重组人血管内皮抑素联合放化疗在非小细胞肺癌的临床观察

Clinical Observation on Efficacy of Endostar Combined with Chemoradiotherapy in Treatment of Non-small Cell Lung Cancer

目的观察重组人血管内皮抑素（恩度）联合放化疗和恩度联合化疗对非小细胞肺癌（NSCLC）的疗效及毒副反应。方法经病理证实43例NSCLC（Ⅱa~Ⅲb）,按随机原则并参考病人意愿分为实验组（恩度＋放化疗）24例和对照组（恩度＋化疗）19例,化疗方案吉西他滨1 000 mg/m2,第1、8 d,顺铂20 mg/m2,第1~5 d,28 d 1周期,共3~4周期;恩度15 mg/d,同步每化疗周期的第1~14 d。放疗采用常规剂量分割2 Gy/d,总剂量60~66 Gy,与第一周期化疗同时进行。结果有2例出现明显心脏毒性或骨髓抑制,未完成治疗,只作毒性分析。实验组的完全缓解率高于对照组（P〈0.05）,中位无疾病进展时间分别为8.3月和4.7月,1年生存率分别为78.3%和55.6%（P〈0.05）,完全缓解病例主要集中在Ⅱa期鳞癌,实验组未明显增加治疗的毒副反应。结论恩度联合放化疗治疗非晚期肺鳞癌有较好近期疗效,延长无疾病生存时间及1年生存率,安全性好。

Objective To investigate the effects and toxicities of recombinant human endostatin（endostar） combined with chemoradiotherapy or chemotherapy for non-small cell lung caner（NSCLC）.Methods Forty-three histologically confirmed NSCLC（Ⅱa~Ⅲb） patients were randomly divided into experimental group（endostar ＋ chemoradiotherapy,n=24） and control group（endostar ＋ chemotherapy,n=19）.Gemcitabine 1,000 mg/m2 on days 1st and 8th and cisplatin 20 mg/m2 on 1~5 days were intravenously dripped with every 28 days as a consecutive cycle,for 3~4 cycles.Endostar was given 15 mg/d from days 1~14 simultaneously.In the experimental group,the patients received radiotherapy at a total dosage of 60~66 Gy,with fractionation of 2 Gy/d.Results Two patients stopped the therapy for marrow suppression or cardiotoxic adverse reaction.7 patients achieved complete response（CR） in experimental group and only 1 patient achieved CR in control group（P0.05）.The median progression-free survival（PFS） was 8.3 months in experimental group and 4.7 months in control group.The 1-year overall survival（OS） rates were 78.3% and 55.6%,respectively（P0.05）.The patients achieved CR mainly occurred in those with Ⅱa and squamous cell carcinoma.There was no significant difference in the toxicities between the two groups.Conclusions The combination of endostar and chemoradiotherapy increases the CR and prolongs the PFS and 1-year OS of the patients with squamous cell carcinoma and non-advanced NSCLC.The toxicities are tolerable.