A prospective, phase II, open-label study (JO22903) of first-line erlotinib in Japanese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small-cell lung cancer (NSCLC).

Introduction: The epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor erlotinib is associated with survival benefits in patients with EGFR mutation-positive non-small-cell lung cancer (NSCLC). This phase II, single-arm study examined the efficacy and safety of first-line erlotinib in Japanese patients with EGFR mutation-positive NSCLC.

Methods: Eligible patients received erlotinib 150 mg/day until disease progression or unacceptable toxicity.

A randomised, placebo-controlled, double-blind study of aprepitant in nondrinking women younger than 70 years receiving moderately emetogenic chemotherapy.

Background: We evaluated the efficacy of aprepitant plus granisetron and an increased dose of dexamethasone in selected patients undergoing moderately emetogenic chemotherapy (MEC).

Methods: Nondrinking women <70 years undergoing MEC were randomly assigned to aprepitant (day 1, 125 mg; days 2 and 3, 80 mg) or placebo. Dexamethasone on days 1-3 was 12, 4, and 4 mg with aprepitant and 20, 8, and 8 mg with placebo.

LUX-Lung 4: a phase II trial of afatinib in patients with advanced non-small-cell lung cancer who progressed during prior treatment with erlotinib, gefitinib, or both.

Purpose: New molecular targeted agents are needed for patients with non-small-cell lung cancer (NSCLC) who progress while receiving erlotinib, gefitinib, or both. Afatinib, an oral irreversible ErbB family blocker, has preclinical activity in epidermal growth factor receptor (EGFR [ErbB1]) mutant models with EGFR-activating mutations, including T790M.

Patients And Methods: This was a Japanese single-arm phase II trial conducted in patients with stage IIIB to IV pulmonary adenocarcinoma who progressed after ≥ 12 weeks of prior erlotinib and/or gefitinib.

Predictive impact of adiponectin for detecting dysglycemia in non-fasting Japanese employees with metabolic risk factors.

The screening of dysglycemia in the non-fasting state is a challenging issue in healthcare practice. We investigated whether the additional measurement of circulating adiponectin levels could improve screening performance. We used a database of 1190 Japanese employees with metabolic risk factors, who underwent a 75-g oral glucose tolerance test (OGTT), following non-fasting health check-ups.

Evaluation of hypertriglyceridemia using non-fasting health checkup data in a Japanese population.

Aim: Some employees have difficulty undergoing health checkups in the workplace in a fasting state. However, hypertriglyceridemia is usually diagnosed based on fasting triglyceride (TG) measurements. The current study investigated the performance of non-fasting health checkup data for predicting hypertriglyceridemia in a Japanese population.

Cytokeratin 19 fragment predicts the efficacy of epidermal growth factor receptor-tyrosine kinase inhibitor in non-small-cell lung cancer harboring EGFR mutation.

Background: EGFR gene mutation is independently associated with a favorable response in non-small-cell lung cancer (NSCLC) patients receiving epidermal growth factor receptor -tyrosine kinase inhibitors (EGFR-TKIs), regardless of sex or smoking history. Squamous cell carcinoma patients harboring EGFR mutations show a significantly worse response to EGFR-TKIs compared with adenocarcinoma patients. We hypothesized that the serum cytokeratin 19 fragment (CYFRA 21-1) is associated with the efficacy of EGFR-TKIs in EGFR-mutated NSCLC patients.

Histology and smoking status predict survival of patients with advanced non-small-cell lung cancer. Results of West Japan Oncology Group (WJOG) Study 3906L.

Introduction: Smoking status is one of the prognostic factors in advanced non-small-cell lung cancer (NSCLC). Currently, adenocarcinoma (Ad) histology is considered a predictive factor in advanced NSCLC. We investigated the correlation between histology or smoking status and survival of NSCLC patients receiving chemotherapy.

Crizotinib administered via nasogastric and percutaneous endoscopic gastrostomy tubes for the successful treatment of ALK-rearranged lung cancer in a patient with poor performance status.

Crizotinib-an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor-is effective in non-small-cell lung cancers (NSCLCs) that express ALK. Here, we report a patient with ALK-positive lung adenocarcinoma who was administered crizotinib via nasogastric and percutaneous endoscopic gastrostomy (PEG) tubes, with positive results. This case indicates that patients with ALK-positive NSCLC may successfully be treated with crizotinib via nasogastric or PEG tubes.

Lung squamous cell carcinoma in a young female never smoker: a case report.

A lung squamous cell carcinoma complicated by lung abscess was found in a 38-year-old female never smoker. After a transbronchial lung biopsy, she complained of chest pain and had a persistent fever. A right middle lobectomy was performed to alleviate her symptoms and complete surgical resection was achieved.

Pancreatic beta cell function in lean and obese Japanese with various degrees of glucose tolerance.

The aim of the current study was to investigate whether obese subjects have different insulin secretory capacity compared to lean subjects with the same glucose tolerance in a Japanese population. We included a total of 1749 Japanese employees who underwent 75-g oral glucose tolerance test (OGTT). The study population was divided into deciles of 120-min glucose levels and the indices of insulin secretion and insulin sensitivity in each decile were compared between the subjects with and without obesity (body mass index ≥ 25 kg/m2).

Effect of sarpogrelate treatment on the prognosis after endovascular therapy for critical limb ischemia.

5-Hydroxytryptamine type 2 antagonists are used to treat symptomatic peripheral arterial disease. However, it remains unknown as to whether the administration of sarpogrelate, a 5-hydroxytryptamine type 2 antagonist, improves the prognosis after endovascular therapy for critical limb ischemia (CLI). We performed a retrospective analysis using a database of 386 Japanese patients undergoing endovascular therapy for CLI.

Nested case control study of proteomic biomarkers for interstitial lung disease in Japanese patients with non-small-cell lung cancer treated with erlotinib: a multicenter phase IV study (JO21661).

Background: Interstitial lung disease (ILD) is a serious adverse drug reaction associated with epidermal growth factor receptor tyrosine-kinase inhibitors (EGFR TKIs). Its risk factors are yet to be fully elucidated. We sought to identify proteomic biomarkers associated with ILD development in erlotinib-treated Japanese patients with non-small-cell lung cancer (NSCLC) to build predictive models.

Dose reduction or intermittent administration of erlotinib: which is better for patients suffering from intolerable toxicities?

Erlotinib is an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor that is widely used in the treatment of non-small cell lung cancer. Skin rashes and diarrhea are frequent side effects of erlotinib therapy. When these toxicities become intolerable, dose reduction is commonly performed.

Preexisting interstitial lung disease is inversely correlated to tumor epidermal growth factor receptor mutation in patients with lung adenocarcinoma.

Introduction: Interstitial lung disease (ILD), especially idiopathic pulmonary fibrosis, has been shown to be associated with lung carcinogenesis. However, an association between epidermal growth factor receptor (EGFR) mutation status and preexisting ILD in patients with lung adenocarcinoma is unknown.

Methods: Between January 2008 and April 2012, we analyzed 602 patients with lung adenocarcinoma.

The utility of carotid ultrasonography in identifying severe coronary artery disease in asymptomatic type 2 diabetic patients without history of coronary artery disease.

Objective: Although many studies have shown that carotid intima-media thickness (IMT) is associated with coronary artery disease (CAD), it remains inconclusive whether assessment of carotid IMT is useful as a screening test for asymptomatic but severe CAD in diabetic patients.

Research Design And Methods: A total of 333 asymptomatic type 2 diabetic patients without history of CAD underwent exercise electrocardiogram or myocardial perfusion scintigraphy for detection of silent myocardial ischemia, and those whose test results were positive were subjected to coronary computed tomography angiography or coronary angiography. The ability of carotid IMT to identify severe CAD corresponding to treatment with revascularization was examined by receiver-operating characteristic (ROC) curve analyses.

Circulating soluble RAGE as a predictive biomarker of cardiovascular event risk in patients with type 2 diabetes.

It is still controversial whether circulating soluble form of receptor for AGE (sRAGE) is associated with atherosclerosis in diabetic patients. In this study, we enrolled 276 Japanese type 2 diabetic subjects without history of cardiovascular disease (CVD), assessed their baseline clinical and biochemical data including serum sRAGE levels, and prospectively evaluated the association between these parameters and CVD events. The median follow-up period was 5.

Regular insulin, rather than rapid-acting insulin, is a suitable choice for premeal bolus insulin in lean patients with type 2 diabetes mellitus.

The aim of the present study was to compare the usefulness of premeal rapid-acting and regular insulin in type 2 diabetes patients. A total of 56 type 2 diabetic patients were investigated during hospitalization. Premeal rapid-acting insulin was applied instead of other medications.

Association of myeloperoxidase G-463A gene polymorphism with diabetic nephropathy in Japanese type 2 diabetic subjects.

It is possible that myeloperoxidase (MPO) contributes to the pathogenesis of diabetic nephropathy through the production of reactive oxygen species and HOCl/OCl⁻. In this study, we examined the relationship between renal damage and MPO G-463A gene polymorphism that is associated with its transcription activity in diabetic patients. We evaluated the association between MPO G-463A polymorphism and the prevalence of proteinuria and estimated GFR (eGFR) in 1448 Japanese type 2 diabetic subjects.

Improved lipid profiles are associated with reduced incidence of coronary vascular events in asymptomatic patients with type 2 diabetes and impaired myocardial perfusion.

Aim: Individuals with type 2 diabetes are at high risk for cardiovascular events; however, a modality that could reduce risk has not been fully evaluated. We examined the annual incidence rate of cardiovascular events in asymptomatic Japanese diabetic patients who underwent gated myocardial perfusion single-photon computed tomography (SPECT).

Methods: Asymptomatic patients (n= 485) aged ≥50 years and with either a maximal carotid artery intima-media thickness of ≥1.

Efficacy of liraglutide therapy in Japanese type 2 diabetic patients insufficiently controlled with basal-supported oral therapy.

Unlabelled: (J Diabetes Invest, doi: 10.1111/j.2040-1124.

Plasma pentraxin 3 levels are associated with carotid IMT in type 1 diabetic patients.

Aims: Pentraxin3 (PTX3), a recently discovered inflammatory mediator, is produced abundantly in various cells in atherosclerotic lesions, and therefore, its plasma level could reflect local inflammation at the site of atherosclerotic lesion. The present study evaluated whether plasma PTX3 levels are associated with subclinical atherosclerosis in young subjects with type 1 diabetes.

Methods: Plasma PTX3 levels, urinary albumin excretion, diabetic retinopathy, and carotid intima-media thickness (IMT) were examined in 78 Japanese type 1 diabetic patients (30 men and 48 women, aged 28.

How sensitive are epidermal growth factor receptor-tyrosine kinase inhibitors for squamous cell carcinoma of the lung harboring EGFR gene-sensitive mutations?

Introduction: Epidermal growth factor receptor (EGFR) mutations are found mostly in adenocarcinoma, and rarely in squamous cell carcinoma (SQC). Little is known about SQC harboring EGFR mutations.

Methods: Between April 2006 and October 2010, we investigated the incidence of EGFR activating mutations in SQC of the lung using the peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method.