A PROSPECTIVE RANDOMIZED STUDY OF CHEMOTHERAPY ADJUNCTIVE TO DEFINITIVE RADIOTHERAPY IN ADVANCED NASOPHARYNGEAL CARCINOMA
A PROSPECTIVE RANDOMIZED STUDY OF CHEMOTHERAPY ADJUNCTIVE TO DEFINITIVE RADIOTHERAPY IN ADVANCED NASOPHARYNGEAL CARCINOMA
复制标题
DOI：
10.1016/0360-3016(95)00218-n
复制
发表时间：
1995-10-15
影响因子：
7
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：进行一项前瞻性随机试验，比较放化疗与单纯放疗治疗局部晚期鼻咽癌的效果。 方法和材料：纳入 82 例经组织学证实为 Ho's N3 分期或任何 N 分期且淋巴结直径大于或等于 4 cm 的鼻咽癌患者。 77 名患者的肿瘤反应和生存情况可进行评估。患者被随机分配接受两个周期的顺铂 100 mg/m(2) 第 1 天，5-氟尿嘧啶 1000 mg/m(2) 24 小时输注，在根治性放疗前第 2、3 和 4 天，以及四个周期的放疗后化疗（37 名患者）或单独放疗（40 名患者）。所有患者均接受鼻咽部和颈部的根治性放射治疗。鼻咽和上颈采用常规分割治疗至 66 Gy，下颈至 58 Gy。标准放疗后对任何残留淋巴结进行加强放疗（7.5 Gy/两次分次/周）。结果：双臂的患者特征（包括分期）相似。新辅助化疗的总体缓解率为 81%（19% 完全缓解，62% 部分缓解）。两组中因咽旁疾病或残留淋巴结加重而接受放疗的比率没有显着差异。放化疗的总体完全缓解率为 100%，单纯放疗的总体完全缓解率为 95%。放化疗组的毒性主要是骨髓抑制、肾毒性以及恶心和呕吐。两只手臂的粘膜炎程度没有显着差异。没有出现与治疗相关的死亡。中位随访时间为 28.5 个月。放化疗组的 2 年总生存率为 80%，放疗组为 80.5%。放化疗组的 2 年无病生存率为 68%，放疗组为 72%，两组之间没有显着差异。两组之间的局部复发率、远处转移率和中位复发时间也没有显着差异。 结论：尽管 II 期试验的肿瘤缓解率令人鼓舞，但这项前瞻性随机试验表明，在局部晚期鼻咽癌的治疗中，辅助化疗与放疗没有任何益处。
Purpose: A prospective randomized trial was conducted to compare chemoradiotherapy against radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal carcinoma.Methods and Materials: Eighty-two patients with histologically proven nasopharyngeal carcinoma who had either Ho's N3 staging or any N stage with a nodal diameter of greater than or equal to 4 cm were entered. Seventy-seven patients were evaluable for tumor response and survival. The patients were randomized to receive two cycles of cisplatin 100 mg/m(2) Day 1, 5-fluorouracil 1000 mg/m(2) 24-h infusion Days 2, 3, and 4 before radical radiotherapy, and four cycles of postradiotherapy chemotherapy (37 patients) or radiotherapy alone (40 patients). All patients received radical radiotherapy to the nasopharynx and neck. The nasopharynx and upper neck were treated to 66 Gy by conventional fractionation and the lower neck to 58 Gy. Booster radiotherapy (7.5 Gy/two fractions/week) was given to any residual nodes after standard radiotherapy.Results: The patient characteristics, including staging, were similar in both arms. The overall response rate to neoadjuvant chemotherapy was 81% (19% complete response, 62% partial response). The rates of radiotherapy for boosting parapharyngeal disease or residual lymph nodes were not significantly different in the two arms. The overall complete response rate to chemoradiotherapy was 100%, and to radiotherapy alone, 95%. Toxicities in the chemoradiotherapy arm were mainly myelosuppression, nephrotoxicity, and nausea and vomiting. The degree of mucositis was not significantly different in the two arms. There was no treatment-related death. The median follow up was 28.5 months. The 2-year overall survival was 80% in the chemoradiotherapy arm and 80.5% in the radiotherapy arm. The 2-year disease-free survival was 68% in the chemoradiotherapy arm and 72% in the radiotherapy arm, without significant difference between the two arms. The locoregional relapse rate, distant metastatic rate, and median time to relapse were also not significantly different between the two arms.Conclusion: Despite promising tumor response rates from Phase II trials, this prospective randomized trial has demonstrated no benefit from adjunctive chemotherapy to radiotherapy in the treatment of locoregionally advanced nasopharyngeal carcinoma.