Real-world efficacy and prognostic factors of lenvatinib plus PD-1 inhibitors in 378 unresectable hepatocellular carcinoma patients

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Abstract

Introduction

Combining lenvatinib with a programmed cell death protein-1 (PD-1) inhibitor has been explored for the treatment of un-resectable hepatocellular carcinoma (uHCC). This study aimed to investigate the real-world efficacy of and prognostic factors for survival associated with lenvatinib plus PD-1 inhibitor treatment in a large cohort of Asian uHCC patients even the global LEAP-002 study failed to achieve the primary endpoints.

Methods

Patients with uHCC treated with lenvatinib and PD-1 inhibitors were included. The primary endpoints were overall survival (OS) and progression-free survival (PFS), and the secondary endpoints were the objective response rate (ORR) and adverse events (AEs). Prognostic factors for survival were also analyzed.

Results

A total of 378 uHCC patients from two medical centers in China were assessed retrospectively. The median patient age was 55 years, and 86.5% of patients were male. Hepatitis B virus (HBV) infection (89.9%) was the dominant etiology of uHCC. The median OS was 17.8 (95% confidence interval (CI) 14.0–21.6) months. The median PFS was 6.9 (95% CI 6.0–7.9) months. The best ORR and disease control rate (DCR) were 19.6% and 73.5%, respectively. In multivariate analysis, Child‒Pugh grade, Barcelona Clinic Liver Cancer stage, Eastern Cooperative Oncology Group performance status score, involved organs, tumor burden score, and combination with local therapy were independent prognostic factors for OS. A total of 100% and 57.9% of patients experienced all-grade and grade 3/4 treatment-emergent AEs, respectively.

Conclusion

This real-world study of lenvatinib plus PD-1 inhibitor treatment demonstrated long survival and considerable ORRs and DCRs in uHCC patients in China. The tolerability of combination therapy was acceptable but must be monitored closely.

Supplementary Information

The online version contains supplementary material available at 10.1007/s12072-022-10480-y.

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Most cited references 44

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No effective systemic therapy exists for patients with advanced hepatocellular carcinoma. A preliminary study suggested that sorafenib, an oral multikinase inhibitor of the vascular endothelial growth factor receptor, the platelet-derived growth factor receptor, and Raf may be effective in hepatocellular carcinoma. In this multicenter, phase 3, double-blind, placebo-controlled trial, we randomly assigned 602 patients with advanced hepatocellular carcinoma who had not received previous systemic treatment to receive either sorafenib (at a dose of 400 mg twice daily) or placebo. Primary outcomes were overall survival and the time to symptomatic progression. Secondary outcomes included the time to radiologic progression and safety. At the second planned interim analysis, 321 deaths had occurred, and the study was stopped. Median overall survival was 10.7 months in the sorafenib group and 7.9 months in the placebo group (hazard ratio in the sorafenib group, 0.69; 95% confidence interval, 0.55 to 0.87; P<0.001). There was no significant difference between the two groups in the median time to symptomatic progression (4.1 months vs. 4.9 months, respectively, P=0.77). The median time to radiologic progression was 5.5 months in the sorafenib group and 2.8 months in the placebo group (P<0.001). Seven patients in the sorafenib group (2%) and two patients in the placebo group (1%) had a partial response; no patients had a complete response. Diarrhea, weight loss, hand-foot skin reaction, and hypophosphatemia were more frequent in the sorafenib group. In patients with advanced hepatocellular carcinoma, median survival and the time to radiologic progression were nearly 3 months longer for patients treated with sorafenib than for those given placebo. (ClinicalTrials.gov number, NCT00105443.) 2008 Massachusetts Medical Society

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Author and article information

Contributors

Yinying Lu: luyinying2017@sina.com

Haitao Zhao:

ORCID: http://orcid.org/0000-0002-3444-8044

zhaoht@pumch.cn

Journal

Journal ID (nlm-ta): Hepatol Int

Journal ID (iso-abbrev): Hepatol Int

Title: Hepatology International

Publisher: Springer India (New Delhi )

ISSN (Print): 1936-0533

ISSN (Electronic): 1936-0541

Publication date (Electronic): 8 February 2023

Publication date PMC-release: 8 February 2023

Pages: 1-11

Affiliations

[1 ]GRID grid.413106.1, ISNI 0000 0000 9889 6335, Department of Liver Surgery, State Key Laboratory of Complex Severe and Rare Diseases, , Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), ; Beijing, 100730 China

[2 ]GRID grid.11135.37, ISNI 0000 0001 2256 9319, Peking University 302 Clinical Medical School, ; Beijing, China

[3 ]GRID grid.414252.4, ISNI 0000 0004 1761 8894, Comprehensive Liver Cancer Center, , The Fifth Medical Center of the PLA General Hospital, ; Beijing, 100039 China

[4 ]GRID grid.411918.4, ISNI 0000 0004 1798 6427, Tianjin Medical University Cancer Institute and Hospital, ; Tianjin, China

[5 ]GRID grid.413458.f, ISNI 0000 0000 9330 9891, Guizhou Medical University, ; Guiyang, China

[6 ]GRID grid.413106.1, ISNI 0000 0000 9889 6335, Department of Radiology, , Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, ; Beijing, China

[7 ]GRID grid.413106.1, ISNI 0000 0000 9889 6335, Center of Radiotherapy, , Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, ; Beijing, China

[8 ]GRID grid.413106.1, ISNI 0000 0000 9889 6335, Departmentof Medical Oncology, , Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, ; Beijing, China

[9 ]GRID grid.413106.1, ISNI 0000 0000 9889 6335, Department of Nuclear Medicine, , Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, ; Beijing, China

[10 ]GRID grid.413106.1, ISNI 0000 0000 9889 6335, Department of Pathology, , Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, ; Beijing, China

[11 ]GRID grid.414252.4, ISNI 0000 0004 1761 8894, Senior Department of Oncology, , The Fifth Medical Center of the PLA General Hospital, ; Beijing, China

[12 ]GRID grid.414008.9, ISNI 0000 0004 1799 4638, Department of Hepatobiliary and Pancreatic Surgery, , The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, ; Zhengzhou, China

[13 ]Hepatobiliary and Pancreatic Surgery, Shenzhen Qianhai Shekou Free Trade Zone Hospital, Shenzhen, China

Author information

Haitao Zhao http://orcid.org/0000-0002-3444-8044

Article

Publisher ID: 10480

DOI: 10.1007/s12072-022-10480-y

PMC ID: 9907200

PubMed ID: 36753026

SO-VID: fde0b292-52f2-40a2-975e-f60f86b2e0b2

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 11 October 2022

Date accepted : 27 December 2022

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100019018, Chinese Academy of Medical Sciences Initiative for Innovative Medicine;

Award ID: 2021-I2M-1-061

Award ID: 2021-1-I2M-003

Award Recipient : Xinting Sang Haitao Zhao

Funded by: CAMS Clinical and Translational Medicine Research Funds

Award ID: 2019XK320006

Award Recipient : Haitao Zhao

Funded by: CSCO-Hengrui Cancer Research Fund

Award ID: Y-HR2019-0239

Award ID: Y-HR2020MS-0414

Award ID: Y-HR2020QN-0415

Award Recipient : Xiaobo Yang Xinting Sang Haitao Zhao

Funded by: CSCO-MSD Cancer Research Fund

Award ID: Y-MSDZD2021-0213

Award Recipient : Haitao Zhao

Funded by: FundRef http://dx.doi.org/10.13039/501100018538, National Ten Thousand Talent Program;

Real-world efficacy and prognostic factors of lenvatinib plus PD-1 inhibitors in 378 unresectable hepatocellular carcinoma patients

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Abstract

Introduction

Methods

Results

Conclusion

Supplementary Information

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Karger: Gastroenterology

Most cited references 44

Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries

Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma

Sorafenib in advanced hepatocellular carcinoma.

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