恩度联合新辅助化放疗治疗中低位Ⅱ-Ⅲ期直肠癌的临床观察

Treatment of stageⅡ-Ⅲ middle-low rectal carcinoma with Endu in combination with neoadjuvant chemoradiotherapy

目的:观察重组人血管内皮抑制素(恩度)联合新辅助化放疗对中低位Ⅱ-Ⅲ期直肠癌的近期疗效及安全性。方法:将28例Ⅱ-Ⅲ期中低位直肠癌患者随机分为两组:新辅助化放疗组(对照组)14例,术前给予中等剂量放疗,总剂量为45-50.4Gy,1.8Gy/次,每周5次,放疗同时给予卡培他滨1250mg/(m2·d),分2次口服,持续服用至手术。放疗结束后休息6周手术。恩度联合新辅助化放疗组(试验组)14例,新辅助化放疗同对照组,同时恩度7.5mg/(m2·d),第1-14天,间歇7天重复给药,共2周期。结果:两组患者均完成治疗。试验组CR 4例、PR 8例、SD 2例,RR 85.7%。对照组CR 2例、PR 9例、SD 3例,RR 78.6%。试验组的有效率高于对照组,两组比较差异有统计学意义。试验组Ⅰ-Ⅱ级不良反应发生率为71.4%,Ⅲ-Ⅳ级不良反应发生率为28.6%。治疗中未发现恩度的心脏反应和过敏反应症状。对照组Ⅰ-Ⅱ级不良反应发生率为78.6%,Ⅲ-Ⅳ级不良反应发生率为21.4%,两组比较差异无统计学意义。试验组保肛率92.9%,对照组保肛率78.6%。试验组的保肛率高于对照组,两组比较差异有统计学意义。试验组术后并发症的总发生率为21.4%,对照组总发生率为21.4%,两组比较差异无统计学意义。结论:重组人血管内皮抑制素(恩度)联合新辅助化放疗治疗中低位Ⅱ-Ⅲ期直肠癌安全有效,可以降低肿瘤分期,提高保肛率,不增加不良反应及并发症。

Objective：To explore the outcome and safety of recombinant human endostatin Endu combined with neoadjuvant chemoradiotherapy in treating stage Ⅱ-Ⅲ middle- low rectal carcinoma. Methods： A total of 28 patients with stage Ⅱ - Ⅲ middle - low rectal carcinoma were assigned to two groups ： neoadjuvant chemoradiotherapy group（n = 14, control group） and Endu plus neoadjuvant ehemoradiotherapy group（ n = 14, experiment group）. In control group,the patients received radiation at a dose of 45 -50.4Gy, 1.8Gy per day 5 times a week for 5 weeks, plus capeeitabine at a total dose of 1250mg/（ m^2 · d） （orally bid） until the operation. Six weeks after radiotherapy, the surgical resection was performed. In experiment group, treatment regimen was the same as in control group except that Endu was administered 7.5mg/m2 per day from day 1 to day 14 for a total of 2 cycles at an interval of 7 days. Results： The patients in both groups completed the treatments. Complete response （CR） occurred in 4 cases, partial response（PR） in 8 cases and stable disease（SD） in 2 cases,and the reduction rate（RR） reached 85.7% in experiment group. In control group, CR developed in 2 cases, PR in 9 cases and SD in 3 cases, and RR was 78.6%. The treatment efficacy of Endu plus neoadjuvant chemoradiotherapy was significantly superior to that of neoadjuvant chemoradiotherapy alone. The rate of mild to moderate adverse effects（ grade Ⅰ - Ⅱ ） was 71.4% and that of severe adverse effect（ grade Ⅲ - Ⅳ ） 28.6% in experiment group. Adverse effects involving the heart and anaphylaxis failed to be found in experiment group. In control group, the rate of mild to moderate adverse effects was 78.6% and that of severe adverse effects 21.4%. There was no difference in the rate of adverse effects between the two groups. The rate of anus - sparing was 92.9% in experiment group, significantly higher than 78.6% in control group. The rate of complication was 21.4% in experiment group with no difference found when compared with that in control group （21.4%）. Conclusion： Human endostatin Endu combined with neoadjuvant chemoradiotherapy is effective in treating stage Ⅱ - Ⅲ middle - low rectal carcinoma. This treatment regimen decreases the stage of rectal carcinoma,increases the anus - sparing rate, with no adverse effects and complications elevated, and eventually improves the life quality of the patients.