Randomized trial of radiotherapy versus concurrent chemoradiotherapy followed by adjuvant chemotherapy in patients with American Joint Committee on Cancer/International Union Against Cancer stage III and IV nasopharyngeal cancer of the endemic variety
Randomized trial of radiotherapy versus concurrent chemoradiotherapy followed by adjuvant chemotherapy in patients with American Joint Committee on Cancer/International Union Against Cancer stage III and IV nasopharyngeal cancer of the endemic variety
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DOI：
10.1200/jco.2005.16.790
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发表时间：
2005-09-20
影响因子：
45.3
通讯作者：
Machin, D
中科院分区：
文献类型：
--
作者：
Wee, J;Tan, EH;Machin, D
目的：鼻咽癌（NPC）的Intergroup 00-99试验显示了在放疗基础上加用化疗的益处。然而，有争议的适用性的结果在流行地区的患者。本研究旨在证实00-99试验的结果及其对地方性NPC患者的适用性。患者和方法：1997年9月至2003年5月期间，221名患者被随机分配接受单独放疗（RT）（n = 110）或化放疗（CRT; n = 111）。两组患者均使用标准RT门户和技术在7周内接受70戈伊。CRT患者同时接受顺铂治疗（第1 - 4天25 μ g/m2），第1、4和7周RT和辅助顺铂（第1 - 4天20 Mg/m2）和氟尿嘧啶（第1 - 4天1，000 mg/m（2）），每4周一次所有患者均进行意向治疗分析。中位随访时间为3.2年。结果：38例单纯放疗患者和18例CRT患者发生远处转移。2年累积发生率的差异为17%（95% CI，14%-20%; P = 0.0029）。无病生存的风险比（HR）为0.57（95% CI，0.38 - 0.87; P = 0.0093）。单纯放疗组和CRT组的2年和3年总生存率（OS）分别为78%和85%以及65%和80%。OS的HR为0.51（95%CI，0.31至0.81; P = 0.0061）。结论：本报告证实了00-99试验的结果，并证明了其适用于地方性NPC。本研究也证实化疗可提高鼻咽癌远处转移控制率。
Purpose: The Intergroup 00-99 Trial for nasopharyngeal cancer (NPC) showed a benefit of adding chemotherapy to radiotherapy. However, there were controversies regarding the applicability of the results to patients in endemic regions. This study aims to confirm the findings of the 00-99 Trial and its applicability to patients with endemic NPC.Patients and Methods: Between September 1997 and May 2003, 221 patients were randomly assigned to receive radiotherapy (RT) alone (n = 110) or chemoradiotherapy (CRT; n = 111). Patients in both arms received 70 Gy in 7 weeks using standard RT portals and techniques. Patients on CRT received concurrent cisplatin (25 Mg/m(2) on days 1 to 4) on weeks 1, 4, and 7 of RT and adjuvant cisplatin (20 Mg/m(2) on days 1 to 4) and fluorouracil (1,000 mg/m(2) on days 1 to 4) every 4 weeks (weeks 11, 15, and 19) for three cycles after completion of RT. All patients were analyzed by intent-to-treat analysis. The median follow-up time was 3.2 years.Results: Distant metastasis occurred in 38 patients on RT alone and 18 patients on CRT. The difference in 2-year cumulative incidence was 17% (95% Cl, 14% to 20%; P = .0029). The hazard ratio (HR) for disease-free survival was 0.57 (95% Cl, 0.38 to 0.87; P = .0093). The 2- and 3-year overall survival (OS) rates were 78% and 85% and 65% and 80% for RT alone and CRT, respectively. The HR for OS was 0.51 (95% Cl, 0.31 to 0.81; P = .0061).Conclusion: This report confirms the findings of the Intergroup 00-99 Trial and demonstrates its applicability to endemic NPC. This study also confirms that chemotherapy improves the distant metastasis control rate in NPC.