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Ogura T.,Kanagawa Cardiovascular and Respiratory Center | Taniguchi H.,Tosei General Hospital | Azuma A.,Nippon Medical School | Inoue Y.,Clinical Research Center | And 12 more authors.
European Respiratory Journal

A randomised, double-blind, phase II, dose escalation trial was conducted to assess the safety, tolerability and pharmacokinetics of the tyrosine kinase inhibitor nintedanib, alone and when added to ongoing pirfenidone therapy, in Japanese patients with idiopathic pulmonary fibrosis. 50 Japanese patients were randomised to receive nintedanib or placebo in one of three cohorts (nintedanib 50 mg twice daily or 100 mg twice daily for 14 days, or 150 mg twice daily for 28 days). Patients receiving pirfenidone at inclusion were stratified to every nintedanib dose group and placebo. Adverse events were reported in nine out of 17 patients receiving nintedanib alone and 10 out of 21 patients receiving nintedanib added to pirfenidone. All adverse events were mild or moderate in intensity. Gastrointestinal disorders were the most common adverse event. Maximum plasma concentration and area under the curve at steady state for nintedanib and its metabolites tended to be lower when nintedanib was added to pirfenidone. Nintedanib had no effect on the pharmacokinetics of pirfenidone. In conclusion, further study is needed to evaluate the safety and tolerability profile of nintedanib when added to pirfenidone in patients with idiopathic pulmonary fibrosis. There was a trend toward lower exposure of nintedanib when it was added to pirfenidone. Copyright © ERS 2015. Source

Maemondo M.,Miyagi Cancer Center | Inoue A.,Tohoku University | Kobayashi K.,International University of Japan | Sugawara S.,Sendai Kousei Hospital | And 19 more authors.
New England Journal of Medicine

BACKGROUND: Non-small-cell lung cancer with sensitive mutations of the epidermal growth factor receptor (EGFR) is highly responsive to EGFR tyrosine kinase inhibitors such as gefitinib, but little is known about how its efficacy and safety profile compares with that of standard chemotherapy. METHODS: We randomly assigned 230 patients with metastatic, non-small-cell lung cancer and EGFR mutations who had not previously received chemotherapy to receive gefitinib or carboplatin-paclitaxel. The primary end point was progression-free survival; secondary end points included overall survival, response rate, and toxic effects. RESULTS: In the planned interim analysis of data for the first 200 patients, progression-free survival was significantly longer in the gefitinib group than in the standard-chemotherapy group (hazard ratio for death or disease progression with gefitinib, 0.36; P<0.001), resulting in early termination of the study. The gefitinib group had a significantly longer median progression-free survival (10.8 months, vs. 5.4 months in the chemotherapy group; hazard ratio, 0.30; 95% confidence interval, 0.22 to 0.41; P<0.001), as well as a higher response rate (73.7% vs. 30.7%, P<0.001). The median overall survival was 30.5 months in the gefitinib group and 23.6 months in the chemotherapy group (P = 0.31). The most common adverse events in the gefitinib group were rash (71.1%) and elevated amino transferase levels (55.3%), and in the chemotherapy group, neutropenia (77.0%), anemia (64.6%), appetite loss (56.6%), and sensory neuropathy (54.9%). One patient receiving gefitinib died from interstitial lung disease. CONCLUSIONS: First-line gefitinib for patients with advanced non-small-cell lung cancer who were selected on the basis of EGFR mutations improved progression-free survival, with acceptable toxicity, as compared with standard chemotherapy. (UMIN-CTR number, C000000376.) Copyright © 2010 Massachusetts Medical Society. Source

Iwasawa T.,Kanagawa Cardiovascular and Respiratory Center
Japanese journal of radiology

We evaluated the relation between the severity of idiopathic pulmonary fibrosis (IPF) and the incidence of pneumothorax on computed tomography (CT) images. In this retrospective study, we evaluated the presence of pneumothorax in 56 consecutive patients who died of IPF from the initial CT to death. We quantitatively analyzed a total of 207 CT images and measured the volume of the normal pattern (N-pattern) and each lesion pattern on the initial CT and their serial changes. The effects of pneumothorax and clinical and CT features on survival were evaluated using Cox regression analysis. Pneumothorax occurred in 17 of 56 patients. Comparison of the pneumothorax (+) and (-) groups showed the initial vital capacity (VC) was lower (P = 0.005) and the follow-up period was shorter (P = 0.03) in the former group. The decrease in the N-pattern volume in the pneumothorax(+) group was significantly faster than in the pneumothorax(-) group (P = 0.013). Cox regression analyses identified a rapid decrease in N-pattern volume (P = 0.008) and a rapid decrease in VC (P = 0.002), but not pneumothorax, as significant predictors of poor survival. Pneumothorax in IPF patients is associated with lower VC and rapid deterioration of CT findings. The findings suggest that pneumothorax is a complication of advanced IPF. Source

Ogata R.,Kanagawa Cardiovascular and Respiratory Center
Nihon Kokyūki Gakkai zasshi = the journal of the Japanese Respiratory Society

A 71-year-old man was referred because of fever and productive cough. His chest radiograph showed a large cavitary mass with an intracavitary mycetoma-like lesion in the left middle lung field. We undertook bronchoscopy and CT-guided biopsy, and both bronchial lavage fluid culture and CT-guided biopsy culture revealed Scedosporium apiospermum. On a diagnosis of lung scedosporiosis, he was treated with 200 mg/day voriconazole for 2 months, but his symptoms did not improve. Measurement of the plasma voriconazole level showed low plasma concentration levels (peak level: 2.15 microg/ml, trough level: 0.72 microg/ml). We then increased the voriconazole dosage from 200 mg/day to 400 mg/day. After that, his symptoms and chest radiograph findings improved immediately, accompanied by an elevated plasma voriconazole level (peak level: 5.13 microg/ml, trough level: 3.13 microg/ml). We believe that measurement of plasma voriconazole levels is useful to determine its dosage in lung scedosporiosis. Source

Tae I.,Kanagawa Cardiovascular and Respiratory Center
Magnetic Resonance in Medical Sciences

Pulmonary arterial hypertension (PAH) is a syndrome that results from restricted blood flow through the pulmonary arterial circulation, which leads to a pathological increase in pulmonary vascular resistance (PVR) and ultimately to right heart failure. The prognosis of patients with PAH has improved with the recent development of new medications. The need for new noninvasive diagnostic tools is increasing. Magnetic resonance (MR) imaging is the gold standard for assessing the right ventricle (RV). Its high degree of reproducibility makes it ideal for monitoring changes in RV parameters in response to therapy. MR imaging can also provide both anatomical and functional information about pulmonary hemodynamics. This article reviews the current status of MR imaging of the right side of the heart and pulmonary circulation in patients with PAH and other associated pulmonary diseases. © 2013 Japanese Society for Magnetic Resonance in Medicine. Source

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