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无进展生存期作为抗血管生成疗法治疗晚期结直肠癌的替代终点

Progression-free Survival as a Surrogate End-point in Advanced Colorectal Cancer Treated with Antiangiogenic Therapies.

作者信息

Montagnani Francesco, DI Leonardo Greta, Pino Maria Simona, Martella Francesca, Perboni Simona, Ribecco Angela, Fioretto Luisa

机构信息

Oncology Department, Istituto Tumori Toscano (I.T.T.), Azienda Usl Toscana Centro, Ospedale Santa Maria Annunziata, Florence, Italy

Oncology Department, Istituto Tumori Toscano (I.T.T.), Azienda Usl Toscana Centro, Ospedale Santa Maria Annunziata, Florence, Italy.

出版信息

Anticancer Res. 2016 Aug;36(8):4259-65.

Abstract

BACKGROUND

It is not clear if progression-free survival (PFS) is a good surrogate end-point for overall survival (OS) for metastatic colorectal cancer if antiangiogenic therapies are used.

MATERIALS AND METHODS

We investigated randomized controlled trials testing antiangiogenic agents against chemotherapy. Log hazard ratios (HR) for PFS and OS were used to construct linear regression models. The surrogate threshold effect (STE) was calculated.

RESULTS

Thirteen studies and 24 comparison arms were available, including 7,179 patients. This model returned a significant correlation between PFS and OS (R(2)=0.68, p<0.001) with an STE of 0.83. Analysis restricted to first-line gave similar results (R(2)=0.68, p<0.001, STE=0.75).

CONCLUSION

There is a significant correlation between the effect of treatment on PFS and OS. PFS remains a good surrogate end-point for OS even if anti-angiogenic agents are used.

摘要

背景

对于转移性结直肠癌患者,如果使用抗血管生成疗法,无进展生存期(PFS)是否是总生存期(OS)的良好替代终点尚不清楚。

材料与方法

我们调查了测试抗血管生成药物与化疗对比的随机对照试验。使用PFS和OS的对数风险比(HR)构建线性回归模型。计算替代阈值效应(STE)。

结果

共有13项研究和24个比较组,纳入7179例患者。该模型显示PFS与OS之间存在显著相关性(R² = 0.68,p < 0.001),STE为0.83。仅分析一线治疗结果相似(R² = 0.68,p < 0.001,STE = 0.75)。

结论

治疗对PFS和OS的影响之间存在显著相关性。即使使用抗血管生成药物,PFS仍是OS的良好替代终点。

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