Department of Oncology, The Sixth People Hospital, Medical College of Shanghai Jiao Tong University, Shanghai 200233, China.
Cancer Chemother Pharmacol. 2012 Jan;69(1):99-106. doi: 10.1007/s00280-011-1678-9. Epub 2011 May 24.
To compare docetaxel-based doublet with single-agent docetaxel as second-line treatment in non-small-cell lung cancer (NSCLC).
We systematically searched for randomized clinical trials that compared docetaxel-based doublet with single-agent docetaxel in patients with histologically proven non-small-cell lung cancer. The primary end point was overall survival (OS). Secondary end points were progression-free survival, overall response rate, 1-year survival rate, and grade 3 or 4 toxicity. Data were extracted from the studies by two independent reviewers. The meta-analysis was performed by Stata version 10.0 software (Stata Corporation, College Station, TX, USA).
Eight randomized clinical trials (totally 2,126 patients) were eligible. Meta-analysis showed that there was significant improvement in PFS (HR 0.81, 95% CI 0.69-0.96, P = 0.013) and overall response rate (OR 1.42, 95% CI 1.13-1.80, P = 0.03) in docetaxel-based doublet group, compared with docetaxel alone, though the pooled HR for overall survival (HR 0.93, 95% CI 0.80-1.07, P = 0.308) showed no significant difference between the two groups. However, there were more incidences of grade 3 or 4 neutropenia (OR 1.2, 95% CI 1.00-1.45, P = 0.05), thrombocytopenia (OR 4.53, 95% CI 1.75-11.75, P = 0.002), and diarrhea (OR 1.78, 95% CI 1.16-2.74, P = 0.008) in docetaxel-based doublet group. With regard to the risk of grade 3 or 4 anemia (OR 1.95, 95% CI 0.62-6.17, P = 0.25), fatigue (OR 1.09, 95% CI 0.75-1.59, P = 0.66), and nausea and vomiting (OR 1.75, 95% CI 0.78-3.91, P = 0.17), there was no significant difference between the two groups.
This was the first meta-analysis of docetaxel-based doublet versus single-agent docetaxel as second-line therapy in the treatment of non-small-cell lung cancer. The results indicated that docetaxel-based doublet therapy did not gain any benefit in survival but significantly improved PFS and better ORR versus single-agent docetaxel. However, more incidences of grade 3 or 4 neutropenia, thrombocytopenia, and diarrhea were observed in docetaxel-based doublet group.
比较多西他赛为基础的双联方案与单药多西他赛作为二线治疗非小细胞肺癌(NSCLC)的疗效。
我们系统地检索了比较组织学证实的非小细胞肺癌患者中单药多西他赛与多西他赛为基础的双联方案的随机临床试验。主要终点为总生存期(OS)。次要终点为无进展生存期、总缓解率、1 年生存率和 3 或 4 级毒性。两名独立评审员从研究中提取数据。使用 Stata 版本 10.0 软件(Stata 公司,德克萨斯州学院站)进行荟萃分析。
共有 8 项随机临床试验(共 2126 例患者)符合条件。荟萃分析显示,与单药多西他赛相比,多西他赛为基础的双联方案在无进展生存期(HR 0.81,95%CI 0.69-0.96,P=0.013)和总缓解率(OR 1.42,95%CI 1.13-1.80,P=0.03)方面有显著改善,但两组的总生存期(HR 0.93,95%CI 0.80-1.07,P=0.308)的合并 HR 无显著差异。然而,多西他赛为基础的双联方案组中 3 或 4 级中性粒细胞减少症(OR 1.2,95%CI 1.00-1.45,P=0.05)、血小板减少症(OR 4.53,95%CI 1.75-11.75,P=0.002)和腹泻(OR 1.78,95%CI 1.16-2.74,P=0.008)的发生率更高。至于 3 或 4 级贫血(OR 1.95,95%CI 0.62-6.17,P=0.25)、疲劳(OR 1.09,95%CI 0.75-1.59,P=0.66)和恶心呕吐(OR 1.75,95%CI 0.78-3.91,P=0.17)的风险,两组间无显著差异。
这是首个多西他赛为基础的双联方案与单药多西他赛作为二线治疗非小细胞肺癌的荟萃分析。结果表明,多西他赛为基础的双联方案治疗并未在生存方面获益,但与单药多西他赛相比,无进展生存期显著延长,总缓解率更好。然而,多西他赛为基础的双联方案组中 3 或 4 级中性粒细胞减少症、血小板减少症和腹泻的发生率更高。