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目的探讨重组人血管内皮抑制素(恩度)诱导肿瘤血管正常化时联合化疗治疗晚期非小细胞肺癌(NSCLC)的疗效及安全性。方法收集经病理组织学或细胞学确诊的Ⅲ、Ⅳ期NSCLC患者43例,随机分为恩度“窗口期”联合化疗组(A)和恩度同步化疗组(B)。A组21例,具体为:恩度15mg静滴,d1～d14;多西紫杉醇75mg/m2静滴,d5;B组22例,恩度用法同A组,多西紫杉醇75mg/m2静滴,d1。两组均21天为1周期。按照RECIST 1.1和NCI CTC 3.0标准分别评价近期疗效和毒副反应。用Kaplan-Meier法进行生存分析。结果 A、B两组患者的有效率分别为14.2%和9.1%(P=0.63),疾病控制率分别为57.1%和54.6%(P=0.76),中位无进展生存期分别为3.7个月和3.5个月(P=0.19),中位总生存期分别为10.2个月和10.5个月(P=0.77)。两组的主要不良反应表现为脱发、血液学毒性和乏力,差异无统计学意义。结论恩度“窗口期”联合化疗与恩度同步化疗治疗NSCLC在有效率、生存期和不良反应方面未见明显差异。
Objective To investigate the efficacy and safety of recombinant human endostatin (Estradiol) in inducing tumor vascular normalization combined with chemotherapy for advanced non-small cell lung cancer (NSCLC). Methods Forty - three patients with stage Ⅲ and Ⅳ NSCLC diagnosed by histopathology or cytology were randomly divided into three groups: group B (n = 1) and group B (n = 1). A group of 21 cases, specifically: Endometritis 15mg intravenous drip, d1 ~ d14; docetaxel 75mg / m2 intravenous drip, d5; B group of 22 cases, the same degree of grace with group A, docetaxel 75mg / d1. Both groups were 21 days for a cycle. According to RECIST 1.1 and NCI CTC 3.0 standards were evaluated in the short term efficacy and toxicity. Survival analysis was performed using Kaplan-Meier method. Results The effective rates of A and B patients were 14.2% and 9.1% respectively (P = 0.63), the disease control rates were 57.1% and 54.6% (P = 0.76) respectively, and the median progression-free survival rates were 3.7 months And 3.5 months (P = 0.19) respectively, with a median overall survival of 10.2 months and 10.5 months, respectively (P = 0.77). The two groups showed the main adverse reactions of alopecia, hematological toxicity and fatigue, the difference was not statistically significant. Conclusions There is no significant difference in the efficiency, survival time and adverse reactions between the first degree and the second phase of combined chemotherapy and Endostar chemotherapy in the treatment of NSCLC.