Ma J, Mai H Q, Hong M H, Min H Q, Mao Z D, Cui N J, Lu T X, Mo H Y
Department of Nasopharyngeal Carcinoma, Cancer Center, Sun Yat-sen University of Medical Sciences, Guangzhou, People's Republic of China.
J Clin Oncol. 2001 Mar 1;19(5):1350-7. doi: 10.1200/JCO.2001.19.5.1350.
A prospective randomized trial was performed to evaluate the contribution of neoadjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma.
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.
Between July 1993 and July 1994, 456 patients were entered onto the study, with 228 patients randomized 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).
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.
进行一项前瞻性随机试验，以评估新辅助化疗对局部晚期鼻咽癌患者的作用。
局部晚期鼻咽癌患者分别接受单纯放疗（放疗组）或新辅助化疗加放疗（化疗/放疗组）。化疗/放疗组给予由两至三个周期的顺铂（100mg/m²，第1天）、博来霉素（10mg/m²，第1天和第5天）及氟尿嘧啶（5-FU；800mg/m²，第1天至第5天，持续静脉输注）组成的新辅助化疗，随后进行放疗。两组所有患者均采用根治性放疗的统一方式进行治疗。
1993年7月至1994年7月期间，456例患者进入本研究，228例患者随机分配至各治疗组，449例患者（放疗组225例，化疗/放疗组224例）可进行评估。根据意向性治疗原则，所有456例患者均纳入生存分析。化疗/放疗组的5年总生存率（OS）为63%，放疗组为56%（P = 0.11）。放疗组的无复发生存（RFS）时间中位数为50个月，化疗/放疗组未达到。放疗组的5年RFS率为49%，化疗/放疗组为59%（P = 0.05）。化疗/放疗组的5年局部无复发生存率为82%，放疗组为74%（P = 0.04）。两组在远处转移无进展方面无显著差异（化疗/放疗组79%；放疗组75%；P = 0.40）。
这项随机研究未能证明对局部晚期鼻咽癌患者添加新辅助化疗有任何显著的生存获益。因此，鼻咽癌的新辅助化疗不应在临床试验背景之外使用。
