晚期结直肠癌临床研究终点：无进展生存期,总生存期或其他

Endpoint in Advanced Colorectal Cancer Clinical Trials :Progression-Free Survival,Overall Survival or Other Indicators

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）,the primary endpoint of clinical trials in metastatic colorectal cancer（mCRC）,has been regarded as the ＂gold standard＂.Serving as standard primary endpoint and efficacy evaluation of single line,the role of OS is challenged by the remarkable extension of OS in mCRC patients during the last decade.In the era of chemotherapy alone before 1999,progression-free survival（PFS） was considered as a reliable surrogate of OS.With the accumulation of effective subsequent treatment,the less impact of PFS on OS result in decreased PFS for OS alternative.The correlation between PFS and OS also decreased in the regimens combined with target agents,especially with antiangiogenesis agents.The new studies on duration of disease control（DDC） and time to failure of strategy（TFS） reveal their potential alternation to OS.This review conducts the availability of these surrogates for the reference in clinical trials ＇ design and interpretation.