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中国癌症防治杂志

中国癌症防治杂志 ›› 2014, Vol. 6 ›› Issue (3): 265-270.doi: 10.3969/j.issn.1674-5671.2014.03.10

• 临床研究 • 上一篇    下一篇

重组人血管内皮抑制素联合吉西他滨与吉西他滨单药一线治疗老年晚期非小细胞肺癌的随机对照研究

  

  1. 福建医科大学临床教学医院 福州肺科医院肿瘤科；福建莆田市涵江医院呼吸内科
  • 出版日期:2014-09-25 发布日期:2014-10-17

Comparison of gemcitabine alone and gemcitabine combined with Rh-endostatin as first-line treatment for elderly with advanced non-small cell lung cancer：a randomized controlled trial

  • Online:2014-09-25 Published:2014-10-17

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被引次数

7

摘要： 目的 观察重组人血管内皮抑制素（恩度）联合吉西他滨（GEM）和GEM单药治疗老年晚期非小细胞肺癌（non-small cell lung cancer，NSCLC）的疗效和安全性。方法 128例经病理证实的符合入选标准的老年晚期NSCLC患者，采用前瞻性、开放性、随机对照的临床研究设计，按1∶1比例随机分为联合组和单药组，联合组66例接受恩度联合GEM治疗，单药组62例只用GEM单药治疗。化疗2个周期后按照实体瘤评价标准评价疗效，记录疾病控制率（DCR）、中位无疾病进展生存时间（mPFS）、中位生存时间（mOS）。每个周期按照NCICTC 3.0标准评价毒副反应。结果 治疗后联合组 PR 11例，SD 36例，PD 15例。单药组PR 6例，SD 26例，PD 24例。联合组与单药组的客观有效率（ORR）按意向性分析（intention to treat analysis，ITT）分别为16.7%、9.7%，（P=0.326），按符合方案集分析（per-protocol，PP）分别为17.7%、10.7%，（P=0.278），差异均无统计学意义。DCR按PP分析分别为75.8%、57.1%，（P=0.031），差异具有统计学意义。mPFS分别为4.0个月、3.7个月，（P=0.027），差异具有统计学意义。mOS分别为9.1个月、8.5个月，（P=0.418）， 差异无统计学意义。两组主要毒副反应以骨髓抑制发生率较高，但多为Ⅰ级/Ⅱ级，Ⅲ级/Ⅳ级少见，差异无统计学意义。结论 恩度联合GEM一线治疗老年NSCLC具有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。

关键词: 肺肿瘤, 非小细胞肺癌, 重组人血管内皮抑制素, 老年, 单药化疗

Abstract: Objective To compare the efficacy and safety of gemcitabine alone or in combination with Rh-endostatin as a first-line treatment for elderly patients with advanced non-small cell lung cancer（NSCLC）. Methods A total of 128 elderly patients with pathology-confirmed，advanced NSCLC were recruited between 1 April 2009 and 31 May 2013 and randomized to receive gemcitabine alone （n=62） or gemcitabine with Rh-endostatin（n=66）. Therapeutic efficacy was evaluated strictly according to RECIST criteria after 2 treatment cycles，and median survival time（mOS）and median progression-free survival（mPFS）were recorded. Per-cycle safety and efficacy were evaluated for all subjects according to NCICTC 3.0 criteria. Results In the group receiving combination therapy，11 cases were PR，36 were SD，and 15 were PD.In the gemcitabine-alone group，6 cases were PR，26 were SD，and 24 were PD. Overall response rate was similar between the combination group and gemcitabine-alone group，in terms of both ITT（16.7% vs 9.7%，P=0.326） and PP（17.7% vs 10.7%，P=0.278）. However，the two groups differed significantly in DCR（PP）（75.8% vs 57.1%，P=0.031） and mPFS（4.0 vs 3.7 months，P=0.027），and mOS was similar between the two groups（9.1 vs 8.5 months，P=0.418）. Major toxic effects included bone marrow aplasia，such as neutropenia and anemia，which generally correlated with the chemotherapy regimen（most were G 1/2；a few were G 3/4）. Conclusion The combination of gemcitabine and Rh-endostatin offers therapeutic benefits to elderly patients with advanced NSCLC and may be reasonably tolerated by most patients.

Key words: Lung neoplasm, Non-small cell lung cancer, Recombinant human endostatin, Elderly, Single-agent chemotherapy