重组人血管内皮抑素联合TP方案术后辅助治疗非小细胞肺癌的疗效分析

Recombinant human endostatin combined with TP regimen as postoperative adjuvant treatment for non-small-cell lung cancer

目的评价重组人血管内皮抑素联合多西紫杉醇和卡铂(TP)方案术后辅助治疗非小细胞肺癌(NSCLC)的中、长期疗效。方法采用随机对照试验,搜集2006年10月-2008年7月经病理确诊为NSCLC且行完全性手术切除的患者76例,随机分为两组(n=38):试验组采用重组人血管内皮抑素(恩度)联合TP方案治疗,对照组单用TP方案治疗。术后随访40个月,评估两组患者无病生存时间(DFS)和总生存率(OS)的差异,检测外周血中血管内皮细胞(CEC)数量的变化及肿瘤组织微血管密度(MVD)的差异。结果试验组中位无病生存时间长于对照组(39.4 vs 27.6个月,P<0.05),且3年生存率高于对照组(89.4%vs 57.9%,P<0.05)。治疗后两组CEC均有下降,第4周期化疗后试验组的下降较对照组更为显著(P<0.05)。Ⅰ、Ⅱ及Ⅲ期患者的MVD有统计学差异(P<0.05),有淋巴结转移组MVD高于无淋巴结转移组,低分化组MVD高于中、高分化组(P<0.05)。结论与单纯化疗比较,重组人血管内皮抑素联合TP方案术后辅助治疗NSCLC能延长患者的无病生存期,提高3年生存率。CEC是一个较好的预测化疗联合抗血管生成治疗效果的指标。

Objective To evaluate the mid-term and long-term efficacy of recombinant human endostatin （rh-endostatin, EndostarTM） in combination with docetaxel and carboplatin （TP） regimen as a postoperative adjuvant treatment for non-small-cell lung cancer （NSCLC）. Methods A randomized controlled trial was conducted in 76 patients who were admitted from October 2006 to July 2008. These patients were diagnosed with NSCLC and experienced complete excision. They were randomly divided into two groups （n=38）： EndostarTM plus TP regimen was adopted for the treatment group, while only the TP regimen was used for the control group. After 40 months of postoperative followup, the difference in disease-free survival （DFS） and overall survival （OS） between the two groups was evaluated, and the number of circulating endothelial cells （CECs） and tumor microvessel density （MVD） were measured. Results DFS was significantly longer in the treatment group than that in the control group （39.4 months versus 27.6 months, P〈0.05）. The three-year OS rate of the treatment group was significantly higher than that of the control group （89.4% versus 57.9%, P〈0.05）. The CECs decreased in both groups after the treatment. The rate of decline in the treatment group was significantly more marked after four cycles of chemotherapy treatment compared with the control group （P〈0.05）. There was a significant difference in the MVD between stages I, II, and III （P〈0.05）. The MVD in the cases with positive lymph nodes was significantly higher than that in the cases with negative lymph nodes. The MVD in poor differentiation was higher than that in moderate/good si TM . differentiation （P〈0.05）. Conclusions By comparing with the mple chemotherapy treatment, Endostar plus TP regimen as an adjuvant treatment was able to prolong the DFS and improve the three-year OS rate of NSCLC patients. CECs are a good indicator for predicting the efficacy of chemotherapy plus anti-angiogenesis treatment.