Overall survival should be the primary endpoint in clinical trials for advanced non-small-cell lung cancer
Overall survival should be the primary endpoint in clinical trials for advanced non-small-cell lung cancer
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DOI：
10.3747/co.20.1226
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发表时间：
2013-04-01
期刊：
影响因子：
2.6
通讯作者：
Burkes, R. L.
中科院分区：
文献类型：
--
作者：
Cheema, P. K.;Burkes, R. L.
最近一期《当代肿瘤学》上的一篇文章探讨了无进展生存期（PFS）作为转移性结直肠癌、转移性肾细胞癌和卵巢癌抗肿瘤药物临床试验终点的有效性。支持PFS作为总生存期（os）的替代终点。与上述肿瘤类型一样，自2000年以来，晚期非小细胞肺癌（NSCLC）的活性药物使用量有所上升。这些药物的范围从改进的细胞毒如培美曲塞，到靶向治疗如表皮生长因子受体酪氨酸激酶抑制剂和靶向EML4-ALK基因突变的药物。最近，组织学在治疗反应和治疗结果中起着重要作用。随着晚期非小细胞肺癌患者治疗选择的增加，人们越来越担心，在临床试验中，用os测量药物的疗效可能会被稀释，从而低估其真正的临床益处。这种可能性，再加上患者更早获得有效药物的需求，导致了对晚期非小细胞肺癌os终点替代疗法的研究。本文是最近一篇关于PFS的文章的后续文章。尽管在其他肿瘤类型中，PFS作为os的有效替代终点已取得进展，但在晚期NSCLC中，这种替代尚未得到正式验证。在此之前，os仍应是晚期NSCLC临床试验的主要终点。
An article in a recent edition of Current Oncology explored the validation of progression-free survival (PFS) as an endpoint in clinical trials of antineoplastic agents for metastatic colorectal cancer, metastatic renal cell carcinoma, and ovarian cancer. The support for PFS as a surrogate endpoint for overall survival (os) was elucidated. As with the aforementioned tumour types, advanced non-small-cell lung cancer (NSCLC) has seen a rise in active agents since the year 2000. Those agents range from improved cytotoxics such as pemetrexed, to targeted therapies such as tyrosine kinase inhibitors of the epidermal growth factor receptor and agents that target the EML4-ALK gene mutation. More recently, it has also become apparent that histology plays an important role in the response to and outcomes of treatment. With the therapeutic options for patients with advanced NSCLC increasing, concerns are being raised that the efficacy of drugs measured by os may be diluted in clinical trials, thereby underestimating their true clinical benefit. That possibility, together with the need to have efficacious drugs available to patients earlier, has resulted in the search for a surrogate to the os endpoint in advanced NSCLC. The present article follows up the recent article on PFS as a surrogate. Although advances in identifying PFS as a valid surrogate endpoint for os have been made in other tumour types, in advanced NSCLC, such surrogacy has not been formally validated. Until it has, os should remain the primary endpoint of clinical trials in advanced NSCLC.