Qiuhe Wang1, Dongdong Xia1, Wei Bai1, Enxin Wang1, Junhui Sun2, Ming Huang3, Wei Mu4, Guowen Yin5, Hailiang Li6, Hui Zhao7, Jing Li8, Chunqing Zhang9, Xiaoli Zhu10, Jianbing Wu11, Jiaping Li12, Weidong Gong13, Zixiang Li14, Zhengyu Lin15, Xingnan Pan16, Haibin Shi17, Guoliang Shao18, Jueshi Liu19, Shufa Yang20, Yanbo Zheng21, Jian Xu22, Jinlong Song23, Wenhui Wang24, Zhexuan Wang1, Yuelin Zhang2, Rong Ding3, Hui Zhang4, Hui Yu5, Lin Zheng6, Weiwei Gu7, Nan You8, Guangchuan Wang9, Shuai Zhang10, Long Feng11, Lin Liu12, Peng Zhang13, Xueda Li14, Jian Chen15, Tao Xu16, Weizhong Zhou17, Hui Zeng18, Yongjin Zhang19, Wukui Huang20, Wenjin Jiang21, Wen Zhang22, Wenbo Shao23, Lei Li24, Jing Niu1, Jie Yuan1, Xiaomei Li1, Yong Lv1, Kai Li1, Zhanxin Yin1, Jielai Xia25, Daiming Fan26, Guohong Han27. 1. 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. 2. Department of Hepatobiliary and Pancreatic Interventional Cancer, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China. 3. Department of Minimally Invasive International Therapy, The Third Affiliated Hospital of Kunming University, Tumour Hospital of Yunnan Province, Kunming, China. 4. Department of Radiology, The Southwest Hospital, Third Military Medical University, Chongqing, China. 5. Department of Interventional Radiology, Jiangsu Provincial Cancer Hospital, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China. 6. Department of Interventional Radiology, Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China. 7. Department of Interventional Radiology, The Affiliated Hospital of Nantong University, Nantong, China. 8. Department of Hepatobiliary Surgery, Xinqiao Hospital, Third Military Medical University, Chongqing, China. 9. Department of Gastroenterology and Hepatology, Shandong Province Hospital Affiliated to Shandong University, Jinan, China. 10. Department of Interventional Radiology, The First Affiliated Hospital of Soochow University, Suzhou, China. 11. Department of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang, China. 12. Department of Interventional Radiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. 13. Department of Interventional Radiology, Tangdu Hospital, Fourth Military Medical University, Xi'an, China. 14. Interventional Medical Centre of the Affiliated Hospital of Qingdao University, Qingdao, China. 15. Department of Interventional Radiology, First Affiliated Hospital of Fujian Medical University, Fuzhou, China. 16. Clinical Liver Diseases Research Centre, Nanjing Military Command, 180th Hospital of PLA, Quanzhou, China. 17. Department of Interventional Radiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. 18. Department of Radiology, Zhejiang Cancer Hospital, Hangzhou, China. 19. Department of Interventional Radiology and Vascular Surgery, Hunan Provincial People's Hospital, Changsha, China. 20. Department of Interventional Radiology, The Affiliated Tumour Hospital of Xinjiang Medical University, Urumqi, China. 21. Department of Interventional Radiology, Yantai Yuhuangding Hospital, Yantai, China. 22. Department of Medical Imaging, Nanjing General Hospital of the Nanjing Military Command, Nanjing, China. 23. Department of Interventional Therapy, Shandong Tumour Hospital, Jinan, China. 24. Department of Interventional Medicine, The First Affiliated Hospital of Lanzhou University, Lanzhou, China. 25. Department of Health Statistics, Fourth Military Medical University, Xi'an, China. 26. State Key Laboratory of Cancer Biology, National Clinical Research Centre for Digestive Disease and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China. 27. 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. Electronic address: hangh@fmmu.edu.cn.
Abstract
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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. LAY SUMMARY: 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.
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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. LAY SUMMARY: 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.
Authors: Josep M Llovet; Thierry De Baere; Laura Kulik; Philipp K Haber; Tim F Greten; Tim Meyer; Riccardo Lencioni Journal: Nat Rev Gastroenterol Hepatol Date: 2021-01-28 Impact factor: 46.802