Details of a Researcher - HINOTSU Shiro

Papers - HINOTSU Shiro

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Asia prostate cancer study (A-CaP Study) launch symposium

Hideyuki Akaza, Yoshihiko Hirao, Choung-Soo Kim, Mototsugu Oya, Seiichiro Ozono, Dingwei Ye, Matthew Cooperberg, Shiro Hinotsu, Ji Youl Lee, Gang Zhu, Mikio Namiki, Shigeo Horie, Byung Ha Chung, Chung-Hsin Chen, Ng Chi Fai, Lukman Hakim, Edmund Chiong, Jason Letran, Rainy Umbas, Kazuhiro Suzuki, Kazuo Nishimura, Teng Aik Ong, Bannakij Lojanapiwat, Tong-lin Wu, Wun-Jae Kim, Declan Murphy, Osamu Ogawa, Peter Carroll, Seiji Naito, Taiji Tsukamoto

Prostate International ( Elsevier B.V. ) 4 ( 3 ) 88 - 96 2016.09 [Refereed]

The Asian Prostate Cancer (A-CaP) Study is an Asia-wide initiative that has been developed over the course of 2 years. The A-CaP Study is scheduled to begin in 2016, when each participating country or region will begin registration of newly diagnosed prostate cancer patients and conduct prognosis investigations. From the data gathered, common research themes will be identified, such as comparisons among Asian countries of background factors in newly diagnosed prostate cancer patients. This is the first Asia-wide study of prostate cancer and has developed from single country research efforts in this field, including in Japan and Korea. The inaugural Board Meeting of A-CaP was held on December 11, 2015 at the Research Center for Advanced Science and Technology, The University of Tokyo, attended by representatives of all participating countries and regions, who signed a memorandum of understanding concerning registration for A-CaP. Following the Board Meeting an A-CaP Launch Symposium was held. The symposium was attended by representatives of countries and regions participating in A-CaP, who gave presentations. Presentations and a keynote address were also delivered by representatives of the University of California San Francisco, USA, and the Peter MacCallum Cancer Centre, Australia, who provided insight and experience on similar databases compiled in their respective countries.

DOI PubMed

Study about the Efficacy of Metformin to Immune Function in Cancer Patients

Mototsugu Watanabe, Hiromasa Yamamoto, Shingo Eikawa, Kazuhiko Shien, Tadahiko Shien, Junichi Soh, Katsuyuki Hotta, Jun Wada, Shiro Hinotsu, Toshiyoshi Fujiwara, Katsuyuki Kiura, Hiroyoshi Doihara, Shinichiro Miyoshi, Heiichiro Udono, Shinichi Toyooka

ACTA MEDICA OKAYAMA ( OKAYAMA UNIV MED SCHOOL ) 70 ( 4 ) 327 - 330 2016.08 [Refereed]

A study to evaluate the effect of metformin on the immune system was commenced in July 2014. Metformin is one of the most commonly prescribed drugs for type 2 diabetes, and previous studies have reported that metformin has an anti-tumor effect. The aim of this study is to evaluate the efficacy of metformin on the immune system in human cancer patients in vivo. The primary outcome parameter will be the rate change in the population of CD8(+) T cells, which produce multiple cytokines.

DOI PubMed

Essential content of evidence-based clinical practice guidelines for bladder cancer: The Japanese Urological Association 2015 update

Yoshinobu Kubota, Noboru Nakaigawa, Hiroyuki Nishiyama, Shiro Hinotsu, Osamu Ogawa, Keiji Inoue, Seiichiro Ozono, Eiji Kikuchi, Tsuneharu Miki, Hideyasu Matsuyama, Tomoaki Fujioka, Chikara Ohyama, Hiroyuki Fujimoto, Haruhito Azuma, Tomonori Habuchi, Masayuki Nakagawa, Takashi Mizowaki, Yoshiyuki Matsui, Takashi Kobayashi, Kimito Osaka, Hiroshi Furuse, Yoshio Naya, Wataru Obara, Takuya Koike, Takahiro Yoneyama, Yasuhiro Hashimoto, Shingo Hatakeyama, Atsushi Imai, Hiroyuki Nakanishi, Tomohiko Hara, Norihiko Tsuchiya, Takamitsu Inoue, Junichi Ohta, Kotaro Suzuki, Atsushi Fujikawa, Susumu Umemoto, Koji Izumi, Sumio Noguchi

International Journal of Urology 23 ( 8 ) 640 - 645 2016.08

The Japanese Urological Association revised the clinical practice guidelines for bladder cancer in April 2015. This was the first update carried out in the 6 years since the development of the initial clinical practice guidelines for bladder cancer in 2009. The descriptive content was revised, and additions were made with a focus on new-found evidence and advances in the latest medical practices, and on the basis of the increasingly aging population observed in the underlying social context in Japan. An algorithm for the treatment of bladder cancer has been presented as a new trial. In the present article, we will introduce the essential contents and clinical questions that address the present revisions.

DOI PubMed

Diversity in treatment modalities of Stage II/III urothelial cancer in Japan: sub-analysis of the multi-institutional national database of the Japanese Urological Association.

Takuya Koie, Chikara Ohyama, Hiroyuki Fujimoto, Hiroyuki Nishiyama, Jun Miyazaki, Shiro Hinotsu, Eiji Kikuchi, Mizuaki Sakura, Junichi Inokuchi, Tomohiko Hara, Chikara Ohyama, Hiroyuki Nishiyama, Masato Fujisawa, Hirotsugu Uemura, Hiroyuki Fujimoto, Kazuhiro Suzuki, Masatoshi Eto, Isao Hara, Akio Matsubara, Norio Nonomura, Hiroyuki Nakanishi, Takuya Koie, Hiroomi Kanayama, Tsuneharu Miki, Tomoharu Fukumori, Seiji Naito

Japanese journal of clinical oncology 46 ( 5 ) 468 - 74 2016.05 [Refereed] [International journal]

OBJECTIVE: We aimed to survey treatment modalities for the patients with Stage II/III urothelial cancer in Japan. METHODS: We used the multi-institutional national database of the Japanese Urological Association from 348 Japanese institutions, in which a total of 3707 patients with muscle-invasive bladder cancer and 1538 with upper urinary tract urothelial carcinoma were registered in 2008 and 2011, respectively. Primary treatment was classified as surgery alone, surgery with chemotherapy, surgery with radiation, radiation alone, chemotherapy alone, combination of radiation and chemotherapy and observation. Overall and cancer-specific survivals were examined using the Kaplan-Meier method, and survival in the subgroups was analyzed using the log-rank test. RESULTS: In Stage II/III bladder cancer patients, 49.7% of those were treated with radical operation and 22.3% received observation only. A total 97.2% of Stage II/III upper urinary tract urothelial carcinoma patients treated with radical surgery. A total 30.4% of Stage II/III bladder cancer patients received chemotherapy. Majority of the patients received cisplatin-based regimen, however, regimens of chemotherapy was rich in variety up to 13 regimens. Chemotherapy regimens for the patients with upper urinary tract urothelial carcinoma were also various up to eight regimens. Overall and cancer-specific survivals were statistically significantly stratified according to the clinical stage. The upper urinary tract urothelial carcinoma patients diagnosed with clinical stage T3 had significantly poor prognosis compared with those diagnosed with clinical stage T2. CONCLUSIONS: This study demonstrated the variety of treatments used for Japanese patients with Stage II/III urothelial cancer. Treatment standardization for these entities may be necessary.

DOI PubMed

Laparoscopic Versus Open Nephroureterectomy in Muscle-Invasive Upper Tract Urothelial Carcinoma: Subanalysis of the Multi-Institutional National Database of the Japanese Urological Association

Jun Miyazaki, Hiroyuki Nishiyama, Hiroyuki Fujimoto, Chikara Ohyama, Takuya Koie, Shiro Hinotsu, Eiji Kikuchi, Mizuaki Sakura, Junichi Inokuchi, Tomohiko Hara

JOURNAL OF ENDOUROLOGY ( MARY ANN LIEBERT, INC ) 30 ( 5 ) 520 - 525 2016.05 [Refereed]

Objectives: Open nephroureterectomy (ONU) is the current standard for muscle-invasive upper tract urothelial carcinoma (UTUC) in the European Association of Urology/Japanese Urological Association (JUA) guidelines. In this study, we compared the postsurgical survival of muscle-invasive UTUC patients treated with ONU or with laparoscopic nephroureterectomy (LNU), using the multi-institutional national database of the JUA. Methods: The 1509 patients with UTUC who were diagnosed at 348 Japanese institutions in 2005 were registered. We collected the clinical data of the patients in 2011. The muscle-invasive UTUC patients who underwent ONU or LNU were identified, and survival curves were estimated using the Kaplan-Meier method. Results: Overall, 749 pT2cNxM0 patients underwent a nephroureterectomy (ONU, n=527 and LNU, n=222). The overall survival and cause-specific survival rates were not significantly different between the ONU and LNU groups (p=0.1263 and p=0.0893, respectively). In addition, 459 of the 749 (61.3%) patients experienced disease recurrence (bladder recurrence, local recurrence, or distant metastasis), with no significant difference between the ONU and LNU groups. Even when patients were stratified by pT3/pT4 and/or pN+, overall survival was not significantly different between the ONU and LNU groups (p=0.2876). The results of a univariate analysis showed that lymphovascular invasion was an independent prognostic factor for overall survival, but the surgical approaches were not found to be associated with overall survival. Conclusions: Our data suggest that there is no evidence that the oncologic outcome of LNU is inferior to that of ONU in muscle-invasive UTUC, when the appropriate patients are selected.

DOI PubMed

[Epidemiology of prostate cancer: International variation].

Hinotsu S

Nihon rinsho. Japanese journal of clinical medicine 74 Suppl 3 34 - 38 2016.05 [Refereed]

PubMed

Clinical outcomes and nadir prostate-specific antigen (PSA) according to initial PSA levels in primary androgen deprivation therapy for metastatic prostate cancer

Yasuhide Kitagawa, Satoru Ueno, Kouji Izumi, Yoshifumi Kadono, Atsushi Mizokami, Shiro Hinotsu, Hideyuki Akaza, Mikio Namiki

WORLD JOURNAL OF UROLOGY ( SPRINGER ) 34 ( 3 ) 319 - 327 2016.03 [Refereed]

Purpose To investigate the clinical outcomes of metastatic prostate cancer patients and the relationship between nadir prostate-specific antigen (PSA) levels and different types of primary androgen deprivation therapy (PADT). This study utilized data from the Japan Study Group of Prostate Cancer registry, which is a large, multicenter, population-based database. Methods A total of 2982 patients treated with PADT were enrolled. Kaplan-Meier analysis was used to compare progression-free survival (PFS) and overall survival (OS) in patients treated using combined androgen blockade (CAB) and non-CAB therapies. The relationships between nadir PSA levels and PADT type according to initial serum PSA levels were also investigated. Results Among the 2982 enrolled patients, 2101 (70.5 %) were treated with CAB. Although CAB-treated patients had worse clinical characteristics, their probability of PFS and OS was higher compared with those treated with a non-CAB therapy. These results were due to a survival benefit with CAB in patients with an initial PSA level of 5001000 ng/mL. Nadir PSA levels were significantly lower in CAB patients than in non-CAB patients with comparable initial serum PSA levels. Conclusions A small survival benefit for CAB in metastatic prostate cancer was demonstrated in a Japanese large-scale prospective cohort study. The clinical significance of nadir PSA levels following PADT was evident, but the predictive impact of PSA nadir on OS was different between CAB and non-CAB therapy.

DOI PubMed

Impact of multimodal treatment on prognosis for patients with metastatic upper urinary tract urothelial cancer: Subanalysis of the multi-institutional nationwide case series study of the Japanese Urological Association

Junichi Inokuchi, Seiji Naito, Hiroyuki Fujimoto, Tomohiko Hara, Mizuaki Sakura, Hiroyuki Nishiyama, Jun Miyazaki, Eiji Kikuchi, Shiro Hinotsu, Takuya Koie, Chikara Ohyama

INTERNATIONAL JOURNAL OF UROLOGY ( WILEY-BLACKWELL ) 23 ( 3 ) 224 - 230 2016.03 [Refereed]

ObjectivesTo describe the nature of metastatic upper urinary tract urothelial cancer and determine the prognostic predictors or treatment modality associated with all-cause mortality. MethodsWithin the nationwide case series study of the Japanese Urological Association, consisting of 1509 patients with urinary tract urothelial cancer diagnosed in 2005, we identified 102 patients with metastatic urinary tract urothelial cancer. Univariate and multivariate survival analyses identified prognostic outcome variables. ResultsPredominant sites of distant metastasis at diagnosis were the lungs (54.9%), distant lymph nodes (37.3%), bone (32.4%) and liver (19.6%). Of 102 patients, 70 patients (68.6%) died during the median follow-up period of 6 months, and the 2-year overall survival rate was estimated at 22%. The median survival time to all-cause mortality was 8.5 months (95% confidence interval 6.4-10.7 months). On multivariate analysis, independent predictive factors for all-cause mortality were age (hazard ratio 2.36, P = 0.015) and liver metastasis (hazard ratio 2.35, P = 0.037). Patients who received multimodal treatment including chemotherapy and surgery showed significantly better prognosis (median survival time 25.8 months) compared with patients treated with chemotherapy alone (median survival time 7.3 months) or best supportive care (median survival time 4.3 months). ConclusionsAge at diagnosis and the presence of liver metastasis seem to have an impact on survival of metastatic urinary tract urothelial cancer patients. Multimodal treatment including systemic chemotherapy and surgery might result in better prognosis in some of these patients.

DOI PubMed

Validation of TNM classification for metastatic prostatic cancer treated using primary androgen deprivation therapy

Yoshifumi Kadono, Takahiro Nohara, Satoru Ueno, Kouji Izumi, Yasuhide Kitagawa, Hiroyuki Konaka, Atsushi Mizokami, Mizuki Onozawa, Shiro Hinotsu, Hideyuki Akaza, Mikio Namiki

WORLD JOURNAL OF UROLOGY ( SPRINGER ) 34 ( 2 ) 261 - 267 2016.02 [Refereed]

The current tumor-node-metastasis (TNM) classification system has been used for many years. The prognosis of patients with metastatic prostate cancer (mPC) treated using primary androgen deprivation therapy (PADT) was analyzed according to the TNM classification. A total of 5618 cases with lymph node metastases only (N1M0), non-regional lymph node metastasis (M1a), bone metastasis (M1b), and distant metastasis (M1c) were selected from the Japanese Study Group of Prostate Cancer database. Overall survival (OS), cancer-specific survival (CSS), and progression-free survival (PFS) rates were calculated using Kaplan-Meier analysis. The influence of clinical variables on patient prognosis was evaluated using the Cox proportional hazard regression model. The 5-year OS, CSS, and PFS were 76.0, 83.2, and 38.8 % in N1M0, 57.5, 69.0, and 23.0 % in M1a, 54.0, 63.1, and 23.0 % in M1b, and 40.0, 51.5, and 16.6 % in M1c, respectively. OS, CSS, and PFS worsened as the stages progressed. OS, CSS, and PFS were all significantly worse in N1M1b compared with N0M1b. Multivariate analysis revealed that OS and CSS were worse in patients with a Gleason score a parts per thousand yen8 and that combined androgen blockade (CAB) treatment provided better OS than non-CAB treatments at any tumor stage. However, OS and CSS were worse in individuals with a prostate-specific antigen > 100 ng/ml only in M1b. Patient prognosis worsened with stage progression; therefore, current TNM classification system of mPC for PADT was shown to be trustworthy. Each PC cell that develops bone or lymphoid metastasis may exhibit different characteristics.

DOI PubMed

Sitagliptin monotherapy has better effect on insulinogenic index than glimepiride monotherapy in Japanese patients with type 2 diabetes mellitus: a 52-week, multicenter, parallel-group randomized controlled trial

Yaeko Kondo, Norio Harada, Akihiro Hamasaki, Shizuka Kaneko, Koichiro Yasuda, Eiichi Ogawa, Shin-ichi Harashima, Hiroko Yoneda, Yoshihito Fujita, Norikazu Kitano, Yoshio Nakamura, Fujio Matsuo, Megumi Shinji, Shiro Hinotsu, Takeo Nakayama, Nobuya Inagaki

DIABETOLOGY & METABOLIC SYNDROME ( BIOMED CENTRAL LTD ) 8 15 2016.02 [Refereed]

Background: The 52-week monotherapy with the dipeptidyl peptidase-4 inhibitor sitagliptin and the sulphonylurea glimepiride on early-phase insulin secretion in Japanese patients with type 2 diabetes mellitus (T2DM) is not known. Methods: A randomized, parallel-group, open-label trial was conducted at 18 centers between February, 2011 and March, 2013. 171 outpatients with T2DM were recruited and randomly assigned to glimepiride or sitagliptin by minimization. Doses of glimepiride (0.25-1.0 mg/day) and sitagliptin (25-100 mg/day) were adjusted for hemoglobin A1c (HbA1c) > 6.9 %. Analyses were performed on full analysis set (FAS) of randomized subjects taking medications as allocated, and underwent 75 g oral glucose tolerance test (OGTTs) before and after treatment. The primary outcome was insulinogenic index to quantify early-phase insulin secretion after treatment, which was evaluated by analysis of covariance (ANCOVA). Results: Of 171 enrolled subjects, 68 in the sitagliptin group and 65 in the glimepiride group were included in the FAS (mean age, 64 years; baseline (HbA1c), 7.4 %). The primary outcome revealed a significantly higher insulinogenic index in the sitagliptin group than that in the glimepiride group (p = 0.036). Sitagliptin also reduced plasma glucose levels at 60 and 120 min during OGTT compared with glimepiride, while achieving a similar improvement in HbA1c during treatment. Body weight did not change in either of the two groups, and one case of hypoglycemia was observed in the glimepiride group. Conclusions: Sitagliptin shows better effects on insulinogenic index after 52-week treatment compared with glimepiride in Japanese patients with T2DM.

DOI PubMed

Trans-Pacific variation in outcomes for men treated with primary androgen-deprivation therapy (ADT) for prostate cancer

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

BJU INTERNATIONAL ( WILEY-BLACKWELL ) 117 ( 1 ) 102 - 109 2016.01 [Refereed]

Objectives To compare directly survival outcomes of primary androgen-deprivation therapy (PADT) in Japan, where this treatment is endorsed by guidelines, with outcomes in the USA, where it is not. Patients and Methods Data were compared between men receiving PADT in the USA Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) registry and the Japanese Cancer of the Prostate (J-CaP) registry database. Competing risks regression was used to assess prostate cancer-specific mortality (CSM), adjusting for age, Japan Cancer of the Prostate Risk Assessment (J-CAPRA) score, diagnosis year, and treatment type [combined androgen blockade (CAB) vs castration monotherapy], comorbidity, and practice type. Results Men on PADT in J-CaP (13 880 men) were older than those in CaPSURE (1633 men), and had higher-risk disease (mean J-CAPRA score 3.8 vs 2.1, P < 0.001). They more often received CAB: 66.9% vs 46.4% (P < 0.001). Despite different risk profiles between the cohorts, CSM was similar on univariate analysis (log-rank P = 0.88). On multivariable regression, the subhazard ratio for CSM was 0.52 for J-CaP vs CaPSURE (95% confidence interval 0.40-0.68). Conclusions Men on PADT in Japan have less than half the adjusted CSM than those in the USA. These findings support both existing guidelines endorsing PADT in Asia and discouraging its use in the West. Elucidating the reasons behind these substantial differences, which probably include both genetic and dietary/environmental factors, may help explain the varying epidemiology of prostate cancer on either side of the Pacific.

DOI PubMed

Prognostic factors of recurrent disease in upper urinary tract urothelial cancer after radical nephroureterectomy: Subanalysis of the multi-institutional national database of the Japanese Urological Association

Tomohiko Hara, Hiroyuki Fujimoto, Mizuaki Sakura, Junichi Inokuchi, Hiroyuki Nishiyama, Jun Miyazaki, Chikara Ohyama, Takuya Koie, Eiji Kikuchi, Shiro Hinotsu

INTERNATIONAL JOURNAL OF UROLOGY ( WILEY-BLACKWELL ) 22 ( 11 ) 1013 - 1020 2015.11 [Refereed]

ObjectivesTo explore predictive factors of disease recurrence after radical nephroureterectomy in patients with upper urinary tract urothelial cancer. MethodsA multi-institutional national database promoted by the Japanese Urological Association including 293 institutions and 1172 patients was used for the present study. Patient with non-metastatic upper urinary tract urothelial cancer who underwent primary radical nephroureterectomy with curative intent were analyzed. Univariate analysis using the Kaplan-Meier method and multivariate Cox regression models with stepwise selection was used to evaluate time to recurrence after surgery. ResultsThe median duration of follow up was 55.8months, and disease recurred in 325 (27.7%) patients at a median of 11.4months after radical nephroureterectomy. According to a Cox proportional hazards model, the Union International Contre le Cancer 2002 pathological stage of the primary tumor, lymph node status, presence of lymphatic and/or vascular invasion, infiltrative growth pattern, and age were independent predictors (P<0.05) of recurrence-free survival. ConclusionsDespite several limitations, our analysis suggests that pathological tumor stage, lymph node status, lymphovascular invasion, infiltrative growth pattern and age represent important prognostic variables after radical nephroureterectomy in Japanese patients with upper urinary tract urothelial cancer. This information could be potentially used to select patients for adjuvant systemic therapy.

DOI PubMed

Impact of smoking on the age at diagnosis of upper tract urothelial carcinoma: Subanalysis of the Japanese Urological Association multi-institutional national database

Jun Miyazaki, Hiroyuki Nishiyama, Hiroyuki Fujimoto, Chikara Ohyama, Takuya Koie, Shiro Hinotsu, Eiji Kikuchi, Mizuaki Sakura, Junichi Inokuchi, Tomohiko Hara

INTERNATIONAL JOURNAL OF UROLOGY ( WILEY-BLACKWELL ) 22 ( 11 ) 1023 - 1027 2015.11 [Refereed]

ObjectivesTo examine the influence of smoking history on the diagnosis and other tumor characteristics of upper tract urothelial carcinoma in Japan. MethodsA total of 1509 patients with upper tract urothelial carcinoma who were diagnosed in 2005 from 348 Japanese institutions were registered using the multi-institutional national database of the Japanese Urological Association and included in this analysis. Clinical data of the patients were collected in 2011. The associations between the patients' self-reported smoking history and their age at the diagnosis of upper tract urothelial carcinoma, sex, pathological Tstage and tumor grade were analyzed. ResultsThe mean age at the diagnosis of upper tract urothelial carcinoma was approximately 5years earlier for the 238 current smokers than for the 618 current non-smokers (P<0.0001). Similar associations between smoking and the early diagnosis of upper tract urothelial carcinoma were shown in the sex subgroups and in subgroups stratified by pathological Tstages. Among the current smokers, the age at diagnosis for the smoking 20 cigarettes per day group was 6.5years lower than that of the <20 cigarettes per day group, which was significantly different (P<0.0001). ConclusionCurrent smoking is a significant risk factor for the earlier diagnosis of upper tract urothelial carcinoma. The finding is important from the perspective of both healthcare and medical economies.

DOI PubMed

Phase II clinical trial of sorafenib plus interferon-alpha treatment for patients with metastatic renal cell carcinoma in Japan

Masatoshi Eto, Yoshiaki Kawano, Yoshihiko Hirao, Koji Mita, Yoichi Arai, Taiji Tsukamoto, Katsuyoshi Hashine, Akio Matsubara, Tomoaki Fujioka, Go Kimura, Nobuo Shinohara, Katsunori Tatsugami, Shiro Hinotsu, Seiji Naito

BMC CANCER ( BIOMED CENTRAL LTD ) 15 667 2015.10 [Refereed]

Background: To improve antitumor effects against metastatic renal cell carcinoma (mRCC), use of molecular target-based drugs in sequential or combination therapy has been advocated. In combination therapy, interferon (IFN)-alpha amplified the effect of sorafenib in our murine model (J Urol 184: 2549, 2010), and cytokine-treated mRCC patients in Japan had good prognoses (Eur Urol 57: 317, 2010). We thus conducted a phase II clinical trial of sorafenib plus IFN-alpha for untreated mRCC patients in Japan. Methods: In this multicenter, prospective study, provisionally registered patients with histologically confirmed metastatic clear cell RCC received natural IFN-alpha (3 dosages of 3 million U per week) for 2 weeks. Only IFN-alpha-tolerant patients were registered to this trial, and treated additionally with oral sorafenib (400 mg, bid). The primary end point of the study was rate of response (CR + PR) to sorafenib plus IFN-alpha treatment assessed using RECIST v1.0. The secondary end points were disease control rate (CR + PR + SD), progression free survival (PFS), overall survival (OS), and safety of the combined treatment. PFS and OS curves were plotted using the Kaplan-Meier method. Results: From July 2009 to July 2012, a total of 53 untreated patients were provisionally registered, and 51 patients were finally registered. Rate of Response to the combined therapy of sorafenib plus IFN-alpha was 26.2 % (11/42) (CR 1, PR 10). The median PFS was 10.1 months (95 % CI, 6.4 to 18.5 months), and the median OS has not been reached yet. The combined therapy increased neither the incidence of adverse effects (AE) nor the incidence of unexpected AE. A limitation was that a relatively high number of patients (9 patients) were excluded for eligibility criteria violations. Conclusion: Our data have demonstrated that sorafenib plus IFN-alpha treatment is safe and effective for untreated mRCC patients.

DOI PubMed

Long-term outcomes of combined androgen blockade therapy in stage IV prostate cancer

Taeko Matsuoka, Koji Kawai, Tomokazu Kimura, Takahiro Kojima, Mizuki Onozawa, Jun Miyazaki, Hiroyuki Nishiyama, Shiro Hinotsu, Hideyuki Akaza

JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY ( SPRINGER ) 141 ( 4 ) 759 - 765 2015.04 [Refereed]

To clarify which subset of stage IV prostate cancer patients benefit from combined androgen blockade (CAB) using Japanese nationwide database. A total of 3,752 patients with stage IV disease from the prospective nationwide cohort database of the Japan Study Group of Prostate Cancer (J-CaP) were enrolled. All patients started primary androgen deprivation therapy (PADT) between 2001 and 2003, and the present study was performed using the data set from December 2011. Patients were divided into two groups according to initial treatments: CAB with luteinizing hormone-releasing hormone agonist (LHRH) plus anti-androgen (AA) and non-CAB treatments such as LHRH monotherapy. The overall survival (OS) and cancer-specific survival (CSS) for each group were estimated by the Kaplan-Meier method. A total of 2,967 patients (79.1 %) received CAB. Overall, no significant difference was observed in OS and CSS between the CAB group and the non-CAB group. However, CAB resulted in significantly better OS and CSS compared to non-CAB in patients with very high Japan Cancer of the Prostate Risk Assessment (J-CAPRA) scores of ten or greater (P = 0.007 and 0.013, respectively). Multivariate analysis revealed that CAB was an independent predictive factor for better OS (P = 0.013, hazard ratio = 0.83). Based on large-scale nationwide database, as PADT for prostate cancer patients with very high-risk disease, CAB resulted in better OS than other endocrine treatments.

DOI PubMed

A high incidence of WT1 abnormality in bilateral Wilms tumours in Japan, and the penetrance rates in children with WT1 germline mutation

Kaneko Y, Okita H, Haruta M, Arai Y, Oue T, Tanaka Y, Horie H, Hinotsu S, Koshinaga T, Yoneda A, Ohtsuka Y, Taguchi T, Fukuzawa M

British Journal of Cancer 112 1121 - 1133 2015.03

<p>Background: Bilateral Wilms tumours (BWTs) occur by germline mutation of various predisposing genes; one of which is WT1 whose abnormality was reported in 17-38% of BWTs in Caucasians, whereas no such studies have been conducted in East-Asians. Carriers with WT1 mutations are increasing because of improved survival. Methods: Statuses of WT1 and IGF2 were examined in 45 BWTs from 31 patients with WT1 sequencing and SNP array-based genomic analyses. The penetrance rates were estimated in WT1-mutant familial Wilms tumours collected from the present and previous studies. Results: We detected WT1 abnormalities in 25 (81%) of 31 patients and two families, which were included in the penetrance rate analysis of familial Wilms tumour. Of 35 BWTs from the 25 patients, 31 had small homozygous WT1 mutations and uniparental disomy of IGF2, while 4 had large 11p13 deletions with the retention of 11p heterozygosity. The penetrance rate was 100% if children inherited small WT1 mutations from their fathers, and 67% if inherited the mutations from their mothers, or inherited or had de novo 11p13 deletions irrespective of parental origin (P=0.057). Conclusions: The high incidence of WT1 abnormalit

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Domperidone With ORT in the Treatment of Pediatric Acute Gastroenteritis in Japan: A Multicenter, Randomized Controlled Trial

Fumiyo Kita, Shiro Hinotsu, Tohru Yorifuji, Hisashi Urushihara, Tetsuro Shimakawa, Kenji Kishida, Yoshihiro Wakazono, Eiko Yamauchi, Hiroshi Sasaki, Tatsutoshi Nakahata, Koji Kawakami

ASIA-PACIFIC JOURNAL OF PUBLIC HEALTH ( SAGE PUBLICATIONS INC ) 27 ( 2 ) NP174 - NP183 2015.03 [Refereed]

Domperidone is an antiemetic that is often prescribed for children with acute gastroenteritis in Japan. In this study, the authors assessed the efficacy of domperidone prescription in combination with oral rehydration treatment (ORT) in the treatment of vomiting during acute gastroenteritis in children during the early period. They performed a prospective multicenter randomized trial in Japan. Patients received either ORT or ORT and domperidone prescription. The primary outcome was the proportion of patients who had vomiting during the first 2 hours after randomization. A total of 56 children were eligible; 24 received ORT alone, and 32 received ORT and prescribed domperidone suppository. Results showed that 27.3% of children in the ORT group vomited as compared with 20.7% of children in the ORT and domperidone group (P = .41). In this study, it appears that domperidone in combination with ORT in the treatment of acute gastroenteritis does not reduce vomiting in the early period.

DOI PubMed

The changing patterns of dispensing branded and generic drugs for the treatment of gastroesophageal reflux disease between 2006 and 2011 in Japan: a retrospective cohort study

Kyoko Murata, Shiro Hinotsu, Shota Hamada, Yasumasa Ezoe, Manabu Muto, Koji Kawakami

BMC HEALTH SERVICES RESEARCH ( BIOMED CENTRAL LTD ) 15 76 2015.02 [Refereed]

Background: Despite rising healthcare costs, generic drugs are less frequently dispensed in Japan compared with other developed countries. This study aimed to describe changes in dispensing of branded and generic drugs and to explore possible factors that promote the use of generic drugs. Methods: We conducted a retrospective cohort study using a Japanese medical and pharmacy claims database. All proton pump inhibitors (PPIs) and histamine H-2-receptor antagonists (H2RAs) with indications for gastroesophageal reflux disease (GERD) described on Japanese labels were included. Patterns of dispensing branded and generic drugs for the treatment of GERD between 2006 and 2011 were analyzed. Multivariate logistic regression was applied to investigate factors associated with receiving generic drugs. Results: The study cohort included 14,590 patients (male: 50.2%, mean age: 43.1 years). Branded drugs for GERD were still frequently dispensed despite an increase in the share of generic drugs. Only 4.3% of patients who initially received branded drugs switched to generic drugs. The percentage of patients who received only generic drugs increased over time (6.5% to 22.1%). The frequency of generic drug dispensing was the highest in the setting where both prescription and dispensing were implemented in clinics (43.3%), while the lowest in the setting where both prescription and dispensing were implemented in hospitals (11.5%). Factors associated with receiving generic drugs included year of dispensing (adjusted OR 2.22, 95% CI 1.94 to 2.55 for 2009-11 v 2006-8), prescription and dispensing setting (OR 1.81, 95% CI 1.44 to 2.26 for prescription in hospitals and dispensing in community pharmacies; OR 2.21, 95% CI 1.80 to 2.72 for prescription in clinics and dispensing in community pharmacies; and OR 4.55, 95% CI 3.68 to 5.62 for prescription and dispensing in clinics v prescription and dispensing in hospitals) and H2RAs (OR 1.64, 95% CI 1.49 to 1.81 compared to PPIs). Conclusions: The share of generic drugs for the treatment of GERD increased over time although branded drugs for GERD were still dispensed frequently. The use of generic drugs for GERD was influenced not only by government policies but also by changes in treatment approach and the setting of prescription and dispensing.

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Experience with Androgen Deprivation Therapy for Prostate Cancer in Japan and Future Perspectives

Yasuhide Kitagawa, Satoru Ueno, Hiroyuki Konaka, Atsushi Mizokami, Shiro Hinotsu, Hideyuki Akaza, Mikio Namiki

CURRENT CANCER DRUG TARGETS ( BENTHAM SCIENCE PUBL LTD ) 15 ( 4 ) 314 - 326 2015 [Refereed]

Novel anti-androgens and androgen biosynthesis inhibitors have been developed to treat castration-resistant prostate cancer. However, knowledge of androgen deprivation therapy (ADT) has not been developed in the criticism, including information regarding the adverse effects of hormonal therapy. We hypothesize that there are ethnic differences in the efficacy and adverse effects of ADT; therefore, this review summarizes the experience of ADT, mainly in Japan. A risk stratification instrument, the Japan Cancer of the Prostate Risk Assessment (J-CAPRA) score, was developed based on the Japan Study Group of Prostate Cancer registry, which is a large, multicenter, population-based database. It revealed that clinical outcomes were substantially better for males treated with ADT in Japan compared with those in the United States. Moreover, there were small survival differences in patients with localized and locally advanced cancer who received local therapy and primary ADT in another Japanese cohort study. In terms of adverse effects, including bone loss and cardiovascular risk, ADT appears to be better tolerated in Japanese populations than in Western cohorts. An ongoing randomized controlled trial of a trimodality treatment comprising brachytherapy, external beam radiation therapy, and neoadjuvant with or without adjuvant ADT in patients with localized high-risk prostate cancer will provide novel insights regarding adjuvant ADT. As a future perspective, the optimal selection of the type of primary ADT, including combining androgen blockade and novel hormonal compounds, adjusted according to each patient's clinicopathological background, may provide better clinical outcomes in patients with advanced prostate cancer.

PubMed

Patterns and trends in diagnostic tests used for detection of colorectal cancer after screening with the immunochemical fecal occult blood test in Japan

Yamamichi J, Seto K, Hinotsu S, Nagata K, Kobayashi Y, Urushihara H, Kawakami K

Open Journal of Clinical Diagnostics 5 107 - 116 2015 [Refereed]

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