RECIST 1.1 与 irRECIST 评估肿瘤的比较，以及与总生存期的关系。
Comparison of tumor assessments using RECIST 1.1 and irRECIST, and association with overall survival.
机构信息
EMD Serono Research & Development Institute, Inc, Billerica, Massachusetts, USA, an affiliate of Merck KGaA.
Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
出版信息
J Immunother Cancer. 2022 Feb;10(2). doi: 10.1136/jitc-2021-003302.
BACKGROUND
Patients treated with immune checkpoint inhibitors (ICIs) may experience pseudoprogression, which can be classified as progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.1 and could lead to inappropriate treatment discontinuation. Immune-response criteria were developed to better capture novel response patterns seen with ICIs.
METHODS
We pooled data from 1765 patients with 12 types of advanced solid tumors treated with avelumab (an anti-programmed death ligand 1 (PD-L1) monoclonal antibody) monotherapy in the JAVELIN Solid Tumor and JAVELIN Merkel 200 trials, conducted a comparative analysis of tumor assessments by investigators according to RECIST 1.1 and immune-related RECIST (irRECIST), and evaluated the correlation between progression-free survival (PFS) and overall survival (OS).
RESULTS
In total, 147 patients (8.3%) had a best overall response (BOR) of PD by RECIST 1.1 but had immune-related disease control by irRECIST (defined as immune-related BOR (irBOR) of immune-related stable disease or better). This discordance was seen irrespective of PD-L1 status and observed across all tumor types. Overall, PFS and immune-related PFS showed similar imputed rank correlations with OS.
CONCLUSIONS
The use of irRECIST identified a subset of patients with a BOR of PD by RECIST 1.1 but an irBOR of immune-related disease control by irRECIST with a distinctive survival curve, thereby providing more clinically relevant information than RECIST 1.1 alone. However, as a surrogate endpoint for OS in the whole population, immune-related PFS by irRECIST did not show improved predictive value compared with PFS by RECIST 1.1.
背景
接受免疫检查点抑制剂（ICI）治疗的患者可能会出现假性进展，根据实体瘤反应评估标准（RECIST）V.1.1，这可能被归类为进展性疾病（PD），并可能导致治疗不当终止。免疫反应标准的制定是为了更好地捕捉到 ICI 带来的新型反应模式。
方法
我们汇总了在 JAVELIN 实体瘤和 JAVELIN Merkel 200 试验中接受avelumab（一种抗程序性死亡配体 1（PD-L1）单克隆抗体）单药治疗的 12 种晚期实体瘤 1765 例患者的数据，对研究者根据 RECIST 1.1 和免疫相关 RECIST（irRECIST）进行的肿瘤评估进行了比较分析，并评估了无进展生存期（PFS）和总生存期（OS）之间的相关性。
结果
共有 147 例患者（8.3%）根据 RECIST 1.1 最佳总体缓解（BOR）为 PD，但根据 irRECIST 具有免疫相关疾病控制（定义为免疫相关 BOR（irBOR）为免疫相关稳定疾病或更好）。这种不一致性无论 PD-L1 状态如何，在所有肿瘤类型中都观察到。总体而言，PFS 和免疫相关 PFS 与 OS 具有相似的推断秩相关性。
结论
使用 irRECIST 确定了一组患者，这些患者根据 RECIST 1.1 为 PD，但根据 irRECIST 为 irBOR 免疫相关疾病控制，其生存曲线具有独特性，因此比单独使用 RECIST 1.1 提供了更具临床意义的信息。然而，作为整个人群 OS 的替代终点，irRECIST 的免疫相关 PFS 与 RECIST 1.1 的 PFS 相比，并未显示出改善的预测价值。
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