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目的:观察重组人血管内皮抑制素(恩度)联合单药治疗老年晚期非小细胞肺癌(NSCLC)的疗效和安全性。方法:2007-10-01-2011-06-30,本院63例经病理确诊符合入选标准的老年晚期NSCLC患者,通过简单随机抽样的方法,按1∶1随机分成治疗组和对照组,治疗组接受恩度联合吉西他滨(GEM)治疗方案,对照组只用吉西他滨方案。化疗2个周期后按照实体瘤疗效评价标准(RECIST)评价客观有效率(ORR)、疾病控制率(DCR)、中位至疾病进展时间(mT-TP)。每周期按照NCI CTC 3.0版标准评价毒性反应(AE)。结果:所有的病例均进行疗效和安全评价,治疗组部分有效(PR)6例,疾病稳定(SD)19例,疾病进展(PD)6例。ORR与对照组比较,差异无统计学意义(19.4%vs 12.5%,P=0.457)。两组DCR差异具有统计学意义(80.7%vs 56.3%,P=0.038)。两组mTTP对比,差异有统计学意义(3.9个月vs 3.4个月,P=0.024)。治疗组和对照组分别已死亡的18例和20例,中位生存时间(median overall surviv-al,mOS)差异无统计学意义(9.2个月vs 7.5个月,P=0.524)。毒性反应以骨髓抑制发生率较高,多为G1/G2,G3/G4少见,两组差异无统计学意义。结论:恩度联合单药化疗老年NSCLC显示出一定的抗肿瘤活性和较好的疾病控制率,安全性较好,临床受益率高,是一种有临床应用前景的治疗方法。
Objective: To observe the efficacy and safety of recombinant human endostatin (Endostar) combined with monotherapy in the treatment of advanced non-small cell lung cancer (NSCLC). Methods: From 2007-10-01 to 2011-06-30, 63 cases of elderly patients with advanced NSCLC confirmed by pathology were randomly divided into treatment group and control group according to the method of simple random sampling. The group received en GEM combined gemcitabine (GEM) regimen and the control group only gemcitabine regimen. After 2 cycles of chemotherapy, the objective response rate (ORR), disease control rate (DCR) and median to disease progression time (mT-TP) were evaluated according to RECIST. Toxicity (AE) was evaluated weekly according to NCI CTC version 3.0. Results: All the cases were evaluated for efficacy and safety. The treatment group was partially effective (PR) in 6 cases, stable disease (SD) in 19 cases and disease progression (PD) in 6 cases. There was no significant difference between ORR and control group (19.4% vs 12.5%, P = 0.457). The differences between the two groups of DCR were statistically significant (80.7% vs 56.3%, P = 0.038). The difference between the two groups was statistically significant (3.9 months vs 3.4 months, P = 0.024). There were no significant differences in the median overall survival time (median overall survival time-mOS) between the treatment group and the control group (9.2 months vs. 7.5 months, P = 0.524). Toxicity to the higher incidence of bone marrow suppression, mostly G1 / G2, G3 / G4 rare, no significant difference between the two groups. Conclusions: Endostar combined with single-drug chemotherapy in elderly NSCLC shows some anti-tumor activity and better disease control rate, which is safe and has a high clinical benefit rate. It is a promising method for clinical treatment.