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总生存期(overall survival,OS)是转移性结直肠癌(metastatic colorectal cancer,m CRC)临床试验的主要研究终点,被认为是“金标准”。因为mCRC患者的OS较十年前有明显延长,OS作为临床试验的主要研究终点和评价疗效都受到挑战。在1999年前的单纯化疗时代,无进展生存期(progression-free survival,PFS)被认为是OS的可靠替代终点,由于有效后线治疗的增加,PFS对OS的影响越来越小,其替代性降低;在含靶向药物方案中,尤其是抗血管生成药物治疗中,PFS和OS的相关性也下降。疾病控制时间(duration of disease control,DDC)和治疗策略失败时间(time to failure of strategy,TFS)等新的研究终点逐步显示替代OS的可能性。文章对以上内容进行综述,希望对临床试验的设计和解读提供参考。
Overall survival (OS) is the primary endpoint of the clinical trial of metastatic colorectal cancer (mCRC) and is considered the “gold standard.” Because mCRC patients have a significantly longer OS than ten years ago, OS as a primary endpoint of clinical trials and evaluation of efficacy are challenged. In the era of chemotherapy alone prior to 1999, progression-free survival (PFS) was considered a reliable surrogate endpoint for OS and the effect of PFS on OS was less and less due to an increase in effective back-line therapy Sexual decline; in targeted drug regimens, especially antiangiogenic drug treatment, the correlation between PFS and OS also decreased. New research endpoints such as duration of disease control (DDC) and time to failure of strategy (TFS) have gradually shown the potential for OS replacement. The article summarizes the above contents, hoping to provide a reference for the design and interpretation of clinical trials.