference 0.9% (95%CI: -2.6 to 4.5%). Furthermore, 10-year disease-free survival was 81.0% versus 86.4% (p = 0.11) in the “low” and “intermediate” risk group, respectively.

Conclusion

The 10-year results in patients treated with breast conserving surgery followed by APBI using multicatheter brachytherapy are comparable as well between “low risk” and “intermediate risk” groups according to GEC-ESTRO criteria as between “suitable” and “cautionary” risk groups according to ASTRO criteria. Based on the present long-term results of APBI, refinement of available recommendations for APBI patient selection criteria should be discussed to allow more patients to be treated with APBI after breast conserving surgery.

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来源期刊

Brachytherapy 医学-核医学

CiteScore

3.40

自引率

21.10%

发文量

119

审稿时长

9.1 weeks

期刊介绍： Brachytherapy is an international and multidisciplinary journal that publishes original peer-reviewed articles and selected reviews on the techniques and clinical applications of interstitial and intracavitary radiation in the management of cancers. Laboratory and experimental research relevant to clinical practice is also included. Related disciplines include medical physics, medical oncology, and radiation oncology and radiology. Brachytherapy publishes technical advances, original articles, reviews, and point/counterpoint on controversial issues. Original articles that address any aspect of brachytherapy are invited. Letters to the Editor-in-Chief are encouraged.