Cutting Edge Research for Exploration of Biomolecules for Gemcitabine-Based Chemo-Resistant Advanced Bile Duct Cancer: From Basic Study to Clinical Trial

Wu, Chiao‐En; Yeh, Chun‐Nan

doi:10.3390/biom11111626

Cited by 4 publications

(3 citation statements)

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“…CCA has a poor prognosis because most patients are diagnosed with advanced disease, resulting in poor responses to systemic therapies (e.g., palliative chemotherapy), making it harder to achieve complete remission ( Wu and Yeh, 2021 ). The median duration of survival from CCA is shorter than 2 years, and 90% of individuals die within 5 years of the initial diagnosis ( Simile et al, 2019 ; American Cancer Society, 2020 ).…”

Section: Introductionmentioning

confidence: 99%

Safety analysis of pemigatinib leveraging the US Food and Drug administration adverse event reporting system

Zhang

Liang

et al. 2023

Front. Pharmacol.

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Background: Cholangiocarcinoma (CCA) is a highly lethal and aggressive epithelial tumor of the hepatobiliary system. A poor prognosis, propensity for relapse, low chance of cure and survival are some of its hallmarks. Pemigatinib, the first targeted treatment for CCA in the United States, has been demonstrated to have a significant response rate and encouraging survival data in early-phase trials. The adverse events (AEs) of pemigatinib must also be determined.Objective: To understand more deeply the safety of pemigatinib in the real world through data-mining of the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).Methods: Disproportionality analysis was employed in a retrospective pharmacovigilance investigation to identify the AEs linked to pemigatinib use as signals. Data were collected between 1 January 2020 to 30 June 2022. Four data-mining methods (proportional reporting odds ratio; proportional reporting ratio; Bayesian confidence propagation neural networks of information components; empirical Bayes geometric means) were used to calculate disproportionality.Results: A total of 203 cases using pemigatinib as the prime-suspect medication were found in our search, which involved 99 preferred terms (PTs). Thirteen signals of pemigatinib-induced AEs in seven System Organ Classes were detected after confirming the four algorithms simultaneously. Nephrolithiasis was an unexpected significant AE not listed on the drug label found in our data-mining. Comparison of the differences between pemigatinib and platinum drugs in terms of 33 PTs revealed that 13 PTs also met the criteria of the four algorithms. Ten of these PTs were identical to those compared with all other drugs, in which (excluding a reduction in phosphorus in blood) other PT signal values were higher than those of all other drugs tested. However, comparison of the differences between pemigatinib and infigratinib in terms of the 33 PTs revealed no significant signals in each algorithm method.Conclusion: Some significant signals were detected between pemigatinib use and AEs. PTs with apparently strong signals and PTs not mentioned in the label should be taken seriously.

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Section: Introductionmentioning

confidence: 99%

Safety analysis of pemigatinib leveraging the US Food and Drug administration adverse event reporting system

Zhang

Liang

et al. 2023

Front. Pharmacol.

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“…Cholangiocarcinoma (CCA), or biliary tract cancer (BTC), is a malignancy arising from the epithelium of the bile ducts [ 1 ]. Chronic inflammation in parasitic infections, primary sclerosing cholangitis, congenital fibropolycystic liver, hepatitis B and C viruses, and Caroli’s diseases are major causes of CCA [ 2 , 3 ].…”

Section: Introductionmentioning

confidence: 99%

“…CCA has a poor prognosis, as most cases are diagnosed at an advanced stage and respond poorly to current systemic treatment [ 1 ]. The CCA patients have medium survival of fewer than two years.…”

Section: Introductionmentioning

confidence: 99%

Precision Medicine in Cholangiocarcinoma: Past, Present, and Future

Cheng

Chen

2022

Life

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Cholangiocarcinoma (CCA), or biliary tract cancer, has a poor prognosis. The median survival time among patients with CCA is under 2 years from diagnosis, and the global 5-year survival rate is only 10%. First-line therapy with chemotherapeutic agents, gemcitabine plus cisplatin, has traditionally been used to treat unresectable advanced CCA. In recent years, precision medicine has become a mainstream cancer treatment due to innovative next-generation sequencing technology. Several genetic alterations, including mutations, gene fusions, and copy number variations, have been found in CCA. In this review, we summarized the current understanding of genetic profiling in CCA and targeted therapy in CCA. Owing to the high heterogeneity of CCA, tumor microenvironmental factors, and the complexity of tumor biology, only pemigatinib, infigratinib, ivosidenib, larotrbctinib, and entrectinib are currently approved for the treatment of CCA patients with fibroblast growth factor receptor 2 gene (FGFR2) fusion, isocitrate dehydrogenase gene (IDH1) mutation, and neurotrophin receptor tyrosine kinase gene (NRTK) fusion, respectively. Additional targeted therapies, including other FGFR2 inhibitors, PI3K/AKT/mTOR inhibitors, and BRAF-directed targeted therapy, have been discussed for the management of CCA, and immune checkpoint inhibitors, particularly pembrolizumab, can be administered to patients with high microsatellite instability tumors. There is a further need for improvement in precision medicine therapies in the treatment of CCA and discuss the approved and potential targeted therapies for CCA.

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Venous thromboembolism in patients undergoing distal cholangiocarcinoma surgery: Prevalence, risk factors, and outcomes

Chen¹,

Cui²,

Huang³

et al. 2023

Asian Journal of Surgery

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Cutting Edge Research for Exploration of Biomolecules for Gemcitabine-Based Chemo-Resistant Advanced Bile Duct Cancer: From Basic Study to Clinical Trial

Abstract: Bile duct cancer (BDC) has been identified as a highly aggressive cancer arising from epithelial cells of the bile duct, including intrahepatic, perihilar, and extrahepatic [...]

Cited by 4 publications

References 8 publications

Safety analysis of pemigatinib leveraging the US Food and Drug administration adverse event reporting system

Safety analysis of pemigatinib leveraging the US Food and Drug administration adverse event reporting system

Precision Medicine in Cholangiocarcinoma: Past, Present, and Future

Venous thromboembolism in patients undergoing distal cholangiocarcinoma surgery: Prevalence, risk factors, and outcomes

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