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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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.
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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