Correlation between progression-free survival and overall survival in metastatic breast cancer patients receiving anthracyclines, taxanes, or targeted therapies: a trial-level meta-analysis.
Correlation between progression-free survival and overall survival in metastatic breast cancer patients receiving anthracyclines, taxanes, or targeted therapies: a trial-level meta-analysis.
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DOI：
10.1007/s10549-015-3643-5
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发表时间：
2015-12
影响因子：
3.8
通讯作者：
Dranitsaris, George
中科院分区：
文献类型：
--
作者：
Adunlin, George;Cyrus, John W. W.;Dranitsaris, George
在过去的十年中，几种新药已获得转移性乳腺癌（MBC）的监管批准。然而，其中一些批准是基于无进展生存期（PFS）的改善，而没有伴随总生存期（OS）的增加。这导致一些人质疑使用PFS作为药物批准指标的实用性。为了解决在MBC中使用PFS作为OS替代的不确定性，在接受蒽环类、紫杉烷类或靶向治疗的患者中进行了系统性文献综述，随后进行了试验水平相关分析。检索了电子数据库，以识别1990年1月至2015年8月期间发表的随机试验。数据提取包括比较组之间PFS（HRPFS）和OS（HROS）的风险比以及试验水平参数。然后使用加权多变量回归分析来检验HRPFS和HROS之间的关联强度。提供84个比较组的72项试验符合纳入标准。HRPFS是HROS的显著预测因子（模型系数= 0.18，p = 0.04）。然而，仅有31%（即，模型R2）之间的全氟辛烷磺酸的关联的变异性进行了解释。当试验限于≥ 2线设置时，关联强度提高（模型系数= 0.40，p < 0.001），模型R2增加至55%。然而，当仅考虑一线试验时，HRPFS-HROS相关性不再显著（p = 0.90）。HRPFS是MBC随机试验中HROS的预测因子。然而，该效应是由≥二线背景下的试验驱动的。因此，PFS可以作为评价第2种及以后新治疗的试验中OS的合适替代指标。不建议在一线背景下单独使用PFS作为主要试验终点。
Over the past decade, several new drugs have received regulatory approval for metastatic breast cancer (MBC). However, some of these approvals were based on improvement in progression-free survival (PFS), without a concomitant increase in overall survival (OS). This has led some to question the utility of using PFS as a measure for drug approval. To address the uncertainty of using PFS as a surrogate for OS in MBC, a systematic literature review followed by a trial-level correlative analysis was conducted in patients receiving anthracyclines, taxanes, or targeted therapies. Electronic databases were searched to identify randomized trials published between January 1990 and August 2015. Data extraction included hazard ratios for PFS (HRPFS) and OS (HROS) between comparative arms as well as trial-level parameters. Weighted multivariate regression analysis was then used to test the strength of the association between HRPFS and HROS. 72 trials providing 84 comparative arms met the inclusion criteria. HRPFS was a significant predictor of HROS (model coefficient = 0.18, p = 0.04). However, only 31 % (i.e., model R2) of the variability between the PFS–OS association was accounted for. When trials were limited to ≥2nd-line setting, the strength of the association improved (model coefficient = 0.40, p < 0.001) and the model R2 increased to 55 %. However, the HRPFS–HROS association was no longer significant when only 1st-line trials were considered (p = 0.90). HRPFS is a predictor for HROS in MBC randomized trials. However, the effect was driven by trials in the ≥2nd-line setting. Therefore, PFS can be a suitable surrogate for OS in trials evaluating new treatments in the 2nd setting and beyond. The use of PFS alone as a primary trial endpoint in the 1st-line setting is not recommended.
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