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        Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor (REGATTA): a phase 3, randomised controlled trial

        Fujitani, Kazumasa,Yang, Han-Kwang,Mizusawa, Junki,Kim, Young-Woo,Terashima, Masanori,Han, Sang-Uk,Iwasaki, Yoshiaki,Hyung, Woo Jin,Takagane, Akinori,Park, Do Joong,Yoshikawa, Takaki,Hahn, Seokyung,Na Elsevier 2016 LANCET ONCOLOGY Vol.17 No.3

        <P><B>Summary</B></P> <P><B>Background</B></P> <P>Chemotherapy is the standard of care for incurable advanced gastric cancer. Whether the addition of gastrectomy to chemotherapy improves survival for patients with advanced gastric cancer with a single non-curable factor remains controversial. We aimed to investigate the superiority of gastrectomy followed by chemotherapy versus chemotherapy alone with respect to overall survival in these patients.</P> <P><B>Methods</B></P> <P>We did an open-label, randomised, phase 3 trial at 44 centres or hospitals in Japan, South Korea, and Singapore. Patients aged 20–75 years with advanced gastric cancer with a single non-curable factor confined to either the liver (H1), peritoneum (P1), or para-aortic lymph nodes (16a1/b2) were randomly assigned (1:1) in each country to chemotherapy alone or gastrectomy followed by chemotherapy by a minimisation method with biased-coin assignment to balance the groups according to institution, clinical nodal status, and non-curable factor. Patients, treating physicians, and individuals who assessed outcomes and analysed data were not masked to treatment assignment. Chemotherapy consisted of oral S-1 80 mg/m<SUP>2</SUP> per day on days 1–21 and cisplatin 60 mg/m<SUP>2</SUP> on day 8 of every 5-week cycle. Gastrectomy was restricted to D1 lymphadenectomy without any resection of metastatic lesions. The primary endpoint was overall survival, analysed by intention to treat. This study is registered with UMIN-CTR, number UMIN000001012.</P> <P><B>Findings</B></P> <P>Between Feb 4, 2008, and Sept 17, 2013, 175 patients were randomly assigned to chemotherapy alone (86 patients) or gastrectomy followed by chemotherapy (89 patients). After the first interim analysis on Sept 14, 2013, the predictive probability of overall survival being significantly higher in the gastrectomy plus chemotherapy group than in the chemotherapy alone group at the final analysis was only 13·2%, so the study was closed on the basis of futility. Overall survival at 2 years for all randomly assigned patients was 31·7% (95% CI 21·7–42·2) for patients assigned to chemotherapy alone compared with 25·1% (16·2–34·9) for those assigned to gastrectomy plus chemotherapy. Median overall survival was 16·6 months (95% CI 13·7–19·8) for patients assigned to chemotherapy alone and 14·3 months (11·8–16·3) for those assigned to gastrectomy plus chemotherapy (hazard ratio 1·09, 95% CI 0·78–1·52; one-sided p=0·70). The incidence of the following grade 3 or 4 chemotherapy-associated adverse events was higher in patients assigned to gastrectomy plus chemotherapy than in those assigned to chemotherapy alone: leucopenia (14 patients [18%] <I>vs</I> two [3%]), anorexia (22 [29%] <I>vs</I> nine [12%]), nausea (11 [15%] <I>vs</I> four [5%]), and hyponatraemia (seven [9%] <I>vs</I> four [5%]). One treatment-related death occurred in a patient assigned to chemotherapy alone (sudden cardiopulmonary arrest of unknown cause during the second cycle of chemotherapy) and one occurred in a patient assigned to chemotherapy plus gastrectomy (rapid growth of peritoneal metastasis after discharge 12 days after surgery).</P> <P><B>Interpretation</B></P> <P>Since gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor, gastrectomy cannot be justified for treatment of patients with these tumours.</P> <P><B>Funding</B></P> <P>The Ministry of Health, Labour and Welfare of Japan and the Korean Gastric Cancer Association.</P>

      • SCIESCOPUS

        Randomized Controlled Trial Comparing Gastrectomy Plus Chemotherapy with Chemotherapy Alone in Advanced Gastric Cancer with A Single Non-curable Factor: Japan Clinical Oncology Group Study JCOG 0705 and Korea Gastric Cancer Association Study KGCA01

        Fujitani, K.,Yang, H.-K.,Kurokawa, Y.,Park, D. J.,Tsujinaka, T.,Park, B.-J.,Fukuda, H.,Noh, S. H.,Boku, N.,Bang, Y.-J.,Sasako, M.,Lee, J.-I. Oxford University Press 2008 Japanese journal of clinical oncology Vol.38 No.7

        <P>A randomized controlled trial has started in both Japan and Korea to evaluate the role of gastrectomy in the management of incurable advanced gastric cancer (AGC). Patients with AGC diagnosed as having a single non-curable factor are randomized to gastrectomy plus chemotherapy or chemotherapy alone. Surgeons at 33 specialized centers in Japan and at 15 high-volume hospitals in Korea will recruit 330 patients. Primary end-point is overall survival, and secondary end-points are progression-free survival and adverse events associated with either gastrectomy or chemotherapy.</P>

      • KCI등재
      • KCI등재후보

        MEASUREMENT OF AEROSOLS IN ENGINEERED NANOMATERIALS FACTORIES FOR RISK ASSESSMENT

        YUJI FUJITANI,TAKAHIRO KOBAYASHI 성균관대학교(자연과학캠퍼스) 성균나노과학기술원 2008 NANO Vol.3 No.4

        In relation to potential health risks, there is little available information on exposure to aerosols containing nanometer-size particles in work environments in factories producing engineered nanomaterials. We measured the concentrations and size distributions of particles of nanometer-sized to coarse-sized particles in an engineered carbon nanomaterial factory and a titanium dioxide factory. In addition, particles were collected with a quartz fiber filter in the engineered carbon nanomaterial factory, and their morphology was examined by scanning electron microscopy and their carbon composition was examined with a carbon analyzer. In the carbon nanomaterial factory, the particle number increased to more than 105 cm-3 when a vacuum cleaner was used to clean the inside of the producing device, and the particle number increased for particles with a diameter of about 100 nm compared with the background. This is the only case an increase in particle numbers is observed during this measurement. The emitted particles appear to consist of agglomerates of carbon nanomaterial particles smaller than 100 nm. The major fraction was the EC3 fraction (EC: elemental carbon; combustion at 800°C in a 98:2 He/O2 atmosphere), which is a minor fraction in diesel engine particulate matter. This suggests that the combustion temperature can be used to differentiate atmospheric particulate matter from engineered carbon material. Personal sampling conducted in addition to stationary measurements in the titanium dioxide factory indicated that stationary measurements can be used to generate representative data on the basis of the particle number but not the particle mass.

      • Introduction to "Transcolonial Film Coproductions in the Japanese Empire"

        Takashi Fujitani,Nayoung Aimee Kwon 고려대학교 민족문화연구원 2012 Cross-Currents Vol.- No.5

        The articles in this special issue reflect a new and vibrant transnational milieu in which cultural productions under Japanese colonial rule are increasingly scrutinized from perspectives that exceed and often question uncomplicated narratives of national development, stagnation, or oppression, as well as the binary of collaboration versus resistance. Such works call our attention to the antinomies of modernity under Japanese colonial rule, including the often unexpected continuities between colonialism and nationalism, as well as other postcolonial legacies of the colonial era.

      • KCI등재

        죽일 권리와 살릴 권리

        다카시 후지타니(Takashi Fujitani),박선정(번역자) 고려대학교 아세아문제연구소 2008 亞細亞硏究 Vol.51 No.2

        While it is common to describe Japan and the United States during the Second World War as polar opposites, this essay argues that the material and ideological demands of fighting total war (especially the need to mobilize soldiers and workers; and to achieve dominance in the Asia Pacific) forced the two regimes to incorporate their colonial and minority subjects in strikingly similar ways. In both cases this led to a shift from “exclusionary” to “inclusionary” racism and a movement away from (albeit not the displacement of) what Michel Foucault has described as the deductive logic of the “right to kill” toward the productive logic of the “right to make live.” In keeping with this transformation, racism modulated away from its “vulgar” to a more “polite” form so that even as extreme brutality and violence against segments of these despised populations continued, the governing elite also manifested unprecedented concern for the life, reproduction, welfare, and sometimes even happiness of these same peoples. In an important way the legacy of the total war years remains with us, for as in that earlier moment, racism and its disavowal continue to haunt us in their uneasy compatibility.

      • KCI등재

        日本婦人의 社會的 地位

        富士谷あつ子 淑明女子大學校 亞細亞女性問題硏究所 1971 아시아여성연구 Vol.10 No.-

        When all the nations on earth arc concerning on decreasing population in view of balance between food production and increase of population, Japanese are worrying about depopulation and overproduction of rice. In this sense Japan is a peculiar land. However, this peculiarity is a symbol of unbalance in japanese society which is abruptly modernized, industrialized and grown up in financial circumstances. But this peculiarity exercised deep influence on the social position of Japanese women. High level of culture and pervasive education in Japan played an important role for the improvement of women's social position. This fact was especially striking along with overflow of democracy after the World War and the applying of the new constitutional law and civil law. The pervasive education made women self-awake and gave them an ability to carry family plan into effect. This ability women's life cycle was enlarged by full breath. Also a considerable reserve of finance and energy by electrified accomodation gave them leisure time. Inwardly, there happened to arouse a passion for social participation in women, and at the same time, externally, shortage of hands due to the change of industrial structure made the passion rationalized. In particular, in the field of agriculture as an industry undergone a great change, woman labour is newly discussed. Woman problem, along with the recently closed up consumer movement and the protection from public harm movement should be discussed under the subject of the tendency toward the restoration of humanity. It would be fortunate if the woman problem. in Japan could present data for the resolution of the woman problem in all the in procession toward modernization.

      • KCI등재

        Effect of High β-glucan Barley on Postprandial Blood Glucose and Insulin Levels in Type 2 Diabetic Patients

        ( Yukie Fuse ),( Mariko Higa ),( Naoko Miyashita ),( Asami Fujitani ),( Kaoru Yamashita ),( Takamasa Ichijo ),( Seiichiro Aoe ),( Takahisa Hirose ) 한국임상영양학회 2020 Clinical Nutrition Research Vol.9 No.1

        The aim of our study was to investigate whether high β-glucan-containing barley (7.2 g per 100 g) improves postprandial plasma glucose levels and suppresses postprandial insulin levels during a meal tolerance test in type 2 diabetic patients. A meal tolerance test (500 kcal) was conducted using two types of test meals: a test meal with white rice (WR) alone (WR diet) and a test meal with WR mixed with 50% barley (BR diet) as staple food. The side dish was the same in the both meals. The changes in plasma glucose and serum C-peptide immunoreactivity (CPR) levels for 180 minutes after ingestion of the test meals were compared. Ten patients with type 2 diabetes (age 52.5 ± 15.1 years, and 7 males and 3 females) were included in this study. The mean HbA1c level and body mass index were 8.8 ± 1.4%, and 29.7 ± 4.5 kg/m<sup>2</sup>, respectively. Plasma glucose levels after ingestion of the WR diet or BR diet peaked at 60 minutes, which showed no significant differences between the two types of test meals. However, the incremental area under the curve (IAUC) of plasma glucose levels after ingestion of BR diet was significantly lower than that of WR diet. The serum CPR levels at 180 min and their IAUC over 180 minutes after ingestion of BR diet were significantly lower than those of WR diet. Conclusion: Increase in postprandial plasma glucose and insulin levels was suppressed by mixing high-β-glucan barley with WR in type 2 diabetic patients.

      • SCOPUS

        Financial Reporting Opacity, Audit Quality and Crash Risk: Evidence from Japan

        CHAE, Soo-Joon,NAKANO, Makoto,FUJITANI, Ryosuke Korea Distribution Science Association 2020 The Journal of Asian Finance, Economics and Busine Vol.7 No.1

        This study examines the effect of financial reporting opacity and audit quality on stock price crash risk using listed firms in Japan. This study is the first research to examine the effect of financial reporting opacity on crash risk using a Japanese listed company. Furthermore, the effect of audit quality on crash risk is verified. High level auditors can mitigate crash risk by playing a role as a corporate governance device mechanism to reduce agency costs. We use a logistic regression and linear regression model to test whether financial reporting opacity and audit quality affect crash risk using listed firms in the Japanese stock exchange market during the fiscal years 2015 January through 2017 February. The results of this study suggest that the financial reporting opacity variable shows a positive relationship with CRASH, which states that a firm with more opaque financial reporting increases crash risk. The results suggest also that the firms audited by Big4 auditors experience less crash risk, implying that the audit quality in Japan can be one of the factors mitigating firm's crash risk. This study provides implications for financial reporting and audit quality to external stakeholders who wants to avoid losses.

      • KCI등재

        Effect of High β-glucan Barley on Postprandial Blood Glucose Levels in Subjects with Normal Glucose Tolerance: Assessment by Meal Tolerance Test and Continuous Glucose Monitoring System

        ( Mariko Higa ),( Yukie Fuse ),( Naoko Miyashita ),( Asami Fujitani ),( Kaoru Yamashita ),( Takamasa Ichijo ),( Seiichiro Aoe ),( Takahisa Hirose ) 한국임상영양학회 2019 Clinical Nutrition Research Vol.8 No.1

        The effect of white rice (WR) mixed with high β-glucan-containing barley at 50% on improvement of postprandial blood glucose levels was assessed by meal tolerance test and continuous glucose monitoring (CGM) in 15 healthy subjects with normal glucose tolerance (age 31.6 ± 12.9 years old, 4 males and 11 females). A meal tolerance test (500 kcal) was conducted using 2 types of test meals: a test meal only with WR and a test meal WR mixed 50% barley, and the side dish was the same in both meals. Blood glucose levels of the subjects 180 minutes after ingestion of the test meals were compared. In addition, a CGM device was attached to the subjects for 2 days when the WR or barley as a staple food was provided 3 times a day for consecutive days, and the daily variation of glucose was investigated. The glucose levels 30 minutes after dietary loads and the area under the blood concentration-time curve over 180 minutes were significantly decreased in the barley consumption group. In CGM, 24-hour mean blood glucose and 24-hour standard deviation of blood glucose were also significantly decreased after ingestion of the barley. Postprandial glucose level elevation was suppressed by mixing high-β-glucan barley with WR in subjects with normal glucose tolerance.

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