Details of a Researcher - HINOTSU Shiro

Papers - HINOTSU Shiro

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Sixth Joint Meeting of J-CaP and CaPSUREuA Multinational Perspective on Prostate Cancer Management and Patient Outcomes

Hideyuki Akaza, Shiro Hinotsu, Matthew R. Cooperberg, Byung-Ha Chung, Ji Youl Lee, Rainy Umbas, Taiji Tsukamoto, Mikio Namiki, Peter Carroll

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 43 ( 7 ) 756 - 766 2013.07 [Refereed]

This report summarizes the presentations and discussions that took place at the Sixth Joint Meeting of J-CaP and CaPSURE held in San Francisco, USA, in August 2012. The J-CaP and CaPSURE Joint Initiative was established in 2007 with the objective of analyzing, reviewing, comparing and contrasting data for prostate cancer patients from Japan and the USA within the two important large-scale, longitudinal, observational databasesuJ-CaP and CaPSURE. Since this initial collaboration between teams in the USA and Japan, the initiative has now expanded to include representatives of other Asian countries, several of whom have either established or are planning their own national prostate cancer databases. Several key topics were considered at this Sixth Joint Meeting including the current status of the J-CaP and CaPSURE databases and opportunities for collaboration with the more recently developed Asian prostate cancer databases. The latest comparative data from J-CaP and CaPSURE regarding outcomes following androgen deprivation therapy and combined androgen blockade were also reviewed. The possibility of a global chemoprevention trial to investigate the influence of soy isoflavones on prostate cancer incidence was considered. In addition, the ongoing debate regarding the role of screening and the use of active surveillance as a treatment option in the USA was discussed. The collaborators agreed that sharing of data and treatment practices on a global scale would undoubtedly benefit the clinical management of prostate cancer patients worldwide.

DOI PubMed

Economic evaluation of pravastatin for primary prevention of coronary artery disease based on risk prediction from JALS-ECC in Japan

Yoshie Onishi, Shiro Hinotsu, Yoko M. Nakao, Hisashi Urushihara, Koji Kawakami

Value in Health Regional Issues 2 ( 1 ) 5 - 12 2013.05 [Refereed]

Objectives: The clinical efficacy of 3-hydroxy-3-methyl-glutaryl-CoA (HMG-CoA) reductase inhibitor (statin) therapy in cardiovascular disease has been established in clinical trials. Nonetheless, it is unclear to whom and when statin treatment should be initiated for patients without cardiovascular disease with regard to overall absolute risk reduction of cardiovascular disease and the cost-effectiveness of long-term statin therapy. The objective of this study was to examine the cost-effectiveness of pravastatin 10 mg/d compared with no-drug therapy for primary prevention of coronary artery disease (CAD), using cardiac risk factors from risk predictions for CAD from Japanese cohort studies. Methods: A Markov transition model was used to evaluate the cost-effectiveness of pravastatin compared with no-drug therapy. The incidence of acute myocardial infarction was estimated by using risk predictions for CAD in Japan. A hypothetical population from 45 to 75 years old was examined by using the cardiac risk factors. Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio over a lifetime horizon were estimated from a perspective of payers. Results: Incremental cost-effectiveness ratios of pravastatin therapy compared with no-drug therapy were 9,677,000 yen per QALY in 55-year-old men and 8,648,000 yen per QALY in 65-year-old men with diabetes mellitus, hypertension (grade II), and smoking as cardiac risk factors. Pravastatin therapy was not cost-effective compared with no-drug therapy in all subgroups evaluated. Conclusions: Using risk prediction for CAD based on a Japanese cohort with no history of cardiovascular events, the cost-effectiveness of pravastatin for primary prevention of CAD may not be cost-effective in populations at both low and high cardiac risk. © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

DOI PubMed

Socioeconomic advantages of longer screening intervals for men with low prostate-specific antigen levels in prostate cancer mass screening

Takashi Kobayashi, Rei Goto, Shiro Hinotsu, Osamu Ogawa

Acta Urologica Japonica 59 ( 3 ) 159 - 166 2013.03 [Refereed]

In prostate specific antigen (PSA)-based prostate cancer mass screening, the optimal re-screening interval is still in question, although guidelines suggest that a prolonged interval would be safe and cost-saving. We examined the socioeconomic feasibility of prolonged re-screening interval based on individual baseline PSA values. Markov decision-analytic models of prostate cancer screening were established for cost-effectiveness comparison of prolonged re-screening in men with low (≤ 1 ng/ml) PSA level (metainterval strategy) and annual re-screening in every participant (control strategy). Effectiveness and socioeconomic feasibility were evaluated according to quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER Δ cost per Δ QALY), respectively. As a result, outcomes including cancer detection rates and stage shift suggested that these models well recapitulated actual prostate cancer mass screening. The meta-interval strategy was more cost-effective than the control strategy. The ICER for the control strategy with respect to the meta-interval strategy exceeded US$62,000/QALY through the sensitivity analyses for every assumption. The meta-interval strategy was more effective and less expensive if the trade-off of impaired clinical outcomes caused by delayed detection was small. In conclusion, our models suggest that the meta-interval strategy is more cost-effective than annual screening. It can be even more effective if the interval is determined appropriately such that cancer can be detected within the therapeutic window.

PubMed

Randomized controlled study of natural interferon α as adjuvant treatment for stage II or III renal cell carcinoma

Shiro Hinotsu, Koji Kawai, Seiichiro Ozono, Tomoyasu Tsushima, Noriaki Tokuda, Koichiro Nomata, Seiji Naito, Hideyuki Akaza

International Journal of Clinical Oncology 18 ( 1 ) 68 - 74 2013.02 [Refereed]

Background: The prophylactic effect of postoperative interferon on recurrence and distant metastasis in stage II or III renal cell carcinoma is unclear. In most studies, interferon has been administered for 6 months or less. Therefore, we performed a clinical study of the efficacy of 1-year postoperative administration of natural interferon α, which is generally used in Japan. Methods: The subjects were patients diagnosed with stage II or III renal cell carcinoma who underwent radical nephrectomy. The subjects were randomly allocated to receive an intramuscular injection of natural interferon α (3 million to 6 million units) 3 times a week for 1 year or to receive follow-up observation until recurrence or metastasis occurred. Chest and abdominal CT were performed once yearly for all patients. The primary endpoint was progression-free survival. Results: From September 2001 to August 2006, a total of 107 patients were registered, but 7 subsequently withdrew from the study. Therefore, 100 patients were included in the analysis. The primary endpoint of progression-free survival did not differ significantly between the groups that received natural interferon α or follow-up observation (p = 0.456, log-rank test). However, peak hazards of progression in the interferon group were delayed for about 6-10 months compared with the observation group. Conclusion: Progression-free survival showed no improvement after administration of natural interferon α to patients with stage II or III renal cell carcinoma for 1 year after radical nephrectomy. The peak hazards of progression might be delayed by about 6 months by interferon administration. © 2011 Japan Society of Clinical Oncology.

DOI PubMed

Predictive value of clinical chorioamnionitis in extremely premature infants

Hironobu Tokumasu, Shiro Hinotsu, Fumiyo Kita, Koji Kawakami

PEDIATRICS INTERNATIONAL ( WILEY-BLACKWELL ) 55 ( 1 ) 35 - 38 2013.02 [Refereed]

Background Clinical chorioamnionitis and histological chorioamnionitis are important risk factors for neonatal complications and neurodevelopmental impairment in premature infants. It is unclear, however, whether a diagnosis of clinical chorioamnionitis is sufficient to establish a diagnosis of histological chorioamnionitis. The aim of this study was to evaluate the predictive value of clinical chorioamnionitis in the diagnosis of histological chorioamnionitis in extremely premature infants. Methods This study was a secondary analysis of data from the Neonatal Research Network in Japan, a population-based cohort study aimed at identifying the clinical characteristics and morbidity of very low-birthweight infants. Data for extremely premature infants <28weeks' gestational age from 2003 to 2007, were used. Subset analysis investigated positive predictive value by gestational age. Results Of the 2470 infants analyzed, 786 were diagnosed with clinical chorioamnionitis and 1129 with histological chorioamnionitis. The positive predictive value of clinical chorioamnionitis for histological chorioamnionitis was 86.6% (681/786; 95% confidence interval [CI]: 84.488.6%), sensitivity was 60.3% (681/1129; 95%CI: 58.861.7%), and specificity was 92.2% (1236/1341; 95%CI: 90.993.3%). In subset analysis, the positive predictive value was particularly high at 23weeks of gestation (89.1%; 115/129), with sensitivity of 65.3% (115/176) and specificity of 89.6% (120/134). Conclusions The finding that clinical chorioamnionitis is a useful predictor of histological chorioamnionitis provides important insights into the relationship between these two diagnoses, and has important implications in determining the appropriate timing of delivery of extremely premature infants.

DOI PubMed

A survey of physicians' understanding of the regulatory systems for clinical trials in japan.

Yamauchi Y, Kawashima Y, Urushihara H, Uosaki F, Kobayashi Y, Hinotsu S, Nakagawa M, Kawakami K

General Medicine 14(2) 92-103 2013.02 [Refereed]

Cross-National Comparison of Medical Costs Shared by Payers and Patients: A Study of Postmenopausal Women with Early-Stage Breast Cancer Based on Assumption Case Scenarios and Reimbursement Fees

Shota Hamada, Shiro Hinotsu, Hiroshi Ishiguro, Masakazu Toi, Koji Kawakami

BREAST CARE ( KARGER ) 8 ( 4 ) 282 - 288 2013 [Refereed]

Background: The objectives of this study were to estimate and cross-nationally compare the medical costs shared by payers and patients and the distributions of medical costs by cost category. Material and Methods: We estimated the medical costs covered from definitive diagnosis to completion of treatments of early-stage breast cancer and follow-up, assuming almost identical medical care provided in Japan, the UK, and Germany. The analysis was performed from the payer's perspective. Medical costs were calculated by multiplying the unit costs by the number of units consumed, based on assumption case scenarios. The medical costs incurred by payers or patients were estimated according to the cost-sharing and the cost-bearing systems in each country. Results: The total medical costs in Japan were much lower than those in the UK and Germany, and these differences were mainly caused by the low costs of surgery and radiotherapy in Japan. For the base-case scenario, the co-payment in Japan ((sic) 3,486) was found to be 6.4-fold higher than that in Germany ((sic) 548). The payers in the European countries paid 2.9-fold more than those in Japan ((sic) similar to 25,000 vs. (sic) 8,627). Conclusion: Our results will be useful for policy makers in considering how to share medical costs and how to allocate limited resources.

DOI PubMed

Psychotropic Prescription Patterns Among Patients Diagnosed With Depressive Disorder Based on Claims Database in Japan

Yoshie Onishi, Shiro Hinotsu, Toshiaki A. Furukawa, Koji Kawakami

CLINICAL DRUG INVESTIGATION ( ADIS INT LTD ) 33 ( 8 ) 597 - 605 2013 [Refereed]

Clinical guidelines recommend monotherapy with antidepressants for the treatment of major depression. This study examined prescription patterns with regard to both duration and type of treatment used among patients with newly diagnosed non-psychotic major depression based on a claims database from health insurance societies between 2008 and 2011 in Japan. A retrospective cohort (N = 600,000) followed up for 4 years was used to identify patients (age a parts per thousand yen18 years) with newly diagnosed non-psychotic major depression. The prescription patterns and polypharmacy were examined. Four different types of pharmaceutical drugs were defined as possible psychotropic agents for major depression: (1) first- and/or second-generation antidepressants; (2) benzodiazepines; (3) sulpiride; and (4) antipsychotics. The data were analyzed by an intent-to-treat approach at months 0, 1, 3, 6, and 12 from the date of diagnosis. A total of 7,338 patients (3,684 males and 3,654 females, mean age 36.8 +/- A 10.9 years) with newly diagnosed non-psychotic major depression were identified. The median duration of treatment was 122 days. The proportion of patients in the cohort prescribed at least one type of defined psychotropic agents was 75.6 % (month 0), 47.3 % (month 1), 36.0 % (month 3), 26.8 % (month 6), and 17.4 % (month 12). The proportion of patients in the cohort prescribed at least one first- and/or second-generation antidepressant was 50.2 % (month 0), 34.9 % (month 1), 27.5 % (month 3), 20.3 % (month 6), and 12.5 % (month 12). The proportion of patients receiving at least one benzodiazepine was 58.0 % (month 0), 36.7 % (month 1), 27.1 % (month 3), 20.0 % (month 6), and 12.0 % (month 12). The proportion of patients receiving an antidepressant as monotherapy was only 12.0 % (month 0), 7.8 % (month 1), 6.5 % (month 3), 4.8 % (month 6), and 2.9 % (month 12), whereas the proportion of patients treated with a benzodiazepine alone was 13.5 % (month 0), 6.9 % (month 1), 4.6 % (month 3), 3.5 % (month 6), and 2.7 % (month 12). Various combinations of polypharmacy were observed. The most common was a combination of at least one antidepressant and benzodiazepine, which was prescribed to 36.7 % (month 0), 25.8 % (month 1), 19.9 % (month 3), 14.9 % (month 6), and 9.2 % (month 12) of the cohort. Based on analysis of prescription patterns and type of treatment used for treating non-psychotic major depression, a majority of patients were not treated according to the recommended guidelines in Japan. Various patterns of prescription and use of polypharmacy were observed over time. The median duration of treatment was shorter than the recommendation (6 months) in the guidelines.

DOI PubMed

Evaluation of primary androgen deprivation therapy in prostate cancer patients using the J-CAPRA risk score.

Akaza H, Hinotsu S, Usami M, Ogawa O, Kitamura T, Suzuki K, Tsukamoto T, Naito S, Namiki M, Hirao Y, Murai M

Prostate international 1 ( 2 ) 81 - 88 2013 [Refereed] [International journal]

PURPOSE: To determine the influence of maximal androgen blockade (MAB) and non-MAB hormonal therapy with an luteinizing hormone releasing hormone (LHRH) analog on overall survival of prostate cancer patients in the Japan Study Group of Prostate Cancer (J-CaP) registry according to risk, as assessed using the novel J-CAPRA risk instrument. To undertake a multivariate analysis combining J-CAPRA risk score, type of hormonal therapy and comorbidities, in order to assess their impact on overall survival. METHODS: The J-CaP database includes men in Japan diagnosed with any stage of prostate cancer between 2001 and 2003 and treated with primary androgen deprivation therapy (PADT), as monotherapy or in combination. A total of 26,272 men were enrolled and of these 19,265 were treated with PADT. This analysis was undertaken using the latest data set (30 April, 2010) including a total of 15,727 patients who received PADT and had follow-up data for periods ranging from 0 to 9.2 years. RESULTS: MAB for prostate cancer patients with intermediate- or high-risk disease has a significant benefit in terms of overall survival compared with LHRH analog monotherapy or surgical castration alone. Better results may be achieved in older (≥75 years) patients. Patient comorbidities are an important factor in determining overall survival, notably in older patients, and should be considered when selecting therapy. CONCLUSIONS: Based on large-scale registry data, this report is the first to analyze the outcomes of MAB therapy in patients with prostate cancer at a wide range of disease stages. MAB therapy may provide significant survival benefits in intermediate- and high-risk patients.

DOI PubMed

A survey of non-small cell lung cancer patients with meningeal carcinomatosis in Japan: Incidence and medical resource consumption.

S.Ohno, S.Hinotsu, K.Murata, S.Tanaka, K.Kawakami

Adv Pharmacoepidem Drug Safety 2 133 2013 [Refereed]

Methylation of the RASSF1A promoter is predictive of poor outcome among patients with Wilms tumor

Junjiro Ohshima, Masayuki Haruta, Yuiko Fujiwara, Naoki Watanabe, Yasuhito Arai, Tadashi Ariga, Hajime Okita, Tsugumichi Koshinaga, Takaharu Oue, Shiro Hinotsu, Hisaya Nakadate, Hiroshi Horie, Masahiro Fukuzawa, Yasuhiko Kaneko

PEDIATRIC BLOOD & CANCER ( WILEY ) 59 ( 3 ) 499 - 505 2012.09 [Refereed]

Background Wilms tumor (WT) has a survival rate of 90% following multimodality therapy. Nevertheless, there are some groups of patients with event-free survival rates less than 75%. In addition to clinical prognostic factors, loss of heterozygosity at 1p and/or 16q has been used to determine treatment intensity. However, the incidence of this abnormality is low, and new biomarkers are still needed. Procedure We analyzed methylation status of three tumor suppressor genes; Ras-association domain family 1 protein, isoform A (RASSF1A), DCR2, and CASP8, in 84 WTs using conventional methylation-specific PCR (cMSP), and the results were correlated with outcome. Furthermore, we analyzed the methylation status of RASSF1A by quantitative MSP (qMSP) in 171 WTs, and evaluated clinical and genetic differences between the methylated and unmethylated tumors. Results RASSF1A was the most frequently methylated gene identified by cMSP, and associated with a poor outcome. Patients with a RASSF1A-methylated tumor had shorter overall and event-free survival periods (P?=?0.043 and 0.018, respectively), when a cut-off value of 7% by qMSP was used. The methylation was more frequent in tumors of older children than younger children (P?<?0.001), and in advanced-stage tumors than early stage tumors (P?=?0.001). However, multivariate analysis could not confirm the prognostic significance of RASSF1A methylation, possibly because of a small number of advanced stage tumors examined. RASSF1A methylation was correlated with LOH at 1p and/or 16q (P?=?0.017), but not with WT1 abnormality, suggesting the methylation and LOH to involve the same tumorigenic pathway. Conclusions The methylation status of RASSF1A might be a novel biomarker to predict outcome of WT patients. Pediatr Blood Cancer 2012;59:499505. (c) 2012 Wiley Periodicals, Inc.

DOI PubMed

Analysis of Intravesical Recurrence After Bladder-preserving Therapy for Muscle-invasive Bladder Cancer

Mizuki Onozawa, Naoto Miyanaga, Shiro Hinotsu, Jun Miyazaki, Takehiro Oikawa, Tomokazu Kimura, Ei-ichiro Takaoka, Koji Kawai, Toru Shimazui, Hideyuki Sakurai, Hiroyuki Nishiyama, Hideyuki Akaza

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 42 ( 9 ) 825 - 830 2012.09 [Refereed]

The aim of the present study was to analyze the pattern of recurrences after bladder-preserving therapy for muscle-invasive bladder cancer. The subjects were 77 patients with T2-3N0M0 bladder cancer whose bladder was preserved by intra-arterial chemotherapy and radiation. The patterns of the first recurrences were retrospectively analyzed. With a median follow-up of 38.5 months, 17 patients (22.1) experienced intravesical recurrence without metastasis, 14 (82.4) of which were cases of non-muscle-invasive bladder cancer recurrence and 3 (17.6) of which were muscle-invasive bladder cancer recurrences. Muscle-invasive bladder cancer recurred at the same site as the initial tumor site in all three cases, whereas non-muscle-invasive bladder cancer recurred at different sites in 64 of the patients in that group. The peak hazard of the non-muscle-invasive bladder cancer recurrence was observed at around a year after treatment. Recurrent non-muscle-invasive bladder cancer was of a significantly lower histological grade with lower Ki-67-labeling indices than the initial muscle-invasive bladder cancer. Twelve (85.7) of 14 patients with non-muscle-invasive bladder cancer recurrence achieved disease-free status. The multivariate analysis revealed that multiplicity, grade and tumor size were significantly correlated with the recurrence (P 0.0001, 0.0442 and 0.0412, respectively). Most of the recurrences after bladder-preserving therapy were cases of non-muscle-invasive bladder cancer. The recurrence pattern and characteristics of the tumors did not differ from those of primary non-muscle-invasive bladder cancer. Patients with high-risk factors would be candidates for prophylactic intravesical therapy for non-muscle-invasive bladder cancer recurrence.

DOI PubMed

The cost of antiemetic therapy for chemotherapy-induced nausea and vomiting in patients receiving platinum-containing regimens in daily practice in Japan: a retrospective study

Shota Hamada, Shiro Hinotsu, Katsuhito Hori, Hiroshi Furuse, Takehiro Oikawa, Junichi Kawakami, Seiichiro Ozono, Hideyuki Akaza, Koji Kawakami

SUPPORTIVE CARE IN CANCER ( SPRINGER ) 20 ( 4 ) 813 - 820 2012.04 [Refereed]

The objective of this study was to estimate the cost of antiemetic therapy for chemotherapy-induced nausea and vomiting (CINV) in daily practice in Japan. This was a retrospective observational study using medical records. Eligible patients were those with bladder or testicular cancer receiving platinum-containing highly emetogenic chemotherapy. The incidence of CINV on days 1-5 in single-day chemotherapy and on days 1-9 in multiple-day chemotherapy, and the costs of antiemetic therapy directly associated with the administration of antiemetics were estimated. The analysis of costs was performed from a hospital perspective. A total of 54 patients or 169 chemotherapy courses were included. In all chemotherapy courses 5-HT3 receptor antagonists were used on the day(s) that platinum-containing agents were administered and frequently used on subsequent days. In contrast, the use of corticosteroids was infrequent. Acute CINV in single-day chemotherapy was well controlled, but the incidences of delayed CINV in single-day chemotherapy and CINV in multiple-day chemotherapy were relatively high. The costs for antiemetic therapy were $484.65 in courses with CINV and $318.56 in courses without CINV, and the difference was approximately $170 per chemotherapy course, which was considered to be mainly imputable to the prevalence of CINV. The cost of antiemetic therapy for CINV is substantial in Japan as well as in other countries, and it is suggested that the onset of CINV is a possible cost driver. The improvements in antiemetic therapy may contribute not only to improved patient well-being but also to a reduction of economic burden.

DOI PubMed

Effects of renin-angiotensin system blockades on cardiovascular outcomes in patients with diabetes mellitus: A systematic review and meta-analysis

Yoko M. Nakao, Satoshi Teramukai, Sachiko Tanaka, Shinji Yasuno, Akira Fujimoto, Masato Kasahara, Kenji Ueshima, Kazuhiro Nakao, Shiro Hinotsu, Kazuwa Nakao, Koji Kawakami

DIABETES RESEARCH AND CLINICAL PRACTICE ( ELSEVIER IRELAND LTD ) 96 ( 1 ) 68 - 75 2012.04 [Refereed]

Aim: To determine whether renin-angiotensin system (RAS) blockade is beneficial for cardiovascular outcomes in patients with diabetes mellitus (DM) using meta-analysis. Methods: The MEDLINE and Cochrane library databases were searched for randomized controlled trials published up to June 2010. We also reviewed reference lists from identified trials and review articles to identify any other relevant studies, and the ClinicalTrials.gov website to identify randomized controlled trials that were registered as completed but not yet published. A random-effects model was used to combine the estimates for risk ratios (RR). Results: Eligible studies were randomized controlled trials (including post hoc analyses) assessing the effects of angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers on cardiovascular events compared to controls in patients with DM. Nineteen clinical trials with 41,042 patients and 6039 cardiovascular events were identified. RAS blockade significantly reduced the risk of major cardiovascular events (RR 0.92, 95% confidence interval [CI] 0.84-1.00, I-2 statistic 53%) and myocardial infarction (RR 0.82, 95% CI 0.72-0.94, I-2 = 55%). There were trends towards fewer strokes and lower all-cause mortality but these were not statistically significant. Conclusions: The available evidence shows that treatment with RAS blockade can routinely be considered for diabetic patients to reduce major cardiovascular events. (C) 2011 Elsevier Ireland Ltd. All rights reserved.

DOI PubMed

Fifth joint meeting of J-CaP and CaPSURE: Advancing the global understanding of prostate cancer and its management

Hideyuki Akaza, Peter Carroll, Matthew R. Cooperberg, Shiro Hinotsu

Japanese Journal of Clinical Oncology 42 ( 3 ) 226 - 236 2012.03 [Refereed]

This report summarizes the presentations and discussions that took place at the Fifth Joint Meeting of J-CaP and CaPSURE held in Tokyo, Japan, in July 2011. The J-CaP and CaPSURE Joint Initiative was established in 2007 with the objective of analyzing, reviewing, comparing and contrasting data on prostate cancer patients from Japan and the USA within the two important large-scale, longitudinal, observational databases-J-CaP and CaPSURE. Since its inception, the initiative has reviewed a wide range of topics and generated valuable data on the patterns of prostate cancer treatment and patient outcomes in the two geographical regions. The objectives of this 5th Joint Meeting were to provide an update on the current status of the J-CaP and CaPSURE databases, and also to discuss perspectives from a range of other Asian countries-Japan, China, Indonesia and Korea-on the use of androgen deprivation therapy for prostate cancer. The collaborators recognize that large databases, such as J-CaP and CaPSURE, provide valuable 'real-world' information, to complement data from clinical trials, which can help to advance the clinical management of prostate cancer patients worldwide. It is anticipated that in the near future, the Joint Initiative will expand globally to include patient registries from other countries so that best practice can be shared and regional differences in patients, treatments and outcomes can be explored. © The Author 2012. Published by Oxford University Press. All rights reserved.

DOI PubMed

Editorial Comment to Population screening for prostate cancer: An overview of available studies and meta-analysis

Shiro Hinotsu

INTERNATIONAL JOURNAL OF UROLOGY ( WILEY-BLACKWELL ) 19 ( 2 ) 108 - 109 2012.02 [Refereed]

DOI PubMed

[Health service research (19) "Guideline for medical care and health service research"].

Hinotsu S

[Nihon koshu eisei zasshi] Japanese journal of public health 59 ( 2 ) 120 - 125 2012.02 [Refereed]

PubMed

Prostate Cancer Chemoprevention Study: An investigative randomized control study using purified isoflavones in men with rising prostate-specific antigen

Naoto Miyanaga, Hideyuki Akaza, Shiro Hinotsu, Tomoaki Fujioka, Seiji Naito, Mikio Namiki, Satoru Takahashi, Yoshihiko Hirao, Shigeo Horie, Taiji Tsukamoto, Mitsuru Mori, Hirokazu Tsuji

Cancer Science 103 ( 1 ) 125 - 130 2012.01 [Refereed]

Our previous case-control study suggested that equol, a metabolite of isoflavone, has a preventive effect on prostate cancer. To examine the prostate cancer risk based on isoflavone intake and equol production, we carried out a phase II, randomized, double-blind, placebo-controlled trial of oral isoflavone (60mg/day) for 12months. The inclusion criteria were Japanese men between 50 and 75years of age, a serum prostate-specific antigen level of 2.5-10.0ng/mL, and a single, negative prostate biopsy within 12months prior to enrollment. The study included 158 men in eight Japanese centers. Their median age was 66.0years, and the numbers of equol producers and non-producers were 76 (48%) and 82 (52%), respectively. The majority of adverse events were mild or moderate in severity, and the scheduled intake of tablets was completed by 153 patients (96.8%). The prostate-specific antigen value showed no significant difference before and after treatment. Of the 89 patients evaluated by central pathological review, the incidence of biopsy-detectable prostate cancer in the isoflavone and placebo groups showed no significant difference (21.4%vs 34.0%, P=0.140). However, for the 53 patients aged 65years or more, the incidence of cancer in the isoflavone group was significantly lower than that in the placebo group (28.0%vs 57.1%, P=0.031). These results support the value of isoflavone for prostate cancer risk reduction. A large-scale phase III randomized study of isoflavone tablets in men with different hereditary factors and living environments is warranted. Registered with the UMIN Clinical Trials Registry (UMIN-CTR) for clinical trials in Japan (C000000446). © 2011 Japanese Cancer Association.

DOI PubMed

Chromosomal variability of human mesenchymal stem cells cultured under hypoxic conditions

Hanae Ueyama, Tomohisa Horibe, Shiro Hinotsu, Tomoaki Tanaka, Takeomi Inoue, Hisashi Urushihara, Akira Kitagawa, Koji Kawakami

JOURNAL OF CELLULAR AND MOLECULAR MEDICINE ( WILEY-BLACKWELL ) 16 ( 1 ) 72 - 82 2012.01 [Refereed]

Bone marrow derived human mesenchymal stem cells (hMSCs) have attracted great interest from both bench and clinical researchers because of their pluripotency and ease of expansion ex vivo. However, these cells do finally reach a senescent stage and lose their multipotent potential. Proliferation of these cells is limited up to the time of their senescence, which limits their supply, and they may accumulate chromosomal changes through ex vivo culturing. The safe, rapid expansion of hMSCs is critical for their clinical application. Chromosomal aberration is known as one of the hallmarks of human cancer, and therefore it is important to understand the chromosomal stability and variability of ex vivo expanded hMSCs before they are used widely in clinical applications. In this study, we examined the effects of culturing under ambient (20%) or physiologic (5%) O2 concentrations on the rate of cell proliferation and on the spontaneous transformation of hMSCs in primary culture and after expansion, because it has been reported that culturing under hypoxic conditions accelerates the propagation of hMSCs. Bone marrow samples were collected from 40 patients involved in clinical research. We found that hypoxic conditions promote cell proliferation more favourably than normoxic conditions. Chromosomal aberrations, including structural instability or aneuploidy, were detected in significantly earlier passages under hypoxic conditions than under normoxic culture conditions, suggesting that amplification of hMSCs in a low-oxygen environment facilitated chromosomal instability. Furthermore, smoothed hazard-function modelling of chromosomal aberrations showed increased hazard after the fourth passage under both sets of culture conditions, and showed a tendency to increase the detection rate of primary karyotypic abnormalities among donors aged 60 years and over. In conclusion, we propose that the continuous monitoring of hMSCs will be required before they are used in therapeutic applications in the clinic, especially when cells are cultured under hypoxic conditions.

DOI PubMed

Prostate Cancer Chemoprevention Study: An investigative randomized control study using purified isoflavones in men with rising prostate-specific antigen

Naoto Miyanaga, Hideyuki Akaza, Shiro Hinotsu, Tomoaki Fujioka, Seiji Naito, Mikio Namiki, Satoru Takahashi, Yoshihiko Hirao, Shigeo Horie, Taiji Tsukamoto, Mitsuru Mori, Hirokazu Tsuji

CANCER SCIENCE ( WILEY-BLACKWELL ) 103 ( 1 ) 125 - 130 2012.01 [Refereed]

Our previous case-control study suggested that equol, a metabolite of isoflavone, has a preventive effect on prostate cancer. To examine the prostate cancer risk based on isoflavone intake and equol production, we carried out a phase II, randomized, double-blind, placebo-controlled trial of oral isoflavone (60 mg/day) for 12 months. The inclusion criteria were Japanese men between 50 and 75 years of age, a serum prostate-specific antigen level of 2.5-10.0 ng/mL, and a single, negative prostate biopsy within 12 months prior to enrollment. The study included 158 men in eight Japanese centers. Their median age was 66.0 years, and the numbers of equol producers and non-producers were 76 (48%) and 82 (52%), respectively. The majority of adverse events were mild or moderate in severity, and the scheduled intake of tablets was completed by 153 patients (96.8%). The prostate-specific antigen value showed no significant difference before and after treatment. Of the 89 patients evaluated by central pathological review, the incidence of biopsy-detectable prostate cancer in the isoflavone and placebo groups showed no significant difference (21.4%vs 34.0%, P = 0.140). However, for the 53 patients aged 65 years or more, the incidence of cancer in the isoflavone group was significantly lower than that in the placebo group (28.0%vs 57.1%, P = 0.031). These results support the value of isoflavone for prostate cancer risk reduction. A large-scale phase III randomized study of isoflavone tablets in men with different hereditary factors and living environments is warranted. Registered with the UMIN Clinical Trials Registry (UMIN-CTR) for clinical trials in Japan (C000000446). (Cancer Sci 2012; 103: 125-130)

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