Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Jul 22;10(6):629-640.
doi: 10.1159/000517393. eCollection 2021 Nov.

Redefining Tumor Burden in Patients with Intermediate-Stage Hepatocellular Carcinoma: The Seven-Eleven Criteria

Ya-Wen Hung  1 , I-Cheng Lee  1   2 , Chen-Ta Chi  1   2   3 , Rheun-Chuan Lee  4 , Chien-An Liu  4 , Nai-Chi Chiu  4 , Hsuen-En Hwang  4 , Yee Chao  5 , Ming-Chih Hou  1   2 , Yi-Hsiang Huang  1   2   3
Affiliations

Redefining Tumor Burden in Patients with Intermediate-Stage Hepatocellular Carcinoma: The Seven-Eleven Criteria

Ya-Wen Hung et al. Liver Cancer. .

Abstract

Background and aims: For patients with intermediate-stage hepatocellular carcinoma (HCC), the definition of high tumor burden remains controversial. This study aimed to compare the prognostic value of different criteria of tumor burden in patients with intermediate-stage HCC undergoing transarterial chemoembolization (TACE).

Methods: From 2007 to 2019, 632 treatment-naive patients with intermediate-stage HCC undergoing TACE were retrospectively enrolled. We compared different criteria of tumor burden in discriminating radiologic response and survival, including up-to-7, up-to-11, 5-7, 7 lesions criteria, and newly proposed 7-11 criteria.

Results: The proportions of patients classified as high tumor burden were varied by different criteria. Among the 5 criteria, 7-11 criteria have the best performance to discriminate complete response (CR) and overall survival (OS) after TACE. In patients with low, intermediate, and high tumor burden classified by 7-11 criteria, the CR rate was 21, 12, and 2.5%, respectively (p < 0.001), and the median OS was 33.1, 22.3, and 11.9 months, respectively (p < 0.001). By multivariate analysis, 7-11 criteria were significantly associated with CR (intermediate vs. high burden, odds ratio = 4.617, p = 0.002; low vs. high burden, odds ratio = 8.675, p < 0.001) and OS (intermediate vs. high burden, hazard ratio = 0.650, p < 0.001; low vs. high burden, hazard ratio = 0.520, p < 0.001). Seven to 11 criteria also had the lowest corrected Akaike information criteria, highest homogeneity value, and highest area under the receiver operating characteristic curve in predicting 1-, 2-, and 3-year mortality among all criteria.

Conclusion: Conventional definitions of tumor burden were not optimal for patients with intermediate HCC. The new 7-11 criteria had the best discriminative power in predicting radiologic response and survival in patients with intermediate-stage HCC undergoing TACE.

Keywords: Hepatocellular carcinoma; Transarterial chemoembolization; Tumor burden.

PubMed Disclaimer

Conflict of interest statement

Y.-H.H. has received research grants from Gilead Sciences and Bristol-Meyers Squibb and honoraria from Abbvie, Gilead Sciences, Bristol-Meyers Squibb, Ono Pharmaceutical, Merck Sharp & Dohme, Eisai, Eli Lilly, Ipsen, and Roche and has served in an advisory role for Abbvie, Gilead Sciences, Bristol-Meyers Squibb, Ono Pharmaceuticals, Eisai, Eli Lilly, Ipsen, Merck Sharp & Dohme, and Roche. Other authors declare no conflicts of interest.

Figures

Fig. 1
Fig. 1
Comparison of different criteria of high tumor burden and distribution of radiologic response after TACE. a Up-to-7 criteria. b Up-to-11 criteria. c 5–7 criteria. d Seven lesions criteria. e 7–11 criteria. CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; TACE, transarterial chemoembolization.
Fig. 2
Fig. 2
Kaplan-Meier curves of RFS after complete response and OS of HCC patients undergoing TACE. a RFS stratified by 7–11 criteria. b OS stratified by 7–11 criteria. HCC, hepatocellular carcinoma; TACE, transarterial chemoembolization; OS, overall survival; RFS, recurrence-free survival.
See this image and copyright information in PMC

References

    1. Arnold M, Abnet CC, Neale RE, Vignat J, Giovannucci EL, McGlynn KA, et al. Global burden of 5 major types of gastrointestinal cancer. Gastroenterology. 2020;159((1)):335–49.e15. - PMC - PubMed
    1. European Association for the Study of the Liver EASL clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2018;69((1)):182–236. - PubMed
    1. Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, et al. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018;67((1)):358–80. - PubMed
    1. Omata M, Cheng AL, Kokudo N, Kudo M, Lee JM, Jia J, et al. Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update. Hepatol Int. 2017;11((4)):317–70. - PMC - PubMed
    1. Piscaglia F, Ogasawara S. Patient selection for transarterial chemoembolization in hepatocellular carcinoma: importance of benefit/risk assessment. Liver Cancer. 2018;7((1)):104–19. - PMC - PubMed