恩度联合NP方案治疗晚期复治非小细胞肺癌的临床随机对照研究

A randomized clinical trial of NVB plus DDP with Rh-endostatin in the treatment of advanced retreated non-small-cell lung cancer patients

目的评价恩度联合长春瑞宾和顺铂（NP）方案治疗晚期非小细胞肺癌（NSCLC）的疗效和安全性。方法2007年2月-2008年10月，35例经病理学或组织细胞学证实为Ⅲb期或Ⅳ期的NSCLC复治患者，随机分为恩度联合NP方案组和NP方案组。观察有效率、临床受益率（CBR）、疾病进展时间（TTP）、1年存活率、中位生存时间（MST）以及安全性。结果恩度组和对照组RR分别为18．75％和6．6％（P=0．305）；CBR分别为75％和40％（P=0．046）；中位TTP分别为5个月和3．9个月（P=0．011）；1年存活率分别为50％和33．3％，MST分别为11．7个月和10．3个月，两组生存曲线之间比较，恩度组要好于对照组（P=0．039）。恩度组与对照组在血液学及非血液学毒性反应方面无统计学差异。结论恩度联合NP方案能提高晚期复治NSCLC的疗效和生存，且安全性好，有临床应用价值，值得进一步应用观察。

Objective Background and objective Phase Ⅲ study revealed that the addition of Rh-endostatin to vinorelbine and cisplatin （NP） regimen resulted in improvement in response rate, survival time, and showed less toxicity in advanced NSCLC patients. This study was to evaluate the efficacy and safety of Rh-endostatin combined with NP regimen for advanced retreated NSCLC patients. Methods Thirty-five histologically or cytologically confirmed stage Ⅲb or Ⅳ retreated NSCLC patients were randomly enrolled in trial group （rh-endostatin plus NP） or control group （NP）. The trial endpoints included response rate, clinical benefit rate, time to progression, i-year survival rate, median survival time and safety. Results Response rate was 18.75% in the trial group and 6.6% in the control group（P = 0. 305）. The clinical benefit rate was 75% in the trial group and 40% in the control group（P = 0. 046）. The median TTP was 5 months in the trial group and 3.9 months in the control group（P = 0. 011）. 1-year survival rate was 50% in the trial group and 33.3% in the control group. The median survival time was 11.7 months in the trial group and 10.3 months in the control group, respectively. The comparison of survival curve between two groups showed that the trial group was associated with better survival （P = 0. 039）. There were no significant differences in incidence of hematologic and non-hematologic toxicity between two groups.Conclusion Rh-endostatin combined with NP regimen for advanced pretreated NSCLC patients shows a better efficacy, survivaland salty. It is worthy of further clinical studies.