Araujo Raphael L C, Herman Paulo, Riechelmann Rachel P
Raphael L C Araujo, Department of Upper Gastrointestinal and Hepato-Pancreato-Bliliary Sugery, Barretos Cancer Hospital, Barretos, SP 14784-400, Brazil.
World J Clin Oncol. 2017 Jun 10;8(3):266-272. doi: 10.5306/wjco.v8.i3.266.
To verify whether recurrence-free survival (RFS) surrogates overall survival (OS) in phase III trials for resectable colorectal liver metastases (CRLM).
MEDLINE, EMBASE, and Scopus databases were consulted. Eligible studies were phase III trials testing any type of systemic therapy (neoadjuvant, adjuvant or perioperative) added to surgery in patients with resectable CRLM. A linear regression model based on hazard ratios (HR) of OS and RFS was performed.
Of 3059 studies, 5 phase III trials (1162 patients) were included for analyses. A linear regression weighted by each trial was used to estimate the association between each HR and RFS. The originated formula was: OS HR = (0.93 × RFS HR) + 0.14; with RFS 95%CI (0.48-1.38), with = 0.007.
This association suggests that RFS could work as a putative surrogate endpoint of OS in this population, avoiding bigger, longer and more resource-consuming trials. The OS could be assumed based on RFS and our model could be useful to better estimate sample size calculations of phase III trials of CRLM aiming for OS.
验证在可切除结直肠癌肝转移（CRLM）的III期试验中，无复发生存期（RFS）是否可替代总生存期（OS）。
查阅了MEDLINE、EMBASE和Scopus数据库。符合条件的研究为III期试验，测试在可切除CRLM患者的手术基础上添加任何类型的全身治疗（新辅助、辅助或围手术期）。基于OS和RFS的风险比（HR）进行线性回归模型分析。
在3059项研究中，纳入了5项III期试验（1162例患者）进行分析。采用每项试验加权的线性回归来估计每个HR与RFS之间的关联。得出的公式为：OS HR =（0.93×RFS HR）+ 0.14；RFS的95%置信区间为（0.48 - 1.38），P = 0.007。
这种关联表明，在该人群中RFS可作为OS的假定替代终点，避免进行规模更大、时间更长且资源消耗更多的试验。可根据RFS推断OS，且我们的模型可能有助于更好地估计以OS为目标的CRLM III期试验的样本量计算。
