Comparison of weekly versus triweekly cisplatin delivered concurrently with radiation therapy in patients with locally advanced nasopharyngeal cancer: A multicenter randomized phase II trial (KCSG-HN10-02)
Comparison of weekly versus triweekly cisplatin delivered concurrently with radiation therapy in patients with locally advanced nasopharyngeal cancer: A multicenter randomized phase II trial (KCSG-HN10-02)
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DOI：
10.1016/j.radonc.2015.11.030
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发表时间：
2016-02-01
影响因子：
5.7
通讯作者：
Ahn, Myung-Ju
中科院分区：
文献类型：
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作者：
Lee, Ji Yun;Sun, Jong-Mu;Ahn, Myung-Ju
目的：尽管对治疗相关并发症的高度关注，但每三周给予顺铂同时进行一个疗程的放射治疗（RT）已成为局部晚期鼻咽癌（NPC）治疗的标准方案。我们进行了一项随机II期研究，比较每周一次和三每周一次的顺铂在放疗期间的疗效和毒性。材料和方法：局部晚期NPC （II-IVb期）患者被随机分配到七个剂量的顺铂（40 mg/m(2)），每周一次，或三个剂量的顺铂（100 mg/m2），每3周同时给予一次。结果：109名符合条件的患者中，53名被分配到每周一次的方案，56名被分配到三周的方案。两组在人口学和临床特征方面具有可比性。两种方案的平均放射治疗剂量（68.3 Gy vs. 67.3 Gy, p = 0.559）和平均顺铂剂量(248.9 mg/m（2) vs. 256.6 mg/m(2), p = 0.433）无显著差异。主要终点为3年无进展生存期，两种方案间无差异（64.9% vs. 63.8%, p = 0.074）。总体而言，两组3-4级毒性的发生率相似（47.2% vs 39.3%, p = 0.443）。治疗结束后3周与功能结果相关的生活质量（QoL）在每周方案中更好。结论：虽然没有明确的结论可以得出，每周一次的顺铂方案似乎与改善的生活质量有关，并且在疗效和毒性方面并不逊于标准的三周方案。2015爱思唯尔爱尔兰有限公司版权所有。
Purpose: Triweekly delivery of cisplatin concurrent with a course of radiation therapy (RT) has been the standard regimen for treatment of locally advanced nasopharyngeal carcinoma (NPC) despite a high level of concern regarding treatment-related complications. We conducted a randomized phase II study to compare weekly and triweekly cisplatin delivery during RT with respect to efficacy and toxicity profiles.Material and methods: Patients with locally advanced NPC (stage II-IVb) were randomly assigned to a regimen of either seven doses of cisplatin (40 mg/m(2)) given once a week or three doses of cisplatin (100 mg/m2) given every 3 weeks concurrently during RT.Results: Of 109 eligible patients, 53 were assigned to the weekly regimen and 56 to the triweekly regimen. The two groups were comparable with respect to demographic and clinical characteristics. There were no significant differences in mean RT dose (68.3 Gy vs. 67.3 Gy, p = 0.559) and mean cisplatin dose (248.9 mg/m(2) vs. 256.6 mg/m(2), p = 0.433) between the two regimens. The primary endpoint was 3-year progression-free survival, which was not different between the regimens (64.9% vs. 63.8%, p = 0.074). Overall, the occurrence of grade 3-4 toxicities was similar between the two arms (47.2% vs. 39.3%, p = 0.443). Quality of life (QoL) related to functional outcomes 3 weeks after treatment completion was better for the weekly regimen.Conclusions: Although no definitive conclusions can be made, a once-weekly cisplatin regimen appears to be associated with improved QoL and is not inferior to the standard triweekly regimen with respect to efficacy and toxicity profiles. (C) 2015 Elsevier Ireland Ltd. All rights reserved.