沈金闻,莫 淼.MRI引导的体部立体定向放疗对比CT引导的体部立体定向放疗治疗前列腺癌:MIRAGE随机临床研究解读[J].肿瘤学杂志,2023,29(10):890-897.
MRI引导的体部立体定向放疗对比CT引导的体部立体定向放疗治疗前列腺癌:MIRAGE随机临床研究解读
Magnetic Resonance Imaging-Guided vs Computed Tomography-Guided Stereotactic Body Radiotherapy for Prostate Cancer: Interpretation of the MIRAGE Randomized Clinical Trial
投稿时间:2023-10-08  
DOI:10.11735/j.issn.1671-170X.2023.10.B013
中文关键词:  前列腺癌  体部立体定向放射治疗  急性毒性反应  患者报告生活质量评分
英文关键词:prostate cancer  stereotactic body radiotherapy  acute toxicity  patient reported quality of life score
基金项目:
作者单位
沈金闻 浙江省肿瘤医院中国科学院杭州医学研究所浙江省放射肿瘤学重点实验室 
莫 淼 复旦大学附属肿瘤医院复旦大学上海医学院肿瘤学系 
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中文摘要:
      摘 要:MIRAGE是一项前瞻性、随机对照、单中心Ⅲ期优效性研究,该研究旨在确定MRI引导下的计划靶区外扩边界缩减能否显著降低前列腺癌体部立体定向放疗(stereotactic body radiotherapy,SBRT)患者中度毒性反应发生率,次要研究终点包括急性2度及以上胃肠道毒性反应以及患者报告生活质量评分的动态变化。因期中分析显示主要研究终点已提前达到预设统计检验水准,故研究提前中止招募,最终纳入156例患者(CT引导组77例,MRI引导组79例)。分析结果显示,MRI引导组的急性2度及以上泌尿生殖毒性反应发生率显著低于CT引导组(24.4% vs 43.4%,P=0.01)。此外,急性2度及以上胃肠道毒性反应发生率以及部分患者报告生活质量结局指标也显示MRI引导组优于CT引导组。因此,MRI引导相比较于CT引导的前列腺SBRT,能显著降低患者中度急性毒性反应和提高患者报告生活质量,但能否持续获益仍需长期随访结果来确认。
英文摘要:
      Abstract: MIRAGE is a prospective, randomized, controlled, single-center phase Ⅲ superiority study designed to determine whether reducing the PTV margin guided by MRI can significantly reduce the incidence of moderate toxicity in patients undergoing prostate stereotactic body radiotherapy(SBRT). The primary endpoint of the study was acute genitourinary toxicity of grade 2 or higher, and the secondary endpoints included acute gastrointestinal toxicity of grade 2 or higher and dynamic changes in patient-reported quality of life scores. Due to the interim analysis showing that the number of enrolled patients had reached the statistical analysis requirements, the study was closed to accrual early. A total of 156 patients (77 in the CT-guided group and 79 in the MRI-guided group) were included in the study. The results showed that the incidence of acute grade 2 or higher genitourinary toxicity in the MRI-guided group was significantly lower than that in the CT-guided group (24.4% vs 43.4%, P=0.01). In addition, the incidence of acute gastrointestinal toxicity of grade 2 or higher and some patients’ reported quality of life outcomes also showed that the MRI-guided group was superior to the CT-guided group. Therefore, MRI-guided prostate SBRT can significantly reduce moderate acute toxicity compared to CT-guided. However, long-term follow-up outcomes are still needed to determine whether the long-term toxicity can be reduced and whether the long-term efficacy is consistent.
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