Purpose Treating solid tumors with cancer immunotherapy (CIT) can result in unconventional responses and overall survival (OS) benefits that are not adequately captured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. We describe immune-modified RECIST (imRECIST) criteria, designed to better capture CIT responses. Patients and Methods Atezolizumab data from clinical trials in non-small-cell lung cancer, metastatic urothelial carcinoma, renal cell carcinoma, and melanoma were evaluated. Modifications to imRECIST versus RECIST v1.1 included allowance for best overall response after progressive disease (PD) and changes in PD definitions per new lesions (NLs) and nontarget lesions. imRECIST progression-free survival (PFS) did not count initial PD as an event if the subsequent scan showed disease control. OS was evaluated using conditional landmarks in patients whose PFS differed by imRECIST versus RECIST v1.1. Results The best overall response was 1% to 2% greater, the disease control rate was 8% to 13% greater, and the median PFS was 0.5 to 1.5 months longer per imRECIST versus RECIST v1.1. Extension of imRECIST PFS versus RECIST v1.1 PFS was associated with longer or similar OS. Patterns of progression analysis revealed that patients who developed NLs without target lesion (TL) progression had a similar or shorter OS compared with patients with RECIST v1.1 TL progression. Patients infrequently experienced a spike pattern (TLs increase, then decrease) but had longer OS than patients without TL reversion. Conclusion Evaluation of PFS and patterns of response and progression revealed that allowance for TL reversion from PD per imRECIST may better identify patients with OS benefit. Progression defined by the isolated appearance of NLs, however, is not associated with longer OS. These results may inform additional modifications to radiographic criteria (including imRECIST) to better reflect efficacy with CIT agents.

中文翻译：

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实体瘤免疫调节反应评估标准 (imRECIST)：评估癌症免疫疗法临床益处的完善指南

目的 用癌症免疫疗法 (CIT) 治疗实体瘤可能会导致非常规反应和总生存 (OS) 益处，而实体瘤反应评估标准 (RECIST) v1.1 无法充分体现这些益处。我们描述了免疫修饰的 RECIST (imRECIST) 标准，旨在更好地捕捉 CIT 反应。患者和方法 评估了来自非小细胞肺癌、转移性尿路上皮癌、肾细胞癌和黑色素瘤临床试验的 Atezolizumab 数据。对 imRECIST 与 RECIST v1.1 的修改包括允许进行性疾病 (PD) 后的最佳总体反应以及每个新病灶 (NL) 和非目标病灶的 PD 定义的变化。如果后续扫描显示疾病控制，imRECIST 无进展生存 (PFS) 不会将初始 PD 计为事件。在因 imRECIST 与 RECIST v1.1 不同 PFS 的患者中，使用条件标志物评估 OS。结果 与 RECIST v1.1 相比，imRECIST 的最佳总体反应提高了 1% 至 2%，疾病控制率提高了 8% 至 13%，中位 PFS 延长了 0.5 至 1.5 个月。imRECIST PFS 与 RECIST v1.1 PFS 的延长与更长或相似的 OS 相关。进展分析模式显示，与 RECIST v1.1 TL 进展的患者相比，发生无靶病变 (TL) 进展的 NL 的患者具有相似或更短的 OS。患者很少经历尖峰模式（TL 增加，然后减少），但比没有 TL 逆转的患者具有更长的 OS。结论 对 PFS 以及反应和进展模式的评估表明，根据 imRECIST 允许从 PD 逆转 TL 可以更好地识别具有 OS 益处的患者。然而，由孤立的 NL 外观定义的进展与更长的 OS 无关。这些结果可能会告知对放射学标准（包括 imRECIST）的额外修改，以更好地反映 CIT 药物的疗效。