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Shimoyama N.,Jikei University School of Medicine | Gomyo I.,Saito Yukoukai Hospital | Gomyo I.,Red Cross | Katakami N.,Institute of Biomedical Research and Innovation Hospital | And 4 more authors.
International Journal of Clinical Oncology | Year: 2015

Background: Breakthrough cancer pain typically has a rapid onset and relatively short duration. Due to this temporal profile, it may not be adequately relieved by oral opioid analgesics. The sublingual fentanyl orally disintegrating tablet is a formulation by which fentanyl can be rapidly absorbed across the oral mucosa producing rapid-onset analgesia, and which may be effective for breakthrough pain treatment. Methods: A multicenter, randomized, placebo-controlled, double-blind comparative study was conducted to evaluate the efficacy and safety of the sublingual fentanyl tablet at optimized doses for breakthrough pain treatment in cancer patients treated with strong opioid analgesics at fixed intervals. The optimal dose was determined by open-label dose titration. The efficacy and safety of a 12-week extended treatment were also evaluated. Results: Eleven of 42 subjects who received the sublingual fentanyl tablet experienced adverse drug reactions. Common reactions were somnolence, constipation, nausea, and vomiting. No serious adverse reactions occurred. Sublingual fentanyl tablets at optimal doses and placebo were administered to 37 subjects in a double-blinded manner. A significant analgesic effect of the sublingual fentanyl tablet was present compared to placebo at 30 min after administration. The sublingual fentanyl tablet was also effective and safe during extended treatment, in which changes in basal opioid doses as well as sublingual fentanyl tablet doses were made as needed. Conclusion: Sublingual fentanyl tablets at doses determined by titration were effective and safe for breakthrough pain treatment in cancer patients treated with strong opioid analgesics at fixed intervals. Extended treatment up to 12 weeks was also effective and safe. © 2014, Japan Society of Clinical Oncology.


Nakagomi T.,Hyogo College of Medicine | Molnar Z.,University of Oxford | Taguchi A.,Institute of Biomedical Research and Innovation Hospital | Nakano-Doi A.,Hyogo College of Medicine | And 5 more authors.
Stem Cells and Development | Year: 2012

Increasing evidence indicates that neural stem/progenitor cells (NSPCs) reside in many regions of the central nervous system (CNS), including the subventricular zone (SVZ) of the lateral ventricle, subgranular zone of the hippocampal dentate gyrus, cortex, striatum, and spinal cord. Using a murine model of cortical infarction, we recently demonstrated that the leptomeninges (pia mater), which cover the entire cortex, also exhibit NSPC activity in response to ischemia. Pial-ischemia-induced NSPCs expressed NSPC markers such as nestin, formed neurosphere-like cell clusters with self-renewal activity, and differentiated into neurons, astrocytes, and oligodendrocytes, although they were not identical to previously reported NSPCs, such as SVZ astrocytes, ependymal cells, oligodendrocyte precursor cells, and reactive astrocytes. In this study, we showed that leptomeningeal cells in the poststroke brain express the immature neuronal marker doublecortin as well as nestin. We also showed that these cells can migrate into the poststroke cortex. Thus, the leptomeninges may participate in CNS repair in response to brain injury. Copyright © 2012, Mary Ann Liebert, Inc. 2012.


Fujita S.,Institute of Biomedical Research and Innovation Hospital | Katakami N.,Institute of Biomedical Research and Innovation Hospital | Masago K.,Kyoto University | Yoshioka H.,Kurashiki Central Hospital | And 6 more authors.
BMC Cancer | Year: 2012

Background: Elderly patients are more vulnerable to toxicity from chemotherapy. Activating epidermal growth factor receptor (EGFR) mutations in non-small-cell lung cancer (NSCLC) are associated with enhanced response to EGFR tyrosine-kinase inhibitors. We studied patients with advanced NSCLC for whom treatment was customized based on EGFR mutation status.Methods: We screened 57 chemotherapy-naïve patients with histologically or cytologically confirmed NSCLC, stage IIIB or IV, aged 70 years or older, and with an Eastern Cooperative Oncology Group performance status 0 or 1, for EGFR exon 19 codon 746-750 deletion and exon 21 L858R mutation. Twenty-two patients with EGFR mutations received gefitinib; 32 patients without mutations received vinorelbine or gemcitabine. The primary endpoint was the response rate.Results: The response rate was 45.5% (95% confidence interval [CI]: 24.4%, 67.8%) in patients with EGFR mutations and 18.8% (95% CI: 7.2%, 36.4%) in patients without EGFR mutations. The median overall survival was 27.9 months (95%CI: 24.4 months, undeterminable months) in patients with EGFR mutations and 14.9 months (95%CI: 11.0 months, 22.4 months) in patients without EGFR mutations. In the gefitinib group, grade 3/4 hepatic dysfunction and dermatitis occurred in 23% and 5% of patients, respectively. In patients treated with vinorelbine or gemcitabine, the most common grade 3 or 4 adverse events were neutropenia (47%; four had febrile neutropenia), anemia (13%), and anorexia (9%). No treatment-related deaths occurred.Conclusions: Treatment customization based on EGFR mutation status deserves consideration, particularly for elderly patients who often cannot receive second-line chemotherapy due to poor organ function or comorbidities.Trial registration: This trial is registered at University hospital Medical Information Network-clinical trial registration (http://www.umin.ac.jp/ctr/index/htm) with the registration identification number C000000436. © 2012 Fujita et al.; licensee BioMed Central Ltd.


Goto K.,National Cancer Center Hospital East | Nishio M.,The Cancer Institute Hospital of the Japanese Foundation for Cancer Research | Yamamoto N.,National Cancer Center Hospital | Chikamori K.,National Hospital Organization | And 8 more authors.
Lung Cancer | Year: 2013

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. The primary endpoints were progression-free survival (PFS) and safety. Results: A high degree of concordance was observed between different mutation testing methodologies, suggesting feasibility of early, rapid detection of EGFR mutations. Median PFS was 11.8 months (95% confidence interval [CI]: 9.7-15.3) at data cut-off (1 June 2012) (n= 102). Exon 19 deletions seemed to be associated with longer PFS compared with L858R mutations; T790M mutations were tentatively linked with shorter PFS. The safety profile was as expected: rash (any grade; 83%) and diarrhea (any grade; 81%) were most common. Six interstitial lung disease (ILD)-like cases were reported, and 5 were confirmed as ILD-like events by the extramural committee. Two patients died of treatment-related pneumonitis (JAPIC Clinical Trials Information number: Japic CTI-101085). Conclusion: Erlotinib should be considered for first-line treatment in this subset of Japanese patients, with close monitoring for ILD-like events. © 2013 The Authors.


Shimozono M.,Kobe City Medical Center General Hospital | Oishi A.,Kobe City Medical Center General Hospital | Oishi A.,Institute of Biomedical Research and Innovation Hospital | Hata M.,Kobe City Medical Center General Hospital | And 2 more authors.
Graefe's Archive for Clinical and Experimental Ophthalmology | Year: 2011

Background: To evaluate the prognostic value of foveal microstructures as determined using spectral-domain optical coherence tomography (SD-OCT) in eyes with surgically closed macular holes (MHs). Methods: Thirty eyes of 30 patients that underwent successful vitrectomy for idiopathic MHs were studied. Best-corrected visual acuity (BCVA) and SD-OCT images of the fovea were examined preoperatively and at 2 weeks, 1, 3, and 6 months postoperatively. The SD-OCT characteristics evaluated included MH diameter, external limiting membrane (ELM) defect diameter, photoreceptor inner/outer segment (IS/OS) junction defect diameter, the presence or absence of subretinal fluid (SRF), central foveal thickness (CFT), and outer foveal thickness (the distance between the ELM and the inner border of the retinal pigment epithelium). The correlations between SD-OCT parameters and BCVA were analyzed. Results: The IS/OS junction defect diameter was most strongly correlated with BCVA at 2 weeks and 1 month postoperatively while outer foveal thickness showed the strongest correlation with BCVA at 3 and 6 months. Outer foveal thickness gradually increased over the follow-up period. Among the pre- and early postoperative quantitative parameters, the only significant predictors of BCVA at 6 months were the IS/OS junction defect diameter and outer foveal thickness at 2 weeks (p=0.012, p=0.018, respectively). Disrupted ELM at 2 weeks was also associated with significantly poorer BCVA at 6 months (p<0.001). Conclusions: An increase in outer foveal thickness, indicating photoreceptor outer segment restoration, is an important factor for visual recovery after MH surgery. © 2011 Springer-Verlag.


Shimozono M.,Kobe City Medical Center General Hospital | Uemura A.,Kobe City Medical Center General Hospital | Uemura A.,Institute of Biomedical Research and Innovation Hospital | Hirami Y.,Kobe City Medical Center General Hospital | And 4 more authors.
Journal of Refractive Surgery | Year: 2010

PURPOSE: To investigate the distribution of corneal spherical aberration in Japanese eyes with cataract for implantation of aspheric intraocular lenses (IOLs). METHODS: Corneal spherical aberration (Zernike coefficient Z 0 4) in the central 6-mm zone was measured with a wavefront analyzer (KR9000PW, Topcon) in 257 eyes of 168 Japanese patients with cataract. Axial length was also measured for each eye. RESULTS: Mean corneal spherical aberration was 0.203±0.100 μm (range: -0.103 to 0.497 μm). A significant negative correlation was found between axial length and corneal spherical aberration (r=-0.135, P=.036). CONCLUSIONS: Corneal spherical aberration varied among cataract patients and correlated with axial length. Japanese patients showed a relatively smaller corneal spherical aberration than previous studies of Caucasians. Preoperative measurement of wavefront aberrations is thus important in using aspheric IOLs. Copyright © SLACK Incorporated.


Shimozono M.,Kobe City Medical Center General Hospital | Oishi A.,Kobe City Medical Center General Hospital | Oishi A.,Institute of Biomedical Research and Innovation Hospital | Hata M.,Kobe City Medical Center General Hospital | And 6 more authors.
American Journal of Ophthalmology | Year: 2012

Purpose: To evaluate the prognostic value of the cone outer segment tips (COST) and other features using spectral-domain optical coherence tomography (SD-OCT) in patients undergoing epiretinal membrane (ERM) surgery. Design: Retrospective observational case series. Methods: Fifty eyes of 49 patients that underwent vitrectomy for idiopathic ERM were studied. Best-corrected visual acuity (BCVA) and SD-OCT images were examined preoperatively and at 1 and 6 months postoperatively. The SD-OCT features evaluated included central foveal thickness (CFT) and the status and defect diameter of the external limiting membrane (ELM), the photoreceptor inner/outer segment (IS/OS) junction, and the COST line. The associations between SD-OCT parameters and BCVA were analyzed. Results: There was no ELM disruption found, and thus the eyes were categorized into 3 groups: Group A, with a continuous IS/OS and COST line; Group B, with a continuous IS/OS but disrupted COST line; and Group C, with a disrupted IS/OS and COST line. At 6 months, Group A showed a significantly better BCVA than Group B (P <.005), and poorer BCVA was noted in Group C (P =.034). Defect diameters of IS/OS and COST line were also significantly correlated with BCVA postoperatively. The BCVA at 6 months was better in order of Group A, B, and C as assigned at baseline (P <.05) or 1 month (P <.001). There was no significant correlation between CFT and BCVA. Conclusions: The status of the COST line, in conjunction with the IS/OS junction, is a useful prognostic factor after ERM surgery. © 2012 Elsevier Inc.


Saito H.,Aichi Cancer Center Research Institute | Yoshizawa H.,Niigata University | Yoshimori K.,Fukujuji Hospital | Katakami N.,Institute of Biomedical Research and Innovation Hospital | And 3 more authors.
Annals of Oncology | Year: 2013

Background: We evaluated the efficacy and safety of single-dose fosaprepitant in combination with intravenous granisetron and dexamethasone. Patients and methods: Patients receiving chemotherapy including cisplatin (≥70 mg/m. 2) were eligible. A total of 347 patients (21% had received cisplatin with vomiting) were enrolled in this trial to receive the fosaprepitant regimen (fosaprepitant 150 mg, intravenous, on day 1 in combination with granisetron, 40 μg/kg, intravenous, on day 1 and dexamethasone, intravenous, on days 1-3) or the control regimen (placebo plus intravenous granisetron and dexamethasone). The primary end point was the percentage of patients who had a complete response (no emesis and no rescue therapy) over the entire treatment course (0-120 h). Results: The percentage of patients with a complete response was significantly higher in the fosaprepitant group than in the control group (64% versus 47%, P = 0.0015). The fosaprepitant regimen was more effective than the control regimen in both the acute (0-24 h postchemotherapy) phase (94% versus 81%, P = 0.0006) and the delayed (24-120 h postchemotherapy) phase (65% versus 49%, P = 0.0025). Conclusions: Single-dose fosaprepitant used in combination with granisetron and dexamethasone was well-tolerated and effective in preventing chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic cancer chemotherapy, including high-dose cisplatin. © The Author 2012.


PubMed | Kobe City Medical Center General Hospital and Institute of Biomedical Research and Innovation Hospital
Type: | Journal: Head & neck | Year: 2016

The efficacy of posttreatment surveillance (18) F-fluorodeoxyglucose positron emission tomography ((18) F-FDG PET)/CT was evaluated in patients with head and neck squamous cell carcinoma (HNSCC).The subjects were 158 patients with HNSCC who underwent PET/CT after definitive treatment. PET/CT detection of subclinical recurrence or a second primary cancer and the effect of timing of PET/CT scans on survival were analyzed.Recurrence or a second primary cancer occurred in 70 patients, and 67% of these cases were detected by PET/CT. Detection rates were 17%, 9%, 5%, and 5% in the first, second, third, and fourth scans at 4, 9, 15, and 21 months, respectively. In multivariate analysis, patients who underwent early first scans had significantly better disease-specific (hazard ratio [HR]=0.37; p=.031) and overall (HR=0.45; p=.040) survival compared with those who underwent late first scans.Earlier detection of subclinical lesions by surveillance PET/CT within 4 months after treatment may improve survival in patients with HNSCC. 2015 Wiley Periodicals, Inc. Head Neck 38: E511-E518, 2016.


Kuriyama T.,Institute of Biomedical Research and Innovation Hospital
Nihon Hoshasen Gijutsu Gakkai zasshi | Year: 2012

We made the fusion image of both stent and platinum coil after embolization of an unruptured aneurysm. After scanning with cone beam computed tomography, we made three dimensional (3D) images of stent and coil and fused them. We can evaluate unruptured aneurysm after embolization by using a fusion image. 3D-fusion image is useful on clinical cases.

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