Evaluation of fully automated chemiluminescent enzyme immunoassays for hepatitis B core-related antigen components, phosphorylated and non-phosphorylated hepatitis B core antigens: clinical significance and dynamics during hepatitis B e antigen seroconversion.

To assess the performance and clinical relevance of three assays-hepatitis B core-related antigen (HBcrAg), hepatitis B core antigen (HBcAg), and phosphorylated HBcAg (pHBcAg)-in quantifying HBcrAg, a critical biomarker of hepatitis B virus (HBV) infection, fully automated chemiluminescent enzyme immunoassays (CLEIA) for two HBcAg variants were developed. Cutoff values for HBcAg and pHBcAg assays were established at 2.50 and 2.

Restoration of the gut-microbiota-liver axis after hepatitis C virus eradication.

Background & Aims: We previously reported altered intestinal environmental features during HCV infection. Here, we aimed to characterize the gut-microbiota-liver axis in patients with chronic hepatitis C after a sustained virological response (SVR).

Methods: A total of 174 patients with HCV infection were enrolled in a cross-sectional study: 95 with chronic hepatitis (CH-HCV group) and 79 with cirrhosis or hepatocellular carcinoma (LC/HCC-HCV group).

Innovative hepatitis C screening: Clinical utility of the HCV antigen-antibody assay in Japan.

The Elecsys HCV Duo (HCV Duo) detects anti-HCV antibodies (Duo/anti-HCV) and HCV core antigen (Duo/HCV-Ag), offering an efficient, cost-effective, and rapid HCV screening. We evaluated HCV Duo's utility in Japan. We analyzed 373 samples (120 HCV RNA-detectable and 253 HCV RNA-undetectable) from chronic hepatitis C (CHC) patients.

Long-Term Complete Response to Pembrolizumab in Tumor Mutation Burden-High Small Cell Lung Cancer: A Case Report.

Introduction: Extensive-stage small-cell lung cancer (ED-SCLC) has a poor prognosis. There are few case reports on the therapeutic effect of pembrolizumab in advanced SCLC with high tumor mutation burden (TMB-high).

Case Presentation: A 65-year-old woman was diagnosed with ED-SCLC.

Current global applications of HBcrAg assays in the management of chronic hepatitis B.

Hepatitis B core-related antigen (HBcrAg) is a vital marker for monitoring chronic hepatitis B (CHB) as it correlates with hepatitis B (HBV) DNA and covalently closed circular DNA (cccDNA). The iTACT-HBcrAg assay, approved in Japan, provides highly sensitive and automated testing, reducing patient burden by requiring smaller specimen volumes and offering shorter processing times. Crucial for managing HBV reactivation and predicting hepatocellular carcinoma, it delivers consistent and reliable results.

First-line nivolumab plus platinum chemotherapy and bevacizumab for advanced nonsquamous non-small cell lung cancer: A 3-year follow-up of the phase 3 randomized TASUKI-52 trial.

Objectives: In the randomized phase III TASUKI-52 trial, nivolumab with carboplatin, paclitaxel, and bevacizumab significantly prolonged the progression-free survival (PFS) of treatment-naive patients with advanced or recurrent nonsquamous non-small cell lung cancer (NSCLC). Here, we report the long-term outcomes of patients treated with nivolumab plus carboplatin, paclitaxel, and bevacizumab with 3 years of follow-up.

Methods: Patients with stage IIIB/IV or recurrent nonsquamous NSCLC without sensitizing EGFR, ALK, or ROS1 mutations were randomized (1:1) to receive either nivolumab or placebo, in addition to carboplatin, paclitaxel, and bevacizumab, every 3 weeks.

Clinical usefulness of an ultra-high-sensitivity hepatitis B surface antigen assay to determine the cessation of treatment for HBV reactivation.

Introduction And Objectives: We aimed to compare the usefulness of the ultra-high-sensitivity hepatitis B surface antigen (iTACT-HBsAg), high-sensitivity hepatitis B core-related antigen (iTACT-HBcrAg), and anti-HBs assays in determination of cessation of nucleot(s)ide analogue (NA) treatment to prevent against hepatitis B virus (HBV) reactivation.

Patients And Methods: Twenty-two patients who developed HBV reactivation under immunosuppressive therapy or chemotherapy and had been administered NA and subsequently discontinued were enrolled. The stored serum samples taken at NA cessation were applied to iTACT-HBsAg (lower limit of detection; 0.

Lorlatinib overcomes alectinib-induced hemolytic anemia in an ALK fusion positive non-small-cell lung cancer patient with severe tumor-associated liver failure: A case report.

Hemolytic anemia is a rare and unique complication of alectinib, not observed with other anaplastic lymphoma kinase (ALK) inhibitors. Here, we present a case of an ALK fusion-positive non-small-cell lung cancer (NSCLC) patient who developed liver failure due to diffuse liver metastasis at initial diagnosis. Treatment was initiated with low-dose alectinib, but the patient developed severe hemolytic anemia.

Induction of IGHV3-53 public antibodies with broadly neutralising activity against SARS-CoV-2 including Omicron subvariants in a Delta breakthrough infection case.

Background: Emergence of SARS-CoV-2 variants that escape neutralising antibodies hampers the development of vaccines and therapeutic antibodies against SARS-CoV-2. IGHV3-53/3-66-derived public antibodies, which are generally specific to the prototype virus and are frequently induced in infected or vaccinated individuals, show minimal affinity maturation and high potency against prototype SARS-CoV-2.

Methods: Monoclonal antibodies isolated from a Delta breakthrough infection case were analysed for cross-neutralising activities against SARS-CoV-2 variants.

Phase III KEYNOTE-789 Study of Pemetrexed and Platinum With or Without Pembrolizumab for Tyrosine Kinase Inhibitor‒Resistant, -Mutant, Metastatic Nonsquamous Non-Small Cell Lung Cancer.

Purpose: Epidermal growth factor receptor () tyrosine kinase inhibitors (TKIs) are standard first-line therapy for -mutant, metastatic non-small cell lung cancer (NSCLC); however, most patients experience disease progression. We report results from the randomized, double-blind, phase III KEYNOTE-789 study of pemetrexed and platinum-based chemotherapy with or without pembrolizumab for TKI-resistant, -mutant, metastatic nonsquamous NSCLC (ClinicalTrials.gov identifier: NCT03515837).

Impact of body surface area on efficacy and safety in patients with EGFR-mutant non-small cell lung cancer treated with osimertinib as a first-line treatment.

Background: The most recommended treatment for stage IV EGFR-positive lung cancer is osimertinib monotherapy. The dosage of osimertinib is fixed at 80 mg/day regardless of body surface area (BSA), however some patients withdraw or reduce the dosage due to adverse events (AEs).

Methods: We performed a retrospective cohort study of 98 patients with EGFR mutation-positive non-small cell lung cancer (NSCLC), who received 80 mg osimertinib as the initial treatment.

Clinical performance of Circulating HBV RNA and iTACT-HBcrAg Assays in HBeAg-negative and HBsAg-cleared Chronic Hepatitis B Patients.

Hepatitis B virus (HBV) RNA and hepatitis B core-related antigen (HBcrAg) have been reported to reflect the transcriptional activity of covalently closed circular HBV DNA. We retrospectively investigated the proportions of quantifiable serum HBV RNA and immunoassay for total antigen including complex via pretreatment-hepatitis B core-related antigen (iTACT-HBcrAg) in chronic hepatitis B patients negative for hepatitis B e antigen (HBeAg) and/or with hepatitis B surface antigen (HBsAg) seroclearance. This study included 246 HBeAg-negative HBV-infected patients, who comprised 13 with liver cirrhosis (LC, the LC group), 118 chronic hepatitis (CH, the CH group), and 115 inactive carriers (IC, the IC group), and 44 patients with HBsAg seroclearance.

Serum interleukin-6 levels at the start of the second course of atezolizumab plus bevacizumab therapy predict therapeutic efficacy in patients with advanced hepatocellular carcinoma: a multicenter analysis.

Background And Aim: Serum interleukin-6 (IL-6) before the administration of atezolizumab plus bevacizumab (Atez + Bev) is a prognostic biomarker in patients with hepatocellular carcinoma (HCC) treated with Atez + Bev. We previously revealed that the neutrophil-to-lymphocyte ratio and serum chemokine levels during treatment with Atez + Bev were more useful as prognostic biomarkers. Therefore, we examined the predictive ability of serum IL-6 for the efficacy of Atez + Bev in patients with HCC.

Two Concepts of Hepatitis B Core-Related Antigen Assay: A Highly Sensitive and Rapid Assay or an Effective Tool for Widespread Screening.

Hepatitis B core-related antigen (HBcrAg) reflects the activity of intrahepatic covalently closed circular DNA. HBcrAg can be detected even in chronic hepatitis B patients in whom serum HBV DNA or hepatitis B surface antigen is undetectable. The HBcrAg measurement system was developed based on two concepts.

Osimertinib after Chemoradiotherapy in Stage III -Mutated NSCLC.

Background: Osimertinib is a recommended treatment for advanced non-small-cell lung cancer (NSCLC) with an epidermal growth factor receptor () mutation and as adjuvant treatment for resected -mutated NSCLC. EGFR tyrosine kinase inhibitors have shown preliminary efficacy in unresectable stage III -mutated NSCLC.

Methods: In this phase 3, double-blind, placebo-controlled trial, we randomly assigned patients with unresectable -mutated stage III NSCLC without progression during or after chemoradiotherapy to receive osimertinib or placebo until disease progression occurred (as assessed by blinded independent central review) or the regimen was discontinued.

Exceptionally long-lasting response to dabrafenib plus trametinib treatment in a patient with lung adenocarcinoma harboring the BRAF V600E mutation with high expression of PD-L1: A case report.

We present a patient with lung adenocarcinoma showing high PD-L1 expression and BRAF V600E mutation, who achieved a remarkable long-term response to the combination therapy of dabrafenib and trametinib (DT treatment) after disease progression on immunotherapy. This case may provide an opportunity for clinicians to consider the order of administration of immunotherapy and molecular targeted therapy for BRAF V600E-positive lung cancer.

Long-term experience with tepotinib in Japanese patients with MET exon 14 skipping NSCLC from the Phase II VISION study.

Tepotinib is a highly selective MET tyrosine kinase inhibitor (TKI) that has demonstrated robust and durable clinical activity in patients with MET exon 14 (METex14) skipping non-small-cell lung cancer (NSCLC). In the Phase II VISION study, patients received oral tepotinib 500 mg once daily. The primary endpoint was an objective response by an independent review committee (IRC) according to RECIST v1.

Potent CTLs can be induced against tumor cells in an environment of lower levels of systemic MFG-E8.

The direction and magnitude of immune responses are critically affected when dead cells are disposed of. Milk fat globule-epidermal growth factor-factor 8 (MFG-E8) promotes the engulfment of apoptotic normal and cancerous cells without inducing inflammation. We have previously reported that a certain proportion of the cancer cells express abundant MFG-E8, and that such expression is associated with the shorter survival of patients with esophageal cancer who had received chemotherapy before surgery.

Clinical application of the Lung Cancer Compact Panel using various types of cytological specimens in patients with lung cancer.

Background: The Lung Cancer Compact Panel (compact panel) is a gene panel that can detect driver alterations with high sensitivity in liquid samples, including tumor cells. This study examined the ability of a compact panel to detect genetic mutations in liquid specimens used in clinical practice.

Methods: Three cohorts, bronchoscopic biopsy forceps washing (washing cohort), pleural effusion (pleural cohort), and spinal fluid (spinal cohort), were analyzed using the compact panel.

Utility of needle biopsy in centrally located lung cancer for genome analysis: a retrospective cohort study.

Background: It is essential to collect a sufficient amount of tumor tissue for successful next-generation sequencing (NGS) analysis. In this study, we investigated the clinical risk factors for avoiding re-biopsy for NGS analysis (re-genome biopsy) in cases where a sufficient amount of tumor tissue could not be collected by bronchoscopy.

Methods: We investigated the association between clinical factors and the risk of re-genome biopsy in patients who underwent transbronchial biopsy (TBB) or endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and required re-genome biopsy in cases enrolled in LC-SCRUM Asia, a prospective nationwide genome screening project in Japan.

Low frequency of intracranial progression in advanced NSCLC patients treated with cancer immunotherapies.

Intracranial metastases are common in nonsmall-cell lung cancer (NSCLC) patients, whose prognosis is very poor. In addition, intracranial progression is common during systemic treatments due to the inability to penetrate central nervous system (CNS) barriers, whereas the intracranial effects of cancer immunotherapies remain unclear. We analyzed clinical data to evaluate the frequency of intracranial progression in advanced NSCLC patients treated with PD-1 blockade therapies compared with those treated without PD-1 blockade therapies, and found that the frequency of intracranial progression in advanced NSCLC patients treated with PD-1 blockade therapies was significantly lower than that in patients treated with cytotoxic chemotherapies.