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用于评估转移性结直肠癌肝转移患者治疗反应的放射组学参数:来自 CAVE-GOIM mCRC 二期试验的结果。

Radiomic Parameters for the Evaluation of Response to Treatment in Metastatic Colorectal Cancer Patients with Liver Metastasis: Findings from the CAVE-GOIM mCRC Phase 2 Trial.

机构信息

Department of Precision Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy.

Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, IEO, IRCCS, Milan, Italy.

出版信息

Clin Drug Investig. 2024 Jul;44(7):541-548. doi: 10.1007/s40261-024-01372-0. Epub 2024 Jun 17.

Abstract

BACKGROUND

CAVE is a single arm, Phase 2 trial, that demonstrated anti-tumor activity of cetuximab rechallenge plus avelumab in patients with RAS wild type (wt) metastatic colorectal cancer (mCRC).

OBJECTIVE

We conducted a post hoc analysis to identify potential radiomic biomarkers for patients with CRC liver metastasis (LM).

PATIENTS AND METHODS

Patients with LM that could be measured by enhanced contrast phase computed tomography (CT) imaging at baseline and at first response evaluation were included. Multiple texture parameters were extracted with the LifeX Software. Delta-texture (D-TA) variations were calculated by comparing data at baseline and after treatment.

RESULTS

Overall, 55/77 patients (71%) had LM; 39 met the inclusion criteria for the current analysis. The D-TA parameters that significantly correlated at univariate analysis with median progression-free survival (mPFS) were Entropy (p = 0.021), Homogeneity (p < 0.001) and Dissimilarity (p = 0.002). At multivariate analysis, only Homogeneity resulted significant for PFS (p = 0.001). Patients (19/39, 48.7%) with reduction of Homogeneity experienced better mPFS (4.6 vs 2.9 months; HR 0.45; 95% CI 0.23-0.88; p = 0.021) and median overall survival (mOS) (17.3 vs 6.8 months; HR 0.40, 95% CI 0.21-0.80; p = 0.010). A trend to better mPFS, was also observed in patients with RAS/BRAF wt circulating tumor DNA and reduction of Homogeneity. Overall survival was significantly better in this subgroup of patients with low Homogeneity: mOS was 17.8 (95% CI 15.5-20.2) versus 6.8 months (95% CI 3.6-10.0) (HR 0.34, 95% CI 0.14-0.81; p = 0.016).

CONCLUSION

Reduction in the D-TA parameter Homogeneity by radiomic analysis correlates with improved outcomes in patients with LM receiving cetuximab rechallenge plus avelumab therapy. Larger prospective studies are needed to validate and confirm these findings.

摘要

背景

CAVE 是一项单臂、2 期临床试验,结果表明在 RAS 野生型(wt)转移性结直肠癌(mCRC)患者中,西妥昔单抗重挑战联合avelumab 具有抗肿瘤活性。

目的

我们进行了一项事后分析,以确定 CRC 肝转移(LM)患者的潜在放射组学生物标志物。

患者和方法

纳入基线和首次反应评估时可通过增强对比期 CT 成像测量的 LM 患者。使用 LifeX 软件提取多个纹理参数。通过比较基线和治疗后的数据计算 Delta-texture(D-TA)变化。

结果

总体而言,77 例患者中有 55 例(71%)患有 LM;39 例符合当前分析的纳入标准。在单变量分析中,与中位无进展生存期(mPFS)显著相关的 D-TA 参数是熵(p = 0.021)、同质性(p < 0.001)和差异性(p = 0.002)。多变量分析中,只有同质性对 PFS 有意义(p = 0.001)。D-TA 同质性降低的患者(19/39,48.7%)mPFS 更好(4.6 个月 vs 2.9 个月;HR 0.45;95%CI 0.23-0.88;p = 0.021)和中位总生存期(mOS)(17.3 个月 vs 6.8 个月;HR 0.40,95%CI 0.21-0.80;p = 0.010)。在 D-TA 同质性降低且 RAS/BRAF wt 循环肿瘤 DNA 的患者中,mPFS 也观察到改善的趋势。在 D-TA 同质性低的患者中,OS 显著更好:mOS 为 17.8(95%CI 15.5-20.2)个月 vs 6.8(95%CI 3.6-10.0)个月(HR 0.34,95%CI 0.14-0.81;p = 0.016)。

结论

通过放射组学分析,D-TA 参数同质性的降低与接受 cetuximab 重挑战联合avelumab 治疗的 LM 患者的改善结局相关。需要更大规模的前瞻性研究来验证和确认这些发现。

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