重组人血管内皮抑素联合吉西他滨、顺铂方案双途径给药治疗晚期非小细胞肺癌的临床研究

The clinical study of the dual-route administration with recombinant human endostatin plus gemcitabine and cisplatin regimen on advanced non-small cell lung cancer

目的研究重组人血管内皮抑素（恩度）联合吉西他滨＋顺铂方案双途径给药治疗中晚期非小细胞肺癌（NSCLC）的有效性和安全性。方法选择NSCLC患者40例,分为恩度联合GP方案双途径给药治疗组（试验组）和单纯GP方案双途径治疗组（对照组）,每组20例。试验组方案为：吉西他滨1000mg/m2＋顺铂50mg/m2＋恩度30mg,肿瘤靶动脉灌注d1;恩度15mg静滴,d2~d13;吉西他滨1000mg/m2静滴,d8。对照组仅用GP方案动脉灌注,剂量、方法同试验组,静脉化疗用吉西他滨单药,方法、剂量同试验组。比较两组患者的有效率（RR）、疾病控制率（DCR）、1年生存率、无进展生存期（PFS）、总生存期（OS）和毒副反应等方面的差异。结果试验组与对照组比较,RR分别为45%和10%（P〈0.05）,DCR分别为100%和90%（P〉0.05）,1年生存率分别为55%和30%（P〉0.05）,PFS分别为7.5个月和5.9个月（P〈0.05）,OS分别为12.7个月和12.3个月（P〉0.05）。两组均未出现严重毒副反应,且组间比较差异无统计学意义。结论恩度联合GP方案双途径治疗晚期NSCLC临床疗效确切,用药安全,无进展生存时间有所延长,但总体生存期改善不明显,其最佳用药方式有待进一步深入研究。

Objective To investigate the efficacy and the safety of the dual-route administration for advanced non-small cell lung cancer （NSCLC） patients treated with recombinant human endostatin （endostar） plus gemcitabine （GEM） and cisplatin（DDP） regimen （ GP regimen）. Methods Forty patients were divided into experimental and control group with 20 cases in each group. The experimental group was treated with dual-route administration （GEM 1000mg/m^2 ＋ DDP 50mg/m^2 ＋ endostar 30mg/m^2 targeted arterial infusion d1 , GEM 1000mg/m^2 venous infusion ds , endostar 15mg venous infusion d2-d13 ） and the control group was treated by dualroute administration of GP regime only with the same dosage of the experimental group. The response rate （ RR）, the disease control rate （DCR）, the 1-year survival rate, progression free survival （PFS）, the overall survival （OS） and the adverse effect of the two groups were evaluated. Results Comparing the experimental group and control group, RR were 45% and 10% （ P 〈 0. 05 ） , DCR were 100% and 90% （P 〉0. 05）, 1-year suvival rate were 55% and 30% （P 〉0. 05）, PFS were 7.5 and 5.9 months（P 〈0. 05） , and OS were 12. 7 and 12. 3 months（P 〉0. 05）. Both the two group displayed mild adverse effect, and there were no statistical differences between them. Conclusion The dual-route administration with endostar and GP regimen is effective and safe for advanced NSCLC, which can be an optional treatment with better PFS. However, the OS has not improved too much. Therefore, researches should be continued to determine the best optimized therapeutic program.