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Gut 使用不可切除肝转移的放射学标记来预测接受FOLFIRI和贝伐单抗治疗的结直肠癌患者的结局的早期评价。
影响因子:31.793 DOI:10.1136/gutjnl-2018-316407
作者: Dohan A,Gallix B,Guiu B,Le Malicot K,Reinhold C,Soyer P,Bennouna J,Ghiringhelli F,Barbier E,Boige V,Taieb J,Bouché O,François E,Phelip JM,Borel C,Faroux R,Seitz JF,Jacquot S,Ben Abdelghani M,Khemissa-Akouz F,Genet D,Jouve JL,Rinaldi Y,Desseigne F,Texereau P,Suc E,Lepage C,Aparicio T,Hoeffel C,PRODIGE 9 Investigators and PRODIGE 20 Investigators. 发表时间:2020-07-10 10:03:24
keywords: Dohan AGallix BGuiu BLe Malicot KReinhold CSoyer PBennouna JGhiringhelli FBarbier EBoige VTaieb JBouché OFrançois EPhelip JMBorel CFaroux RSeitz JFJacquot SBen Abdelghani MKhemissa-Akouz FGenet DJouve JLRinaldi YDesseigne FTexereau PSuc ELepage CAparicio THoeffel CPRODIGE 9 Investigators and PRODIGE 20 Investigators.
关键词: 化疗 临床决策 结直肠癌 结直肠转移 计算机图像分析
Abstract
PURPOSE:The objective of this study was to build and validate a radiomic signature to predict early a poor outcome using baseline and 2-month evaluation CT and to compare it to the RECIST1·1 and morphological criteria defined by changes in homogeneity and borders. METHODS:This study is an ancillary study from the PRODIGE-9 multicentre prospective study for which 491 patients with metastatic colorectal cancer (mCRC) treated by 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) and bevacizumab had been analysed. In 230 patients, computed texture analysis was performed on the dominant liver lesion (DLL) at baseline and 2 months after chemotherapy. RECIST1·1 evaluation was performed at 6 months. A radiomic signature (Survival PrEdiction in patients treated by FOLFIRI and bevacizumab for mCRC using contrast-enhanced CT TextuRe Analysis (SPECTRA) Score) combining the significant predictive features was built using multivariable Cox analysis in 120 patients, then locked, and validated in 110 patients. Overall survival (OS) was estimated with the Kaplan-Meier method and compared between groups with the logrank test. An external validation was performed in another cohort of 40 patients from the PRODIGE 20 Trial. RESULTS:In the training cohort, the significant predictive features for OS were: decrease in sum of the target liver lesions (STL), (adjusted hasard-ratio(aHR)=13·7, p=1·93×10-7), decrease in kurtosis (ssf=4) (aHR=1·08, p=0·001) and high baseline density of DLL, (aHR=0·98, p<0·001). Patients with a SPECTRA Score >0·02 had a lower OS in the training cohort (p<0·0001), in the validation cohort (p<0·0008) and in the external validation cohort (p=0·0027). SPECTRA Score at 2 months had the same prognostic value as RECIST at 6 months, while non-response according to RECIST1·1 at 2 months was not associated with a lower OS in the validation cohort (p=0·238). Morphological response was not associated with OS (p=0·41). CONCLUSION:A radiomic signature (combining decrease in STL, density and computed texture analysis of the DLL) at baseline and 2-month CT was able to predict OS, and identify good responders better than RECIST1.1 criteria in patients with mCRC treated by FOLFIRI and bevacizumab as a first-line treatment. This tool should now be validated by further prospective studies. TRIAL REGISTRATION:Clinicaltrial.gov identifier of the PRODIGE 9 study: NCT00952029.Clinicaltrial.gov identifier of the PRODIGE 20 study: NCT01900717.
摘 要
用途: 本研究的目的是建立和验证使用基线和 2 个月评估CT预测早期不良结局的放射学特征,并将其与RECIST1 · 1 和定义的形态学标准进行比较。通过同质性和边界的变化。 方法: 本研究是一项来自PRODIGE-9 多中心前瞻性研究的辅助研究,其中 491 例转移性结直肠癌 (mCRC) 患者接受 5-氟尿嘧啶、亚叶酸钙和伊立替康 (FOLFIRI) 治疗。并对贝伐单抗进行了分析。在 230 例患者中,对基线和化疗后 2 个月的显性肝脏病变 (DLL) 进行了计算机纹理分析。6 个月时进行RECIST1 · 1 评价。影像组学特征 (使用对比增强CT纹理分析 (SPECTRA) 评分对接受FOLFIRI和贝伐单抗治疗的mCRC患者进行生存预测) 结合显著的预测特征,在 120 例患者中使用多变量Cox分析建立,然后锁定,并在 110 例患者中进行验证。用Kaplan-Meier法估计总生存期 (OS),并用logrank检验进行组间比较。在来自PRODIGE 20 试验的另一组 40 例患者中进行了外部验证。 结果: 在训练队列中,OS的显著预测特征为: 目标肝脏病变 (STL) 总和减少,(校正hasard-ratio(aHR)= 13 · 7,p = 1 · 93 × 10-7) 、峰度降低 (ssf = 4) (aHR = 1 · 08,p = 0 · 001) 和DLL基线密度高,(aHR = 0 · 98,p<0 · 001)。SPECTRA评分> 0 · 02 的患者在训练队列中OS较低 (p<0 · 0001),在验证队列中 (p<0 · 0008) 和在外部验证队列 (p = 0 · 0027)。2 个月时的光谱评分与 6 个月时的RECIST具有相同的预后价值,而根据RECIST1 · 1 在 2 个月时的无应答与验证队列中较低的OS无关 (p = 0 · 238)。形态学反应与OS无关 (p = 0 · 41)。 结论: 基线和 2 个月CT的放射学特征 (结合STL的减少、密度和DLL的计算纹理分析) 能够预测OS,并在接受FOLFIRI和贝伐单抗作为一线治疗的mCRC患者中确定优于RECIST1.1 标准的良好应答者。这个工具现在应该通过进一步的前瞻性研究来验证。 试验注册: Clinicaltrial.gov PRODIGE 9 研究的标识符: NCT00952029.Clinicaltrial。PRODIGE 20 研究的gov标识符: nct01900717。
期刊介绍
英文简介 : Gut, a leading international journal in gastroenterology has an established reputation for publishing first class clinical research of the alimentary tract, the liver, biliary tree and pancreas.
中文简介 : (来自Google、百度翻译) 《肠道》是国际领先的胃肠病学杂志,以发表消化道、肝脏、胆道和胰腺的一流临床研究而享有盛誉。
CIRCULATION RESEARCH 期刊中科院评价数据
新中科院分区
大类(学科) 小类(学科) 学科排名
医学

GASTROENTEROLOGY & HEPATOLOGY (胃肠肝病学)

3/80
新发布的期刊年发文量
年度总发文量 年度论文发表量 年度综述发表量
195 188 7

总被引频次 :43400

特征因子 : 0.068140

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