鼻咽癌调强放疗同步节拍化疗的临床研究

Clinical study of intensity-modulated radiotherapy combined with metronomic chemotherapy in the treatment of nasopharyngeal carcinoma

目的观察鼻咽癌调强放疗(intensity modulated radiation therapy,IMRT)同步口服卡培他滨节拍化疗的疗效及毒副反应。方法 118例鼻咽癌患者,随机分为实验组和对照组,对照组给予6MXV-X线根治性调强适形放疗,实验组在进行调强放射治疗的同时,节拍性口服卡培他滨每次500mg,每日2次,疗程12个月或至疾病进展为止。观察临床疗效和毒副反应。结果共有111例患者完成实验,近期疗效:实验组有效率(RR)100%,对照组有效率98.3%,两组间差异无统计学意义(P>0.05)。远期疗效:实验组1、3、5年生存率分别为96.5%、92.3%和78.3%,中位总生存时间(OS)为58.838个月,中位无进展生存时间(PFS)为40.719个月;对照组1、3、5年生存率分别为89.7%、77.8%和50.0%,中位OS为50.126个月,中位PFS为24.962个月。两组间总生存时间和无进展生存时间均有统计学差异(OS:χ2=5.587,P=0.018;PFS:χ2=3.868,P=0.049)。两组治疗结束后均出现VEGF、PDGF-BB水平下降,TSP-1水平升高,且实验组变化的幅度较对照组更为显著,两组间各指标变化水平均有统计学差异(P<0.05)。两组不良反应主要表现为白细胞减少、皮肤反应及口腔、口咽部黏膜反应,两组间不良反应无统计学差异(P>0.05)。结论鼻咽癌调强放疗同步口服卡培他滨节拍化疗能提高患者的远期生存率,增强抗肿瘤新生血管形成能力,而并未增加毒副反应发生率及严重程度。

Objective To investigate the efficacy and toxicity of intensity-modulated radiation therapy （IMRT） com- bined with metronomic chemotherapy of Capecitabine in the treatment of nasopharyngeal carcinoma. Methods 118 pa- tients with nasopharyngeal carcinoma were randomized into two groups. The control group was given IMRT alone, while the study group was given metronomic chemotherapy of Capeeitabine （500mg, bid） in addition to IMRT. The clinical outcome and adverse reactions were observed. Results 111 patients had completed the study. The response rate （RR） of the study group and control group was 100% and 98. 3% respectively, and no significant differences were noted between the groups （P〉0. 05）. The 1-, 3-, 5-year survival rates of the study group were 96. 5%, 92. 3%, 78. 3%, respectively, and those of the control group were 89. 7%, 77. 8%, 50. 0%, respectively. The median overall survival （OS） and pro-gression-fi＇ee survival （PFS） of the study group were significantly higher than those of the control group （OS： 58. 838 months vs 50. 126 months; PFS： 40. 719 months vs 24. 962 months） （P 〈0. 05）. The changes of the levels for VEGF, PDGF-BB and TSP-1 were also significantly different between the groups （P 〈 0. 05）. Treatment-related toxicity was simi- lar and slight. Conclusion IMRT combined with metronomic chemotherapy of Capecitabine can improve the clinical effi- cacy in the treatment of nasopharyngeal carcinoma, with slight adverse reactions as being well tolerated.