Dana-Farber Cancer Institute, 450 Brookline Ave., Dana 1234, Boston, MA 02215, USA.
J Natl Cancer Inst. 2012 Oct 17;104(20):1534-41. doi: 10.1093/jnci/djs353. Epub 2012 Aug 27.
Although progression-based endpoints, such as progression-free survival, are often key clinical trial endpoints for anticancer agents, the clinical meaning of "objective progression" is much less certain. As scrutiny of progression-based endpoints in clinical trials increases, it should be remembered that the Response Evaluation Criteria In Solid Tumors (RECIST) progression criteria were not developed as a surrogate for survival. Now that progression-free survival has come to be an increasingly important trial endpoint, the criteria that define progression deserve critical evaluation to determine whether alternate definitions of progression might facilitate the development of stronger surrogate endpoints and more meaningful trial results. In this commentary, we review the genesis of the criteria for progression, highlight recent data that question their value as a marker of treatment failure, and advocate for several research strategies that could lay the groundwork for a clinically validated definition of disease progression in solid tumor oncology.
虽然基于进展的终点（如无进展生存期）通常是抗癌药物临床试验的关键终点，但“客观进展”的临床意义却远不明确。随着对临床试验中基于进展的终点的审查增加，应该记住，实体瘤反应评估标准（RECIST）的进展标准并不是作为生存的替代指标而开发的。既然无进展生存期已成为越来越重要的试验终点，那么定义进展的标准就值得进行严格评估，以确定是否可以用其他进展定义来促进更有力的替代终点和更有意义的试验结果。在这篇评论中，我们回顾了进展标准的起源，强调了最近的数据，这些数据对它们作为治疗失败标志物的价值提出了质疑，并主张采取几种研究策略，为实体肿瘤肿瘤学中经临床验证的疾病进展定义奠定基础。
