Effect of Total Dose and Fraction Size on Survival of Patients With Locally Recurrent Nasopharyngeal Carcinoma Treated With Intensity-Modulated Radiotherapy: A Phase 2, Single-Center, Randomized Controlled Trial
Effect of Total Dose and Fraction Size on Survival of Patients With Locally Recurrent Nasopharyngeal Carcinoma Treated With Intensity-Modulated Radiotherapy: A Phase 2, Single-Center, Randomized Controlled Trial
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DOI：
10.1002/cncr.28934
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发表时间：
2014-11-15
期刊：
影响因子：
6.2
通讯作者：
Han, Fei
中科院分区：
文献类型：
--
作者：
Tian, Yun-ming;Zhao, Chong;Han, Fei
背景：调强放疗(IMRT)治疗局部复发鼻咽癌患者的总剂量和分割大小的最佳模型尚不清楚。作者设计了一项随机的第二阶段临床试验，以考察两种不同模型的有效性，目的是确定一个最佳模型。方法将2003年1月至2007年12月收治的117例局部复发非转移性鼻咽癌患者随机分为两种不同的治疗模式：A组59例，27次60次；B组58例，68次34次。两组都接受了每周5次每日一次的治疗。所有患者均接受单纯调强放射治疗。结果中位随访时间为25.0个月。5年总生存率A组高于B组(44.2%比30.3%；P=.06)，局部无故障生存率略低于B组(63.7%比71.0%；P=.41)。严重的晚期并发症是死亡的主要原因。B组黏膜坏死和大出血发生率分别为50.8%和31.0%，明显高于A组的28.8%(P=0.02)和18.6%(P=.12)。肿瘤体积(P
BACKGROUND The optimal model of total dose and fraction size for patients with locally recurrent nasopharyngeal carcinoma treated with intensity-modulated radiotherapy (IMRT) remains unclear. The authors designed a randomized phase 2 clinical trial to investigate the efficacy of 2 different models, with the objective of determining an optimal model. METHODS Between January 2003 and December 2007, a total of 117 patients with locally recurrent nonmetastatic nasopharyngeal carcinoma were randomized to 2 different models of total dose and fraction size: group A (59 patients) received 60 gray in 27 fractions and group B (58 patients) received 68 gray in 34 fractions. Both groups received 5 daily fractions per week. All patients received IMRT alone. RESULTS The median follow-up was 25.0 months. The 5-year overall survival in group A was higher than that in group B (44.2% vs 30.3%; P =.06), and the local failure-free survival in group A was slightly lower than that in group B (63.7% vs 71.0%; P =.41). Severe late complications were the main cause of death. The incidences of mucosal necrosis and massive hemorrhage in patients in group B were significantly higher than those among patients in group A at 50.8% versus 28.8% (P =.02) and 31.0% versus 18.6% (P =.12), respectively. Tumor volume (P