Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan,
Gastric Cancer. 2014 Apr;17(2):362-70. doi: 10.1007/s10120-013-0274-6. Epub 2013 Jun 5.
The correlation between progression-free survival (PFS) or time to progression (TTP) and overall survival (OS) has been evaluated in patients with advanced gastric cancer (AGC) who received first-line chemotherapy. No corresponding analysis has been done in patients who have undergone second-line chemotherapy.
We evaluated the correlation between PFS, TTP, objective response rate (ORR), disease control rate (DCR), and OS in patients with AGC who underwent second-line chemotherapy. Correlations were evaluated by Spearman rank correlation coefficient (ρ).
Sixty-four trials, including 10 randomized studies, were selected for analysis. Median PFS/TTP moderately correlated with OS (ρ = 0.56). The correlation tended to be stronger in non-Asian trials (ρ = 0.74) than in Asian trials (ρ = 0.37). ORR and DCR did not strongly correlate with OS (ρ = 0.38 for ORR; ρ = 0.54 for DCR). The hazard ratio of PFS and OS in each of the arms of the 10 randomized studies also showed a low correlation (ρ = 0.36).
PFS/TTP, ORR, and DCR did not correlate sufficiently with OS to be used as surrogate endpoints in patients with AGC who have undergone second-line chemotherapy. Further research is needed based on individual patient data from ongoing randomized trials.
在接受一线化疗的晚期胃癌（AGC）患者中，已经评估了无进展生存期（PFS）或进展时间（TTP）与总生存期（OS）之间的相关性。但在接受二线化疗的患者中，尚未进行相应的分析。
我们评估了接受二线化疗的 AGC 患者的 PFS、TTP、客观缓解率（ORR）、疾病控制率（DCR）与 OS 之间的相关性。采用 Spearman 秩相关系数（ρ）进行相关性评估。
共纳入 64 项试验，其中包括 10 项随机研究。中位 PFS/TTP 与 OS 中度相关（ρ=0.56）。非亚洲试验（ρ=0.74）的相关性强于亚洲试验（ρ=0.37）。ORR 和 DCR 与 OS 的相关性不强（ORR 的 ρ=0.38；DCR 的 ρ=0.54）。10 项随机研究中各治疗组的 PFS 和 OS 的风险比也显示出低度相关性（ρ=0.36）。
在接受二线化疗的 AGC 患者中，PFS/TTP、ORR 和 DCR 与 OS 的相关性不足以作为替代终点。需要根据正在进行的随机试验中的个体患者数据进行进一步的研究。
