索拉非尼治疗肝细胞癌患者中，根据 mRECIST 早期肿瘤退缩和反应评估预测总生存期。

Early tumor shrinkage and response assessment according to mRECIST predict overall survival in hepatocellular carcinoma patients under sorafenib.

机构信息

Department of Radiology, University Hospital, LMU Munich, Marchioninistrasse 15, 81377, Munich, Germany.

Department of Internal Medicine and Gastroenterology, Niels-Stensen-Kliniken Marienhospital, Osnabrück, Germany.

出版信息

Cancer Imaging. 2022 Jan 4;22(1):1. doi: 10.1186/s40644-021-00439-x.

DOI:10.1186/s40644-021-00439-x

PMID:34983668

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8725442/

Abstract

BACKGROUND

The aim of this study was to explore the relationship between follow-up imaging characteristics and overall survival (OS) in advanced hepatocellular carcinoma (HCC) patients under sorafenib treatment.

METHODS

Associations between OS and objective response (OR) by mRECIST or early tumor shrinkage (ETS; ≥20% reduction in enhancing tumor diameter at the first follow-up imaging) were analyzed in HCC patients treated with sorafenib within a multicenter phase II trial (SORAMIC). 115 patients were included in this substudy. The relationship between survival and OR or ETS were explored. Landmark analyses were performed according to OR at fixed time points. Cox proportional hazards models with OR and ETS as a time-dependent covariate were used to compare survival with factors known to influence OS.

RESULTS

The OR rate was 29.5%. Responders had significantly better OS than non-responders (median 30.3 vs. 11.4 months; HR, 0.38 [95% CI, 0.22-0.63], p < 0.001), and longer progression-free survival (PFS; median 10.1 vs. 4.3 months, p = 0.015). Patients with ETS ≥ 20% had longer OS (median 22.1 vs. 11.4 months, p = 0.002) and PFS (median 8.0 vs. 4.3 months, p = 0.034) than patients with ETS < 20%. Besides OR and ETS, male gender, lower bilirubin and ALBI grade were associated with improved OS in univariate analysis. Separate models of multivariable analysis confirmed OR and ETS as independent predictors of OS.

CONCLUSION

OR according to mRECIST and ETS in patients receiving sorafenib treatment are independent prognostic factors for OS. These parameters can be used for assessment of treatment benefit and optimal treatment sequencing in patients with advanced HCC.

摘要

背景

本研究旨在探讨索拉非尼治疗晚期肝细胞癌（HCC）患者的随访影像学特征与总生存期（OS）之间的关系。

方法

在一项多中心 II 期试验（SORAMIC）中，分析了接受索拉非尼治疗的 HCC 患者的 OS 与 mRECIST 客观缓解（OR）或早期肿瘤退缩（ETS；首次随访影像学时增强肿瘤直径至少减少 20%）之间的关系。该亚研究共纳入 115 例患者。探索了生存与 OR 或 ETS 的关系。根据 OR 在固定时间点进行了 landmark 分析。使用 OR 和 ETS 作为时变协变量的 Cox 比例风险模型，比较了与影响 OS 的因素相关的生存情况。

结果

OR 率为 29.5%。与无反应者相比，有反应者的 OS 明显更好（中位 30.3 与 11.4 个月；HR，0.38 [95% CI，0.22-0.63]，p<0.001），且无进展生存期（PFS；中位 10.1 与 4.3 个月，p=0.015）更长。ETs≥20%的患者 OS （中位 22.1 与 11.4 个月，p=0.002）和 PFS （中位 8.0 与 4.3 个月，p=0.034）均长于 ETS<20%的患者。除了 OR 和 ETS，在单变量分析中，男性、较低的胆红素和 ALBI 分级与 OS 改善相关。多变量分析的独立模型证实了 OR 和 ETS 是 OS 的独立预测因素。