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Effectiveness of Lenvatinib Versus Sorafenib for Unresectable Hepatocellular Carcinoma in Patients with Hepatic Decompensation

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Abstract

Background/Aim

Lenvatinib and sorafenib are currently available to treat patients with advanced hepatocellular carcinoma (HCC). However, since the clinical trials evaluating the efficacy of lenvatinib and sorafenib included only patients with Child–Pugh class A, little is known about the effectiveness of the treatments in patients with hepatic decompensation. We compared the effectiveness of lenvatinib and sorafenib in decompensated patients with unresectable HCC.

Methods

Consecutive patients who were classified as Child–Pugh class B or C and received lenvatinib or sorafenib as first-line systemic therapy for unresectable HCC between November 2018 and April 2020 at a tertiary referral center were included in this retrospective study. The primary outcome was overall survival (OS), and the secondary outcomes were progression-free survival (PFS), time-to-progression, best overall tumor response, and safety profiles.

Results

Among 94 patients, 34 received lenvatinib and 60 received sorafenib. The median OS was 4.1 months (95% confidence interval [CI], 2.9–5.2): 4.2 months (95% CI, 2.9–5.3) for lenvatinib and 4.1 months (95% CI, 2.7–6.4) for sorafenib. The treatment regimen was not associated with significant improvement in OS after adjusting for covariables (adjusted hazard ratio [aHR], 0.92; 95% CI, 0.54–1.54; P = 0.74). The treatment regimen was not an independent predictor of PFS (lenvatinib vs. sorafenib; aHR, 0.77; 95% CI, 0.48–1.24; P = 0.28). HRs were maintained even after balancing with the inverse probability treatment weighting method. Objective response rates were 11.8% and 6.7% in patients receiving lenvatinib and sorafenib, respectively (P = 0.45). Ten patients in both groups (five in the lenvatinib group and five in the sorafenib group) underwent dose modification due to adverse events, and significant difference was not observed between the treatment groups (P = 0.49).

Conclusion

The effectiveness of lenvatinib and sorafenib was comparable for the treatment of unresectable HCC in decompensated patients.

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Abbreviations

aHR:

Adjuvant hazard ratio

BCLC:

Barcelona clinic liver cancer

BOR:

Best overall response

CI:

Confidence interval

HCC:

Hepatocellular carcinoma

HR:

Hazard ratio

IPTW:

Inverse probability treatment weighting

IQR:

Interquartile range

mRECIST:

Modified response evaluation criteria in solid tumors

OS:

Overall survival

PFS:

Progression-free survival

TTP:

Time-to-progression

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Funding

This study was supported by research grants from the Liver Research Foundation of Korea as part of Bio Future Strategies Research Project.

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Authors and Affiliations

  1. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea

    Min Kyung Park, Yun Bin Lee, Na Ryung Choi, Minseok Albert Kim, Heejoon Jang, Joon Yeul Nam, Eun Ju Cho, Jeong-Hoon Lee, Su Jong Yu, Yoon Jun Kim & Jung-Hwan Yoon

  2. Department of Biostatistics, College of Medicine, Korea University, Seoul, Korea

    Hyemi Moon

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  1. Min Kyung Park
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  2. Yun Bin Lee
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Contributions

The corresponding author (YBL) had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design were carried out by YBL. Acquisition, analysis, and interpretation of data were done by all authors. Drafting of the manuscript was done by MKP and YBL. Critical revision of the manuscript for important intellectual content was done by YJK and J-HY. Statistical analysis was carried out by MKP, HM, and YBL. Obtained funding was done by YBL. Administrative, technical, or material support was given by NRC, MAK, HJ, JYN, EJC, J-HL, and SJY. Supervision: J-HY.

Corresponding author

Correspondence to Yun Bin Lee.

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Conflict of interest

Dr. Lee YB reports receiving research grant from Samjin Pharmaceuticals and Yuhan Pharmaceuticals; Dr. Lee JH reports receiving research grant from Yuhan Pharmaceuticals and lecture fees from GreenCross Cell, Daewoong Pharmaceuticals, and Gilead Korea; Dr. Yu SJ reports receiving research grants from Yuhan Pharmaceuticals and Daewoong Pharmaceuticals; Dr. Kim YJ reports receiving research grants from AstraZeneca, Boston Scientific, Daewoong Pharmaceuticals, Yuhan Pharmaceuticals, and Samjin Pharmaceuticals, and lecture fees from Bayer HealthCare Pharmaceuticals, Gilead Science, and MSD Korea; Dr. Yoon JH reports receiving research grants from AstraZeneca, Daewoong Pharmaceuticals, and Hanmi Pharmaceuticals. No other potential conflicts of interest relevant to this article are reported.

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Park, M.K., Lee, Y.B., Moon, H. et al. Effectiveness of Lenvatinib Versus Sorafenib for Unresectable Hepatocellular Carcinoma in Patients with Hepatic Decompensation. Dig Dis Sci 67, 4939–4949 (2022). https://doi.org/10.1007/s10620-021-07365-9

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  • DOI: https://doi.org/10.1007/s10620-021-07365-9

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