诱导化疗联合同步放化疗治疗局部晚期头颈部鳞癌的随机对照研究  

A randomized control trial of induction chemotherapy combined with concurrent chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinoma

作　　者：陈建武[1] 张幸平[2] 郑建清[1] 苏菁菁[1] 吴敏[1] 肖丽华[1] 

机构地区：[1]福建医科大学附属第二医院放疗科,泉州362000 [2]重庆医科大学附属第一医院肿瘤科,重庆400016

出　　处：《重庆医科大学学报》2011年第9期1103-1106,共4页Journal of Chongqing Medical University

摘　　要：目的:局部晚期(T3T4/N2N3)头颈部鳞癌的标准治疗为同步放化疗,在同步放化疗基础上加上诱导化疗是否能进一步提高生存率国际上仍有争议。本文随机对照研究分析诱导化疗+同步放化疗治疗局部晚期头颈部鳞癌的结果。方法:2005年1月至2007年6月我院首次接受治疗的局部晚期头颈部鳞癌患者120例,所有患者均不能手术,绝大多数为T4或N3,分别占92.5%及70.0%,随机分组研究,试验组(NAC+CCR):诱导化疗+同步放化疗60例;对照组(CCR):单纯同步放化疗60例。NAC+CCR组先用紫杉醇135～150 mg/m2 d1+顺铂75～100 mg/m2 d1,21 d为1个周期,连续使用2个周期,之后用同样的化疗方案于放疗d1,d22予以同步放化疗;CCR组仅予以同步放化疗,于放疗d1,d22,d43予以紫杉醇135～150 mg/m2+顺铂75～100 mg/m2。2组放疗剂量及放疗时间相仿,原发灶照射剂量中位数为70 Gy(66～74 Gy),颈部淋巴结阳性区域照射剂量66～70 Gy,中位放疗时间51 d(46～59 d)。用Kaplan-Meier及Log-rank法计算和比较2组病人的生存率。结果:(1)NAC+CCR组与CCR组相比,有提高总生存率(Overall survivial,OS)及无进展生存率(Progression-free survival,PFS)的趋势,2组1、3年、5年OS分别为86.94%vs 73.16%、36.82%vs 33.59%、25.09%vs 20.11%,χ2=1.288,P=0.256,1、3、5年PFS分别为:70.18%vs 61.84%、31.84%vs 28.71%、21.66%vs 16.71%,χ2=1.972,P=0.160。NAC+CCR组与CCR组中位总生存时间分别为26.97月及23.66月。(2)治疗结束后观察12周,NAC+CCR组及CCR组的完全缓解率(Complete remission,CR)分别为65.0%及26.7%(χ2=17.76,P=0.00)。(3)NAC+CCR组及CCR组3～4级急性毒副反应及远期并发症发生率差异无统计学意义。(4)NAC+CCR组远处转移率明显低于CCR组,分别为15.0%及33.3%,χ2=5.50,P=0.02。结论:NAC+CCR组与CCR组相比能显著提高近期CR,减低远处转移发生率,提高OS和PFS的趋势,未见增加近期及远期毒副反应,可望成为局部晚期头颈部鳞癌的标准治疗之一。Objective：Concurrent chemoradiotherapy is considered to be the standard for patients with locally advanced（T3T4/N2N3） head and neck squamous cell carcinoma.Whether induction chemotherapy before concurrent chemoradiation could further improve survival or not is still controversial internationally.This randomized control trial will analyze the results of induction chemotherapy combined with concurrent chemoradiotherapy for locally advanced head and neck squamous cell carcinoma（LAHNSCC）.Methods： 120 cases with LAHNSCC treated in our hospital from January 2005 to June 2007 were randomized to Treatment Group（NAC＋CCR） and Control Group（CCR）.60 cases in the Treatment Group received induction chemotherapy followed by concurrent chemoradiotherapy,while 60 cases in the Control Group accepted concurret chemoradiotherapy alone.All the patients were inoperable.The majority had T4 or N3（92.5% and 70.0%,respectively）.NAC＋CCR was given two cycles neo-chemotherapy of paclitaxel,135~150 mg/m2,and cisplatin,75~100 mg/m2 on day 1,every 3 weeks followed by chemoradiotherapy with the same regimen on day 1,day 22 and 43 during radiotherapy.CCR received chemoradiotherapy of paclitaxel,135~150 mg/m2,and cisplatin,75~100 mg/m2 on day 1,day 22 and 43 during radiotherapy.The radiation dose and radiation time of both groups were comparable.The median radiation dose of primary tumor was 70 Gy（66~74 Gy）.Radiation dose of neck positive lymph node drainage region was 66~70 Gy.The median radiation time was 51 days（46~59 days）.The survival rates were analyzed and compared by Kaplan-Meier and Log-rank.Results：（1）Group NAC＋CCR tends to improve the overall survival（OS） and progression free survival（PFS） but no reach significant difference,compared with group CCR.the 1,3 and 5-year OS of group NAC＋CCR and CCR was 86.94% vs 73.16%;36.82% vs 33.59%;25.09% vs 20.11%,respectively,χ2=1.288,P=0.256,while the 1,3 and 5-year PFS was 70.18% vs 61.84%;31.84% vs 28.71%;21.66% vs 16.71%,respectively,χ2=1.972

关 键 词：局部晚期头颈部鳞癌 诱导化疗 同步放化疗 

分 类 号：R739.91[医药卫生—肿瘤]