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Lenvatinib with or without immune checkpoint inhibitors for patients with unresectable hepatocellular carcinoma in real-world clinical practice

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Abstract

Background

Lenvatinib is regarded as the first-line therapy for patients with unresectable hepatocellular carcinoma (HCC). This study assessed the efficacy and safety of lenvatinib with or without immune checkpoint inhibitors (ICIs) in patients with unresectable HCC.

Methods

In this multicentric retrospective study, patients with unresectable HCC who treated with lenvatinib with or without ICIs would be enrolled. Overall survival, progression-free survival, objective response rate, and disease control rate were calculated to assess the antitumor response.

Results

Between January 2019 and August 2020, 65 patients received lenvatinib plus ICIs while other 45 patients received lenvatinib. The baseline characteristics were comparable between the two groups. Lenvatinib plus ICIs provided significantly higher overall survival (hazard ratio = 0.47, 95% CI 0.26–0.85; p = 0.013) and progression-free survival (hazard ratio = 0.35, 95% CI 0.20–0.63; p < 0.001) than lenvatinib monotherapy. Moreover, patients with lenvatinib plus ICIs had significantly higher objective response rate (41.5% vs 20.0%, p = 0.023) and disease control rate (72.3% vs 46.7%, p = 0.009) per RECIST v1.1 than those with lenvatinib. No treatment-related deaths were observed. Grade 3 or greater adverse events occurring in 10% or more of patients in either treatment group were hypertension [13 (20.0%) of 65 patients treated with lenvatinib plus ICIs vs 8 (17.8%) of 45 patients treated with lenvatinib], and palmar–plantar erythrodysesthesia [seven (10.8%) vs two (4.4%)].

Conclusions

In this real-world study, lenvatinib combined with ICIs showed significantly promising efficacy and manageable safety than lenvatinib alone in patients with unresectable HCC.

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Data availability

The data underlying this article will be shared on reasonable request to the corresponding author.

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Funding

J.-H.Z is in part supported by the National Natural Science Foundation of China (82060510), “Guangxi BaGui Scholars” Special Fund (2019AQ20), the Natural Science Foundation of Guangxi Province (2018GXNSFBA138018 and 2020GXNSFAA159022), the Graduate Course Construction Project of Guangxi Medical University (YJSA2017014), and the Guangxi Undergraduate Training Program for Innovation and Entrepreneurship (202110598178 and 202110598073). B.-D.X is in part supported by the “High-level innovation team and outstanding scholar program in Guangxi Colleges and Universities.”

Author information

Authors and Affiliations

  1. Hepatobiliary Surgery Department, Guangxi Liver Cancer Diagnosis and Treatment Engineering and Technology Research Center, Guangxi Medical University Cancer Hospital, Nanning, 530021, China

    Kang Chen, Lei Liu, Zhu-Jian Deng, Le Li, Xiu-Mei Liang, Lu-Nan Qi, Zhi-Ming Zhang, Wen-Feng Gong, Shan Huang, Wei-Ping Yuan, Liang Ma, Bang-De Xiang, Le-Qun Li & Jian-Hong Zhong

  2. Radiology Department, Guangxi Medical University Cancer Hospital, Nanning, China

    Wei Wei

  3. Hepatobiliary Surgery Department, The Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, China

    Lei Liu

  4. Ultrosound Department, Guangxi Medical University Cancer Hospital, Nanning, China

    Ping-Ping Guo

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  1. Kang Chen
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Contributions

J.-H.Z conceived the study; all authors participated in the acquisition of the data; K.C and J.-H.Z analyzed data; K.C, W.W and J.-H.Z assessed tumor response; J.-H.Z drafted and revised the manuscript; all authors have read and approved the final version to be published.

Corresponding authors

Correspondence to Le-Qun Li or Jian-Hong Zhong.

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Conflict of interest

The authors have no conflict of interest to declare that are relevant to the content of this article.

Ethical statement

All the procedures were carried out in accordance with the 1975 Declaration of Helsinki. This study was approved by the institutional review board of Guangxi Medical University Cancer Hospital (number LW2021026) and the Fourth Affiliated Hospital of Guangxi Medical University (number LW2021003).

Consent to participate

Patient consent was waived due to the retrospective nature of the study.

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Kang Chen, Wei Wei, Lei Liu these authors contributed equally to this work.

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Chen, K., Wei, W., Liu, L. et al. Lenvatinib with or without immune checkpoint inhibitors for patients with unresectable hepatocellular carcinoma in real-world clinical practice. Cancer Immunol Immunother 71, 1063–1074 (2022). https://doi.org/10.1007/s00262-021-03060-w

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