Preliminary results of a randomized study on therapeutic gain by concurrent chemotherapy for regionally-advanced nasopharyngeal carcinoma: NPC-9901 Trial by the Hong Kong Nasopharyngeal Cancer Study Group
Preliminary results of a randomized study on therapeutic gain by concurrent chemotherapy for regionally-advanced nasopharyngeal carcinoma: NPC-9901 Trial by the Hong Kong Nasopharyngeal Cancer Study Group
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DOI：
10.1200/jco.2004.00.7542
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发表时间：
2005-10-01
影响因子：
45.3
通讯作者：
Lau, JT
中科院分区：
文献类型：
--
作者：
Lee, AWM;Lau, WH;Lau, JT
目的这项随机研究比较了同步化放疗（CRT）与单独放疗（RT）治疗伴有晚期淋巴结疾病的鼻咽癌（NPC）的结果。患者和方法T1- 4 N2 - 3 MO期非角化/未分化NPC患者随机接受CRT或RT。两组均采用相同的RT技术和剂量分割进行治疗。CRT患者在第1、22和43天给予顺铂100 mg/m2，第71、99和127天开始给予顺铂80 mg/m2和氟尿嘧啶1,000 mg/m2/d，共96 h。结果从1999年至2004年1月，348例符合条件的患者被随机分配;中位随访时间为2.3年。两组在所有预后因素和RT参数方面均保持良好平衡。CRT组3年无失败生存率显著更高（72% vs62%，P = 0.027），主要是由于局部控制改善（92% vs82%，P = 0.005）。然而，远距离控制并没有显著改善（76%对73%，P =.47），总生存率几乎相同（78%对78%，P =.97）。此外，CRT组的急性毒性明显更高（84% vs53%，P
Purpose This randomized study compared the results achieved by concurrent chemoradiotherapy (CRT) versus radiotherapy (RT) alone for nasopharyngeal carcinoma (NPC) with advanced nodal disease.Patients and Methods Patients with nonkeratinizing/undifferentiated NPC staged T1-4N2-3MO were randomized to CRT or RT. Both arms were treated with the same RT technique and dose fractionation. The CRT patients were given cisplatin 100 mg/m(2) on days 1, 22, and 43, followed by cisplatin 80 mg/m(2) and fluorouracil 1,000 mg/m(2)/d for 96 hours starting on days 71, 99, and 127.Results From 1999 to January 2004, 348 eligible patients were randomly assigned; the median follow-up was 2.3 years. The two arms were well-balanced in all prognostic factors and RT parameters. The CRT arm achieved significantly higher failure-free survival (72% v 62% at 3-year, P =.027), mostly as a result of an improvement in locoregional control (92% v 82%, P =.005). However, distant control did not improve significantly (76% v 73%, P =.47), and the overall survival rates were almost identical (78% v 78%, P =.97). In addition, the CRT arm had significantly more acute toxicities (84% v 53%, P