Details of a Researcher - HINOTSU Shiro

Papers - HINOTSU Shiro

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Transarterial chemotherapy alone versus transarterial chemoembolization for hepatocellular carcinoma: A randomized phase III trial

Takuji Okusaka, Hiroshi Kasugai, Yasukazu Shioyama, Katsuaki Tanaka, Masatoshi Kudo, Hiromitsu Saisho, Yukio Osaki, Michio Sata, Shigetoshi Fujiyama, Takashi Kumada, Keiko Sato, Seiichiro Yamamoto, Shiro Hinotsu, Tosiya Sato

JOURNAL OF HEPATOLOGY ( ELSEVIER SCIENCE BV ) 51 ( 6 ) 1030 - 1036 2009.12 [Refereed]

Background/Aims: Transcatheter arterial chemoembolization (TACE) is a combination of transarterial infusion chemotherapy (TAI) and embolization, and has been widely used to treat patients with hepatocellular carcinoma (HCC). However, since the impact of adding embolization on the survival of patients treated with TAI had never been evaluated in a phase III study, we conducted a multi-center, open-label trial comparing TACE and TAI to assess the effect of adding embolization on survival. Methods: Patients with newly diagnosed unresectable HCC were randomly assigned to either a TACE group or a TAI group. Zinostatin stimalamer was injected into the hepatic artery, together with gelatin sponge in the TACE group and without gelatin sponge in the TAI group. Treatment was repeated when follow-up computed tomography showed the appearance of new lesions in the liver or re-growth of previously treated tumors. Results: Seventy-nine patients were assigned to the TACE group, and 82 were assigned to the TAI group. The two groups were comparable with respect to their baseline characteristics. At the time of the analysis, 51 patients in the TACE group and 58 in the TAI group had died. The median overall survival time was 646 days in the TACE group and 679 days in the TAI group (p = 0.383). Conclusions: The results of this study suggest that treatment intensification by adding embolization did not increase survival over TAI with zinostatin stimalamer alone in patients with HCC. (C) 2009 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Outcome of pediatric renal tumor treated using the Japan Wilms Tumor Study-1 (JWiTS-1) protocol: a report from the JWiTS Group

Takaharu Oue, Masahiro Fukuzawa, Hajime Okita, Hideo Mugishima, Hiroshi Horie, Jun-ichi Hata, Masahiro Saito, Miwako Nozaki, Motoaki Chin, Hisaya Nakadate, Shiro Hinotsu, Tsugumichi Koshinaga, Yasuhiko Kaneko, Yoshihiro Kitano, Yukichi Tanaka

PEDIATRIC SURGERY INTERNATIONAL ( SPRINGER ) 25 ( 11 ) 923 - 929 2009.11 [Refereed]

In 1996, the Japan Wilms Tumor Study (JWiTS) group was founded to elucidate the efficacy and safety of the regimen established by the National Wilms Tumor Study (NWTS) group in the USA, and a multicenter cooperative study (JWiTS-1) was started in Japan. This report reviews the results of JWiTS-1. A total of 307 patients with malignant renal tumor were enrolled in the JWiTS-1 study between 1996 and 2005. Central pathological diagnosis and follow-up data were available in 210 cases. The protocol regimens were similar to the NWTS-5 regimens. Clinical stage was classified according to the Japanese Staging System. Five-year overall survival (OS) rate was 91.1% for nephroblastoma, 72.9% for clear cell sarcoma of the kidney (CCSK), and 22.2% for rhabdoid tumor of the kidney (RTK). In the nephroblastoma patients, 5-year OS was 90.5% for stage I disease, 92.2% for stage II, 90.9% for stage III, 86.7% for stage IV, and 78.7% for stage V. The OS of patients in the JWiTS-1 study were comparable with the results of other multicenter studies in the USA and Europe. The outcome for patients with nephroblastoma and CCSK was fair. In contrast, the cure rate for those with RTK was not satisfactory. New treatment strategies are needed for patients with RTK.

Good Laboratory Practice (GLP) status of Asian countries and its implementation in non-clinical safety studies in pharmaceutical drug development

Madoka Sasaki, Shiro Hinotsu, Koji Kawakami

JOURNAL OF TOXICOLOGICAL SCIENCES ( JAPANESE SOC TOXICOLOGICAL SCIENCES ) 34 ( 5 ) 493 - 500 2009.10 [Refereed]

Non-clinical animal studies to assess the safety of compounds under development have to comply with Good Laboratory Practice (GLP). The Organization for Economic Co-operation and Development (OECD) has established the Mutual Acceptance of Data (MAD) system in OECD member countries for the mutual acceptance of non-clinical safety study data. Since 1997 non-OECD-member countries have also been able to participate in the MAD system, if the country meets the level of standardized compliance with OECD GLP. Thus, several Asian non-OECD countries are trying to develop their GLP standards in order to become official members of the MAD system. Pharmaceutical companies face significant expense in the drug-development process, including the cost of non-clinical safety studies; in response, companies in Asian countries are seeking to establish GLP facilities to provide cost-effective services for drug development. To assess the quality and cost of GLP performance in Asian countries, in this study we approached GLP facilities in a number of Asian countries to obtain price and quality information on a 'virtual compound' to be assessed in non-clinical safety studies. Also, the development status of GLP in Asian Countries in terms of policy and infrastructure was analyzed. We found that, among Asian countries, India and Singapore may be candidates for participation in the MAD system in terms of their compliance with GLP, language, and costs. These findings will be beneficial to pharmaceutical companies planning GLP studies in Asian Countries.

Risk Assessment Among Prostate Cancer Patients Receiving Primary Androgen Deprivation Therapy

Matthew R. Cooperberg, Shiro Hinotsu, Mikio Namiki, Kazuto Ito, Jeanette Broering, Peter R. Carroll, Hideyuki Akaza

JOURNAL OF CLINICAL ONCOLOGY ( AMER SOC CLINICAL ONCOLOGY ) 27 ( 26 ) 4306 - 4313 2009.09 [Refereed]

Purpose Prostate cancer epidemiology has been marked overall by a downward risk migration over time. However, in some populations, both in the United States and abroad, many men are still diagnosed with high-risk and/or advanced disease. Primary androgen deprivation therapy (PADT) is frequently offered to these patients, and disease risk prediction is not well-established in this context. We compared risk features between large disease registries from the United States and Japan, and aimed to build and validate a risk prediction model applicable to PADT patients. Methods Data were analyzed from 13,740 men in the United States community-based Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) registry and 19,265 men in the Japan Study Group of Prostate Cancer (J-CaP) database, a national Japanese registry of men receiving androgen deprivation therapy. Risk distribution was compared between the two datasets using three well-described multivariable instruments. A novel instrument (Japan Cancer of the Prostate Risk Assessment [ J-CAPRA]) was designed and validated to be specifically applicable to PADT patients, and more relevant to high-risk patients than existing instruments. Results J-CaP patients are more likely than CaPSURE patients to be diagnosed with high-risk features; 43% of J-CaP versus 5% of CaPSURE patients had locally advanced or metastatic disease that could not be stratified with the standard risk assessment tools. J-CAPRA-scored 0 to 12 based on Gleason score, prostate-specific antigen level, and clinical stage-predicts progression-free survival among PADT patients in J-CaP with a c-index of 0.71, and cancer-specific survival among PADT patients in CaPSURE with a c-index of 0.84. Conclusion The novel J-CAPRA is the first risk instrument developed and validated for patients undergoing PADT. It is applicable to those with both localized and advanced disease, and performs well in diverse populations.

Fourth Joint Meeting of the American Urological Association and the Japanese Urological Association Specialty Society Program at the 104th Annual Meeting of the American Urological Association at Chicago 2009

Matthew R. Cooperberg, Shiro Hinotsu, Michael B. Chancellor, Yukio Homma, Peter S. Nelson, Hideyasu Matsuyama, Mani Menon, Omer Kucuk, Isao Hara, Shin Egawa, Robert G. Uzzo, Hiro-omi Kanayama, Akihiko Okuyama, Hideyuki Akaza

INTERNATIONAL JOURNAL OF UROLOGY ( WILEY-BLACKWELL PUBLISHING, INC ) 16 ( 8 ) 703 - 703 2009.08 [Refereed]

Preface: We are heartily grateful for the warm support of all of the people concerned, including the moderators and panelists of both societies for giving us the opportunity to hold the 4th American Urological Association/Japanese Urological Association (AUA/JUA) Joint Meeting, held once again at the 104th Annual Meeting of the American Urological Association (25-30 April 2009, Chicago, Illinois, USA). 2009 is a memorable year, being the start of new collaborations between AUA and JUA. The JUA in collaboration with AUA is promoting an academic exchange program whereby outstanding and promising Japanese and American junior faculty members will be given the opportunity to work in the USA and Japan for one month. The program not only allows the sharing of knowledge and experience, but is designed to foster a closer alliance between the AUA and JUA, and assists in identifying future leaders within both organizations. The JUA will have an exhibit booth at the AUA annual meeting, promoting our new joint activities. The Journal of Urology and International Journal of Urology will share reviewers. The JUA will participate in developing AUA guidelines. With all of these activities, the JUA hopes it will provide greater opportunities to young Japanese urologists to participate in educational projects in the US. We would like to thank Professor Robert C. Flanigan, the Secretary General of AUA, Professor Glenn M. Preminger, the Chairman of the AUA Office of Education and the staff of AUA and JUA for supporting our program. We hope to keep holding the joint meeting and have plenty of ideas on themes and forums. We believe that this international program helps to establish a closer relationship between JUA and AUA in the scientific field. Akihiko Okuyama md, President of JUA Hideyuki Akaza md, Chairman of the International Committee of JUA.

Combined Androgen Blockade With Bicalutamide for Advanced Prostate Cancer Long-Term Follow-Up of a Phase 3, Double-Blind, Randomized Study for Survival

Hideyuki Akaza, Shiro Hinotsu, Michiyuki Usami, Yoichi Arai, Hiroshi Kanetake, Seiji Naito, Yoshihiko Hirao

CANCER ( JOHN WILEY & SONS INC ) 115 ( 15 ) 3437 - 3445 2009.08 [Refereed]

BACKGROUND: A previously reported, double-blind, randomized, multicenter phase 3 trial in 205 patients with stage C/D prostate cancer compared combined androgen blockade (CAB) with luteinizing hormone-releasing hormone agonist (LHRH-A) plus bicalutamide 80 mg versus LHRH-A plus bicalutamide-matching placebo (LHRH-A monotherapy). The analysis at a median follow-up of 2.4 years indicated that CAB significantly (P < .001) prolonged the time to progression and the time to treatment failure. In the current report, survival data from a long-term follow-up (median, 5.2 years) were analyzed. METHODS: All deaths irrespective of cause and all prostate cancer-specific deaths were recorded. The data were analyzed using Cox regression analysis and the log-rank test. RESULTS: At a median follow-up of 5.2 years, a significant overall survival advantage was observed in favor of CAB over LHRH-A monotherapy (Cox regression analysis: hazard ratio, 0.78; 95% confidence interval, 0.60-0.99; P = .0498; log-rank test: P = .0425). The difference in cause-specific survival between the 2 groups was not significant. The achievement of a prostate-specific antigen (PSA) nadir concentration <= 1 ng/mL was a prognostic factor for improved survival. More patients attained PSA nadir concentrations <= 1 ng/mL with CAB compared with patients who received LHRH-A monotherapy (81.4% vs 33.7%; P < .001). CONCLUSIONS: CAB with bicalutamide 80 mg offered a significant overall survival benefit compared with LHRH-A monotherapy without reducing tolerability in patients with locally advanced or metastatic prostate cancer. Cancer 2009;115:3437-45. (C) 2009 American Cancer Society.

Clinical outcome of tumor recurrence for Ta, T1 non-muscle invasive bladder cancer from the data on registered bladder cancer patients in Japan: 1999-2001 report from the Japanese Urological Association

Eiji Kikuchi, Hiroyuki Fujimoto, Yoichi Mizutani, Eijiro Okajima, Hiroshi Koga, Shiro Hinotsu, Nobuo Shinohara, Mototsugu Oya, Tsuneharu Miki

INTERNATIONAL JOURNAL OF UROLOGY ( WILEY-BLACKWELL PUBLISHING, INC ) 16 ( 3 ) 279 - 286 2009.03 [Refereed]

To characterize the clinical outcome in a large contemporary series of Japanese patients with newly diagnosed Ta, T1 non-muscle invasive bladder cancer who underwent transurethral bladder tumor resection with or without intravesical chemotherapy or Bacillus Calmette-GuErin (BCG) therapy. We developed a database incorporating newly diagnosed non-muscle invasive bladder cancer data and outcomes from a Japanese bladder cancer registry between 1999 and 2001 and identified a study population of 3237 consecutive patients who had complete data based on pathological features. Median patient age was 69.9 years. The 1-year, 3-year, and 5-year overall recurrence-free survival rates were 77.0%, 61.3%, and 52.8%, respectively. In multivariate analyses, the multiplicity of bladder tumors, tumor size greater than 3 cm, pathological stage T1, tumor grade G3, and the absence of adjuvant intravesical instillation were independent risk factors for tumor recurrence. Overall, 1710 patients (52.8%) received intravesical instillation; chemotherapy in 1314 (76.8%) and BCG treatment in 396 (23.2%). In patients treated with intravesical chemotherapy in which an anthracycline chemo-agent was used in 90.5% of the cases, multivariate analyses demonstrated that male gender, multiple bladder tumors, a tumor size greater than 3 cm, and pathological stage T1 were associated with tumor recurrence. The accumulation and analysis of data from the Japanese National Bladder Cancer Registry made it possible to determine the clinical characteristics, management trends, and survival rates for the period studied. Further study with a dataset created from longer follow-up data would be warranted to analyze tumor progression and disease survival.

Lumbar Intervertebral Disk Degeneration in Athletes

Mika Hangai, Koji Kaneoka, Shiro Hinotsu, Ken Shimizu, Yu Okubo, Shumpei Miyakawa, Naoki Mukai, Masataka Sakane, Naoyuki Ochiai

AMERICAN JOURNAL OF SPORTS MEDICINE ( SAGE PUBLICATIONS INC ) 37 ( 1 ) 149 - 155 2009.01 [Refereed]

Background: Several studies have reported that physical loading related to competitive sports activities is associated with lumbar intervertebral disk degeneration. However, the association between types of sports activities and disk degeneration has not been clarified. Hypothesis: The frequencies of disk degeneration may vary with the competitive sport because of the different postures and actions specific to each sport. Study Design: Cross-sectional study (prevalence); Level of evidence, 3. Methods: Study participants were 308 well-trained university athletes (baseball players, basketball players, kendo competitors, runners, soccer players, swimmers) and 71 nonathlete university students (reference group). Disk degeneration was evaluated using T2-weighted magnetic resonance imaging. A self-reported questionnaire concerning low back pain was also conducted. Results: The proportions of the participants who had disk degeneration among the baseball players (odds ratio, 3.23) and the swimmers (odds ratio, 2.95) were significantly higher than among the nonathletes using logistic regression analysis. When all patients were grouped together, the association between lifetime experience of low back pain and participants with disk degeneration was significant, and a linear association between the degree of severest low back pain experienced and participants with disk degeneration, analyzed by a Cochran-Mantel-Haenszel test, was also significant. Conclusion: Continuous competitive baseball and swimming activities during youth may be associated with disk degeneration. Furthermore, the study indicates that the experience of severe low back pain might be a predictor of disk degeneration in youth. The authors hope that preventive measures and management to protect against disk degeneration and low back pain in athletes will be established by further studies based on these results.

Bladder cancer develops 6 years earlier in current smokers: Analysis of bladder cancer registry data collected by the cancer registration committee of the Japanese Urological Association

Shiro Hinotsu, Hideyuki Akaza, Tsuneharu Miki, Hiroyuki Fujimoto, Nobuo Shinohara, Eiji Kikuchi, Yoichi Mizutani, Hirofumi Koga, Eijiro Okajima, Akihiko Okuyama

INTERNATIONAL JOURNAL OF UROLOGY ( WILEY-BLACKWELL PUBLISHING, INC ) 16 ( 1 ) 64 - 69 2009.01 [Refereed]

It is generally recognized that cigarette smoking is the most important risk factor for bladder cancer. The present study was undertaken to examine the relationships between smoking history of bladder cancer patients and the age of onset of bladder cancer and tumor characteristics. The present study examined the data for 5959 cases (4728 males and 1231 females) collected in the bladder cancer database of the Japanese Urological Association from 1999 to 2001. Patients were divided by smoking history into three categories as current non-smokers, current smokers and unknown smoking history. Relationship between smoking history and the age at diagnosis of bladder cancer, gender, T stage, grade, tumor size, tumor number and initial symptoms was analyzed In both males and females the onset of bladder cancer is about 6 years (6.1 years in males and 5.9 years in females) earlier for current smokers than for current non-smokers. At the time of diagnosis, tumor stage was significantly higher in the current smokers group. The current smokers group tended to have larger tumor size. The finding of 6-year-earlier onset of bladder cancer among current smokers is of great importance to both health care and medical economics. It is essential to make people better informed concerning the need to quit smoking.

IS O-07 Outcome of Pediatric Renal Tumor Treated With the JWiTS-1 Protocol : A Report from the Japanese Wilms Tumor Study Group(International Session 2 Tumor,Science and Art for Sick Children)

Oue Takaharu, Koshinaga Tsugumichi, Fukuzawa Masahiro, Okita Hajime, kaneko Yasuhiko, Nozaki Miwako, Hinotsu Shiro, Horie Hiroshi, Chin Motoaki, Mugishima Hideo

Journal of the Japanese Society of Pediatric Surgeons ( The Japanese Society of Pediatric Surgeons ) 45 ( 3 ) 459 - 459 2009

Factors associated with lumbar intervertebral disc degeneration in the elderly

Mika Hangai, Koji Kaneoka, Shinya Kuno, Shiro Hinotsu, Masataka Sakane, Naotaka Mamizuka, Shinsuke Sakai, Naoyuki Ochiai

SPINE JOURNAL ( ELSEVIER SCIENCE INC ) 8 ( 5 ) 732 - 740 2008.09 [Refereed]

BACKGROUND CONTEXT: Lumbar intervertebral disc degeneration (DD) precedes degenerative diseases of the lumbar spine. Various factors in addition to normal aging are reported to be associated with DD, and recently atherosclerosis and risk factors for cardiovascular diseases (cardiovascular risk factors) have received much attention; however, the links between these risk factors and DD are unclear. PURPOSE: By correlating magnetic resonance images (MRI) with suspected degenerative disc risk factors such as obesity, cardiovascular risk factors, and atherosclerosis, we hope to clarify the factors associated with DD. STUDY DESIGN/SETTING: An observational study. PATIENT SAMPLE: Two hundred seventy adults (51-86 years old) who participated in a health promotion program. OUTCOME MEASURES: DD evaluated based on the signal intensity of MR T2-weighted midsagittal images of the lumbar spine. METHODS: Age, gender, body mass index (BMI), low-density lipoprotein cholesterol (LDLc), triglyceride (TG), glycosylated hemoglobin (HbA(1c)), brachial-ankle pulse wave velocity (baPWV) as an index of atherosclerosis, osteo-sono-assessment index (OSI) calculated from quantitative ultrasound assessment of the calcaneus as an index of bone mineral density (BMD), history of low back pain (LBP), smoking and drinking habits, and physical loading related to occupations and sports were assessed. The univariate relationships between DD and the variables were evaluated, and finally, odds ratios (OR) and 95% confidence intervals (0) for the associations of each factor with DD were calculated using logistic regression at each disc level. RESULTS: Aging correlated significantly with DD of L1/2 (OR, 2.14), L2/3 (OR, 3.56), L3/4 (OR, 2.84), and L4/5 (OR, 3.05); high BMI, with 1-2/3 (OR, 2.98), L3/4 (OR, 3.58), L4/5 (OR, 2.32), and L5/S1 (OR, 3.34); high LDLc, with L4/5 (OR, 2.65); occupational lifting, with L1/2 (OR, 4.25); and sports activities, with L5/S1 (OR, 3.36). CONCLUSIONS: Aging, high BMI, high LDLc, occupational lifting, and sports activities are associated with DD. The results of this study raise our index of suspicion that cardiovascular risk factors and particular physical loading may contribute to DD; however additional studies are required to further investigate associations between DD and these factors. (C) 2008 Elsevier Inc. All rights reserved.

Negative impact of metabolic syndrome on the responsiveness to sildenafil in Japanese men

Takahiro Suetomi, Koji Kawai, Shiro Hinotsu, Akira Joraku, Takehiro Oikawa, Noritoshi Sekido, Naoto Miyanaga, Toru Shimazui, Hideyuki Akaza

JOURNAL OF SEXUAL MEDICINE ( BLACKWELL PUBLISHING ) 5 ( 6 ) 1443 - 1450 2008.06 [Refereed]

Introduction. Several recent studies suggested that the prevalence of erectile dysfunction (ED) was higher in men with metabolic syndrome (MS). Aim. We analyzed the impact of MS on the responsiveness to sildenafil. Methods. A total of 133 ED patients were evaluated for the prevalence of MS and graded on severity of ED. MS was diagnosed according to the International Diabetes Federation (IDF) definition. The severity of ED was evaluated by the International Index of Erectile Function (IIEF) questionnaire. Hormonal parameters were measured for all patients, and the IIEF questionnaire was conducted after administration of eight tablets of 50-mg doses of sildenafil. If the scores to questions 3 and 4 of the IIEF were 4 or higher after administration, the patients were defined as responders to sildenafil. Main Outcome Measures. To clarify the negative impact of MS on the responsiveness to sildenafil. Results. The mean age of the patients was 56.9 years, and 25 patients were diagnosed with MS. The IIEF-erectile function score and the response rate for sildenafil decreased as the number of MS components increased. Logistic regression analysis showed that the presence of MS along with severity of ED and history of pelvic surgery were significant independent risk factors of nonresponse for sildenafil. The hazard ratio for the presence of MS was 3.30 (95% confidence interval [CI]: 1.17-9.73). No meaningful association was observed between total testosterone or free testosterone levels and MS in this population. Conclusion. We demonstrated the negative impact of MS on the responsiveness to sildenafil. Erectile function and response rate for sildenafil decreased as the number of MS components increased.

[Future directions of anticancer drug development in Japan].

Akaza H, Kawai K, Tsuruo T, Tsukagoshi S, Aiba K, Shimada Y, Kakeji Y, Ishikawa H, Ikeda T, Nakamura S, Tamura T, Yamamoto N, Isonishi S, Hinotsu S, Hirose M, Katsura J

Gan to kagaku ryoho. Cancer & chemotherapy 35 ( 2 ) 351 - 360 2008.02 [Refereed]

Evidence-based clinical practice guidelines for prostate cancer (Summary JUA 2006 edition)

Sadao Kamidono, Shinichi Ohshima, Yoshihiko Hirao, Kazuhiro Suzuki, Yoichi Arai, Hiroyuki Fujimoto, Shin Egawa, Hideyuki Akaza, Isao Hara, Shiro Hinotsu, Yoshiyuki Kakehi, Tomonori Hasegawa

INTERNATIONAL JOURNAL OF UROLOGY ( BLACKWELL PUBLISHING ) 15 ( 1 ) 1 - 18 2008.01 [Refereed]

Background variables for the patients with invasive bladder cancer suitable for bladder-preserving therapy

Naoto Miyanaga, Hideyuki Akaza, Shiro Hinotsu, Akira Joraku, Takehiro Oikawa, Noritoshi Sekido, Koji Kawai, Toru Shimazui

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 37 ( 11 ) 852 - 857 2007.11 [Refereed]

Objective: The present study was undertaken to identify the patients suitable for bladder preservation by analysis of our data. Methods: The subjects of this study were all 72 patients with T2-3NOMO bladder cancer who underwent bladder-preserving therapy in our institute. The therapy involved intra-arterial chemotherapy with MTX and CDDP and concomitant radiotherapy. Results: Of the evaluable 70 cases, complete response (CR) was confirmed in 57 cases (81.4%). Among 56 bladder preserved cases, 47 (83.9%) preserved their functioning bladder, and 9 underwent salvage radical cystectomy at the following period. The median follow-up was 45.3 months. The 5-year cause-specific survival rate was 81% and the 5-year overall survival rate was 66%. On the basis of the results of univariate analysis, variables contributing to CR were selected. In T2, tumor size of <= 3 cm was scored 0 and >3 cm was scored 1, whereas single tumor was scored 0 and multiple were scored 1. In T3, tumor size of <= 3 cm was scored 0 and >3 cm was scored 1, whereas G2 was scored 0 and G3 scored 1. The CR rates were 93.8, 92.6, and 62.9% for total scores of 0, 1, and 2, respectively (P = 0.003; score 0 or 1 versus 2). The overall survival rate was significantly higher in the former group (P = 0.003). Conclusion: Bladder-preserving therapy can be acceptable for cases of single T2NOMO tumor with a size of <= 3 cm and for T3NOMO cases with a tumor size of <= 3 cm.

Current status of endocrine therapy for prostate cancer in Japan - Analysis of primary androgen deprivation therapy on the basis of data collected by J-CaP

Shiro Hinotsu, Hideyuki Akaza, Michiyuki Usami, Osamu Ogawa, Susumu Kagawa, Tadaichi Kitamura, Taiji Tsukamoto, Seiji Naito, Mikio Namiki, Yoshihiko Hirao, Masaru Murai, Hidetoshi Yamanaka

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 37 ( 10 ) 775 - 781 2007.10 [Refereed]

Background:Based on the data of current status of endocrine therapy for prostate cancer registered in the Japan Study Group of Prostate Cancer (J-CaP), we conducted an analysis of primary androgen deprivation therapy (PADT) and an interim analysis of the prognosis. Methods: Of the 26 272 cases registered in the server of J-CaP, the 19 409 cases initially receiving PADT were included in this study. The initial therapy was divided into eight categories according to its features. Results: Of the 19 409 patients, 1513 (7.8%) were given anti-androgen monotherapy, 955 patients (4.9%) surgical castration only, 1001 patients (5.2%) surgical castration + anti-androgen, 3015 patients (15.5%) LHRH monotherapy, 1658 patients (8.5%) LH-RH + short-term anti-androgen, 10 434 patients (53.8%) LH-RH + anti-androgen, 37 patients (0.2%) watchful waiting and 796 patients (4.1%) other therapy. In progression-free survival, the prognosis was slightly better following maximum androgen blockade (MAB) in each stage. Conclusions: The pattern of PADT is more typical in Japan compared with that in the United States. Patients who received MAB accounted for 59.0% of all the patients. MAB tends to be more often selected for patients who are rated as being at high risk on the basis of high Gleason score or PSA level upon diagnosis in each clinical stage of the disease. Investigations of the outcome are on-going and they will make clear the significance of this trend in Japan.

Three-weekly docetaxel with prednisone is feasible for Japanese patients with hormone-refractory prostate cancer: A retrospective comparative study with weekly docetaxel alone

Toru Shimazui, Koji Kawai, Naoto Miyanaga, Takahiro Kojima, Noritoshi Sekido, Shiro Hinotsu, Takehiro Oikawa, Akira Joraku, Hideyuki Akaza

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 37 ( 8 ) 603 - 608 2007.08 [Refereed]

Background: We previously reported that weekly treatment with docetaxel alone is useful for and well tolerated by patients with hormone-refractory prostate cancer (HRPC). Here, we compare it with the regimen of docetaxel once every 3 weeks (q3w) plus daily prednisone (PSL) based on a TAX 327 trial in order to clarify the efficacy and toxicity of docetaxel regimens in Japan. Methods: Thirty-two patients with HRPC were treated with docetaxel weekly (regimen 1) or docetaxel q3w plus PSL daily (regimen 2) at Tsukuba University Hospital and the changes in serum prostate-specific antigen (PSA), tumor size and survival were evaluated. The dose of docetaxel in regimen 1 was based on our previous report and that of regimen 2 was modified from a TAX 327 trial. Results: A >50% decrease in PSA was observed in 53% of the patients with a median time to progression of 3.5 months and 69% with 8.5 months with regimens 1 and 2, respectively. Patients who received regimen 2 had a significantly better survival rate than those who received regimen 1. Myelosuppression and neuropathy were statistically more frequent in regimen 2 than in regimen 1. Conclusion: A regimen of docetaxel q3w with PSL daily was associated with a high rate of PSA reduction and prolongation of patient survival. Although docetaxel has not been approved in Japan yet, this treatment is considered feasible for Japanese patients with HRPC.

Prediction of in vitro response to interferon-alpha in renal cell carcinoma cell lines

Toru Shimazui, Yoshihiro Ami, Kazuhiro Yoshikawa, Kazuhiko Uchida, Takahiro Kojima, Takehiro Oikawa, Kogenta Nakamura, Nobuaki Honda, Shiro Hinotsu, Jun Miyazaki, Noriko Kunita, Hideyuki Akaza

CANCER SCIENCE ( BLACKWELL PUBLISHING ) 98 ( 4 ) 529 - 534 2007.04 [Refereed]

We analyzed the correlation between interferon-alpha (IFN alpha) response and gene expression profiles to predict IFN alpha sensitivity and identified key molecules regulating the IFN alpha response in renal cell carcinoma (RCC) cell lines. To classify eight RCC cell lines of the SKRC series into three subgroups according to IFN alpha sensitivity, that is, sensitive, resistant and intermediate group, responses to IFN alpha (300-3000 IU/mL) were quantified by WST-1 assay. Microarray, followed by supervised hierarchical clustering analysis, was applied to selected genes according to IFN alpha sensitivity. In order to find alteration of expression profiles induced by IFN alpha, sequential microarray analyses were performed at 3, 6, and 12 h after IFN alpha treatment of RCC cell lines and mRNA expression level was confirmed using quantitative real time polymerase chain reaction. According to the sequential microarray analysis between IFN alpha-sensitive and -resistant line, seven genes were selected as candidates for IFN alpha-sensitivity-related genes in RCC cell lines. Among these seven genes, we further developed a model to predict tumor inhibition with four genes, that is, adipose differentiation-related protein, microphthalmia associated transcription factor, mitochondrial tumor suppressor 1, and troponin T1 using multiple linear regression analysis (coefficient = 0.948, P = 0.0291) and validated the model using other RCC cell lines including six primary cultured RCC cells. The expression levels of the combined selected genes may provide predictive information on the IFN alpha response in RCC. Furthermore, the IFN alpha response to RCC might be modulated by regulation of the expression level of these molecules.

Does tumor size or microvascular invasion affect prognosis in patients with renal cell carcinoma?

Tomoaki Miyagawa, Toru Shimazui, Shiro Hinotsu, Takehiro Oikawa, Noritoshi Sekido, Naoto Miyanaga, Koji Kawai, Hideyuki Akaza

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 37 ( 3 ) 197 - 200 2007.03 [Refereed]

Background: We retrospectively evaluated the effects of tumor size and microvascular tumor invasion on the clinical outcomes of patients who had undergone radical nephrectomy for renal cell carcinoma (RCC). Methods: One-hundred and sixty-two patients who received radical nephrectomy for localized or locally invasive RCC from1989 to 2002 were included. We evaluated a new cut-off value for tumor size by dividing patients into groups by tumor diameter from 3.0 to 7.0 cm in 1.0 cm increments and compared the prognosis with that predicted by the 2002 TNM classification. We also re-classified localized microvascular tumor invasion as invasive disease. Results: Univariate analyses showed a 5.0 cm cut-off provided the greatest difference in recurrence (p = 0.004) and survival (p = 0.001). Microvascular invasion made no significant difference in tumor recurrence and tumor-specific survival. However, in the new categories used in this study, survival in the locally invasive group was poor compared with the localized group. Conclusion: Our study showed that a tumor diameter of 5.0 cm might be the critical size to determine the prognosis of patients with localized RCC. Microvascular invasion seemed to have the necessity of re-evaluation in the TNM classification for patients with RCC.

The 5th Conference on Asian Trends in Prostate Cancer Hormone Therapy.

Akaza H, Moore MA, Chang SJ, Cheng C, Choi HY, Esuvaranathan K, Hinotsu S, Hong SJ, Kim CS, Kim WJ, Murai M, Naito S, Soebadi D, Song JM, Umbas R, Usami M, Xia S, Yang CR

Asian Pacific journal of cancer prevention : APJCP 8 ( 1 ) 3 - 12 2007.01 [Refereed]

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