重组人血管内皮抑制素联合含铂方案治疗晚期非小细胞肺癌的临床观察

Clinical study of recombinant human vascular endostatin combined with platinum-based chemotherapy in advanced non-small cell lung cancer

目的:评价重组人血管内皮抑制素联合含铂方案治疗晚期非小细胞肺癌的疗效和不良反应。方法:108例晚期非小细胞肺癌患者被随机分入试验组(54例)和对照组(54例)。对照组患者接受含铂化疗方案治疗,试验组患者接受重组人血管内皮抑制素联合含铂化疗方案治疗。观察2组患者的近期有效率和临床获益率以及疾病进展时间和总生存期,并观察治疗前后患者Karnofsky体能状况评分以及血清癌胚抗原水平的变化。结果:试验组的近期有效率为38.46%,对照组为18.87%(P=0.026);试验组的临床获益率为80.77%,对照组为62.26%(P=0.036)。2组患者治疗前后的Karnofsky体能状况评分差异均无统计学意义(P>0.05)。2组患者治疗后的血清癌胚抗原水平均较治疗前明显下降(P<0.05)。试验组的中位疾病进展时间为6.2个月,对照组为4.7个月(P=0.022);试验组的中位总生存期为16.2个月,对照组为14.1个月(P=0.485)。2组患者的不良反应相似,主要为骨髓抑制和消化系统反应等。试验组患者发生心脏毒性的比例高于对照组,但差异无统计学意义(P=0.086)。结论:重组人血管内皮抑制素联合含铂方案治疗晚期非小细胞肺癌的近期疗效较好,可延长疾病进展时间,且耐受性良好。

Objective： To evaluate the efficacy and toxicity of recombinant human endostatin （rh- endostatin） combined with platinum-based chemotherapy in advanced non-small cell lung cancer. Methods： One hundred and eight patients with advanced non-small cell lung cancer were randomly divided into study group （n = 54; receiving rh-endostatin combined with platinum-based chemotherapy） and control group （n = 54; receiving platinum-based chemotherapy）. The short-term response rate （RR）, clinical benefit rate （CBR）, time to progression （TTP） and overall survival （OS） were calculated, and the changes of Karnofsky performance status （KPS） score and serum carcinoembryonic antigen （CEA） level were observed. Results： The short-term RRs of the study group and the control group were 38.46% and 18.87%, respectively （P = 0.026）; the CBRs of the study group and the control group were 80.77% and 62.26%, respectively （P = 0.036）. The difference in KPS score before and after treatment had no statistical significance （P〉0.05）. The serum CEA level was significantly lower after treatment than before treatment in both groups （P〈0.05）. The TTP was 6.2 months in the study group, while which was 4.7 months in the control group; there was a significant difference between the two groups （P = 0.022）. The OS in the study group and control group were 16.2 and 14.1 months, respectively （P= 0.485）. The adverse reactions between the two groups were similar, and the major adverse reactions were bone marrow suppression and gastrointestinal reactions. The rate of cardiotoxicity was higher in the study group than in the control group, but there was no difference between the two groups （P = 0.086）. Conclusion： The combination of rh-endostatin and platinum-based chemotherapy can lead to a better short-term RR and a superior TTP, and it is also well tolerated.