The fine points of end points: phase II trials in lung cancer.

The fine points of end points: phase II trials in lung cancer.
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终点的要点:肺癌的 II 期试验。

DOI:
10.1023/a:1008429313403
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发表时间:
1998
期刊:
Annals of oncology : official journal of the European Society for Medical Oncology
影响因子:
--
通讯作者:
K. Gelmon
K. Gelmon
中科院分区:
--
文献类型:
--
作者:
K. Gelmon

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在过去的几年里,随着非小细胞肺癌(NSCLC)的大量II期研究的开展,活动激增。一些报告已经开始广泛和热情地使用新的药物之前,完成随机III期试验,确定其作用。其他人已经审查了怀疑,提出了对结果和生存的影响的问题。尽管III期随机研究和荟萃分析的结果显示联合化疗优于最佳支持治疗,但仍存在一些问题[1-3]。其中包括:晚期疾病的最佳治疗方案是什么,试验结果是否适用于广泛的肺癌患者人群,对生存率是否有价值的影响,二线治疗的作用是什么,以及我们如何可靠地评估用于NSCLC的新药?对于这种疾病,哪些终点是有效的?
Over the last few years there has been a surge of activity as numerous phase II studies in non-small-cell lung cancer (NSCLC) have been presented. Some reports have initiated the widespread and enthusiastic use of novel agents prior to the completion of randomized phase III trials defining their role. Others have been reviewed with skepticism prompting questions of impact on outcome and survival. Although the results of phase III randomized studies and meta-analyses have shown the superiority of combination chemotherapy over best supportive care, a number of issues remain [1-3]. These include: what is the optimal recipe for the treatment of advanced disease, are trial results applicable to the broad population of lung cancer patients, is there a worthwhile impact on survival, what is the role of second-line therapy and how can we reliably assess new agents for use in NSCLC? What endpoints are valid in this disease?
9-氨基喜树碱治疗晚期非小细胞肺癌的 II 期研究。
DOI: 10.1023/a:1008432729754
发表时间: 1998
期刊: Annals of oncology : official journal of the European Society for Medical Oncology
影响因子: --
作者:
Vokes,EE;Ansari,RH;Masters,GA;Hoffman,PC;Klepsch,A;Ratain,MJ;Sciortino,DF;Lad,TE;Krauss,S;Fishkin,PA;Golomb,HM
通讯作者: Golomb,HM