BP08 演讲时间：下午 5:03

IF 1.7 4区医学 Q4 ONCOLOGY

Brachytherapy Pub Date : 2024-10-25 DOI:10.1016/j.brachy.2024.08.032

Adam Chichel PhD, Adam Kluska PhD, Artur J. Chyrek PhD, Wojciech M. Burchardt PhD

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引用次数: 0

摘要

目的正在进行一项前瞻性单机构非随机开放标签研究（NTC05142202），以确定多导管间质高剂量率近距离放射治疗（HDR-BT）的辅助作用、4Gy）与所采用的 4-5 天 APBI 长期标准（7-8 × 4-4,3 Gy）相比。材料与方法2021年10月至2023年12月期间招募了早期低危乳腺癌患者（pTis-2N0）（根据协议，招募于2024年12月31日结束）。术后在门诊接受为期三天的间质 HDR-BT 辅助治疗（5 次，每次 5.4 Gy；间隔 6 小时；总剂量 27.0 Gy）。治疗后一个月继续随访（FU），然后是三个月至两年，六个月至五年。根据不良事件通用术语标准 v5.0（CTCAE）评估早期毒性（放射性皮炎、血肿、乳房感染、术中乳房损伤、乳房疼痛），直至治疗后 3 个月。我们还将评估早期 1 个月和 3 个月的哈佛评分法美容效果，并记录患者对乳房外观的四级主观评分（优、良、满意、差）。结果 147 名年龄在 65 岁（51-85 岁）的女性接受了治疗。分析结果显示，所有患者均接受了为期 1 个月的治疗，132 名患者（89.9%）接受了为期 3 个月的治疗。一个月疗程的早期毒性反应有：放射性皮炎 G1 - 4（2.7%）；血肿 G1 - 21（14.3%）；乳房疼痛 G1 - 24（16.3%），G2 - 2（1.4%）。治疗三个月后的早期毒性反应为：放射性皮炎 G1 - 2（1.5%）；血肿 G1 - 4（3%）；乳房疼痛 G1 - 18（13.6%），G2 - 1（0.8%）。没有发生乳房感染。治疗后一个月，患者对其美容效果的主观评价为：优57.8%，良36.1%，满意5.4%，差0.7%；治疗后三个月，优61.4%，良31.1%，满意7.1%，差0.0%。临床医生根据哈佛评分表对一个月后的外观进行了评估，结果为 I 级 - 9.5%，II 级 - 81.6%，III 级 - 8.9%，IV 级 - 无；三个月后，结果为 I 级 - 21.2%，II 级 - 74.2%，III 级 - 4.6%，IV 级 - 无。血肿很快自愈。罕见的局部轻微疼痛感较为持久，但不会影响患者的日常活动。根据哈佛评分标准，患者对其外观的主观评价要比临床医生好得多。随着时间的推移，舒适度似乎会有所改善。中期分析显示，HiFi-APBI 方案的早期毒性耐受性非常好。

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BP08 Presentation Time: 5:03 PM

Purpose

A prospective mono-institutional non-randomized open-label study (NTC05142202) is being carried out to establish the role of adjuvant multicatheter interstitial high-dose-rate brachytherapy (HDR-BT) in doubly accelerated and radiobiologically equivalent irradiation scheme of 5 × 5,4 Gy delivered in 3 days of treatment (High Five, HiFi-APBI) compared to the adopted long-term standard of APBI realized in 4-5 days (7-8 × 4-4,3 Gy) in selected women with low-risk invasive breast cancer or carcinoma in-situ. It is to report an interim analysis on the first 1- and 3-month early toxicity profiles and 1- and 3-month early cosmetic outcome results of a novel fractionation scheme adjuvant to breast-conserving surgery.

Material and Methods

Early low-risk breast cancer patients (pT_is-2N₀) were recruited between October 2021 and December 2023 (recruitment closed on 12/31/2024 according to protocol). Postoperative adjuvant treatment with interstitial HDR-BT was given for three days (5 fractions of 5,4 Gy; 6 hours apart; total dose 27,0 Gy) on an outpatient basis. Follow-up (FU) is continued one-month post-treatment, then three months up to 2 years, and six months up to 5 years. Early toxicity incidence (radiodermatitis, hematoma, breast infection, intraoperative breast damage, breast pain) is being assessed according to Common Terminology Criteria for Adverse Events v5.0 (CTCAE) up to 3 months FU. We also assess early 1- and 3-month Harvard scale-based cosmetic outcomes and record patients' feedback on a four-grade subjective breast appearance scale (excellent, good, satisfying, poor). Photographic documentation is being secured.

Results

One hundred forty-seven women aged 65 (51-85) were enrolled. At the time of analysis, all patients reached 1-month FU, and 132 (89,9%) reached 3-month FU. Early toxicities at one-month FU were: radiodermatitis G1 - 4 (2.7%); hematoma G1 - 21 (14.3%); breast pain G1 - 24 (16.3%), G2 - 2 (1.4%). Early toxicities at three-month FU were: radiodermatitis G1 - 2 (1.5%); hematoma G1 - 4 (3%); breast pain G1 - 18 (13.6%), G2 - 1 (0.8%). No breast infections occurred. Patients subjectively assessed their cosmetic outcome after one-month post-treatment as excellent at 57.8%, good at 36.1%, satisfying at 5.4%, and poor at 0.7%; after three months, excellent at 61.4%, good at 31.1%, satisfying at 7.1%, and poor at 0.0%. Clinicians assessed cosmesis on the Harvard scale after one month as grade I - 9.5%, II - 81.6%, III - 8.9%, IV - none; after three months as grade I - 21.2%, II - 74.2%, III - 4.6%, IV - none.

Conclusions

The incidence of early 1- and 3-month toxicity events is low and improves quickly. Hematomas heal quickly and spontaneously. Rare local and slight painful sensations are more persistent but do not disturb patients' daily activity. Patients assess their cosmesis much better subjectively than clinicians do according to the Harvard scale. Cosmesis seems to improve over time. In an interim analysis, the HiFi-APBI regimen appears to be very well tolerated regarding early toxicity.

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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.