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机构地区:[1]福建医科大学教学医院福州肺科医院肿瘤科,福建福州350008
出 处:《中华肿瘤防治杂志》2012年第6期461-464,共4页Chinese Journal of Cancer Prevention and Treatment
基 金:福州市政府科研基金资助(2008-s-12)
摘 要: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 first line Rh-endostatin combination with single-agent gemcitabine as first line treatment in the elderly advanced non-small cell lung cancer(NSCLC). METHODS: From 1 Oct 2007 to 30 Jun 2011, 63 elderly advanced NSCLC confirmed by pathology, were randomly divided equally into control group and trial group, received the treatment of GEM alone or with the endostar. The efficacy was strictly evaluated after 2 cycles according to RECIST criteria and mTTP. Safety was evaluated after every cycle according to NCI CTC 3.0 version criteria. RESULTS: Safety and efficacy evaluation were performed in all cases. Of the trial group, 6 cases were PR, 19 cases were SD, and 6 cases were PD, the ORR of 19.4%(6/31) and the DCR of 80.7%(25/31). There's no statistical difference of ORR between the trial group and the control group (19.4% vs 12.5%, P=0. 457), but statistical difference of DCR (80.7% vs 56.3%, P=0. 038) and mTTP (3.9 months vs 3.4 months, P=0. 024) between two group. Deaths were already 18 cases in the trial group and 20 cases in the control group. There's no statistical difference of mOS between two group (9.2 months vs 7.5 months, P=0. 524). Major toxicities included different extents of bone marrow aplasia, such as neutropenia and anaemia symptoms, which were mainly correlated with the chemotherapy regimen. Most was G1/G2, a few was G3/G4. CONCLUSIONS: Rh-endostatin combination with single agent chemotherapy have antitumor activity for the elderly advanced NSCLC. This combination treatment can be tolerated and may be a promising regimen for the elderly advanced NSCLC.
关 键 词:癌 非小细胞肺/药物疗法 药物疗法 联合 治疗结果
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