Transarterial chemoembolization plus a PD‐1 inhibitor with or without lenvatinib for intermediate‐stage hepatocellular carcinoma

Xiang, Yan-Jun; Wang, Kang; Yu, Hongming; Li, Xiaowei; Cheng, Yuqiang; Feng, Jin-Kai; Bo, Meng-Han; Qin, Yingyi; Zheng, Yun; Shan, Yunfeng; Zhou, Liping; Zhai, Jian; Cheng, Shu‐Qun

doi:10.1111/hepr.13773

Cited by 26 publications

(20 citation statements)

References 51 publications

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“…Moreover, we found that combination locoregional therapy was an independent factor for both better PFS and OS. This result was consistent with the results of previous studies that found that adding locoregional therapy to a lenvatinib plus a PD-1 inhibitor or lenvatinib monotherapy therapeutic regimen could lead to a high response and long survival [9,[35][36][37][38][39].…”

Section: Discussionsupporting

confidence: 92%

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

Che

Wang

et al. 2022

Preprint

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Introduction Combining lenvatinib with a programmed cell death protein-1 (PD-1) inhibitor has been explored for the treatment of unresectable hepatocellular carcinoma (uHCC). This study aimed to investigate the real-world efficacy and prognostic factors of lenvatinib plus PD-1 inhibitor in large cohorts of Asia uHCC patients. 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 response rate (ORR) and adverse events (AEs). Prognostic factors of survival were also analysed. Results A total of 378 uHCC patients from two medical centres in China were included retrospectively. The median age was 55 years, and 86.5% of patients were male. Hepatitis B virus (HBV) infection (89.9%) was the dominant aetiology. The median OS was 17.8 (95% confidence intervals (CIs) 14.0-21.6) months. The median PFS was 6.9 (95% CI 6.0-7.9) months. The best objective response rate (ORR) and disease control rate (DCR) were 19.6% and 73.5%, respectively. In multivariate analysis, Child-Pugh score, Barcelona Clinic Liver Cancer stage, Eastern Cooperative Oncology Group performance status score, involved organs, tumour burden score, and combination with local therapy were independent prognostic factors for OS. 100% and 57.9% patients experienced all grade and grade 3/4 treatment-emergent AEs. Conclusion This real-world study of lenvatinib plus PD-1 inhibitors demonstrated long survival and considerable ORRs and DCRs for uHCC patients in China. The tolerability of combination therapy was acceptable but still be monitored closely.

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Section: Discussionsupporting

confidence: 92%

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

Che

Wang

et al. 2022

Preprint

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“…Xiang et al. reported that the triple therapy for patients with intermediate-stage HCC had an ORR of 64.3%, median OS of 26.0 months, and median PFS of 22.5 months ( 55 ). In addition, a global randomized Phase 3 LEAP-012 Study conducted in the United States is ongoing to compare TACE with or without lenvatinib plus pembrolizumab for intermediate-stage HCC that are not amenable to curative treatment.…”

Section: Therapeutic Responses Of Lenvatinib Plus Tace With Pd-1 Inhi...mentioning

confidence: 99%

“…After PD-1 inhibitors therapy, the expression of VEGF and FGF in patients with PD was significantly higher than that of SD patients ( 30 ). Lenvatinib inhibited these angiogenic growth factors and was associated with T-cell activation, enhanced the antitumor immunity, and increased the efficacy of PD-1 inhibitors ( 54 , 55 , 74 ). Additionally, the JAK/STAT3 signaling pathway was activated by FGFR2 signals accompanied with increasing PD-L1 expression according to Li et al.…”

Section: Why the Combination Therapy Of Lenvatinib Plus Tace With Pd-...mentioning

confidence: 99%

Lenvatinib plus transarterial chemoembolization with or without immune checkpoint inhibitors for unresectable hepatocellular carcinoma: A review

Sun

Xu²,

Meng

et al. 2022

Front. Oncol.

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Lenvatinib plus transarterial chemoembolization (TACE)have become the first choice for patients with hepatocellular carcinoma (HCC) that are unsuitable for TACE. Sorafenib plus TACE therapy for patients with portal vein tumor thrombus (PVTT) achieved positive results. However, Lenvatinib plus TACE appeared to achieve a more advantageous result for these patients based on the phase 3 REFLECT trial. Both TACE and lenvatinib therapy have immune-stimulating effects, so would lenvatinib plus TACE and immune checkpoint inhibitors be an advantageous therapy for unresectable HCC (uHCC)? Thirteen articles from PubMed were explored to determine the efficacy and safety of lenvatinib plus TACE with or without PD-1 inhibitors therapy. Most of the adverse events (AEs) were manageable. Lenvatinib plus TACE therapy was superior to lenvatinib monotherapy with intermediate stage HCC especially beyond up-to-seven criterion and was superior to TACE monotherapy in patients with uHCC or sorafenib plus TACE therapy in patients with PVTT. Objective response rates (ORRs) of 53.1%–75%, median progression free survival (PFS) of 6.15–11.6 months, and median overall survival (OS) of 14.5–18.97 months were achieved in the lenvatinib plus TACE group. Levatinib plus TACE and PD-1 inhibitors achieved ORRs of 46.7% –80.6%, median PFS of 7.3–13.3 months, and median OS of 16.9–24 months. Control studies also confirmed the triple therapy was superior to lenvatinib plus TACE in patients with uHCC. Overall, the triple therapy is a promising treatment for patients with uHCC, including main PVTT and extrahepatic metastasis. Lenvatinib plus TACE therapy was also preferable for intermediate stage HCC beyond up-to-seven criterion and for patients with PVTT.

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“…Treatment options include surgical resection, image-guided ablation, liver transplantation, transarterial chemoembolization (TACE), sorafenib, and lenvatinib (2). Different treatments are indicated at particular clinical stages, and combination therapies are often used (2)(3)(4). Although multiple treatment options are available, the prognosis of unresectable HCC remains poor (5).…”

Section: Introductionmentioning

confidence: 99%

Transarterial chemoembolization plus lenvatinib with or without programmed death-1 inhibitors for patients with unresectable hepatocellular carcinoma: A propensity score matching study

Guo

Gao

et al. 2022

Front. Oncol.

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PurposeWe conducted a retrospective study to compare transarterial chemoembolization (TACE) plus lenvatinib plus programmed death-1 (PD-1) inhibitors with TACE plus lenvatinib in patients with unresectable hepatocellular carcinoma (HCC).Patients and methodsPatients with HCC were analyzed from January 2018 to January 2022 in three hospitals. Patients received TACE plus lenvatinib with or without PD-1 inhibitors (TACE+L+PD-1 or TACE+L, respectively). The baseline characteristics of the two groups were compared, and propensity score matching (PSM) was performed. Overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) of the two groups were compared. Adverse events in the two groups were analyzed.ResultsA total of 166 patients were evaluated (TACE+L+PD-1, n = 75; TACE+L, n = 91). Before PSM, OS was prolonged in the TACE+L+PD-1 group (p = 0.010), but PFS was similar between the two groups (p = 0.18). ORR was higher in the TACE+L+PD-1 group (p = 0.047). After PSM, estimated OS rates at 6, 12, and 24 months were 97.9%, 84.6%, and 74.1%, respectively, in the TACE+L+PD-1 group (n = 48) and 93.1%, 66.1%, and 43.4%, respectively, in the TACE+L group (n = 48). Estimated PFS rates at 3, 6, and 12 months were 81.9%, 61.8%, and 30.9%, respectively, in the TACE+L group and 95.7%, 82.1%, and 68.4%, respectively, in the TACE+L+PD-1 group. OS, PFS, and ORR were improved in the TACE+L+PD-1 group compared to the TACE+L group (p = 0.030; p = 0.027; p = 0.013). The safety of the TACE+L+PD-1 regimen was acceptable.ConclusionsThe addition of PD-1 inhibitors to TACE+L significantly improved clinical outcomes in patients with unresectable HCC. Side effects were manageable.

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Transarterial chemoembolization plus a PD‐1 inhibitor with or without lenvatinib for intermediate‐stage hepatocellular carcinoma

Cited by 26 publications

References 51 publications

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

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

Lenvatinib plus transarterial chemoembolization with or without immune checkpoint inhibitors for unresectable hepatocellular carcinoma: A review

Transarterial chemoembolization plus lenvatinib with or without programmed death-1 inhibitors for patients with unresectable hepatocellular carcinoma: A propensity score matching study

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