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Arima T.,Funabashi Municipal Medical Center | Nagata O.,Cancer Institute Hospital of JFCR | Miura T.,Funabashi Municipal Medical Center | Ikeda K.,Funabashi Municipal Medical Center | And 3 more authors.
American Journal of Emergency Medicine | Year: 2014

Study objective This study sought to determine and compare the utility of the Airway scope (AWS; Pentax Corporation, Tokyo, Japan) and the conventional Macintosh laryngoscope (MLS) for intubation in the prehospital setting. Methods In this randomized controlled trial in the prehospital setting, the primary outcome was time required for intubation, and the secondary outcomes were ultimate success, first attempt success, and difficulty of intubation. The intent-to-treat principle was used to analyze time to intubation. Ultimate success was defined as intubation completed within 600 s regardless of the device ultimately used. Results A total of 109 patients, primarily with cardiac arrest, were randomly assigned to the AWS or MLS arms. Median time (interquartile range) to intubation was 155 (71-216) s with the AWS versus 120 (60-170) s with the MLS (P =.095). Ultimate success rate was slightly lower with the AWS (96.4%) than with the MLS (100%) (P =.496), while the first attempt success rate was significantly lower (46% and 75%, respectively; P =.002). There was no significant difference in difficulty of intubation (P =.066). Multivariate logistic regression analysis revealed that cervical immobilization and oral contamination, such as vomit, was associated with first attempt success (odds ratio [95% confidence interval]: 0.11 [0.01-0.87] and 0.43 [0.18-0.99], respectively). Conclusion Despite its many advantages seen in other settings, the AWS did not show superior efficacy to the MLS in relation to time required for intubation, ultimate or first attempt success rate, or difficulty level of intubation in the prehospital setting. © 2013 Elsevier Inc. Source


Mukai H.,National Cancer Center Hospital East | Takahashi S.,Cancer Institute Hospital of JFCR | Nozawa M.,Kinki University | Onozawa Y.,Shizuoka Cancer Center | And 3 more authors.
Cancer Chemotherapy and Pharmacology | Year: 2014

Purpose: The purpose of the study is to analyze the pharmacokinetic (PK) profile of cabazitaxel and evaluate its safety and tolerability as a 1-h IV infusion every 3 weeks in Japanese patients with castration-resistant prostate cancer (CRPC). Methods: Seventeen patients were treated with cabazitaxel at doses of 20 and 25 mg/m2 for PK analyses. Dose escalation was performed only in the absence of dose-limiting toxicity (DLT). The maximum tolerated dose (MTD) was the highest dose at which less than 33 % of the patients developed DLT. Results: Cabazitaxel exhibited a triphasic elimination profile with a long terminal half-life of 116 ± 29.0 or 113 ± 28.0 h after IV infusion of 20 or 25 mg/m2 cabazitaxel, respectively. The major differences in the PK parameters of cabazitaxel and docetaxel were cabazitaxel's fairly high clearance rate, representing approximately half the hepatic flow, and its large volume of distribution at steady-state conditions. No DLT was observed during Cycle 1. Mild-to-moderate hematological adverse events (AEs), including neutropenia, and other AEs typically associated with taxanes were observed; all AEs were manageable. Cabazitaxel at 25 mg/m 2 every 3 weeks was selected as the MTD in Japanese patients. Conclusions: The PK parameters of cabazitaxel in Japanese CRPC patients were comparable with those previously determined in Caucasian subjects. The safety and tolerability of cabazitaxel were also comparable in both ethnic populations. © 2014 Springer-Verlag Berlin Heidelberg. Source


Sogabe Y.,Mitoyo General Hospital | Ohshima K.-I.,National Hospital Organization Okayama Medical Center | Azumi A.,Kobe Kaisei Hospital | Takahira M.,Kanazawa University | And 4 more authors.
Graefe's Archive for Clinical and Experimental Ophthalmology | Year: 2014

Background: It is well-known that the lacrimal gland (LG) may be affected in IgG4-related ophthalmic disease (IgG4ROD). Recently, IgG4-related ophthalmic lesions other than those of the lacrimal gland have been reported. However, no study to date has revealed the details of these lesions. This study was conducted to evaluate the location and frequency of lesions found in conjunction with IgG4ROD using radiological imaging. Methods: Radiological images and clinical records of 65 patients collected from seven institutions in Japan were reviewed retrospectively. All patients had been pathologically diagnosed with IgG4ROD. Patients of mucosa-associated lymphoid tissue lymphoma associated with IgG4-related lesions were excluded. Orbital magnetic resonance imaging or computed tomography findings were evaluated. Results: Of the 65 patients, 31 (47.7 %) had lesions involving the LG alone, whereas 34 (52.3 %) had lesions involving the areas other than LG, including eight patients who had lesions without any LG involvement. IgG4-related ophthalmic lesions included LG enlargement in 57 patients (87.7 %), trigeminal nerve branch enlargement in 25 (38.5 %), extraocular muscle enlargement in 16 (24.6 %), diffuse orbital fat lesions in 15 (23.1 %), orbital mass lesions in 11 (16.9 %), eyelid lesions in eight (12.3 %), and nasolacrimal duct lesion in one (1.5 %). Six patients (9.2 %) presented with visual disturbance due to optic nerve disturbance, eight (12.3 %) with a restriction of ocular movement, and 19 (29.2 %) with exophthalmos. Conclusions: Thirty-four (52.3%) of the 65 IgG4ROD patients had lesions in areas other than LG. Lesions were found in the trigeminal nerve branch including pterygopalatine fossa, extraocular muscles, orbital fat, eyelid, and nasolacrimal duct. © Springer-Verlag 2014. Source


Nishio M.,Cancer Institute Hospital of JFCR
Japanese Journal of Lung Cancer | Year: 2015

Purpose. Maintenance therapy has become a new paradigm of treatment for advanced non-small cell lung cancer (NSCLC), and several clinical trials of maintenance regimens have been reported. In this session, we reviewed recently updated data for these trials and clarified the standard maintenance therapy regimen for advanced NSCLC. Results. The updated overall survival (OS) results of the AVAPERL study, which evaluated cisplatin-pemetrexed (PEM)-bevacizumab (Bev) followed by maintenance PEM and Bev did not show any significant survival benefits for this regimen against cisplatin-PEM-Bev (HR 0.88, 95%CI: 0.64-1.22, p=0.32). The PointBreak study, which compared carboplatin-PEM-Bev followed by maintenance Bev and PEM to carboplatin+ paclitaxel+Bev did not meet the primary endpoint of OS, although the progression free survival (PFS) was significantly prolonged. In addition, the PRONOUNCE study was unable to demonstrate the superiority of carboplatin-PEM followed by maintenance PEM over carboplatin+paclitaxel+Bev in terms of PFS without Grade 4 adverse events. Conclusions. The results of recent clinical trials are not adequate to change the standard regimen of maintenance therapy for advanced NSCLC. Cisplatin-PEM followed by maintenance PEM or carboplatin+ paclitaxel+Bev remains the standard regimen. © 2014 The Japan Lung Cancer Society. Source


Kubota K.,Nippon Medical School | Sakai H.,Saitama Cancer Center | Katakami N.,Institute of Biomedical Research and Innovation | Nishio M.,Cancer Institute Hospital of JFCR | And 16 more authors.
Annals of Oncology | Year: 2015

Background: Platinum-based two-drug combination chemotherapy has been standard of care for patients with advanced nonsmall-cell lung cancer (NSCLC). The primary aim was to compare overall survival (OS) of patients with advanced NSCLC between the two chemotherapy regimens. Secondary end points included progression-free survival (PFS), response, safety, and quality of life (QoL). Patients and methods: Patients with previously untreated stage IIIB or IV NSCLC, an Eastern Cooperative Oncology Group performance status of 0-1 and adequate organ function were randomized to receive either oral S-1 80 mg/m2/day on days 1-21 plus cisplatin 60 mg/m2 on day 8 every 4-5 weeks, or docetaxel 60 mg/m2 on day 1 plus cisplatin 80 mg/m2 on day 1 every 3-4 weeks, both up to six cycles. Results: A total of 608 patients from 66 sites in Japan were randomized to S-1 plus cisplatin (n = 303) or docetaxel plus cisplatin (n = 305). OS for oral S-1 plus cisplatin was noninferior to docetaxel plus cisplatin [median survival, 16.1 versus 17.1 months, respectively; hazard ratio = 1.013; 96.4% confidence interval (CI) 0.837-1.227]. Significantly higher febrile neutropenia (7.4% versus 1.0%), grade 3/4 neutropenia (73.4% versus 22.9%), grade 3/4 infection (14.5% versus 5.3%), and grade 1/2 alopecia (59.3% versus 12.3%) were observed in the docetaxel plus cisplatin than in the S-1 plus cisplatin. There were no differences found in PFS or response between the two arms. QoL data investigated by EORTC QLQ-C30 and LC-13 favored the S-1 plus cisplatin. Conclusion: Oral S-1 plus cisplatin is not inferior to docetaxel plus cisplatin and is better tolerated in Japanese patients with advanced NSCLC. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Source

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