Concurrent chemotherapy-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: Progression-free survival analysis of a phase III randomized trial
Concurrent chemotherapy-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: Progression-free survival analysis of a phase III randomized trial
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DOI：
10.1200/jco.2002.08.149
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发表时间：
2002-04-15
影响因子：
45.3
通讯作者：
Johnson, PJ
中科院分区：
文献类型：
--
作者：
Chan, ATC;Teo, PML;Johnson, PJ
目的：鼻咽癌（NPC）对放疗（RT）和化疗高度敏感。这项随机 III 期试验在局部晚期 NPC 患者中比较了同步顺铂放疗 (CRT) 与单独放疗。患者和方法：Ho 氏 N2 或 N3 期或 N1 期且淋巴结大小大于或等于 4 cm 的患者随机接受每周 40 mg/m(2) 的顺铂治疗，持续 8 周，同时接受根治性放疗 (CRT) 或单独放疗。主要终点是无进展生存期 (PFS)。结果：三百五十名符合条件的患者被随机分组。两组患者的基线特征相当。 CRT 组的毒性明显更多，包括粘膜炎、骨髓抑制和体重减轻。 CRT 组没有出现与治疗相关的死亡，单独 RT 组有 1 名患者在治疗期间死亡。中位随访时间为 2.71 年，CRT 组的 2 年 PFS 为 76%，单独 RT 组为 69%（P = .10），风险比为 1.367（95% 置信区间 [CI]，0.93 至 2.00）。治疗效果与肿瘤分期存在显着的协变量相互作用，亚组分析表明，在 Ha 的 T3 期中，CRT 组存在高度显着性差异（P = .0075），风险比为 2.328（95% Cl，1.26 至 4.28）。对于 T3 期，首次远端失败的时间在统计学上显着差异，有利于 CRT 组 (P = .016)。 结论：流行地区晚期 NPC 患者对同步 CRT 具有良好的耐受性。尽管总体比较中，同步 CRT 组和单独 RT 组的 PFS 没有显着差异，但晚期肿瘤和淋巴结分期患者的 PFS 显着延长。 (C) 2002 年，美国临床肿瘤学会。
Purpose : Nasopharyngeal carcinoma (NPC) is highly sensitive to both radiotherapy (RT) and chemotherapy. This randomized phase III trial compared concurrent cisplatin-RT (CRT) with RT alone in patients with locoregionally advanced NPC.Patients and Methods: Patients with Ho's N2 or N3 stage or N1 stage with nodal size greater than or equal to 4 cm were randomized to receive cisplatin 40 mg/m(2) weekly up to 8 weeks concurrently with radical RT (CRT) or RT alone. The primary end point was progression-free survival (PFS).Results: Three hundred fifty eligible patients were randomized. Baseline patient characteristics were comparable in both arms. There were significantly more toxicities, including mucositis, myelosuppression, and weight loss in the CRT arm. There were no treatment-related deaths in the CRT arm, and one patient died during treatment in the RT-alone arm. At a median follow-up of 2.71 years, the 2-year PFS was 76% in the CRT arm and 69% in the RT-alone arm (P = .10) with a hazards ratio of 1.367 (95% confidence interval [CI], 0.93 to 2.00). The treatment effect had a significant covariate interaction with tumor stage, and a subgroup analysis demonstrated a highly significant difference in favor of the CRT arm in Ha's stage T3 (P = .0075) with a hazards ratio of 2.328 (95% Cl, 1.26 to 4.28). For T3 stage, the time to first distant failure was statistically significantly different in favor of the CRT arm (P = .016).Conclusion: Concurrent CRT is well tolerated in patients with advanced NPC in endemic areas. Although PFS was not significantly different between the concurrent CRT arm and the RT-alone arm in the overall comparison, PFS was significantly prolonged in patients with advanced tumor and node stages. (C) 2002 by American Society of Clinical Oncology.