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每周一次的乳腺癌Hypofractionated 放射治疗:一项 II 期临床试验的初步结果。

Once-weekly hypofractionated radiotherapy for breast cancer: First results of a phase II clinical trial.

机构信息

Radiotherapy Department, Instituto do Cancer do Ceara, Fortaleza, Brazil.

AC Camargo Cancer Center, Fundacao Antonio Prudente, São Paulo, Brazil.

出版信息

Breast J. 2019 Sep;25(5):953-957. doi: 10.1111/tbj.13372. Epub 2019 Jun 4.

DOI:10.1111/tbj.13372
PMID:31165541
Abstract

Hypofractionated radiotherapy (HF) in 15 or 16 daily fractions is well established as an alternative in early breast cancer after breast-conserving surgery. Evidences for a whole-breast treatment even shorter, in 5-10 fractions, are still scarce. Women 50 years or older, with early breast tumor (pT1-2pN0), after breast-conserving surgery were eligible to enter in this phase II trial and received whole breast once-weekly hypofractionated radiotherapy (wHF-RT) to a total dose of 30 Gy, in 5 fractions of 6 Gy. During treatment and in post-treatment follow-up the toxicity was assessed and graduated according to the "Common Terminology Criteria for Adverse Events" (CTCAE), v3.0. Breast pictures for esthetic comparison were taken in 5 timepoints and 2 breast surgeons independently graduated the cosmetics changes. The trial was registered with ClinicalTrials.gov, number NCT01965483. From October 2013 to November 2015, 44 patients were enrolled in the trial and treated according to the protocol of wHF-RT. The median age was 70.5 years (51-88 years), and the median follow-up was 22 months (9-33 months). Skin erythema was the most common acute adverse event. At the end of radiation, 30 patients (68.2%) had any grade of radiation dermatitis. Concerning cosmetic appearance, there was no significant difference between pretreatment and 1 year assessments. The 2-year overall survival and disease-free survival were, respectively 96.8% and 97.7%. There was only one distant recurrence and no local or regional recurrence. Once-weekly hypofractionated radiotherapy is a feasible and well tolerated alternative for early breast cancer adjuvant management with acceptable acute toxicity and esthetic outcomes.

摘要

在保乳手术后的早期乳腺癌中,15 或 16 次每日分割的短程放疗(HF)已被确立为一种替代方法。关于总剂量为 30 Gy 的 5-10 次分割全乳照射的证据仍然很少。本 II 期临床试验纳入了年龄在 50 岁及以上、接受保乳手术后的早期乳腺肿瘤(pT1-2pN0)的女性,给予每周一次的全乳短程放疗(wHF-RT),5 次分割,每次 6 Gy。在治疗期间和治疗后随访期间,根据“常见不良事件术语标准”(CTCAE),v3.0 评估并分级毒性。在 5 个时间点拍摄乳房照片进行美容比较,2 名乳腺外科医生独立评估美容变化。该试验在 ClinicalTrials.gov 上注册,编号为 NCT01965483。2013 年 10 月至 2015 年 11 月,共有 44 名患者入组该试验,并按照 wHF-RT 方案进行治疗。中位年龄为 70.5 岁(51-88 岁),中位随访时间为 22 个月(9-33 个月)。皮肤红斑是最常见的急性不良反应。放射结束时,30 例患者(68.2%)出现任何级别的放射性皮炎。关于美容外观,治疗前和 1 年评估之间没有显著差异。2 年总生存率和无病生存率分别为 96.8%和 97.7%。仅有 1 例远处复发,无局部或区域复发。每周一次的短程放疗是早期乳腺癌辅助治疗的一种可行且耐受良好的选择,具有可接受的急性毒性和美容效果。

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