同期放化疗联合辅助化疗治疗局部晚期鼻咽癌的前瞻性临床研究

 目的　探讨同期放化疗联合辅助化疗对鼻咽癌高发区人群的疗效及不良反应情况。方法　2006年1月至2010年6月入组141例鼻咽癌患者，随机数字表法分为同期放化疗联合辅助化疗组（70例）和同期放化疗组（71例）。两组均采用二维精确放射治疗和2个疗程顺铂、5-氟尿嘧啶（5-Fu）同步化疗；同期放化疗联合辅助化疗组在放疗结束后3周开始3个疗程顺铂、5-Fu辅助化疗。结果　所有入组患者均按计划完成同期放化疗，同期放化疗联合辅助化疗组有63例完成辅助化疗。两组同步放化疗期和同期放化疗联合辅助化疗组辅助化疗期主要不良反应有黏膜炎、白细胞减少、血小板减少和胃肠道反应，两组比较差异无统计学意义。放疗结束后3个月，同期放化疗联合辅助化疗组和同期放化疗组鼻咽部、颈部淋巴结肿瘤消退率分别为94.4 %（67／70）和87.3 %（62／71）。中位随访36个月。同期放化疗联合辅助化疗组1、2、3年总生存率分别为94.3 %、84.8 %、78.6 %，中位生存期为36个月，同期放化疗组分别为90.1 %、75.0 %、62.5 %，中位生存期为27个月，两组比较差异有统计学意义（χ2＝7.356 ，P＝0.007）。同期放化疗联合辅助化疗组Ⅲ期患者1、2、3年总生存率分别为98.2 %、92.5 %、83.7 %，同期放化疗组分别为93.0 %、83.2 %、68.2 %，中位生存时间均为36个月；两组比较差异有统计学意义（χ2＝8.081， P＝0.005）。同期放化疗联合辅助化疗组Ⅳ期患者1、2、3年总生存率分别为81.3 %、53.8 %、42.9 %，同期放化疗组分别为78.6 %、36.4 %、22.3 %，中位生存时间分别为22个月和14个月，两组比较差异有统计学意义（χ2＝3.903，P＝0.048）。同期放化疗联合辅助化疗组1、2、3年无进展生存率分别为90.0 %、76.2 %、68.8 %，同期放化疗组分别为81.7 %、60.3 %、34.3 %，中位无进展生存时间分别为30个月和22个月，两组比较差异有统计学意义（χ2＝13.616，P＝0.000）。结论　对鼻咽癌高发区Ⅲ、Ⅳ期鼻咽癌患者，该同期放化疗联合辅助化疗方案依从性较高，不良反应相对较低，可提高总生存率及无进展生存率。

Prospective clinical control study on concurrent radiotherapy and chemotherapy combined with adjuvant chemotherapy in nasopharyngeal carcinoma

Objective To investigate the effects and toxic side effects of concurrent radiotherapy and chemotherapy combined with adjuvant chemotherapy in nasopharyngeal carcinoma. Methods 141 patients of nasopharyngeal carcinoma divided into two groups randomly. All patients treated two-dimension exact radiotherapy and concurrent chemotherapy which combined DDP and 5-Fu intravenously for two circles, then experiment group started adjuvant chemotherapy 3 weeks later after above treatment, which intravenous DDP and 5-Fu for other three circles. Results All patients completed concurrent radiotherapy and chemotherapy, 63 patients of treatment group completed adjuvant chemotherapy. The mainly toxic side effect was mucositis, leukopenia and low-platelet, and gastrointestinal reaction during therapy, there is no statistical significance in two groups. The regression rate of lymph nodes is 94.4 % （n=67）and 87.3 % （n=62） in nasopharynx and neck after 3 month of radiotherapy and concurrent chemotherapy. All patients followed up 3 years. The total survival rate of two groups were 94.3 %,84.8 %,78.6 % and 90.1%,75.0 %,62.5 % respectly in 1,2 and 3 year, the mean survival period was 36 months and 27 months, and this differece was statistical significance（ χ^2=7-356 , P=0.007）. The total survival rate of m stage patients of two groups were 98.2 %, 92.5 %, 83.7 % and 93.0 %, 83.2 %, 68.2 % respectly in 1,2 and 3 year, the both mean survival period was 36 months, and this differece was statistical significance （ χ^2=8.081, P=-0.O05）. The total survival rate of Ⅳ stage patients of twogroups were 81.3 %,53.8 %,42.9 % and 78.6 %,36.4 % ,22.3 % respectly in 1,2 and 3 year, the meat survival period were 22 month and 14 month respeetly, and this differeee was statistical significance （ χ^2= 3.903,P=-0.048）. The progression-free survival rate of two groups were 90.0 %,76.2 %,68.8 %,and 81.7 %, 60.3 %,34.3 % respectly in 1,2 and 3 year, the meat progression-free survival period was 30months and 22 months, and this differece was statistical significance as well （χ^2=13.616,P=0.000）. Conclusion The therapy of concurrent radiotherapy and chemotherapy combined with adjuvant chemotherapy was obviously increased total survival rate and progression-free survival rate in nasopharyngeal carcinoma, especially to Ⅲ and Ⅳ stage patient of nasopharyngeal carcinoma. But the long period effects still remains unclear.