5-year results of hypofractionated locoregional radiotherapy in early breast cancer HypoG-01 (UNICANCER): a French multicentre, randomised, non-inferiority, phase 3, open-label, controlled trial.

The UNICANCER HypoG-01 trial aimed to assess morbidity and efficacy of hypofractionated locoregional radiotherapy delivering 40 Gy in 15 fractions (3-week radiotherapy) versus 5-week radiotherapy.

UNICANCER HypoG-01试验旨在评估低分割局部区域放射治疗（40 Gy分15次，即3周放射治疗）与5周放射治疗在不良反应和疗效方面的差异。

Methods

This non-inferiority, open-label, multicentre, randomised phase 3 trial, conducted in 29 centres in France, included female patients 18 years and older, with invasive breast carcinoma requiring nodal irradiation after complete microscopic resection of the primary tumour.

这项非劣效性、开放标签、多中心、随机的III期试验，在法国的29个中心进行，纳入了18岁及以上的女性患者，这些患者患有侵袭性乳腺癌，在对原发肿瘤进行完全显微切除后需要进行淋巴结放疗。

Patients were randomly allocated in a 1:1 ratio to either 3-week radiotherapy (experimental group) or 5-week radiotherapy (control group) to the regional nodes and thoracic wall or breast.

患者按1:1的比例随机分配到实验组的3周放疗或对照组的5周放疗，放疗针对区域淋巴结和胸壁或乳房。

The primary endpoint was ipsilateral arm lymphoedema, defined as a 10% or greater increase in arm circumference at 15 cm proximal, 10 cm distal, or both, to the ipsilateral olecranon relative to baseline and contralateral arm, with a non-inferiority margin on the hazard ratio(HR) of 1·545.

主要终点是同侧上肢淋巴水肿，定义为相对于基线和对侧上肢，在同侧鹰嘴近端15厘米、远端10厘米或两者处上臂周长增加10%或更多，非劣效性边界为风险比（HR）1·545。

This trial was registered at ClinicalTrials.gov (NCT03127995) and is closed to recruitment.

该试验已在ClinicalTrials.gov注册（NCT03127995），目前已停止招募。

Results

Between Sept 26, 2016, and March 27, 2020, 1265 patients were enrolled, and 1221 were included in per-protocol analysis (median follow-up 4·8 years [IQR 4·01-5·02]), 614 assigned to 3-week radiotherapy and 607 to 5-week radiotherapy.

2016年9月26日至2020年3月27日期间，共有1265名患者被纳入研究，其中1221名患者纳入了按方案分析（中位随访时间4.8年 [四分位数间距4.01-5.02]），614名被分配到3周放疗组，607名被分配到5周放疗组。

The median age was 58 years (IQR 49-68).

中位年龄为58岁（四分位数间距49-68岁）。

Arm lymphoedema occurred in 275 (25%) patients (143 with 3-week radiotherapy and 132 with 5-week radiotherapy). 3-week radiotherapy was non-inferior to 5-week radiotherapy regarding arm lymphoedema risk (HR 1·02 [95% CI 0·79-1·31] pnon-inferiority<0·001), with a 3-year cumulative incidenceof 23·4% (95% CI 19·7-27·6) and 22·2% (95% CI 19·5-26·3), respectively.

在275名（25%）患者中发生了臂淋巴水肿（143名接受了3周放疗，132名接受了5周放疗）。3周放疗在臂淋巴水肿风险上不劣于5周放疗（风险比1.02 [95% 置信区间 0.79-1.31] p非劣效性<0.001），3年累积发生率分别为23.4%（95% 置信区间 19.7-27.6）和22.2%（95% 置信区间 19.5-26.3）。

Safety profiles were similar between groups; grade 3 or worse adverse events frequencies were 8% and 13%, respectively.

两组的安全性特征相似；3级或更严重的不良事件发生频率分别为8%和13%。

Following French regulation, data on race and ethnicity were not collected.

根据法国规定，未收集有关种族和民族的数据。

interpretation

3-week radiotherapy (40 Gy in 15 fractions) was found to be non-inferior to 5-week radiotherapy (50 Gy in 25 fractions) for arm lymphoedema risk and was comparably safe regarding other late normal tissue effects for patients prescribed locoregional radiotherapy for early-breast cancer.

研究发现，为期3周的放疗（15次分割，总剂量40 Gy）在上肢淋巴水肿风险方面不劣于为期5周的放疗（25次分割，总剂量50 Gy），并且对于早期乳腺癌患者接受局部区域放疗的其他晚期正常组织效应具有可比的安全性。

funding

French National Cancer Institute.

法国国家癌症研究所