Department of Diagnostic, Molecular and Interventional Radiology, Icahn School of Medicine at Mount Sinai, One Gustave Levy Place, Box 1234, New York, NY, 10029, USA.
BioMedical Engineering and Imaging Institute, Icahn School of Medicine Mount Sinai, New York, NY, USA.
Abdom Radiol (NY). 2022 Mar;47(3):969-980. doi: 10.1007/s00261-021-03386-0. Epub 2021 Dec 29.
PURPOSE: To assess response to programmed death-1 (PD-1) monotherapy (nivolumab) in hepatocellular carcinoma (HCC) patients using RECIST1.1, modified RECIST (mRECIST), and immune RECIST (iRECIST). A secondary objective was to identify clinicolaboratory and imaging variables predictive of progressive disease (PD) and overall survival (OS). METHODS: Patients with HCC treated with nivolumab at a single institution from 5/2016 to 12/2019 with MRI or CT performed ≥ 4 weeks post treatment were retrospectively assessed. Patients who received concurrent locoregional, radiation, or other systemic therapies were excluded. Response was assessed by 2 observers in consensus using RECIST1.1, mRECIST, and iRECIST at 3/6/9/12-month time points. Time to progression (TTP) and OS were recorded. Clinicolaboratory and imaging variables were evaluated as predictors of PD and OS using uni-/multivariable and Cox regression analyses. RESULTS: Fifty-eight patients (42M/16F) were included. 118 target lesions (TL) were identified before treatment. Baseline mean TL size was 49.1 ± 43.5 mm (range 10-189 mm) for RECIST1.1/iRECIST and 46.3 ± 42.3 mm (range 10-189 mm) for mRECIST. Objective response rate (ORR) was 21% for mRECIST/iRECIST/RECIST1.1, with no cases of pseudoprogression. Median OS and median TTP were 717 days and 127 days for RECIST1.1/mRECIST/iRECIST-iUPD (unconfirmed PD). Older age, MELD/Child-Pugh scores, AFP, prior transarterial radioembolization (TARE), and larger TL size were predictive of PD and/or poor OS using mRECIST/iRECIST. The strongest predictor of PD (HR = 2.49, 95% CI 1.29-4.81, p = 0.007) was TARE. The strongest predictor of poor OS was PD by mRECIST/iRECIST at 3 months (HR = 2.26, 95% CI 1.00-5.10, p = 0.05) with borderline significance. CONCLUSION: Our results show ORR of 21%, equivalent for mRECIST, iRECIST, and RECIST1.1 in patients with advanced HCC clinically treated with nivolumab.
目的：使用 RECIST1.1、改良 RECIST（mRECIST）和免疫 RECIST（iRECIST）评估肝细胞癌（HCC）患者对程序性死亡受体-1（PD-1）单药治疗（nivolumab）的反应。次要目标是确定预测疾病进展（PD）和总生存期（OS）的临床实验室和影像学变量。 方法：回顾性评估了 2016 年 5 月至 2019 年 12 月期间在一家机构接受 nivolumab 治疗的 HCC 患者，这些患者在治疗后至少进行了 4 周的 MRI 或 CT 检查。排除了同时接受局部区域、放射或其他全身治疗的患者。在 3/6/9/12 个月的时间点，由 2 名观察者通过共识使用 RECIST1.1、mRECIST 和 iRECIST 对反应进行评估。记录疾病进展时间（TTP）和 OS。使用单变量/多变量和 Cox 回归分析评估临床实验室和影像学变量对 PD 和 OS 的预测作用。 结果：共纳入 58 例患者（42 例男性/16 例女性）。治疗前共确定了 118 个靶病灶（TL）。基线时，RECIST1.1/iRECIST 和 mRECIST 的平均 TL 大小分别为 49.1±43.5mm（范围 10-189mm）和 46.3±42.3mm（范围 10-189mm）。mRECIST/iRECIST/RECIST1.1 的客观缓解率（ORR）为 21%，无假性进展病例。RECIST1.1/mRECIST/iRECIST-iUPD（未确认 PD）的中位 OS 和中位 TTP 分别为 717 天和 127 天。使用 mRECIST/iRECIST，年龄较大、MELD/Child-Pugh 评分、AFP、既往经动脉放射性栓塞术（TARE）和更大的 TL 大小是 PD 和/或不良 OS 的预测因素。TARE 是 PD 的最强预测因子（HR=2.49，95%CI 1.29-4.81，p=0.007）。mRECIST/iRECIST 在 3 个月时 PD 是不良 OS 的最强预测因子（HR=2.26，95%CI 1.00-5.10，p=0.05），具有边缘显著性。 结论：我们的研究结果表明，在接受nivolumab 临床治疗的晚期 HCC 患者中，mRECIST、iRECIST 和 RECIST1.1 的 ORR 相当，为 21%。
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