局部晚期鼻咽癌化疗和放射综合治疗--随机临床研究

目的：研究局部晚期鼻咽癌化疗和放射综合治疗的疗效及毒副反应。方法：1995年9月—1997年7月，86例病理确诊为鼻咽癌、根据福州九二新分期为N2-3的初治患者随机分组，综合治疗组41例，其中2例拒绝接受放疗后的辅助化疗，即综合治疗组可评估39例，单纯放疗组45例。综合治疗组接受2程诱导化疗[每天顺铂(DDP)20mg／m^2，第1～3天，每天氟尿嘧啶(5-FU)500mg／m^2，第1—3天，第二程化疗在第14天进行，放疗在第27天开始)及放疗后3程的辅助化疗。放疗为常规分割放疗。原发灶用^60Co治疗，每次1．85—1．9Gy，一周5次，7—7．5周总剂量65．1—70．3Gy／35—37次。颈部行双侧全颈根治性照射7—7．5周共56．6—65．5Gy／35—38次。如有残留，则局部缩野加量。两组鼻咽加量及颈淋巴结加量无显著差异。结果：中位随访期5．04年，综合治疗组和单纯放疗组五年生存率为72．3％，58．4％，(P=0．154)；无瘤生存率为59．9％，47．7％，(P=0．207)；鼻咽局控率为89．5％，81．4％，(P=0．151)；颈部局控率为88．3％，75．2％，(P=0．134)；无远处转移生存率为76．3％，60．3％，(P=0．181)，发生转移的中位时间分别为1．08年和0．88年。虽未达统计学意义，但综合治疗组有较单纯放疗组提高疗效的趋势。综合治疗组的主要毒性反应为白细胞降低、血小板降低及胃肠道反应。两组急性粘膜反应的严重程度差异无显著性。无与治疗有关的死亡发生。两组后期反应差异无显著性。结论：经5年观察，综合治疗有提高局控、降低远处转移、延迟远处转移的发生、提高无瘤生存率的可能，但均未达统计学意义，综合治疗未明显增加放疗反应。

Chemotherapy adjunctive to definitive radiotherapy in locally advanced nasopharyngeal carcinoma (NPC): prospective randomized study

Purpose:To compare chemoradiotherapy against radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal carcinoma.Methods:From September 1995 to July 1997,eighty-six patients with histologically proven NPC who were staged according to the Fuzhou stage classification to be N 2-3 were entered. Eighty-four patients were evaluable for tumor response and survival. The patients were randomized to receive two cycles of cisplatin (DDP) 20 mg/m 2 on Days 1-3,fluorouracil (5-Fu) 500 mg/m 2 on Days 1-3,before radical radiotherapy (RT),and three cycles of postradiotherapy chemotherapy (39 patients) or radiotherapy alone (45 patients). For chemoradiotherapy (CT-RT) group,the second cycle was given on Day 14 and the radiotherapy was given on Day 27. All patients received radical radiotherapy to the nasopharynx and neck. Radiation therapy consisted of delivering 65.1-70.3 Gy in 35-37 fractions of 1.85-1.9 Gy each over 7-7.5 weeks to the primary site with external beam 60 Co in both groups. The lymph nodes of the neck were given 56.6-65.5 Gy in 7-7.5 weeks. Boost radiotherapy was given to any residual disease. The rates of radiotherapy for boosting primary site or residual lymph nodes were not significantly different in the two arms. Results:The median follow up was 5.04 years. The 5-year actuarial survival rate (ASR) was 72.3% in CT-RT arm and 58.4% in RT arm ( P =0.154). The 5-year disease free survival rate (DFS) was 59.9% in CT-RT arm and 47.7% in RT arm ( P =0.207). The 5-year free from local failure rate (FLF) in nasopharynx was 89.5% in CT-RT arm and 81.4% in RT arm respectively ( P =0.151). The 5-year FLF in neck was 88.3% in CT-RT arm and 75.2% in RT arm respectively ( P =0.134). The 5-year free from distant metastasis rate (FDM) was 76.3% in CT-RT arm and 60.3% in RT arm ( P =0.181). The median time to first distant metastasis was 1.08 years in CT-RT arm and 0.88 year in RT arm. Although the differences did not reach statistical significance,there was some benefit from adjunctive chemotherapy to radiotherapy in the treatment of locoregionally advanced nasopharyngeal carcinoma. Toxicities in CT-RT arm were mainly myelosuppression and nausea and vomiting. There was no significant difference in the incidence and severity of acute mucositis between the two arms during radiotherapy. There was no treatment-related death. Conclusions:This prospective randomized trial demonstrated some benefit in DFS,FLF,FDM from adjunctive chemotherapy to radiotherapy in the treatment of locoregionally advanced nasopharyngeal carcinoma. But the differences were not significant. The chemoradiotherapy increased neither the incidence and severity of acute mucositis nor the late reaction.