Department of Liver Disease and Digestive Interventional Radiology, National Clinical Research Centre for Digestive Disease and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.
Department of Hepatobiliary and Pancreatic Interventional Cancer, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
J Hepatol. 2019 May;70(5):893-903. doi: 10.1016/j.jhep.2019.01.013. Epub 2019 Jan 18.
BACKGROUND & AIMS: Previous prognostic scores for transarterial chemoembolization (TACE) were mainly derived from real-world settings, which are beyond guideline recommendations. A robust model for outcome prediction and risk stratification of recommended TACE candidates is lacking. We aimed to develop an easy-to-use tool specifically for these patients.
Between January 2010 and May 2016, 1,604 treatment-naïve patients with unresectable hepatocellular carcinoma (HCC), Child-Pugh A5-B7 and performance status 0 undergoing TACE were included from 24 tertiary centres. Patients were randomly divided into training (n = 807) and validation (n = 797) cohorts. A prognostic model was developed and subsequently validated. Predictive performance and discrimination were further evaluated and compared with other prognostic models.
The final presentation of the model was "linear predictor = largest tumour diameter (cm) + tumour number", which consistently outperformed other currently available models in both training and validation datasets as well as in different subgroups. The thirtieth percentile and the third quartile of the linear predictor, namely 6 and 12, were further selected as cut-off values, leading to the "six-and-twelve" score which could divide patients into 3 strata with the sum of tumour size and number ≤6, >6 but ≤12, and >12 presenting significantly different median survival of 49.1 (95% CI 43.7-59.4) months, 32.0 (95% CI 29.9-37.5) months, and 15.8 (95% CI 14.1-17.7) months, respectively.
The six-and-twelve score may prove an easy-to-use tool to stratify recommended TACE candidates (Barcelona Clinic Liver Cancer stage-A/B) and predict individual survival with favourable performance and discrimination. Moreover, the score could stratify these patients in clinical practice as well as help design clinical trials with comparable criteria involving these patients. Further external validation of the score is required.
There is currently no prognostic model specifically developed for recommended or ideal transarterial chemoembolization (TACE) candidates with hepatocellular carcinoma, despite these patients being frequently identified as the best target population in pivotal randomized controlled trials. The six-and-twelve score provides patient survival prediction, especially in ideal candidates of TACE, outperforming other currently available models in both training and validation sets, as well as different subgroups. With cut-off values of 6 and 12, the score can stratify ideal TACE candidates into 3 strata with significantly different outcomes and may shed light on risk stratification of these patients in clinical practice as well as in clinical trials.
先前的经动脉化疗栓塞（TACE）预后评分主要来自于超出指南推荐的真实世界环境。缺乏用于推荐 TACE 候选者的结果预测和风险分层的稳健模型。我们旨在为这些患者专门开发一种易于使用的工具。
2010 年 1 月至 2016 年 5 月，来自 24 个三级中心的 1604 名未经治疗的不可切除肝细胞癌（HCC）、Child-Pugh A5-B7 和体能状态 0 且正在接受 TACE 的患者被纳入研究。患者被随机分为训练（n=807）和验证（n=797）队列。开发了一个预后模型，然后进行验证。进一步评估和比较了预测性能和区分度，并与其他预后模型进行了比较。
该模型的最终表现形式为“线性预测因子=最大肿瘤直径（cm）+肿瘤数量”，在训练和验证数据集以及不同亚组中，该模型始终优于其他现有模型。线性预测因子的第三十分位数和第三四分位数，即 6 和 12，被进一步选为截止值，从而得到“六到十二”评分，可以将患者分为 3 个亚组，肿瘤大小和数量总和≤6、>6 但≤12、>12，中位生存时间分别为 49.1（95%CI 43.7-59.4）个月、32.0（95%CI 29.9-37.5）个月和 15.8（95%CI 14.1-17.7）个月，差异具有统计学意义。
“六到十二”评分可能是一种简单易用的工具，可用于分层推荐的 TACE 候选者（巴塞罗那临床肝癌分期 A/B），并具有良好的性能和区分度来预测个体生存。此外，该评分可以在临床实践中对这些患者进行分层，并有助于设计涉及这些患者的具有可比标准的临床试验。需要进一步对该评分进行外部验证。
尽管这些患者在关键随机对照试验中经常被确定为最佳目标人群，但目前尚无专门为推荐或理想 TACE 候选者（HCC）开发的预后模型，这些患者的数量正在增加。“六到十二”评分可提供患者生存预测，尤其是在理想的 TACE 候选者中，在训练集和验证集中以及不同亚组中均优于其他现有模型。通过 6 和 12 的截止值，该评分可以将理想的 TACE 候选者分为 3 个亚组，其结果具有显著差异，这可能为这些患者在临床实践以及临床试验中的风险分层提供思路。
