Long-Term Results of a Prospective Randomized Trial Comparing Neoadjuvant Chemotherapy Plus Radiotherapy with Radiotherapy Alone for Patients with Locoregionally Advanced Nasopharyngeal Carcinoma
10.3321/j.issn:1000-467X.2001.05.014
- VernacularTitle:中晚期鼻咽癌新辅助化疗联合放疗前瞻性 临床试验的长期结果
- Author:
Jun MA
1
;
Hai-Qiang MAI
;
Ming-Huang HONG
;
Hua-Qing MIN
;
Zhi-Da MAO
;
Nian-Ji CUI
Author Information
1. Department of Nasopharyngeal Carcinoma
- From:Chinese Journal of Cancer
2001;20(5):503-510
- CountryChina
- Language:Chinese
-
Abstract:
Objective： A prospective randomized trial was performed to evaluate the contribution of neoadjuvant chemotherapy in the patients with locoregionally advanced nasopharyngeal carcinoma. Methods： The patients with locoregionally advanced nasopharyngeal carcinoma were treated with either radiotherapy alone (RT group) or neoadjuvant chemotherapy plus radiotherapy (CT/RT group). Neoadjuvant chemotherapy consisting of 2-3 cycles of cisplatin (20 mg/m2 on Day 1 to Day 5), bleomycin (7 mg/m2 on Day 1 and Day 5), and 5-FU (500 mg/m2 on Day 1 to Day 5) followed by radiotherapy was given to CT/RT group. All patients were treated in a uniform definitive-intent radiation therapy in two groups. Results： From 1992 to 1993, 457 patients were enrolled and 440 patients (221 in RT group, 219 in CT/RT group) were assessable. The 5-year overall survival (OS) rates were 62％ for CT/RT group and 55％ for RT group (P=0.1335)； The 5-year relapse free survival rate was 48％ versus 58％ , respectively (P=0.0539). The 5-year free local recurrence (FLR) rate was 82％ for CT/RT group, 74％ for RT group (P=0.0412). There was no significant difference in free distant metastasis (FDM) between two treatment groups (CT/RT group, 79％ ; RT group, 75％ ; P=0.4177). Subgroup analyses showed that neoadjuvant chemotherapy improved local control in patients with T3-4 disease, and had no effect in preventing distant metastases in patients with N2-3 disease. Conclusion： Despite improving FLR and RFS, neoadjuvant chemotherapy and radiatherapy failed to gain other survival benefit or reduce distant metastases in patients with locoregionally advanced nasopharyngeal carcinoma. The indication for neoadjuvant chemotherapy is proposed.
