| 祝鸿程,王泽洲,徐裕金.局部晚期食管癌根治性放化疗放疗剂量增加随机对照临床试验——ARTDECO研究解读[J].肿瘤学杂志,2022,28(3):246-253. |
| 局部晚期食管癌根治性放化疗放疗剂量增加随机对照临床试验——ARTDECO研究解读 |
| Summary of A Randomized Phase 3 Trial(ARTDECO) of Dose Escalation in Definitive Chemoradiation for Patients with Locally Advanced Esophageal Cancer |
| 投稿时间：2022-02-15 |
| DOI：10.11735/j.issn.1671-170X.2022.03.B015 |
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| 中文关键词: 放化疗 放射治疗 剂量 食管癌 临床研究 |
| 英文关键词:chemoradiation radiotherapy dose esophageal cancer clinical trial |
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| 中文摘要: |
| 摘 要：ARTDECO研究是一项比较接受根治性放化疗的食管癌患者使用标准剂量放疗与提升剂量放疗的疗效差异的研究。研究对象按组织学结果和T分期分层，并使用最小化随机的技术入组。该研究除了有两次期中分析之外，不涉及到多个主要研究终点，或者多组或亚组分析等多重比较的内容，检验水准分配确定采用O’Brien?鄄Fleming分配法，两次期中分析也没有得出阳性结果，没有中途结束研究。该研究只预设了一个主要研究终点局部无进展生存期，其他研究终点的结果仅为探索性分析，结果显示在食管癌根治性放化疗中，增加原发灶的放疗剂量至61.6 Gy，相比较于50.4 Gy并未显著性改善局部控制，反而增加了毒性发生率，并且没有总生存的获益。或许增加新的治疗方式，同时精准筛选病例，为放疗剂量量体裁衣是未来治疗的发展方向。 |
| 英文摘要: |
| Abstract：ARTDECO study is to compare the efficacy of standard dose and escalated dose radiation in patients with esophageal cancer receiving definitive chemoradiotherapy. Patients were stratified by histologic type and by T stage， and were randomly assigned using a minimization technique. In addition to two interim analyses， the study did not involve multiple main study endpoints， or multiple comparisons such as multiple group or subgroup analyses. The O’Brien-Fleming distribution method was used to determine the significance level. No positive results were obtained from the two interim analyses and the study was not terminated halfway. In this study only one main endpoint， local progression-free survival， was preset and the results of other endpoints were only exploratory analysis. The results indicated that in the definitive chemoradiotherapy of esophageal cancer， dose escalation of the primary tumor to 61.6 Gy did not significantly improve the local control， but increased the incidence of toxicity， while there was no improvement in overall survival. Adding new treatment methods or precisely screening patients to tailor radiotherapy dose might be the future direction of treatment development. |
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