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
Clinical Trial
. 2018 Oct 10;38(1):61.
doi: 10.1186/s40880-018-0331-y.

Adjuvant transcatheter arterial chemoembolization after curative resection for hepatocellular carcinoma patients with solitary tumor and microvascular invasion: a randomized clinical trial of efficacy and safety

Wei Wei  1   2 , Pei-En Jian  1   2 , Shao-Hua Li  1   2 , Zhi-Xing Guo  1   2 , Yong-Fa Zhang  1   2 , Yi-Hong Ling  1   3 , Xiao-Jun Lin  1   2 , Li Xu  1   2 , Ming Shi  1   2 , Lie Zheng  1   4 , Min-Shan Chen  1   2 , Rong-Ping Guo  5   6
Affiliations
Clinical Trial

Adjuvant transcatheter arterial chemoembolization after curative resection for hepatocellular carcinoma patients with solitary tumor and microvascular invasion: a randomized clinical trial of efficacy and safety

Wei Wei et al. Cancer Commun (Lond). .

Abstract

Background: The optimal strategy for adjuvant therapy after curative resection for hepatocellular carcinoma (HCC) patients with solitary tumor and microvascular invasion (MVI) is controversial. This trial evaluated the efficacy and safety of adjuvant transcatheter arterial chemoembolization (TACE) after hepatectomy versus hepatectomy alone in HCC patients with a solitary tumor ≥ 5 cm and MVI.

Methods: In this randomized, open-labeled, phase III trial, HCC patients with a solitary tumor ≥ 5 cm and MVI were randomly assigned (1:1) to receive either 1-2 cycles of adjuvant TACE after hepatectomy (Hepatectomy-TACE) or hepatectomy alone (Hepatectomy Alone). The primary endpoint was disease-free survival (DFS); the secondary endpoints included overall survival (OS) and adverse events.

Results: Between June 1, 2009, and December 31, 2012, 250 patients were enrolled and randomly assigned to the Hepatectomy-TACE group (n = 125) or the Hepatectomy Alone group (n = 125). Clinicopathological characteristics were balanced between the two groups. The median follow-up time from randomization was 37.5 months [interquartile range 18.3-48.2 months]. The median DFS was significantly longer in the Hepatectomy-TACE group than in the Hepatectomy Alone group [17.45 months (95% confidence interval [CI] 11.99-29.14) vs. 9.27 months (95% CI 6.05-13.70), hazard ratio [HR] = 0.70 (95% CI 0.52-0.95), P = 0.020], respectively. The median OS was also significantly longer in the Hepatectomy-TACE group than in the Hepatectomy Alone group [44.29 months (95% CI 25.99-62.58) vs. 22.37 months (95% CI 10.84-33.91), HR = 0.68 (95% CI 0.48-0.97), P = 0.029]. Treatment-related adverse events were more frequently observed in the Hepatectomy-TACE group, although these were generally mild and manageable. The most common grade 3 or 4 adverse events in both groups were neutropenia and liver dysfunction.

Conclusion: Hepatectomy followed by adjuvant TACE is an appropriate option after radical resection in HCC patients with solitary tumor ≥ 5 cm and MVI, with acceptable toxicity.

Keywords: Adjuvant therapy; Hepatectomy alone; Hepatocellular carcinoma; Microvascular invasion; Solitary tumor; Transcatheter arterial chemoembolization.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
A flow diagram illustrating the overall patient enrollment, randomization, and outcomes of this study
Fig. 2
Fig. 2
Kaplan-Meier estimates illustrating the differences in a disease-free survival (DFS) and b overall survival (OS) of the enrolled patients who underwent radical hepatectomy alone against those who had radical hepatectomy and adjuvant TACE. TACE: transcatheter arterial chemoembolization; HR: hazard ratio; CI: confidence interval
Fig. 3
Fig. 3
The subgroup analysis of the a disease-free survival (DFS) and b overall survival (OS) of enrolled patients who underwent radical hepatectomy only compared to those who had radical hepatectomy and adjuvant TACE. HR: hazard ratio; CI: confidence interval; ECOG PS: Eastern Cooperative Oncology Group performance score. Survival data are presented as median with 95% CI in parentheses
See this image and copyright information in PMC

References

    1. Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015;65(2):87–108. doi: 10.3322/caac.21262. - DOI - PubMed
    1. He MK, Le Y, Li QJ, Yu ZS, Li SH, Wei W, et al. Hepatic artery infusion chemotherapy using mFOLFOX versus transarterial chemoembolization for massive unresectable hepatocellular carcinoma: a prospective non-randomized study. Chin J Cancer. 2017;36(1):83. doi: 10.1186/s40880-017-0251-2. - DOI - PMC - PubMed
    1. Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, et al. Cancer statistics in China, 2015. CA Cancer J Clin. 2016;66(2):115–132. doi: 10.3322/caac.21338. - DOI - PubMed
    1. Llovet JM, Bruix J. Novel advancements in the management of hepatocellular carcinoma in 2008. J Hepatol. 2008;48(Suppl 1):S20–S37. doi: 10.1016/j.jhep.2008.01.022. - DOI - PubMed
    1. de Lope CR, Tremosini S, Forner A, Reig M, Bruix J. Management of HCC. J Hepatol. 2012;56(Suppl 1):S75–S87. doi: 10.1016/S0168-8278(12)60009-9. - DOI - PubMed

Publication types