Early toxicity of moderately hypofractionated radiation therapy in breast cancer patients receiving locoregional irradiation: First results of the UNICANCER HypoG-01 phase III trial

IF 4.9 1区医学 Q1 ONCOLOGY

Radiotherapy and Oncology Pub Date : 2025-03-15 DOI:10.1016/j.radonc.2025.110849

Thomas Brion , Robabeh Ghodssighassemabadi , Guillaume Auzac , Youlia Kirova , Séverine Racadot , Mohamed Benchalal , Jean-Baptiste Clavier , Claire Brunaud , Marie-Eve Fouche-Chand , Delphine Argo-Leignel , Karine Peignaux-Casasnovas , Ahmed Benyoucef , David Pasquier , Philippe Guilbert , Julien Blanchecotte , Agnès Tallet-Richard , Assia Lamrani , Marie Bergeau , Gabriele Bielynite , Amandine Ruffier , Sofia Rivera

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引用次数: 0

Abstract

Purpose

To investigate early adverse events (AEs) in HypoG-01, a randomised, controlled, multicentre, non-inferiority phase 3 trial comparing toxicity and efficacy of adjuvant loco-regional moderately hypofractionated radiation therapy versus 2 Gy daily radiation therapy.

Methods

Women ≥ 18 years with T1-3 N0-3 M0 breast cancer were randomised 1:1 after surgery +/- systemic therapy to receive either 40 Gy/15 fractions (3-week-RT) or 50 Gy/25 fractions (5-week-RT) +/-tumour-bed boost. AEs at baseline, end of treatment, and 6-month follow-up were graded using CTCAEV4.0, LENT/SOMA and Harris 4-point scales. Competing risk analysis for cumulative incidence of AEs, worst grade dermatitis according to risk factors, and cosmetic assessment were performed in the intention-to-treat (ITT) population.

Results

From September 2016 to March 2020, 29 sites enrolled 1265 women. The ITT population included 1260 patients (3-week-RT: 631, 5-week-RT: 629). The proportion of patients with maximum grade ≥ 2 AEs were 284 (45 %) in 3-week-RT and 326 (51.8 %) in 5-week-RT. Overall, 88 (7 %) grade 3, one grade 4 and no grade 5 AEs were observed. Reported AEs were mostly dermatitis, fatigue, and pain, numerically lower in 3-week-RT than 5-week-RT. Grade ≥ 2 dermatitis was more frequent in patients receiving a tumour-bed boost or with BMI > 30 but numerically less frequent with 3-week-RT than 5-week-RT even in those subgroups. Of the 552 patients with breast-conserving surgery who completed cosmetic evaluation at M6, 88.4 % had excellent to good cosmetic results with no imbalance between groups.

Conclusion

Early AEs were mild and do not raise safety concerns for 3-week-RT in women receiving nodal RT.

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适度低分割放疗对接受局部放疗的乳腺癌患者的早期毒性：UNICANCER HypoG-01 III期试验的初步结果

目的：研究HypoG-01的早期不良事件（ae），这是一项随机、对照、多中心、非劣效性的3期试验，比较辅助局部-区域中度低分割放射治疗与2 Gy每日放射治疗的毒性和疗效。方法：T1-3 N0-3 M0乳腺癌患者 ≥ 18 岁，在手术+/-全身治疗后按1:1随机分组，接受40 Gy/15分（3周rt）或50 Gy/25分（5周rt） +/-肿瘤床增强治疗。采用CTCAEV4.0、LENT/SOMA和Harris 4分量表对基线、治疗结束和6个月随访时的ae进行评分。在意向治疗（ITT）人群中，根据危险因素对ae累积发生率、最差级别皮炎进行竞争风险分析，并进行化妆品评估。结果：从2016年9月到2020年3月，29个站点招募了1265名女性。ITT人群包括1260例患者（3周rt: 631例，5周rt: 629例）。最大级别 ≥ 2 ae的患者比例在3周rt中为284例（45 %），在5周rt中为326例（51.8 %）。总体而言，88例（7 %）3级ae， 1例4级ae，无5级ae。报告的ae主要是皮炎、疲劳和疼痛，3周的放射治疗比5周的放射治疗在数字上要低。分级 ≥ 2皮炎在接受肿瘤床增加或BMI为 > 30的患者中更为常见，但在数字上，即使在这些亚组中，3周rt的发生率也低于5周rt。在552例在M6完成美容评估的保乳手术患者中，88.4% %的患者美容效果为优至良，组间无不平衡。结论：早期不良反应是轻微的，在接受淋巴结性放射治疗的妇女中，3周的放射治疗不会引起安全性问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Radiotherapy and Oncology 医学-核医学

CiteScore

10.30

自引率

10.50%

发文量

2445

审稿时长

45 days

期刊介绍： Radiotherapy and Oncology publishes papers describing original research as well as review articles. It covers areas of interest relating to radiation oncology. This includes: clinical radiotherapy, combined modality treatment, translational studies, epidemiological outcomes, imaging, dosimetry, and radiation therapy planning, experimental work in radiobiology, chemobiology, hyperthermia and tumour biology, as well as data science in radiation oncology and physics aspects relevant to oncology.Papers on more general aspects of interest to the radiation oncologist including chemotherapy, surgery and immunology are also published.