Results of a prospective randomized trial comparing neoadjuvant chemotherapy plus radiotherapy with radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma
Results of a prospective randomized trial comparing neoadjuvant chemotherapy plus radiotherapy with radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma
复制标题
DOI：
10.1200/jco.2001.19.5.1350
复制
发表时间：
2001-03-01
影响因子：
45.3
通讯作者：
Mo, HY
中科院分区：
文献类型：
--
作者：
Ma, J;Mai, HQ;Mo, HY
目的：为探讨新辅助化疗对局部晚期鼻咽癌的影响，采用前瞻性随机对照研究方法，对局部晚期鼻咽癌患者进行新辅助化疗联合放疗（CT/RT组）和单纯放疗（RT组）。CT/RT组接受新辅助化疗，包括2至3个周期的顺铂（100 mg/m2，第1天）、博莱霉素（10 mg/m2，第1和5天）和氟尿嘧啶（5-FU; 800 mg/m2，第1至5天，持续输注），随后接受放疗。所有患者在一个统一的方式进行治疗，明确的意图放射治疗在两个groups.Results：1993年7月和1994年7月之间，456例患者进入研究，228例患者随机分配到每个治疗组，449例（225在RT组和224在CT/RT组）进行评估。根据意向治疗原则，所有456例患者均纳入生存分析。CT/RT组和RT组的5年总生存率（OS）分别为63%和56%（P = 0.11）。RT组的中位无复发生存期（RFS）为50个月，CT/RT组未达到。RT组的5年RFS率为49%，CT/RT组为59%（P = 0.05）。CT/RT组的5年无局部复发率为82%，RT组为74%（P = 0.04）。两个治疗组之间的无远处转移率无显著差异（CT/RT组，79%; RT组，75%; P = 0.40）。结论：本随机研究未能证明局部晚期鼻咽癌患者增加新辅助化疗有任何显著的生存益处。因此，鼻咽癌的新辅助化疗不应在临床试验范围外使用。J Clin Oncol 19：1350-1357. (C)2001年，美国临床肿瘤学会。
Purpose: A prospective randomized trial was performed to evaluate the contribution of neoadjuvant chemotherapy in patients with to locoregionally advanced nasopharyngeal carcinoma.Patients and Methods: patients with locoregionally advanced nasopharyngeal carcinoma were treated either with radiotherapy alone (RT group) or neoadjuvant chemotherapy plus radiotherapy (CT/RT group). Neoadjuvant chemotherapy consisting of two to three cycles of cisplatin (100 mg/m(2), day 1), bleomycin (10 mg/m(2), days 1 and 5), and fluorouracil (5-FU; 800 mg/m(2), days 1 through 5, continuous infusion) followed by radiotherapy was given to the CT/RT group. All patients were treated in a uniform fashion by definitive-intent radiation therapy in both groups.Results: between July 1993 and July 1994, 456 patients were entered onto the study, with 228 patients randomised to each treatment arm, and 449 patients (225 in the RT group and 224 in the CT/RT group) were assessable. All 456 patients were included in survival analysis according to the intent-to-treat principle. The 5-year overall survival (OS) rates were 63% for the CT/RT group and 56% for the RT group (P = .11). The median relapse-free survival (RFS) time was 50 months for the RT group and not reached for the CT/RT group. the 5-year RFS rate was 49% for the RT group versus 59% for the CT/RT group (P = .05). The 5-year freedom from local recurrence rate was 82% for the CT/RT group and 74% for the RT group (P = .04). There was no significant difference in freedom from distant metastasis between the two treatment groups (CT/RT group, 79%; RT group, 75%; P = .40).Conclusion: This randomized study failed to demonstrate any significant survival benefit with the addition of neoadjuvant chemotherapy for patients with locoregionally advanced nasopharyngeal carcinoma. Therefore, neoadjuvant chemotherapy for nasopharyngeal carcinoma should not be used outside of the context of a clinical trial. J Clin Oncol 19:1350-1357. (C) 2001 by American Society of Clinical Oncology.