| 全晓薇,李佩静,陈晓钟.局部晚期复发鼻咽癌调强放疗中超分割与标准分割模式有效性和安全性的比较：一项多中心、随机、开放标签、Ⅲ期临床试验结果解读[J].肿瘤学杂志,2023,29(5):434-440. |
| 局部晚期复发鼻咽癌调强放疗中超分割与标准分割模式有效性和安全性的比较：一项多中心、随机、开放标签、Ⅲ期临床试验结果解读 |
| Comparison of Efficacy and Safety of Hyper-Fractionation Versus Standard Fractionation in IMRT for Locally Advanced Recurrent Nasopharyngeal Carcinoma： Interpretation of A Multicenter， Randomized， Open-Label，Phase Ⅲ Clinical Trial |
| 投稿时间：2023-05-07 |
| DOI：10.11735/j.issn.1671-170X.2023.05.B015 |
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| 中文关键词: 复发鼻咽癌 放疗分割模式 临床试验 |
| 英文关键词:recurrent nasopharyngeal carcinoma radiation fractionation schedule clinical trials |
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| 中文摘要: |
| 摘 要：局部晚期复发鼻咽癌的再程放疗往往会引起严重的晚期毒性反应，影响患者的生活质量和生存获益。中国广州开展了一项多中心、随机、开放标签、Ⅲ期临床试验，对比了两种不同的放疗剂量-分割模式应用于局部晚期复发鼻咽癌的有效性与安全性。该研究于2015年7月10日至2019年12月23日共纳入局部晚期复发鼻咽癌患者144例，1∶1随机分配至超分割放疗组（65 Gy/54 f，1.2 Gy/f，2 f/d，两次放疗间隔≥6 h）和标准分割放疗组（60 Gy/27 f，2.2 Gy/f，1 f/d）。主要研究终点为严重晚期毒性反应发生率和总生存期，次要研究终点为局部区域无复发生存期和无远处转移生存期。中位随访时间45 （IQR：37.3~53.3）个月，超分割放疗组≥3级晚期毒性反应发生率显著低于标准分割放疗组（34% vs 57%，P=0.023），超分割放疗组患者的5级晚期毒性反应发生率低于标准分割放疗组，分别为7%（鼻出血）和 24%（3%鼻咽部坏死，16%鼻出血和4%颞叶坏死）。超分割放疗组患者的3年总生存率显著优于标准分割放疗组［74.6%（95%CI：64.4%~84.8%） vs 55.0%（95%CI：44.3%~66.6%），HR=0.54（95%CI：0.33~0.88），P=0.014］。该研究为局部晚期复发鼻咽癌患者再程放疗不同剂量-分割模式的选择提供了可靠的证据。 |
| 英文摘要: |
| Abstract： Reirradiation for locally advanced recurrent nasopharyngeal carcinoma is often associated with substantial late toxicity， which affects patients’ quality of life and survival benefits. A multicenter， randomized， open-label， phase Ⅲ clinical trial was conducted in Guangzhou， China， comparing the efficacy and safety of hyper-fractionation and standard fractionation applied to locally advanced recurrent nasopharyngeal carcinoma. Between July 10，2015， and December 23，2019，144 patients were randomly assigned (1∶1) to receive either hyper-fractionation (65 Gy/54 f， 1.2 Gy/f， 2 f/d， with an interval of ≥6 h between radiotherapy sessions) or standard fractionation (60 Gy/27 f， 2.2 Gy/f， 1 f/d). The primary study endpoints were the incidence of severe late complications and overall survival. The secondary end points were local relapse-free survival and survival without distant metastasis. Median follow-up time was 45(IQR: 37.3~53.3) months. Incidence of ≥grade 3 radiotherapy-related late toxicities in the hyper-fractionation group was significantly lower than that in the standard fractionation group (34% vs 57%， P=0.023). The incidence of grade 5 late complications in the hyper-fractionation group(7% for nasal bleeding) was lower than that in standard fractionation group(24%， including 3% for nasopharyngeal necrosis， 16% for nasal bleeding and 4% for temporal lobe necrosis). Patients in the hyper-fractionation group had significantly better 3-year overall survival ［74.6%(95%CI：64.4%~84.8%) vs 55.0%(95%CI：44.3%~66.6%)， HR=0.54(95%CI：0.33~0.88)， P=0.014］. This study provides reliable evidence for the selection of different dose-fractionation modes in reirradiation for patients with locally advanced recurrent nasopharyngeal carcinoma. |
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