Vincenzi Bruno, Di Maio Massimo, Silletta Marianna, D'Onofrio Loretta, Spoto Chiara, Piccirillo Maria Carmela, Daniele Gennaro, Comito Francesca, Maci Eliana, Bronte Giuseppe, Russo Antonio, Santini Daniele, Perrone Francesco, Tonini Giuseppe
Medical Oncology, University Campus Bio-Medico, Rome, Italy.
Clinical Trials Unit, National Cancer Institute, Naples, Italy; Department of Oncology, University of Turin, San Luigi Gonzaga Hospital, Regione Gonzole 10, 10043 Orbassano (TO), Italy.
PLoS One. 2015 Jul 31;10(7):e0133488. doi: 10.1371/journal.pone.0133488. eCollection 2015.
The European Association for the Study of the Liver (EASL) criteria and the modified Response Evaluation Criteria in Solid Tumors (mRECIST) are currently adopted to evaluate radiological response in patients affected by HCC and treated with loco-regional procedures. Several studies explored the validity of these measurements in predicting survival but definitive data are still lacking.
To conduct a systematic review of studies exploring mRECIST and EASL criteria usefulness in predictive radiological response in HCC undergoing loco-regional therapies and their validity in predicting survival.
A comprehensive search of the literature was performed in electronic databases EMBASE, MEDLINE, COCHRANE LIBRARY, ASCO conferences and EASL conferences up to June 10, 2014. Our overall search strategy included terms for HCC, mRECIST, and EASL. Loco-regional procedures included transarterial embolization (TAE), transarterial chemoembolization (TACE) and cryoablation. Inter-method agreement between EASL and mRECIST was assessed using the k coefficient. For each criteria, overall survival was described in responders vs. non-responders patients, considering all target lesions response.
Among 18 initially found publications, 7 reports including 1357 patients were considered eligible. All studies were published as full-text articles. Proportion of responders according to mRECIST and EASL criteria was 62.4% and 61.3%, respectively. In the pooled population, 1286 agreements were observed between the two methods (kappa statistics 0.928, 95% confidence interval 0.912-0.944). HR for overall survival (responders versus non responders) according to mRECIST and EASL was 0.39 (95% confidence interval 0.26-0.61, p<0.0001) and 0.38 (95% confidence interval 0.24-0.61, p<0.0001), respectively.
In this literature-based meta-analysis, mRECIST and EASL criteria showed very good concordance in HCC patients undergoing loco-regional treatments. Objective response according to both criteria confirms a strong prognostic value in terms of overall survival. This prognostic value appears to be very similar between the two criteria.
目前采用欧洲肝脏研究协会(EASL)标准和改良的实体瘤疗效评价标准(mRECIST)来评估接受局部区域治疗的肝癌患者的放射学反应。多项研究探讨了这些测量方法在预测生存方面的有效性,但仍缺乏确凿的数据。
对探索mRECIST和EASL标准在接受局部区域治疗的肝癌患者的预测放射学反应中的有用性及其在预测生存方面的有效性的研究进行系统评价。
截至2014年6月10日,在电子数据库EMBASE、MEDLINE、Cochrane图书馆、美国临床肿瘤学会会议和欧洲肝脏研究协会会议上对文献进行了全面检索。我们的总体检索策略包括肝癌、mRECIST和EASL的检索词。局部区域治疗包括经动脉栓塞(TAE)、经动脉化疗栓塞(TACE)和冷冻消融。使用k系数评估EASL和mRECIST之间的方法间一致性。对于每个标准,在考虑所有靶病变反应的情况下,描述了反应者与无反应者患者的总生存期。
在最初找到的18篇出版物中,7篇报告(包括1357例患者)被认为符合条件。所有研究均以全文发表。根据mRECIST和EASL标准,反应者的比例分别为62.4%和61.3%。在汇总人群中,两种方法之间观察到1286例一致性(kappa统计量0.928,95%置信区间0.912 - 0.944)。根据mRECIST和EASL,总生存期(反应者与无反应者)的风险比分别为(0.39)(95%置信区间(0.26 - 0.61),(p<0.0001))和(0.38)(95%置信区间(0.24 - 0.61),(p<0.0001))。
在这项基于文献的荟萃分析中,mRECIST和EASL标准在接受局部区域治疗的肝癌患者中显示出非常好的一致性。根据这两个标准的客观反应在总生存期方面证实了很强的预后价值。这两个标准之间的预后价值似乎非常相似。