局部区域晚期鼻咽癌放化疗综合治疗效果评价

Long - term Results of Integrated Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma ]]] Clinical Trial

目的 评价局部区域晚期鼻咽癌采用顺铂（DDP）加5-氟尿NN（5-Fu）同步放化疗加辅助化疗的疗效和毒性.方法 将经病理组织学确诊的T3-4N2-3M0初治鼻咽癌患者随机分为试验组和对照组,试验组接受DDP＋5-Fu同步放化疗和辅助化疗（分别在放疗第1、5周及放疗后第1、4周始予DDP30 mg/m2,d1～3,5-Fu500 mg/m2,dl～5）,对照组接受单纯放疗.结果 共160例患者进入本研究,试验组和对照组各80例.中位随诊时间59个月（38～93个月）.试验组和对照组5年局部区域无复发生存率、无远处转移生存率、无瘤生存率、总生存率分别为71.3%和52.3%（X2=5.4,P=0.02）、62.5%和43.6%（X2=5.7,P=0.017）、58.8%和37.2%（X2=7.4,P=0.007）、62.5%和37.2%（X2=10.1,P=0.001）.两组病例均未观察到≥4级急性毒性.试验组0～1级和2～3级白细胞减少症、恶心呕吐、体重下降和口腔粘膜炎的发生率明显高于对照组（P＜0.05）;两组病例的晚期毒性发生率无显著差异（P＞0.05）.结论 高发区局部区域晚期鼻咽癌采用同期加辅助化疗可以明显提高疗效;放化综合治疗增加了治疗的急性毒性,但未增加晚期毒性.

Objective To evaluated the efficacy and toxicities of concurrent chemoradiotherapy and adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma. Methods Patients with nasopharyngeal carcinoma staged T3 -4N2 -3M0 were randomly assigned to receive either radiotherapy alone（RT） or concurrent chemoradiotherapy and adjuvant chemotherapy （CCRT）. All patients received 70 Gy in 7 weeks using standard RT portals and techniques. The CCRT patients were given concurrent cisplatin（ 30 mg/m2 on Day 1 -3）and fluorouracil （ 500 mg/m2 on Days 1-5 ） every 4 weeks （ weeks 1,5 ） for two cycles during RT, followed by cisplatin （ 30 mg/ m2 on Day 1 -3） and fluorouracil （500 mg/m2 on Days 1 -5）every 3 weeks （weeks 1,4） for two cycles after completion of RT. Results Between February 2001 and Augest 2003,160 eligible patients were entered on the study （ 80 radiotherapy alone and 80 chemoradiotherapy）. The median follow - up time was 59 months. The 5 - years local - regional recurrent - free, distant metastasis - free, disease - free and overall survival rate were 52.3% and 71.3% （ X2 =5.4,P=0.02）,43.6% and 62.5% （X2=5.7,P=0.017）,37.2% and 58.8% （X2=7.4,P=0.007）,37.2% and 62.5% （ X2 = 10.1 ,P =0. 001 ） for RT alone and CCRT,respeetively. The CCRT arm had significantly more grade 12 toxicities （ P 〈 0.05 ）, including leucopenia, emesis, weight loss and mucositis. The late toxicities were similar for both arms（P 〉 O. 05 ）. Conclusion We conclude that CCRT is superior to RT alone for patients with locoregionally advanced nasopharyngeal carcinoma in endemic areas. Although there was significantly increase in major acute toxicity, hut no statistically significant increase in major late toxicity.