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含伊立替康方案作为晚期胃癌一线治疗的总生存获益:十个随机对照试验的更新荟萃分析。

Overall survival benefits for irinotecan-containing regimens as first-line treatment for advanced gastric cancer: an updated meta-analysis of ten randomized controlled trials.

机构信息

Department of Oncology, The Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.

出版信息

Int J Cancer. 2013 Jan 15;132(2):E66-73. doi: 10.1002/ijc.27775. Epub 2012 Sep 1.

Abstract

The standard treatment for patients with advanced gastric cancer (AGC) is still debated, and the available data on the benefit of irinotecan-containing regimen as first-line treatment for those patients are controversial. We performed a systematic review and meta-analysis of randomized controlled trials to determine the survival benefits of irinotecan-containing regimens in this setting. A total of 1,837 patients from ten trials were included in the analysis. Our results showed that irinotecan-containing regimens significantly improved overall survival [OS: hazard ratio (HR) 0.86, 95% CI = 0.78-0.94, p = 0.002] and progression-free survival [HR = 0.82, 95% CI = 0.69-0.97, p = 0.026); however, the improvement of time to failure (HR = 0.90; 95% CI = 0.77-1.04, p = 0.15), 1-year survival rate [1-year SR: relative risk (RR) 1.10, 95% CI = 0.97-1.24, p = 0.13] and overall response rate (RR = 1.16, 95% CI = 0.91-1.49, p = 0.24] were nonsignificant. Equivalent frequencies of toxicities were found between the two groups excluding more Grade 3 or 4 fatigue (p = 0.001) in irinotecan-containing regimens. This updated meta-analysis provided strong evidence for a survival benefit of irinotecan-containing regimen as first-line treatment for AGC. A clear advantage of irinotecan-containing over nonirinotecan-containing regimen had not been established. These results should help to inform decisions about patient management and design of future trials.

摘要

对于晚期胃癌(AGC)患者,标准治疗仍存在争议,并且关于伊立替康为基础的方案作为这些患者一线治疗的获益的现有数据存在争议。我们进行了一项系统评价和荟萃分析,以确定伊立替康为基础的方案在该人群中的生存获益。共有来自 10 项试验的 1837 名患者纳入了分析。我们的结果表明,伊立替康为基础的方案显著改善了总生存[OS:风险比(HR)0.86,95%可信区间(CI)=0.78-0.94,p=0.002]和无进展生存[HR=0.82,95%CI=0.69-0.97,p=0.026];然而,失败时间的改善[HR=0.90;95%CI=0.77-1.04,p=0.15]、1 年生存率[1 年 SR:相对风险(RR)1.10,95%CI=0.97-1.24,p=0.13]和总缓解率(RR=1.16,95%CI=0.91-1.49,p=0.24]没有统计学意义。除了伊立替康为基础的方案中更常见的 3 或 4 级疲劳(p=0.001)外,两组之间的毒性发生率相当。这项更新的荟萃分析为伊立替康为基础的方案作为 AGC 的一线治疗提供了生存获益的有力证据。伊立替康为基础的方案与非伊立替康为基础的方案相比并没有明显的优势。这些结果应该有助于为患者管理决策和未来试验设计提供信息。

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