Gil Gabriel Oliveira Bernardes, de Andrade Warne Pedro, Diniz Paulo Henrique Costa, Cantidio Farley Soares, Queiroz Izabella Nobre, Gil Maria Luísa Braga Vieira, Almeida Conceição Aparecida Medeiros, Caldeira Paola Palmer Reis, Regalin Marcos, Silva-Filho Agnaldo Lopes
Department of Radiation Oncology, Rede Mater Dei and Hospital da Baleia, Belo Horizonte, Minas Gerais, Brazil.
Gynecology Department, Universidade Estadual Paulista "Júlio de Mesquita Filho", Botucatu, São Paulo, Brazil.
Front Oncol. 2023 Jun 14;13:1202544. doi: 10.3389/fonc.2023.1202544. eCollection 2023.
This study, conducted during the COVID-19 crisis, primarily aimed to compare the acute toxicity between conventional fractionated radiation therapy (CF-RT) with hypofractionated radiation therapy (HF-RT) among patients who underwent breast-conserving surgery or mastectomy in whom breast or chest wall and regional nodal irradiation (RNI) were indicated. The secondary endpoints were both acute and subacute toxicity, cosmesis, quality of life, and lymphedema features.
In this open and non-inferiority randomized trial, patients (n = 86) were randomly allocated 2:1 in the CF-RT arm (n = 33; 50 Gy/25 fractions ± sequential boost [10 Gy/5 fractions]) versus the HF-RT arm (n = 53; 40 Gy/15 fractions ± concomitant boost [8 Gy/15 fractions]). Toxic effects and cosmesis evaluation used the Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE) and the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/Radiation Therapy Oncology Group (RTOG) scale. For the patient-reported quality of life (QoL), the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) and the breast cancer-specific supplementary questionnaire (QLQ-BR23) were used. Lymphedema was assessed by comparing volume differences between the affected and contralateral arms using the Casley-Smith formula.
Grade 2 and grade 3 dermatitis were lower with HF-RT than with CF-RT (28% 52%, and 0% 6%, respectively; p = 0.022). HF-RT had a lower rate of grade 2 hyperpigmentation (23% 55%; p = 0.005), compared to CF-RT. No other differences in overall rates of physician-assessed grade 2 or higher and grade 3 or higher acute toxicity between HF-RT and CF-RT were registered. There was no statistical difference between groups regarding cosmesis, lymphedema rate (13% 12% HF-RT CF-RT; p = 1.000), and functional and symptom scales, during both the irradiation period and after 6 months of the end of treatment. The results revealed that the subset of patients up to 65 years or older did not show a statistical difference between both arm fractionation schedules (p > 0.05) regarding skin rash, fibrosis, and lymphedema.
HF-RT was non-inferior to CF-RT, and moderate hypofractionation showed lower rates of acute toxicity, with no changes in quality-of-life outcomes.
ClinicalTrials.gov, identifier NCT40155531.
本研究在新冠疫情期间开展，主要目的是比较保乳手术或乳房切除术且需进行乳房或胸壁及区域淋巴结照射（RNI）的患者中，常规分割放疗（CF-RT）与大分割放疗（HF-RT）的急性毒性。次要终点包括急性和亚急性毒性、美容效果、生活质量和淋巴水肿特征。
在这项开放的非劣效性随机试验中，患者（n = 86）按2:1随机分配至CF-RT组（n = 33；50 Gy/25次分割±序贯推量[10 Gy/5次分割]）和HF-RT组（n = 53；40 Gy/15次分割±同步推量[8 Gy/15次分割]）。毒性效应和美容效果评估采用《不良事件通用术语标准》4.03版（CTCAE）以及哈佛/国家外科辅助乳腺和肠道项目（NSABP）/放射肿瘤学组（RTOG）量表。对于患者报告的生活质量（QoL），使用欧洲癌症研究与治疗组织生活质量问卷（EORTC QLQ-C30）和乳腺癌特异性补充问卷（QLQ-BR23）。通过使用卡斯利-史密斯公式比较患侧和对侧手臂的体积差异来评估淋巴水肿。
HF-RT组2级和3级皮炎发生率低于CF-RT组（分别为28%对52%和0%对6%；p = 0.022）。与CF-RT相比，HF-RT组2级色素沉着发生率较低（23%对55%；p = 0.005）。在医生评估的2级或更高以及3级或更高急性毒性的总体发生率方面，HF-RT与CF-RT之间未发现其他差异。在照射期间和治疗结束6个月后，两组在美容效果、淋巴水肿发生率（HF-RT组13%对CF-RT组12%；p = 1.000）以及功能和症状量表方面无统计学差异。结果显示，65岁及以上患者亚组在皮疹、纤维化和淋巴水肿方面，两组分割方案之间无统计学差异（p > 0.05）。
HF-RT不劣于CF-RT，适度大分割放疗显示急性毒性发生率较低，生活质量结果无变化。
ClinicalTrials.gov，标识符NCT40155531。
