National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC); Collaborative Innovation Center for Cancer Medicine, Beijing, China.
Beijing Hospital, National Geriatric Medical Center, Beijing, China.
Cancer Med. 2024 Jan;13(1):e6899. doi: 10.1002/cam4.6899. Epub 2024 Jan 5.
This study aimed to predict the 5-year overall survival (OS) benefit of pola-R-CHP versus R-CHOP in the POLARIX trial based on the 2-year event-free survival (EFS) and progression-free survival (PFS) rates in diffuse large B-cell lymphoma (DLBCL). We identified randomized controlled trials (RCT) published before 31 May 2023. The correlation between the logarithmic (log) hazard ratio (HR) for EFS (HR) or PFS (HR) and the HR for OS (HR) was estimated at the trial-level. Correlation analysis was performed between 2-year PFS or EFS and 5-year OS rates at the treatment arm-level. Linear regression models were used to calculate the 5-year OS of pola-R-CHP and R-CHOP. In the included 20 RCTs, a linear correlation between HR (r = 0.765) or HR (r = 0.534) and HR was observed at the trial- level. Two-year EFS (r = 0.918) or 2-year PFS (r = 0.865) correlated linearly with 5-year OS. Linear regression analysis between 2-year EFS/PFS and 5-year OS gave estimated 5-year OS rates between pola-R-CHP and R-CHOP of 6.4% and 6.3%, respectively. Two-year EFS and PFS are feasible early endpoints in patients with DLBCL treated primarily with immunochemotherapy. The pola-R-CHP regimen is expected to improve 5-year OS.
本研究旨在基于弥漫性大 B 细胞淋巴瘤（DLBCL）的 2 年无事件生存（EFS）和无进展生存（PFS）率，预测 POLARIX 试验中 pola-R-CHP 相对于 R-CHOP 的 5 年总生存（OS）获益。我们确定了截至 2023 年 5 月 31 日之前发表的随机对照试验（RCT）。在试验水平上估计 EFS（HR）或 PFS（HR）的对数（log）风险比（HR）与 OS（HR）的 HR 之间的相关性。在治疗臂水平上，对 2 年 PFS 或 EFS 与 5 年 OS 率进行相关性分析。使用线性回归模型计算 pola-R-CHP 和 R-CHOP 的 5 年 OS。在纳入的 20 项 RCT 中，在试验水平上观察到 HR（r=0.765）或 HR（r=0.534）与 HR 之间存在线性相关性。2 年 EFS（r=0.918）或 2 年 PFS（r=0.865）与 5 年 OS 呈线性相关。在 2 年 EFS/PFS 与 5 年 OS 之间进行线性回归分析，估计 pola-R-CHP 和 R-CHOP 的 5 年 OS 率分别为 6.4%和 6.3%。在主要接受免疫化疗治疗的 DLBCL 患者中，2 年 EFS 和 PFS 是可行的早期终点。预计 pola-R-CHP 方案将提高 5 年 OS。
