Analysis of serum biomarkers (BM) in patients (pts) from a phase 3 study of lenvatinib (LEN) vs sorafenib (SOR) as first-line treatment for unresectable hepatocellular carcinoma (uHCC)

Finn, Richard S.; Kudo, Masatoshi; Cheng, A-L.; Wyrwicz, Lucjan; Ngan, Rkc; Blanc, J.-F.; Baron, Ari David; Vogel, Arndt; Ikeda, Masafumi; Piscaglia, Fabio; Han, Kyung Hee; Qin, Shukui; Minoshima, Yukinori; Funahashi, Yasuhiro; Ren, Min; Dairiki, Ryo; Sachdev, Pallavi; Tamai, Toshiyuki; Dutcus, Corina E.; Evans, T.R. Jeffry

doi:10.1093/annonc/mdx440.022

Cited by 16 publications

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“…For example, in 2017, Finn et al[ 25 ] performed a study that focused on tumor gene expression clustering analysis in patients treated with lenvatinib. Patients were divided into three groups by clustering using expression levels of 36 genes involved in angiogenic and/or growth factor pathways.…”

Section: Discussionmentioning

confidence: 99%

“…Patients were divided into three groups by clustering using expression levels of 36 genes involved in angiogenic and/or growth factor pathways. They found that for patients treated with lenvatinib, improvement in overall survival was seen in the group with higher vascular endothelial growth factor and FGF expression[ 25 ]. Likewise, we found that mutations associated with the lenvatinib target, particularly FGFRs1-4, were less frequent, which may confirm previous findings[ 26 ]; however, further research is required.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of lenvatinib for patients with advanced hepatocellular carcinoma: A retrospective, real-world study conducted in China

Wang¹,

Xu²,

Lin³

et al. 2020

WJG

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BACKGROUND Lenvatinib has become an indispensable part of treatment regimens for patients with advanced hepatocellular carcinoma (aHCC). Several recent real-world studies appear to have confirmed this; however, there are etiological differences. This necessitates further real-world studies of lenvatinib across diverse populations, such as in China. AIM To investigate the efficacy and safety of lenvatinib in a Chinese HCC patient population under real-world conditions. METHODS This is a retrospective and multiregional study involving patients with aHCC receiving lenvatinib monotherapy. Efficacy was assessed using the Response Evaluation Criteria in Solid Tumors version 1.1. Baseline characteristics and adverse events (AEs) were recorded throughout the entire study. RESULTS In total, 54 HCC patients treated with lenvatinib monotherapy were included for final analysis. The objective response rate was 22% ( n = 12) with a progression-free survival (PFS) of 168 d; however, AEs occurred in 92.8% of patients. Multivariate analysis showed that the Barcelona Clinic Liver Cancer stage [hazard ratio (HR) 0.465; 95%CI: 0.23-0.93; P = 0.031], portal vein tumor thrombus (HR 0.38; 95%CI: 0.15-0.94; P = 0.037) and Child-Pugh classifications (HR 0.468; 95%CI: 0.22-0.97; P = 0.042) were significant factors affecting PFS. The sensitivity (56.7%) and specificity (83.3%) of decreasing serum biomarkers including alpha-fetoprotein were calculated in order to predict tumor size reduction. Gene sequencing also provided insights into potential gene mutation signatures related to the effect of lenvatinib. CONCLUSION Our findings confirm previous evidence from the phase III REFLECT study. The majority of patients in this Chinese sample were suffering from concomitant hepatitis B virus-related HCC. However, further analysis suggested that baseline characteristics, changes in serum biomarkers and gene sequencing may hold the key for predicting lenvatinib responses. Further large-scale prospective studies that incorporate more basic medical science measures should be conducted.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of lenvatinib for patients with advanced hepatocellular carcinoma: A retrospective, real-world study conducted in China

Wang¹,

Xu²,

Lin³

et al. 2020

WJG

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“…Lenvatinib has been approved as a first-line systemic treatment option to sorafenib in an open-labeled phase 3 randomized clinical trial (REFLECT) [ 123 ]. In this trial, baseline VEGF, ANG-2, and fibroblast growth factor-2 (FGF-2) serum levels were associated with better overall survival with lenvatinib but not with sorafenib [ 166 ]. Besides, increasing VEGF levels following lenvatinib initiation was associated with better overall survival [ 166 ].…”

Section: Serum and Tissue Biomarkers In Hcc For Response Assessmenmentioning

confidence: 99%

“…In this trial, baseline VEGF, ANG-2, and fibroblast growth factor-2 (FGF-2) serum levels were associated with better overall survival with lenvatinib but not with sorafenib [ 166 ]. Besides, increasing VEGF levels following lenvatinib initiation was associated with better overall survival [ 166 ]. Tumor markers response and assessment through imaging data were evaluated in another retrospective cohort study including pre and post AFP or DCP levels at weeks 2 and 4 from lenvatinib initiation and correlated with the modified Response Evaluation Criteria for Solid Tumors (mRECIST) criteria [ 167 , 168 ].…”

Section: Serum and Tissue Biomarkers In Hcc For Response Assessmenmentioning

confidence: 99%

Biomarkers in Hepatocellular Carcinoma: Diagnosis, Prognosis and Treatment Response Assessment

Piñero

Dirchwolf

Pessôa

2020

Cells

352

255

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Hepatocellular carcinoma (HCC) is one of the main cancer-related causes of death worldwide. Thus, there is a constant search for improvement in screening, diagnosis, and treatment strategies to improve the prognosis of this malignancy. The identification of useful biomarkers for surveillance and early HCC diagnosis is still deficient, with available serum biomarkers showing low sensitivity and heterogeneous specificity despite different cut-off points, even when assessed longitudinally, or with a combination of serum biomarkers. In contrast, HCC biomarkers used for prognostic (when associated with clinical outcomes) or predictive purposes (when associated with treatment response) may have an increased clinical role in the near future. Furthermore, some serum biomarkers are already implicated as a treatment selection tool, whether to provide access to certain therapies or to assess clinical benefit after treatment. In the present review we will discuss the clinical utility and foreseen future of HCC biomarkers implicated in surveillance, diagnosis, prognosis, and post-treatment assessment.

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“…The results of blood biomarker testing were presented at the Congress of the European Society of Medical Oncology in 2017 [38]. Blood VEGF, FGF19, and FGF23 were elevated in the lenvatinib arm but not in the sorafenib arm.…”

Section: Results Of Exploratory Research On Blood Biomarkersmentioning

confidence: 99%

Lenvatinib May Drastically Change the Treatment Landscape of Hepatocellular Carcinoma

Kudo

2018

Liver Cancer

109

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Analysis of serum biomarkers (BM) in patients (pts) from a phase 3 study of lenvatinib (LEN) vs sorafenib (SOR) as first-line treatment for unresectable hepatocellular carcinoma (uHCC)

Cited by 16 publications

References 0 publications

Efficacy and safety of lenvatinib for patients with advanced hepatocellular carcinoma: A retrospective, real-world study conducted in China

Efficacy and safety of lenvatinib for patients with advanced hepatocellular carcinoma: A retrospective, real-world study conducted in China

Biomarkers in Hepatocellular Carcinoma: Diagnosis, Prognosis and Treatment Response Assessment

Lenvatinib May Drastically Change the Treatment Landscape of Hepatocellular Carcinoma

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