重组人血管内皮抑制素联合调强放疗治疗局部晚期低危鼻咽癌随机对照研究

Prospective randomized controlled trials for Endostar combined with intensity-modulated radiation therapy in the treatment of low-risk locally advanced nasopharyngeal carcinoma

目的比较重组人血管内皮抑制素(Endostar)联合调强放疗(IMRT)与IMRT联合化疗治疗局部晚期低危鼻咽癌(LANC)的临床疗效及安全性。方法选取阜阳市人民医院放疗科2011年1月至2016年1月收治的LANC患者80例为研究对象,采用随机数字表法随机分为对照组(n=42)和观察组(n=38)。观察组采用IMRT放疗联合Endostar,对照组采用IMRT联合顺铂(DDP)化疗者,两组放疗疗程为6周。放疗结束后3个月进行近期疗效及不良反应评价;同时观察比较两组患者的远期生存率。结果疗程结束3个月时,观察组和对照组客观缓解率分别为89.5%(34/38)和90.5%(38/42),差异无统计学意义(P>0.05);观察组Ⅲ~Ⅳ级黏膜炎、恶心呕吐和白细胞减低发生率分别为23.7%(9/38)、2.6%(1/38)和2.6%(1/38),均明显低于对照组的42.9%(18/42)、23.8%(10/42)和21.4%(9/42),差异均有统计学意义(P<0.05);观察组患者的中位生存时间为55.6个月,对照组为57.1个月,两组患者中位生存时间差异无统计学意义(HR=1.09,95%CI:0.49~2.38,P>0.05)。结论 Endostar联合IMRT治疗LANC的临床疗效与IMRT联合化疗相当,但不良反应明显降低。

Objective To investigate the efficacy and safety of Endostar combined with intensity-modulated radiation therapy(IMRT) in the treatment of low-risk locally advanced nasopharyngeal carcinoma(LANC), compared with IMRT combined with chemotherapy. Methods Eighty patients with low-risk LANC were retrospectively included in Fuyang People's Hospital from Jan. 2011 to Jan. 2016. The included 80 cases were randomly divided into observation group(n=38) and control group(n=42) according to random number table. Patients in observation group received Endostar combined IMRT treatment, and patients in control group received DDP chemotherapy combined with IMRT. The treatment course was 6 weeks. Three months after radiation, the clinical efficacy and safety were compared between the two groups. The patients were followed up to compare the long-term survival. Results Three months after treatment,the objective response rate were 89.5%(34/38) and 90.5%(38/42) for the observation and control group respectively,with no statistically significant difference(P>0.05). The incidence of grade Ⅲ ~ Ⅳ mucosal inflammation, nausea and vomiting, and leukopenia were 23.7%(9/38), 2.6%(1/38) and 2.6%(1/38) respectively in the observation group, which were significantly lower than those of control group of 42.9%(18/42), 23.8%(10/42), 21.4%(9/42), P<0.05. The median survival time were 55.6 months and 57.1 months for the observation and control group respectively, with no statistically significant difference(HR=1.09, 95% CI: 0.49-2.38, P>0.05). Conclusion The clinical efficacy of Endostar combined with IMRT was comparative to that of IMRT combined chemotherapy in the treatment of low-risk LANC, but the side effects are significantly decreased.