诱导化疗加同期放化疗治疗T_(3～4)N_(2～3)M_0期鼻咽癌的前瞻性随机对照研究

A Prospective and Randomized Study of Induction Chemotherapy Combined with Concurrent Chemoradiotherapy in the Treatment for Nasopharyngeal Carcinoma Stage T_(3～4)N_(2～3)M_0

[目的]评价诱导化疗加同期放化疗治疗T3～4N2～3M0期鼻咽癌的疗效。[方法]2008年5月至2009年6月112例T3～4N2～3M0期鼻咽癌患者随机分为试验组和对照组,两组患者均接受相同的放疗方案。试验组57例接受诱导化疗加同期放化疗,对照组55例接受单纯同期放化疗,诱导化疗方案为PF方案,即DDP30mg/m2,d1～3+5-Fu450mg/m2,d1～3,1次/3周,共2个周期。同期放化疗在诱导化疗结束后3周进行,方案为DDP40mg/m2,每周1次。[结果]中位随访42个月,随访率98.2%,全组3年总生存率为79.3%,试验组和对照组3年总生存率、无瘤生存率、无远处转移生存率、无复发生存率分别为80.5%vs76.2%(P=0.937);63.1%vs57.9%(P=0.653);68.2%vs62.6%(P=0.692);84.1%vs74.4%(P=0.345)。试验组3～4级白细胞减少、黏膜炎发生率分别是21.1%和31.6%,显著高于对照组的5.5%和9.1%(P<0.05)。[结论]诱导化疗加同期放化疗与单纯同期放化疗相比并不能提高T3～4N2～3M0期鼻咽癌3年总生存率、无瘤生存率、无远处转移生存率和无复发生存率。建议推行大样本随机临床对比研究,以进一步明确诱导化疗加同期放化疗治疗局部晚期鼻咽癌的疗效。

[Purpose] To investigate the clinical response of induction chemotherapy combined with concurrent chemoradiotherapy.[Methods] From May 2008 to June 2009,a total of 112 patients with nasopharyngeal carcinoma（NPC） stage T3～4N2～3M0 were randomized into test group（57 patients） and control group（55 patients）.Two groups received the same radiotherapy.Test group received induction chemotherapy combined with concurrent chemoradiotherapy and control group received concurrent chemoradiotherapy alone.The induction chemotherapy regimen including DDP（30mg/m2,d1～3）,continuous 5-Fu infusion（450mg/m2,d1～3） every 3 weeks for 2 cycles.Concurrent chemotherapy regimen was DDP（40mg/m2,once a week） for all patients.[Results] Median follow-up for patients was 42 months.The overall survival（OS） rate was 79.3%.The 3year OS rate was 80.5% in test group and 76.2% in control group（P=0.937）.The disease free survival（DFS） rate was 63.1% in test group and 57.9% in control group（P=0.653）.The distance metastasis free survival（DMFS） rate was 68.2% in test group and 62.6% in control group（P= 0.692）.The recurrence free survival（RFS） rate was 84.1% in test group and 74.4% in control group（P=0.345）.Mucositis and leukopenia grade 3～4 were higher in test group than those in control group significantly（31.6% vs 9.1%,21.1% vs 5.5%,P0.05）.[Conclusion] Induction chemotherapy followed by concurrent chemoradiotherapy could not improve the 3-year OS rate,DFS rate,DMFS rate and RFS rate in NPC patient stage T3～4N2～3M0 comparing with concurrent chemoradiotherapy alone.The benefits of induction chemotherapy followed by concurrent chemoradiotherapy for patients with NPC should be further investigated in large and random samples.