Abstract
IntroductionLenvatinib, a multiple receptor tyrosine kinase inhibitors that target vascular endothelial growth factor receptors and fibroblast growth factor receptors, recently demonstrated a treatment effect in various tumors. This study evaluated the efficacy and safety of lenvatinib for patients with biliary tract cancers (BTCs) who had received ≥1 line of prior systemic anti-BTC therapy.MethodsThis open-label, single-arm study included adult (≥18 years) patients with histologically confirmed BTC. Efficacy and safety were evaluated based on the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) and the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 4.0). Changes in tumor biomarkers throughout the treatment period were recorded.Results41 patients received lenvatinib treatment. The ORR was 12% (95% CI: 1.7–22.7), with a median PFS of 3.8 months (95% CI: 1.3–6.3) and an OS of 11.4 months (95% CI: 6.6–16.2). Thirty-nine (95.1%) patients experienced ≥1 treatment-related adverse event. Decreasing carbohydrate antigen 19-9 (CA19-9) level predicted tumor size reduction in intrahepatic cholangiocarcinoma with a sensitivity of 77.7% and a specificity of 73.9%.ConclusionsLenvatinib which was individualized based on the patient’s weight has promising clinical activity against advanced BTC and had an acceptable safety profile. Additionally, serum biomarkers and gene sequencing may hold the potential to guide our treatment.
Highlights
Lenvatinib, a multiple receptor tyrosine kinase inhibitors that target vascular endothelial growth factor receptors and fibroblast growth factor receptors, recently demonstrated a treatment effect in various tumors
We found lenvatinib plus pembrolizumab was a potentially effective and tolerable non-first-line treatment for refractory biliary tract cancers (BTCs), with an objective response rate (ORR) of 25%, a clinical benefit rate (CBR) of 40.5%, a median progression-free survival (PFS) of 4.9 months, and a median overall survival (OS) of 11.0 months [17]
We evaluated tumor size using enhanced computed tomography (CT), magnetic resonance imaging (MRI), or other available imaging examinations according to RECIST 1.1 at 4–8 weeks after the patient-initiated lenvatinib at the stipulated dose
Summary
Lenvatinib, a multiple receptor tyrosine kinase inhibitors that target vascular endothelial growth factor receptors and fibroblast growth factor receptors, recently demonstrated a treatment effect in various tumors. This study evaluated the efficacy and safety of lenvatinib for patients with biliary tract cancers (BTCs) who had received ≥1 line of prior systemic anti-BTC therapy. The global incidence of BTCs has increased in recent years, in large part due to an increase in the incidence of ICC [2]. Gemcitabine combined with cisplatin (GC) chemotherapy is the standard first-line treatment for advanced BTCs [3–5], and the incidence of adverse reactions accounted for 70%. The ABC-06 study evaluated the benefit derived from FOLFOX (folinic acid, fluorouracil, and oxaliplatin) chemotherapy in patients with advanced BTC and the median overall survival (OS) was improved significantly compared to active symptom control (ASC) (6.2 months vs 5.3 months). For patients who progress on or after the above therapies, the subsequent treatment options are limited
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