Lenvatinib Plus Camrelizumab vs. Lenvatinib Monotherapy as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Multicenter Retrospective Cohort Study

Li, Qi; Cao, Mingtao; Yuan, Guosheng; Cheng, Xiangdong; Zang, Meirong; Chen, Ming; Hu, Xiaoyun; Huang, Jing; Li, Rong; Guo, Yabing; Ruan, Jian; Chen, Jinzhang

doi:10.3389/fonc.2022.809709

Cited by 14 publications

(15 citation statements)

References 68 publications

(95 reference statements)

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“…5 To date, the application of first-line TKIs plus PD-1 inhibitors in uHCC patients has received the consensus of the Chinese hepatobiliary clinical experts [6][7][8] and is widely used in clinical practice. Although previous studies have clarified the efficacy and safety of sorafenib or lenvatinib monotherapy and A+T in aging patients with uHCC, [25][26][27][28] and the efficacy and potential downstaging and conversion ability of TKIs plus PD-1 inhibitors have been explored in previous studies, [9][10][11][12][13][14][15][16][17] whether aging patients would benefit from TKIs plus PD-1 inhibitors, especially for PD-1 inhibitors used in patients aged ≥75 years old, remains unclear before our study. In our study, we found median OS to Notes: *Including reactive cutaneous capillary endothelial proliferation (RCCEP) and immune-mediated rash.…”

Section: Discussionmentioning

confidence: 94%

“…The efficacy, potential downstaging, and conversion ability of TKIs plus PD-1 inhibitors was explored in previous studies. [9][10][11][12][13][14][15][16][17] Aging is a major global trend that has raised great concerns worldwide. With the increasing number of aging citizens, the age-adjusted HCC mortality rate has risen, [18][19][20] including in mainland China.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of TKI Plus PD-1 Inhibitors in Elderly uHCC Patients: A Retrospective Study

Chen¹,

Jin²,

Zhao³

et al. 2022

JHC

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To explore the efficacy and safety of sorafenib-or lenvatinib-based combination therapy with PD-1 inhibitors in elderly patients aged ≥75 years with unresectable hepatocellular carcinoma (uHCC). Patients and Methods: Systemic therapy-naïve uHCC patients who received first-line sorafenib-or lenvatinib-based combination therapy with PD-1 inhibitors were continually reviewed. The primary endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) in accordance with the Response Evaluation Criteria in Solid Tumors version 1.1. Adverse events (AEs) and immune-related AEs (irAEs) were also evaluated. Groups and subgroups were separated at the ages of 65 and 75 years and compared with 1:1 matching. Results: Total 169 eligible patients were enrolled, including 24 aged ≥75 years. Median progression-free survival (PFS) and overall survival (OS) in these 24 elderly patients were 4.6 (95% CI: 2.6-6.6) months, and 17.0 (95% CI: 11.2-22.8) months, with 3-, 6-, 12month OS rate at 82.90%, 73.70%, and 57.50%. Age ≥75 years was confirmed to be a risk factor influencing PFS among patients aged ≥65 years. Adverse events (AEs) were recorded in all these 24 elderly patients, with seven patients experiencing immune-mediated AEs (irAEs). Nearly 30% of elderly patients stopped treatment due to AEs (16% of these due to irAEs). No statistical differences were found in all efficacy endpoints at the cutoff age of 65 years. Conclusion: For patients aged ≥75 years, application of PD-1 inhibitors in combination with sorafenib or lenvatinib is promising, but this has to be done with caution and needs to be confirmed by future prospective studies.

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Section: Discussionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of TKI Plus PD-1 Inhibitors in Elderly uHCC Patients: A Retrospective Study

Chen¹,

Jin²,

Zhao³

et al. 2022

JHC

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“…TKIs+ICIs (11)(12)(13)(14)(15)(16)(17) TKIs combined with ICIs are more effective in conversion therapy than monotherapy. In addition, some patients were successfully downstaged, underwent surgical resection, and achieved a complete pathological response (pCR).…”

Section: Bigeminy Therapymentioning

confidence: 99%

“…In a prospective, uncontrolled, open-label study led by Professor Lu Shichun ( 16 ), PD-1 monoclonal antibodies combined with lenvatinib were investigated for the efficacy in the treatment of liver cancer with macrovascular invasion, and the results showed that the ORR was 53.1%(26/49), and the imaging-based conversion rate reached 51.0%, and 15 patients (30.6%) underwent R0 surgical resection. In a retrospective analysis of lenvatinib combined with camrelizumab versus lenvatinib alone, the efficacy in the combination group was improved compared with the single agent group, showing mPFS increasing from 7.5 months to 10.3 months (P<0.05), ORR increasing from 20.5% to 41.7% (P<0.05) ( 17 ). It showed that TKI drugs combined with PD-1 is a more effective conversion regimen.…”

Section: Application Of Drug Therapy In Conversion Therapymentioning

confidence: 99%

Application of systemic treatment in conversion therapy options for liver cancer

et al. 2022

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Radical hepatectomy is the main treatment method to improve the prognosis of patients with intermediate and early-stage liver cancer. Most liver cancer patients in China are in the advanced stage at the initial diagnosis, losing the opportunity for surgical treatment. Therefore, it is essential to down-stage unresectable liver cancer to resectable liver cancer clinically, which is an important way to improve patients’ survival and a hotspot of current clinical research. In recent years, with the increase in effective treatment methods for liver cancer, the resection rate of conversion surgery for unresectable advanced liver cancer has been significantly improved, and a growing number of patients benefit from conversion therapy. This article mainly reviews the connotation of conversion therapy for liver cancer, the patient selection, the selection of conversion strategy, the timing of sequential operations, the scheme and safety, etc.

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“…In RESCUE, the 18-month survival rate of HCC patients reached 58.1% by camrelizumab combination with apatinib (Xu et al, 2021). Although there are no reports of randomized controlled trials of TKI combined with PD-1 inhibitors compared with TKI monotherapy as the first-line treatment for HCC, in retrospective studies, numerous studies have revealed that the combined treatment of OS and PFS is significantly better than TKI monotherapy (Li et al, 2022;Wu et al, 2022). Nevertheless, it is not clear whether TKI combined with PD-1 inhibitors is better than TKI alone in the second-line treatment.…”

Section: Introductionmentioning

confidence: 99%

TKI or TKI combined with PD-1 inhibitors as second-line treatment for HCC patients after sorafenib failure

Jin¹,

Chen²,

Song³

et al. 2022

Front. Pharmacol.

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Background: Tyrosine kinase inhibitors (TKI) in combination with programmed cell death-1 (PD-1) inhibitors become the potential treatment modality for patients undergoing unresectable hepatocellular carcinoma (uHCC) in the first-line setting. However, the efficacy and safety of this combination regimen in patients after sorafenib failure remains unclear.Methods: Participants in this study included patients with uHCC after sorafenib failure who received TKI monotherapy (TKI group) or TKI combined with PD-1 inhibitors therapy (combination group) in our center from July 2018 to July 2021. The overall survival (OS) was used to be the primary efficacy endpoint, while progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) were applied to be secondary endpoints. In addition, the adverse events are recorded and evaluated.Results: Among the 92 patients contained in this work, 50 patients were categorized into the TKI group, while 42 patients were in the combination group. There existed no evident differences between the two groups concerning the ORR (8.0% vs. 9.5%, p = 1.000). However, the DCR in the combined group was better in relative to that in the TKI group (71.4% vs. 50.0%, p = 0.037). In comparison with the TKI group, it was found that the combination group presented notably better median PFS (8.1 months vs. 4.7 months, p = 0.005) and median OS (21.9 months vs. 16.6 months, p = 0.042). According to multivariate analysis, PFS (HR 0.5, 95% CI: 0.3–0.8, p = 0.005) and OS (HR 0.5, 95% CI: 0.3–1.0, p = 0.051) were improved in the combination group in relative to the TKI group after the adjustment for some risk factors. Additionally, the incidence rates of grade ≥1 adverse event in the TKI group and the combination group were 96.0% and 97.6%, respectively. The most normal adverse event in the TKI group was neutropenia (n = 24,48.0%) and the combination group was hypoalbuminemia (n = 23,54.8%). All of these adverse events improved after symptomatic treatment, and no new toxic events were found to occur.Conclusion: TKI combined with PD-1 inhibitors showed better prognosis with manageable toxicity in uHCC patients after sorafenib failure compared with TKI monotherapy.

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Lenvatinib Plus Camrelizumab vs. Lenvatinib Monotherapy as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Multicenter Retrospective Cohort Study

Cited by 14 publications

References 68 publications

Efficacy and Safety of TKI Plus PD-1 Inhibitors in Elderly uHCC Patients: A Retrospective Study

Efficacy and Safety of TKI Plus PD-1 Inhibitors in Elderly uHCC Patients: A Retrospective Study

Application of systemic treatment in conversion therapy options for liver cancer

TKI or TKI combined with PD-1 inhibitors as second-line treatment for HCC patients after sorafenib failure

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