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转移性肾细胞癌患者临床研究中疾病进展终点和总生存期治疗效果的相关性。

Association between treatment effects on disease progression end points and overall survival in clinical studies of patients with metastatic renal cell carcinoma.

机构信息

PAI (Policy Analysis Inc.), 4 Davis Court, Brookline, MA 02445, USA.

出版信息

Br J Cancer. 2012 Sep 25;107(7):1059-68. doi: 10.1038/bjc.2012.367. Epub 2012 Aug 30.

DOI:10.1038/bjc.2012.367
PMID:22935581
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3461161/
Abstract

BACKGROUND

The relationship between progression-free survival and time to progression (PFS/TTP) and overall survival (OS) has been demonstrated in a variety of solid tumours but not in metastatic renal cell carcinoma (mRCC).

METHODS

A systematic literature search was conducted to identify controlled trials of cytokine or targeted therapies for mRCC reporting information on treatment effects on PFS/TTP and OS for one or more comparison. The associations between treatment effects on PFS/TTP and OS were analysed using linear regression.

RESULTS

Thirty-one studies representing 10943 patients, 75 treatment groups, and 41 comparisons were identified. The correlation coefficient between the negative log of the hazard ratio (HR) for PFS/TTP (-ln HR(PFS/TTP)) vs the negative log of the HR for OS (-ln HR(OS)) was 0.80 (P<0.0001). In linear regression, the coefficient on -ln HR(PFS/TTP) vs -ln HR(OS) was 0.64 (95% confidence interval (CI): 0.470.81; R(2)=0.63), suggesting each 10% relative risk reduction (RRR) for PFS/TTP was associated with a 6% RRR for OS. A 1-month gain in median PFS/TTP was associated with a 1.17-month gain in median OS (95% CI: 0.59,1.76; R(2)=0.28).

CONCLUSION

In trials of treatments for mRCC, treatment effects on PFS/TTP are strongly associated with treatment effects on OS.

摘要

背景

无进展生存期(progression-free survival,PFS)与进展时间(time to progression,TTP)和总生存期(overall survival,OS)之间的关系已在多种实体瘤中得到证实,但在转移性肾细胞癌(metastatic renal cell carcinoma,mRCC)中尚未得到证实。

方法

系统检索了评估细胞因子或靶向治疗 mRCC 的临床试验,以确定报告了一种或多种比较的治疗效果对 PFS/TTP 和 OS 影响的文献。使用线性回归分析 PFS/TTP 和 OS 治疗效果之间的相关性。

结果

确定了 31 项研究,涉及 10943 例患者、75 个治疗组和 41 个比较。PFS/TTP 的风险比(hazard ratio,HR)的负对数(-ln HR(PFS/TTP))与 OS 的 HR 的负对数(-ln HR(OS))之间的相关系数为 0.80(P<0.0001)。在线性回归中,-ln HR(PFS/TTP)与 -ln HR(OS)的系数为 0.64(95%置信区间(confidence interval,CI):0.47~0.81;R(2)=0.63),提示 PFS/TTP 的每 10%相对风险降低(relative risk reduction,RRR)与 OS 的 6% RRR 相关。PFS/TTP 中位数增加 1 个月与 OS 中位数增加 1.17 个月相关(95% CI:0.59,1.76;R(2)=0.28)。

结论

在 mRCC 的治疗试验中,PFS/TTP 的治疗效果与 OS 的治疗效果密切相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b06e/3461161/8d1ab7b4b11d/bjc2012367f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b06e/3461161/b4e7fadd9e31/bjc2012367f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b06e/3461161/8b427e2448bd/bjc2012367f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b06e/3461161/782c4ee7b652/bjc2012367f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b06e/3461161/8d1ab7b4b11d/bjc2012367f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b06e/3461161/b4e7fadd9e31/bjc2012367f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b06e/3461161/8b427e2448bd/bjc2012367f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b06e/3461161/782c4ee7b652/bjc2012367f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b06e/3461161/8d1ab7b4b11d/bjc2012367f4.jpg

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