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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. 低分割局部放射治疗早期乳腺癌HypoG-01 (UNICANCER)的5年结果:一项法国多中心、随机、非劣效、3期、开放标签、对照试验。
Pub Date : 2026-03-07 DOI: 10.1016/s0140-6736(25)02597-8
Sofia Rivera,Robabeh Ghodssighassemabadi,Guillaume Auzac,Thomas Brion,Youlia Kirova,Séverine Racadot,Mohamed Benchalal,Jean-Baptiste Clavier,Claire Charra Brunaud,Anais Groulier,Delphine Argo-Leignel,Karine Peignaux,Ahmed Benyoucef,David Pasquier,Philippe Guilbert,Aurore Goineau,Agnes Tallet,Marie Bergeaud,Assia Lamrani-Ghaouti,Stefan Michiels,
BACKGROUNDHypofractionated radiotherapy is standard for whole-breast radiotherapy, but 50 Gy in 25 fractions (5-week radiotherapy) is still standard in many countries when nodal radiotherapy is needed for morbidity concerns. 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.METHODSThis 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. 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. 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. This trial was registered at ClinicalTrials.gov (NCT03127995) and is closed to recruitment.FINDINGSBetween 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. The median age was 58 years (IQR 49-68). 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 incidence of 23·4% (95% CI 19·7-27·6) and 22·2% (95% CI 19·5-26·3), respectively. Safety profiles were similar between groups; grade 3 or worse adverse events frequencies were 8% and 13%, respectively. Following French regulation, data on race and ethnicity were not collected.INTERPRETATION3-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.FUNDINGFrench National Cancer Institute.
背景:低分割放疗是全乳放疗的标准,但在许多国家,当考虑到发病率需要进行节段放疗时,25段50 Gy(5周放疗)仍然是标准。UNICANCER HypoG-01试验旨在评估低分割局部放射治疗的发病率和疗效,分15次提供40 Gy(3周放疗)和5周放疗。方法:这项非低效性、开放标签、多中心、随机3期试验,在法国29个中心进行,包括18岁及以上的浸润性乳腺癌患者,在原发肿瘤完全显微切除后需要淋巴结照射。患者按1:1的比例随机分配到3周放疗组(实验组)或5周放疗组(对照组)的局部淋巴结和胸壁或乳房。主要终点为同侧臂淋巴水肿,定义为相对于基线和对侧臂,同侧鹰口近端15 cm、远端10 cm或两者的臂围增加10%或更多,风险比(HR)为1.545。该试验已在ClinicalTrials.gov注册(NCT03127995),现已停止招募。研究结果:2016年9月26日至2020年3月27日,1265例患者入组,1221例纳入按方案分析(中位随访时间为4.8年[IQR 4.01 - 5.02]), 614例接受3周放疗,607例接受5周放疗。中位年龄为58岁(IQR 49-68)。275例(25%)患者发生上肢淋巴水肿(143例放疗3周,132例放疗5周)。在手臂淋巴水肿风险方面,3周放疗不低于5周放疗(HR为1.02 [95% CI 0.79 - 1.31] pnon-劣效性< 0.001),3年累积发生率分别为23.4% (95% CI 19.7 - 27.6)和22.2% (95% CI 19.5 - 26.3)。各组之间的安全性概况相似;3级或更严重的不良事件发生率分别为8%和13%。根据法国的规定,没有收集有关种族和民族的数据。研究发现,3周放疗(15组40 Gy)在手臂淋巴水肿风险方面不低于5周放疗(25组50 Gy),对于早期乳腺癌局部局部放疗患者的其他晚期正常组织效应也相当安全。资助法国国家癌症研究所。
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引用次数: 0
Ultra-processed foods in research and policy - Authors' reply. 研究和政策中的超加工食品——作者的答复。
Pub Date : 2026-03-07 DOI: 10.1016/s0140-6736(26)00292-8
Carlos A Monteiro,Leandro F M Rezende,Phillip Baker,Marion Nestle,Camila Corvalán,Barry M Popkin
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引用次数: 0
Why investing in women's health is a societal imperative. 为什么投资于妇女健康是社会的当务之急。
Pub Date : 2026-03-07 DOI: 10.1016/s0140-6736(26)00404-6
Isa Bijloo,Noa S de Smit,Felicia Yarde,Wouter J K Hehenkamp,Carmen van Vilsteren,Derrick Z W Khor,Chiara Benedetto,Mathew Leonardi,Lesley Regan,Tina Tellum,Judith A F Huirne
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引用次数: 0
Offline: The silent torment of Casey Means. 离线:Casey Means的无声折磨。
Pub Date : 2026-03-07 DOI: 10.1016/s0140-6736(26)00454-x
Richard Horton
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引用次数: 0
Medico-legal entanglement: a woman with abdominal pain in Peru. 医法纠纷案:秘鲁一名腹痛妇女。
Pub Date : 2026-03-07 DOI: 10.1016/s0140-6736(26)00426-5
Michele Heisler,Marvel Celeste Sabino Pretel,Zoe Boudart,Lutz Oette
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引用次数: 0
Call to enhance civilian and military blood preparedness 呼吁加强民用和军用血液准备
Pub Date : 2026-03-06 DOI: 10.1016/s0140-6736(26)00322-3
Nadira Frescaline, Andrew Beckett, Michael C Reade
No Abstract
没有抽象的
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引用次数: 0
Time to change internal medicine training for UK resident doctors 是时候改变英国住院医生的内科培训了
Pub Date : 2026-03-06 DOI: 10.1016/s0140-6736(26)00290-4
Nicholas Wong, David Barnes, James Hartley, Patricia Yunger, Chian Chyn Khoo, Neil Bailey, Neil Kelly, Farah Bachar, Daniel Pan
No Abstract
没有抽象的
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引用次数: 0
Cancer in pregnancy: navigating two medical systems. 妊娠期癌症:两种医疗体系的导航。
Pub Date : 2026-03-06 DOI: 10.1016/s0140-6736(26)00465-4
Na'ama Carlin
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引用次数: 0
Pimicotinib: a new agent for an orphan disease. 匹米可替尼:一种治疗孤儿病的新药。
Pub Date : 2026-03-05 DOI: 10.1016/s0140-6736(26)00191-1
Jean-Yves Blay
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引用次数: 0
Changes in paracetamol and leucovorin use after a White House briefing 白宫简报后扑热息痛和亚叶酸素使用的变化
Pub Date : 2026-03-05 DOI: 10.1016/s0140-6736(26)00243-6
Jeremy Samuel Faust, Michael L Barnett
No Abstract
没有抽象的
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引用次数: 0
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The Lancet
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