Comparison of RECIST 1.1 and iRECIST in Patients Treated with Immune Checkpoint Inhibitors: A Systematic Review and Meta-Analysis.
Comparison of RECIST 1.1 and iRECIST in Patients Treated with Immune Checkpoint Inhibitors: A Systematic Review and Meta-Analysis.
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DOI：
10.3390/cancers13010120
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发表时间：
2021-01-01
期刊：
影响因子：
5.2
通讯作者：
Ramaiya NH
中科院分区：
文献类型：
--
作者：
Park HJ;Kim GH;Kim KW;Lee CW;Yoon S;Chae YK;Tirumani SH;Ramaiya NH
iRECIST在评价免疫检查点抑制剂治疗的疗效方面是否比RECIST 1.1具有显著影响存在争议。我们旨在通过系统性综述和荟萃分析，评价iRECIST相对于RECIST 1.1对评估免疫检查点抑制剂治疗疗效的影响。与RECIST 1.1相比，iRECIST对总缓解率和疾病控制率没有影响，但检测到3.9%的患者由于假进展和限制性平均无进展生存期延长0.46个月而导致疾病进展确定日期不一致。因此，与RECIST 1.1相比，iRECIST的应用对缓解相关终点没有影响，但对生存期终点的影响较小。当我们设计免疫检查点抑制剂的临床试验时，应该考虑iRECIST的这种适度获益。尽管iRECIST得到广泛认可，但缺乏iRECIST相对于RECIST 1.1的影响的证据。我们的目的是评价iRECIST对评估免疫检查点抑制剂（ICI）相对于RECIST 1.1的治疗疗效的影响。根据RECIST 1.1和iRECIST评估治疗反应和结局的文章符合资格。提取了基于RECIST 1.1和iRECIST的总缓解率（ORR）和疾病控制率（DCR）数据，以及估计个体患者无进展生存期（PFS）数据所需的数据。使用荟萃回归和汇总发生率比比较估计值。计算两种标准之间PFS的限制性平均生存时间（RMST）的合并差异。共分析了11项研究（6210例患者）。iRECIST的应用对缓解相关终点没有影响，因为与RECIST 1.1相比，ORR和DCR没有显著差异（合并ORR，23.6%和24.7% [p = 0.72]; iRECIST和RECIST 1.1的汇总DCR分别为45.3%和48.7% [p = 0.56]，通过显示PFS的RMST长于RECIST 1.1（合并差异，0.46个月; 95% CI，0.10-0.82个月; p = 0.01），对生存终点的影响较小。当我们设计免疫检查点抑制剂的临床试验时，应该考虑iRECIST的这种适度获益。
It is controversial whether iRECIST has a significant impact over RECIST 1.1 in evaluating the efficacy of immune checkpoint inhibitor treatment. We aimed to evaluate the impact of iRECIST on assessing treatment efficacy of immune checkpoint inhibitors over RECIST 1.1 through a systematic review and meta-analysis. Compared to RECIST 1.1, iRECIST had no impact on the overall response rate and disease control rate but detected 3.9% of patients with discordance in the date of progressive disease determination due to pseudoprogression and prolonged restricted mean progression-free survival time by 0.46 months. Therefore, the application of iRECIST had no impact on the response-related endpoints but had a minor impact on the survival endpoint, compared to RECIST 1.1. Such a modest benefit of iRECIST should be considered when we design a clinical trial for immune checkpoint inhibitors. Despite wide recognition of iRECIST, evidence regarding the impact of iRECIST over RECIST 1.1 is lacking. We aimed to evaluate the impact of iRECIST on assessing treatment efficacy of immune checkpoint inhibitors (ICIs) over RECIST 1.1. Articles that evaluated the treatment response and outcome based on both RECIST 1.1 and iRECIST were eligible. Data regarding overall response rates (ORR) and disease control rate (DCR) based on RECIST 1.1 and iRECIST, and data required to estimate individual patient data of progression-free survival (PFS) were extracted. Estimates were compared using meta-regression and pooled incidence rate ratios. The pooled difference of restricted mean survival time (RMST) of PFS between two criteria were calculated. Eleven studies with 6210 patients were analyzed. The application of iRECIST had no impact on the response-related endpoint by showing no significantly different ORR and DCR from RECIST 1.1 (pooled ORR, 23.6% and 24.7% [p = 0.72]; pooled DCR, 45.3% and 48.7% [p = 0.56] for iRECIST and RECIST 1.1, respectively) and had a minor impact on a survival endpoint by showing longer RMST of PFS than RECIST 1.1 (pooled difference, 0.46 months; 95% CI, 0.10–0.82 months; p = 0.01). Such a modest benefit of iRECIST should be considered when we design a clinical trial for immune checkpoint inhibitors.
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