替加氟在初治局部晚期鼻咽癌维持治疗的疗效观察

The efficacy of Tegafur on the maintenance therapy of local advanced nasopharyngeal carcinoma patients after initial chemoradiotherapy

目的回顾性分析替加氟(Tegafur,FT-207)在局部晚期鼻咽癌维持治疗的近期疗效和毒副反应。方法收集2014年1月~2015年12月本院病理证实为WHOⅡ~Ⅲ型初治的局部晚期鼻咽癌患者160例,签署知情同意书,按是否接受维持治疗分为A组76例,B组84例。两组患者接受诱导化疗加同期放化疗,B组在放化疗结束后接受替加氟维持治疗。维持治疗持续2年或至疾病进展。放疗采用调强放疗技术。按实体瘤疗效评价标准(RECIST3.0)评价疗效。采用Kaplan-Meier法进行生存分析,差异比较采用Log-Rank法双侧检验。结果中位随访期30.8个月,A组和B组的中位无进展生存期分别为25.3个月(95%CI:24.2~26.4)和27.3个月(95%CI:25.6~29.0),χ~2=5.577,P=0.018,差异有统计学意义。两年无复发生存率A组65%,B组87%,χ~2=3.629,P=0.057,差异无统计学意义(P<0.05)。两组的不良反应方面,B组的恶心、呕吐发生率高于A组,χ~2=6.809,P=0.009,差异有统计学意义(P<0.05)。其余毒副反应两组相似。结论替加氟用于局部晚期鼻咽癌患者的维持治疗,延长了无进展生存期;无复发生存率有提高趋势,主要不良反应为恶心,值得临床进一步研究明确疗效。

Objective To evaluate retrospectively the efficacy and toxicity of Tegafurn FT-207 in maintenance treatment of locally advanced nasopharyngeal carcinoma（LA-NPC）. Methods From January 2014 to December 2015,a total of 160 patients with non-metastatic LA-NPC who completed initial treatment were collected and analyzed.Informed consent was signed and the patients were divided into group A（76 cases） and group B（84 cases） according to whether they received maintenance therapy or not.Patients in both groups were received induction chemotherapy plus concurrent chemoradiotherapy,and group B was received tegafur maintenance after the end of chemotherapy.Maintenance therapy was lasted for 2 years or until disease progression.Intensity modulated radiation therapy was used in radiotherapy.The curative effect was evaluated by RECIST 3.0.The survival analysis was carried out by Kaplan-Meier method,and the difference was compared by Log-Rank method. Results The median follow-up time was 30.8 months.The median progression-free survival time of group A and group B were 25.3 months（95CI24.2-26.4） and 27.3 months（95%CI：25.6-29.0）respectively,the difference was statistically significant（χ^2=5.577,P=0.018）.The median progression free survival（PFS） time in group A and group B were 25.3（95%CI：24.2-26.4） months and 27.3（95%CI：25.6-29.0）months respectively,and the difference was statistically significant（χ^2=5.577,P=0.018）.The two-year relapse free survival（RFS） rates in group A and group B were 65% and 87% respectively,and the difference was statistically significant（χ^2=3.629,P=0.057）.The incidence of nausea and vomiting in group B was higher than that in group A（χ^2=6.809,P=0.009）.The other side effects were similar between the two groups. Conclusion Maintenance treatment of locally advanced nasopharyngeal carcinoma with tegafur can prolong progression-free survival,the recurrence-free survival rate is increasing, and the main adverse reaction is nausea,which is worthy of further clinical study.