Details of a Researcher - HINOTSU Shiro

Papers - HINOTSU Shiro

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The case for androgen deprivation as primary therapy for early stage disease: Results from J-CaP and CaPSURE (TM)

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

JOURNAL OF UROLOGY ( ELSEVIER SCIENCE INC ) 176 ( 6 ) S47 - S49 2006.12 [Refereed]

Purpose: We analyzed the outcome of primary androgen depletion therapy, which has gained more attention as a potential therapeutic option in patients with localized or locally advanced prostate cancer as it has been increasingly implemented despite limited data on its therapeutic impact in Japan and the United States. Materials and Methods: We analyzed data from CaPSURE (TM) and the Japanese Prostate Cancer study. Results: In Japan primary androgen depletion therapy has long been the treatment of choice for localized and locally advanced prostate cancer. Based on CaPSURE (TM) data the frequency of primary androgen depletion therapy being chosen to treat localized and locally advanced disease is also increasing in clinical practice in the United States. A study of the outcomes of endocrine therapy is currently being performed in Japan by the Japanese Prostate Cancer Study Group. Conclusions: It is important to obtain such information about the role of primary androgen depletion therapy for localized and locally advanced prostate cancer from studies of natural history and clinical trials. It is also important to update practical treatment guidelines.

Tissue elasticity imaging for diagnosis of prostate cancer: A preliminary report

Naoto Miyanaga, Hideyuki Akaza, Makoto Yamakawa, Takehiro Oikawa, Noritoshi Sekido, Shiro Hinotsu, Koji Kawai, Toru Shimazui, Tsuyoshi Shiina

INTERNATIONAL JOURNAL OF UROLOGY ( BLACKWELL PUBLISHING ) 13 ( 12 ) 1514 - 1518 2006.12 [Refereed]

Background: Elastography is a diagnostic imaging technique that evaluates the hardness of a lesion. It is expected to become a new diagnostic modality for prostate cancer. The aim of this study was to examine the usefulness of elastography in the diagnosis of prostate cancer. Methods: A total of 29 patients with untreated, histologically proven prostate cancer were examined using an elastographic imaging technique. The patient was scanned in the dorsosacral position and the prostate was manually compressed with a transrectal ultrasonic probe. The echo signals from inside the tissue were measured before and after the tissue compression and an elastogram was generated by spatially differentiation of the displacement distribution. Results: Elastography depicted the cancer lesion as a harder tissue than the surrounding normal prostatic tissue. Elastography successfully detected 93% (27 patients) of the untreated prostate cancer lesions. Detection of cancer lesions using elastography was significantly higher than by digital rectal examination (59%; 17 patients) and transrectal ultrasonography (55%; 16 patients). Conclusion: Elastography has great potential as a useful modality for diagnosis of prostate cancer. Differentiation between cancerous and normal tissues can be expected to become more accurate as a result of technical advances in the quantification of tissue hardness.

Treatment outcome of metastatic testicular cancer at a single institution in Japan, a country with low incidence of germ cell tumor

Koji Kawai, Shiro Hinotsu, Takehiro Oikawa, Noritoshi Sekido, Kazunori Hattori, Naoto Miyanaga, Yuichi Hasegawa, Hiroshi Kojima, Toru Shimazui, Hideyuki Akaza

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 36 ( 11 ) 723 - 730 2006.11 [Refereed]

Background: Incidence of testicular cancer is low in Japan. Recent investigations showed that the outcome of metastatic testicular cancer is associated with the experience of the treatment institution. Objectives of the present investigation are to evaluate outcome of a single institution in Japan, and to identify prognostic factors for testicular cancer. Methods: We retrospectively analysed the outcome of 74 patients with metastatic testicular cancer who were treated at Tsukuba University Hospital (TUH) between January 1981 and January 2003. Forty-five patients (61%) were referred to the TUH for the treatment of metastatic disease. The progression-free survival (PFS) rates according to the International Germ Cell Cancer (IGCC) classification and the Indiana University classification were used to evaluate the treatment outcome. Results: The median follow-up period of all patients was 87 months (range, 13-260 months). Forty patients (54%) were classified as having good prognosis, 20 (27%) intermediate, and 14 (19%) poor. The overall 5- and 10-year PFS was 79 and 74%, respectively. The 5-year PFS with good, intermediate and poor prognosis was 90, 70 and 64%, respectively. There was a significant difference between the three groups (P = 0.02), but the survival of the intermediate-prognosis group was not statistically different from that of the poor-prognosis group. The Indiana University classification failed to discriminate the prognoses of moderate and advanced disease, but proved to be an independent prognostic factor for progression-free survival in intermediate- and poor-prognosis patients (P = 0.025, hazard ratio = 5.39). Conclusions: Our treatment outcome is not different from that of the institutions participating in the International Germ Cell Cancer Consensus Group (IGCCCG).

How many uncomplicated male and female overactive bladder patients reveal detrusor overactivity during urodynamic study?

Noritoshi Sekido, Shiro Hinotsu, Koji Kawai, Toru Shimazui, Hideyuki Akaza

INTERNATIONAL JOURNAL OF UROLOGY ( BLACKWELL PUBLISHING ) 13 ( 10 ) 1276 - 1279 2006.10 [Refereed]

Objective: We retrospectively evaluated the incidence of detrusor overactivity (DO) in uncomplicated overactive bladder syndrome (OAB) patients. Methods: From December 1993 to October 2003, 139 adult patients were referred to an urodynamic clinic for urodynamic evaluation of frequency and/or urinary incontinence. Of these, 50 patients (12 males and 38 females) with urgency, without any overt pathological conditions, were retrospectively evaluated in regard to patient age, storage symptoms, urodynamic parameters, and the presence or absence of DO (DO patients or no DO patients, respectively). Results: The overall incidence of DO was 75% (nine of 12 patients) and 36.8% (14 of 38 patients) in male and female patients, respectively. Two of nine male DO patients and five of 14 female DO patients revealed DO after provocative maneuvers. In male patients, all DO patients were OAB wet. In female patients, 13 of 14 DO patients were OAB wet (92.9%), whereas 17 of 24 no DO patients were also OAB wet (70.8%). Compared with no DO patients, female DO patients revealed statistically significant lower maximum cystometric capacity (P = 0.0139) and lower vesical compliance (P = 0.0002). Although aged 60 years or more was associated with DO in univariate analysis in female patients, any symptoms, even incontinence, were not associated with DO in both sexes. Conclusion: It is supposed that, in contrast to male OAB, DO might not be a major underlying cause of uncomplicated female OAB.

Completion and toxicity of induction chemotherapy for metastatic testicular cancer: An updated evaluation of Japanese patients

Koji Kawai, Satoshi Ando, Shiro Hinotsu, Takehiro Oikawa, Noritoshi Sekido, Naoto Miyanaga, Toru Shimazui, Hideyuki Akaza

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 36 ( 7 ) 425 - 431 2006.07 [Refereed]

Background: Combination of bleomycin, etoposide and cisplatin (BEP) remains the standard chemotherapy for testicular cancer. Since the development of BEP in the 1980s, there has been a considerable advance in supportive therapies, such as granulocyte colony-stimulating-factor and 5-HT3 antagonists. Therefore, we re-evaluated the completion and toxicity of BEP combined with modern supportive care. Methods: The medical records of all 42 testicular cancer patients who received induction chemotherapy at Tsukuba University Hospital were reviewed. Toxicities during the induction chemotherapy were graded according to the Japanese CTCAE v3.0. Results: Dose reduction was needed in only three patients. The subsequent chemotherapy was started at the planned 3 week interval or within 3 days of postponement in 89% of the treatment cycles. The average relative dose intensity (RDI) of bleomycin was 0.95, while that for etoposide and cisplatin was 0.97. There was no death due to toxicity. The most frequent toxicity was leukopenia (grade 3 in 44% and grade 4 in 55%). Post-chemotherapy diffusion capacity was significantly decreased in 30% of patients. Two patients developed bleomycin-induced pneumonitis, but recovered successfully. Sixteen patients received second line or salvage chemotherapy after BEP, subsequently. The overall 5 year cause-specific survival rate was 85%. Conclusion: BEP with high RDIs is acceptable if combined with modern supportive care, with acceptable toxicity profile in most patients.

[Recent progress of clinical trials in urologic oncology].

Hinotsu S

Gan to kagaku ryoho. Cancer & chemotherapy 33 ( 2 ) 188 - 192 2006.02 [Refereed]

Renal cell carcinoma with bilateral adrenaland the small intestinal metastases: A case report

Satoshi Ando, Yoshiharu Fukuhara, Jun Miyazaki, Kazunori Hattori, Sadamu Tsukamoto, Shiro Hinotsu, Toru Shimazui, Hideyuki Akaza

Japanese Journal of Urology ( Japanese Urological Association ) 97 ( 1 ) 64 - 67 2006 [Refereed]

A 69-year-old man who had a complaint of melena and hematemesis was 5referred to our hospital for further evaluation and treatment of renal masses, bilateral adrenal swelling and a tumor in the small intestine. The abdominal CT scan demonstrated two tumors sized 45 mm and 15 mm in diameter, located in the center and lower pole of the left kidney. Bilateral adrenal swelling and a small intestinal tumor with invagination were also observed. We diagnosed left renal cell carcinomas with bilateral adrenal metastases or hyperplasia, and a primary or metastatic small intestinal tumor. He received left radical nephrectomy. right adrenalectomy. and small intestinal resection. Pathological diagnosis was renal cell carcinoma, granular cell carcinoma, G2> G3> G1, INFα, v (+), pT1a, pM1, Stage IV. Bilateral adrenal swelling and small intestinal tumor were metastases from the renal cell carcinoma. After operation, we administered interferon-alpha and steroid replacement. He died after 27-month follow-up period because of renal cell carcinoma. Renal cell carcinoma with simultaneous metastases to bilateral adrenal glands and the small intestine is extremely rare.

Serum creatinine and cholesterol levels of testicular cancer patients in long-term follow up

E Hisamatsu, K Kawai, S Hinotsu, N Miyanaga, T Shimazui, H Akaza

INTERNATIONAL JOURNAL OF UROLOGY ( BLACKWELL PUBLISHING ) 12 ( 8 ) 751 - 756 2005.08 [Refereed]

Purpose: Most patients with advanced testicular cancer can be cured with cisplatin-based chemotherapy. Therefore, the long-term effects of the treatment are clinically important. In the present study, we evaluated the serum creatinine and cholesterol levels of long-term survivors of testicular cancer. Methods: Serum creatinine and cholesterol levels were determined in 23 testicular cancer patients who had received cisplatin-based chemotherapy more than 5 years earlier. They were compared with a control group of 16 patients who did not receive chemotherapy. In addition, follow-up data of beyond 10 years after the initial treatment was obtained from 17 patients. We also analysed the trends of both serum creatinine and cholesterol determinations over 10 or more years using a generalized linear model. Results: There was no significant difference in the serum creatinine and cholesterol levels 5 years after the treatment between the chemotherapy and control groups. Analysis using a generalized linear model showed a significant trend toward an increase in serum creatinine in patients who had developed renal dysfunction during chemotherapy (P = 0.0024). The elevation of the serum creatinine level was mainly observed during the first 5 years. In addition, a significant trend toward an increase in serum cholesterol was revealed in both the chemotherapy and control groups. Conclusion: Patients who have developed renal dysfunction during chemotherapy may be at risk of gradually increasing serum creatinine levels even after it has become normal. Although further analysis is needed, we recommend long-term follow up in the survivors of metastatic testicular cancer patients treated with cisplatin-based chemotherapy.

Lectin-reactive alpha-fetoprotein as a marker for testicular tumor activity

K Kawai, T Kojima, N Miyanaga, K Hattori, S Hinotsu, T Shimazui, H Akaza

INTERNATIONAL JOURNAL OF UROLOGY ( BLACKWELL PUBLISHING ASIA ) 12 ( 3 ) 284 - 289 2005.03 [Refereed]

Background:Lens culinaris agglutin (LCA)-affinity electrophoresis resolves serum alpha-fetoprotein (AFP) into three isoforms, AFP-L1, -L2 and -L3. The ratio of AFP-L3 to total AFP (AFP-L3%) is frequently high in hepatocellular carcinoma (HCC) patients, and thus, it is widely used for early diagnosis of HCC. In the present study, we used the subfraction profile of LCA-binding AFP to diagnose and monitor testicular tumor activity. Methods: Serum samples were collected from 21 testicular tumor patients, and the LCA-reactive fractions were determined by LCA-affinity electrophoresis coupled with antibody-affinity blotting. The histological diagnosis was non-seminomatous germ cell tumor (NSGCT) in 15 patients and pure seminoma in six patients. Results: Serum AFP levels were abnormally elevated (> 20 ng/mL) in 10 of 15 NSGCT patients. One NSGCT patient and two seminoma patients showed borderline AFP levels between 10 and 20 ng/mL. LCA-reactive AFP was detected in all 11 NSGCT patients with serum AFP levels above 10 ng/mL, but not in the two seminoma patients with serum AFP levels above 10 ng/mL. In testicular tumor patients, the broad band of AFP-L2 could not be completely separated from AFP-L3. The mean ratio of AFP-L3 plus AFP-L2 (AFP-L2 + 3%) was as high as 94% (range 80-99%) in these patients. Serial determinations of LCA-reactive fractions were performed in eight of the 11 LCA-reactive AFP-positive patients. They included five patients who received chemotherapy, and three patients who underwent orchiectomy for stage I NSGCT. In three of eight patients, LCA-reactive AFP was detected even after normalization of total AFP levels. All three patients relapsed, with elevation of serum AFP within several months. Conclusion: Determination of LCA-reactive AFP might be a useful marker for testicular tumor activity in patients with lower AFP levels.

The 3rd Conference on Asian Trends in Prostate Cancer Hormone Therapy.

Akaza H, Naito S, Chang SJ, Chen KK, Cheng C, Choi HY, Fujioka T, Hinotsu S, Hirao Y, Hong SJ, Kim CS, Kim WJ, Lee SE, Murai M, Ogawa O, Rim JS, Soebadi DM, Song JM, Tsukamoto T, Umbas R, Usami M, Xia S, Yang CR, Yoon JH, Zhou L

Gan to kagaku ryoho. Cancer & chemotherapy 31 ( 8 ) 1285 - 1295 2004.08 [Refereed]

Clinical parameters that predict histology of postchemotherapy retroperitoneal lymph node mass in testicular cancer

M Onozawa, K Kawai, T Yamamoto, S Hinotsu, S Tsukamoto, K Hattori, N Miyanaga, T Shimazui, H Akaza

INTERNATIONAL JOURNAL OF UROLOGY ( BLACKWELL PUBLISHING ASIA ) 11 ( 7 ) 535 - 541 2004.07 [Refereed]

Background: Since the advent of cisplatin-based chemotherapy, the majority of metastatic testicular cancers can be cured by chemotherapy followed by retroperitoneal lymph node dissection (RPLND). However, postchemotherapy RPLND confers no therapeutic benefit if the residual mass contains no viable cells. Therefore, to determine which parameters predict a patient's likelihood of having only necrosis in the residual mass, we retrospectively analyzed clinical parameters of patients who underwent postchemotherapy RPLND. Methods: Data from 27 patients with metastatic testicular cancer were analyzed. The histology of the primary tumor was seminoma in 11 cases and non-seminoma in 16 cases. All of the patients with non-seminoma showed a normalization of tumor markers after chemotherapy. Analysis of clinical parameters included data for the initial histology, pretreatment tumor marker levels, postchemotherapy retroperitoneal mass size, and the histology of the dissected RPLNs. Results: Histological examination of dissected RPLNs showed residual tumor in 27% of seminoma patients and 38% of non-seminoma patients. In seminoma patients, no viable cells were found in all six patients with pretreatment lactate dehydrogenase (LDH) levels below 7.5 times the upper limit of normal, or in all five of the patients with postchemotherapy RPLNs less than 2.5 cm. In non-seminoma patients, no viable cells were found in nine of 10 patients with pretreatment alpha-fetoprotein (AFP) levels less than 2700 ng/mL, or in eight of nine patients with residual mass less than 2.5 cm. Conclusions: Both postchemotherapy RPLN mass size and pretreatment tumor marker levels are possible predictors for necrosis of the residual mass in testicular cancer patients.

Characteristics of patients with prostate cancer who have initially been treated by hormone therapy in Japan: J-CaP surveillance

H Akaza, M Usami, S Hinotsu, O Ogawa, S Kagawa, T Kitamura, T Tsukamoto, S Naito, Y Hirao, M Murai, H Yamanaka

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 34 ( 6 ) 329 - 336 2004.06 [Refereed]

Objective: Hormone therapy for prostate cancer has empirically prevailed in Japan. We planned to evaluate the trends and outcome of hormone therapy for establishing an adequate guideline. Methods: Patients with prostate cancer who were initially treated by hormone therapy were registered through the J-CaP registration system. This report summarizes the background factors. Results: From January 2001 to October 2003, 17 872 patients were registered from 395 institutes throughout Japan. The background factors of 17 312 patients were analyzed. The 17 872 patients were estimated as composing more than half of newly diagnosed prostate cancer patients in Japan. Of these, 22.9, 35.1, 32.9 and 8.6% belonged to T1, T2, T3 and T4, respectively. For the purposes of hormone therapy, 77.5% was primary hormone therapy. Neoadjuvant setting and adjuvant setting were 18.1 and 4.3%, respectively. About 60% of the hormone therapy was combined hormone therapy with LH-RHa plus anti-androgens. Conclusion: Irrespective of patients' age, TNM, stage of illness, or histological background, the majority of prostate cancer patients in Japan are receiving hormone therapy. It is necessary to evaluate whether this trend is merely a continuation of past experience of Japanese urologists or if there is a difference in the profile of effect and side-effect in the case of Japanese patients compared to therapy given in Westerners.

Bladder neck contraction after radical prostatectomy: Morbidity and risk factors

Masakazu Tsutsumi, Satoru Ishikawa, Shiro Hinotsu

Acta Urologica Japonica 50 ( 6 ) 397 - 400 2004.06 [Refereed]

We retrospectively analyzed the morbidity and risk factors of bladder neck contraction (BNC) after retropubic prostatectomy. Of 99 consecutive patients who underwent radical retropubic prostatectomy between 1995 and 2001, 10 (10%) developed anastomotic stricture after surgery. BNC was diagnosed 7 months on average after the surgery. Nine patients were successfully treated by cold-knife incision, but 5 required additional incision against the recurrence of BNC. None of them revealed newly diagnosed stricture or incontinence. Thirteen potential risk factors including age, stage, PSA, neoadjuvant treatment, pathology, intraoperative blood loss, operation time, operator, nerve sparing, extravasation of urine, marginal status, the year of operation, and the method of ureterovesical anastomosis were evaluated using univariate and multivariate analysis. The BNC rate was increased in patients with longer (more than 4 hrs) operations and excessive bleeding (more than 1,000 ml) (p=0.0027, respectively). The year of operation (before 1998, p=0.0015), the method of ureterovesical anastomosis (p=0.0017), operator experience (less than 5 cases, p=0.0056), and neoadjuvant treatment (p=0.09) were also risk factors. In multivariate analysis, the year of operation (p=0.03) and operator experience (p=0.04) were strong predictors of BNC. The skill levels of surgeons and institutes are expected to decrease BNC.

Effect of prophylactic treatment with intravesical epirubicin on recurrence of superficial bladder cancer - The 6th trial of the Japanese Urological Cancer Research Group (JUCRG): A randomized trial of intravesical epirubicin at dose of 20 mg/40 ml, 30 mg/40 ml, 40 mg/40 ml

M Kuroda, T Niijima, T Kotake, H Akaza, S Hinotsu

EUROPEAN UROLOGY ( ELSEVIER SCIENCE BV ) 45 ( 5 ) 600 - 605 2004.05 [Refereed]

Objectives: We compared the prophylactic efficacy and safety of epirubicin (EPI) in primary superficial bladder cancer. Methods: The major inclusion criteria were primary superficial bladder tumour (Ta, T1, G1, G2) and new cases of primary multiple tumours, or recurrent cases. The major exclusion criteria were Tis or G3 tumours. Group A received 17 doses of EPI 20 mg/40 ml over a period of 12 months for a total dose of 340 mg. In contrast, Group B received 12 doses of EPI 30 mg/40 ml over a period of 7 months, while Group C received 9 doses of EPI 40 mg/40 ml over a period of 4 months, both for a total dose of 360 mg. This study enrolled a total of 622 patients diagnosed as having primary superficial bladder cancer during the period from June 1994 through November 1996 at the 118 institutions. Follow-up of the patients was conducted through October 1999. Results: The relationship between the EPI concentration and the recurrence-free rate was evaluated by Tarone's test, and it was found that the recurrence-free rate became significantly higher as the drug concentration increased (p = 0.0375). In the safety evaluation, with regard to adverse drug reactions, pollakiuria and pain on urination occurred at significantly higher incidences as the concentration of the EPI solution increased. Conclusions: The greatest effect of intravesical instillation of EPI after TUR-BT was shown by the regimen using the highest concentration of the drug solution which was administered during a short period of time. (C) 2004 Elsevier B.V. All rights reserved.

Weekly administration of docetaxel in patients with hormone-refractory prostate cancer: a pilot study on Japanese patients

T Kojima, T Shimazui, M Onozawa, S Tsukamoto, S Hinotsu, N Miyanaga, K Hattori, K Kawai, H Akaza

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 34 ( 3 ) 137 - 141 2004.03 [Refereed]

Objective: Although treatment of hormone-refractory prostate cancer (HRPC) is difficult, a single-agent weekly dose of docetaxel has been reported as a promising regimen for patients with HRPC. The purpose of this study was the investigation of the efficacy of docetaxel for Japanese patients with HRPC. Methods: Ten patients with HRPC were treated with weekly docetaxel at Tsukuba University Hospital and were evaluated for the responses with respect to serum prostate-specific antigen (PSA), tumor size and survival. Considering the ethnic balance, the dose of docetaxel was reduced to 30 mg/m(2) weekly compared with 36 mg/m(2) in the study reported previously. Results: A biochemical response (>50% decrease in PSA) was observed in five patients (56%; 5/9) with an average time to progression of 4.5 months. In two partial responders as determined by PSA, respective metastatic lesions in bone and soft tissue were also improved. The estimated median survival duration was 6 months. Most of these responses were accompanied by a significant reduction in the requirement for analgesic agents. No severe toxicity of this regimen was observed, except for gastric ulcer in one patient who was excluded from the evaluation. Conclusions: Weekly administration of docetaxel as a single agent was associated with a high rate of PSA reduction. This treatment is feasible for patients with HRPC, even those who have a poor performance status and extensive prior treatments.

[Molecule based diagnosis].

Akaza H, Ichikawa T, Tsuruo T, Shimada Y, Moriwaki H, Mori M, Noguchi S, Nakamura S, Saijo N, Sone S, Isonishi S, Ohashi Y, Hinotsu S, von Euler M, Blackedge G

Gan to kagaku ryoho. Cancer & chemotherapy 31 ( 1 ) 125 - 133 2004.01 [Refereed] [Domestic journal]

Based on reviews of the concept of diagnostics and in general and in specific tumour areas it was clear that development of diagnostic procedures involving genomics will allow for much better targeted and tailored treatments in the future. This will result in better efficacy and better tolerability of cancer treatments, but will also allow for progress in prediction, diagnosis and dose selection. Large collaborative projects studying the efficacy and safety of drugs on the genome level is promising to bring important benefits to both patients and the national economy by reducing useless drug therapy. In colorectal cancer there are several genetic defects identified that can act as the target for directed therapy in the future. Expressions of tumour specific antigens open the way for immunological targeted therapies. Developments in the understanding of the genomic basis for resistance to anti-tumour therapy is promising to help targeting patients likely to respond and not develop resistance. A Japanese model is being developed to determine the relative risk of breast cancer of Japanese women. Based on this prevention therapies can be instigated. The last four years have seen the introduction of four novel targeted therapies. If this model should become a standard in the future, much stronger collaboration between academic research and pharmaceutical industry need to develop.

A comparison of error detection rates between the reading aloud method and the double data entry method

M Kawado, S Hinotsu, Y Matsuyama, T Yamaguchi, S Hashimoto, Y Ohashi

CONTROLLED CLINICAL TRIALS ( ELSEVIER SCIENCE INC ) 24 ( 5 ) 560 - 569 2003.10 [Refereed]

Data entry and its verification are important steps in the process of data management in clinical studies. In Japan, a kind of visual comparison called the reading aloud (RA) method is often used as an alternative to or in addition to the double data entry (DDE) method. In a typical RA method, one operator reads previously keyed data aloud while looking at a printed sheet or computer screen, and another operator compares the voice with the corresponding data recorded on case report forms (CRFs) to confirm whether the data are the same. We compared the efficiency of the RA method with that of the DDE method in the data management system of the Japanese Registry of Renal Transplantation. Efficiency was evaluated in terms of error detection rate and expended time. Five hundred sixty CRFs were randomly allocated to two operators for single data entry. Two types of DDE and RA methods were performed. Single data entry errors were detected in 358 of 104,720 fields (per-field error rate = 0.34%). Error detection fates were 88.3% for the DDE method performed by a different operator, 69.0% for the DDE method performed by the same operator, 59.5% for the RA method performed by a different operator, and 39.9% for the RA method performed by the same operator. The differences in these rates were significant (p < 0.001) between the two verification methods as well as between the types of operator (same or different). The total expended times were 74.8 hours for the DDE method and 57.9 hours for the RA method. These results suggest that in detecting errors of single data entry, the RA method is inferior to the DDE method, while its time cost is lower. (C) 2003 Elsevier Inc. All rights reserved.

The 2nd conference on Asian trends in prostate cancer hormone therapy.

Akaza H, Chang SJ, Chen KK, Esuvaranathan K, Fujioka T, Hirao Y, Hong SJ, Hinotsu S, Kim WJ, Lau W, Lee SE, Murai M, Naito S, Ogawa O, Rim JS, Soebadi DM, Song JM, Tsukamoto T, Umbas R, Usami M, Yang CR, Yoon JH, Zhou L

Gan to kagaku ryoho. Cancer & chemotherapy 30 ( 10 ) 1533 - 1542 2003.10 [Refereed]

The limited efficacy of methotrexate, actinomycin D and cisplatin (MAP) for patients with advanced testicular cancer

J Miyazaki, K Kawai, H Hayashi, M Onozawa, S Tsukamoto, N Miyanaga, S Hinotsu, T Shimazui, H Akaza

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 33 ( 8 ) 391 - 395 2003.08 [Refereed]

Background: Combination chemotherapy of methotrexate, actinomycin D and cisplatin (MAP) is reported to be effective against gestational choriocarcinoma. Methods: Eight patients with metastatic testicular cancer who had elevated beta-hCG were treated with MAP. They included three refractory cases and two relapsed cases. An additional three patients received MAP as part of the induction therapy. The MAP therapy consisted of methotrexate (10 mg/m(2)) on days 1-5, actinomycin D (0.01 mg/kg) on days 1-5 and cisplatin (70 mg/m(2)) on day 1. Results: In all three refractory patients, MAP failed to achieve tumor marker normalization. However, the elevated tumor markers normalized after MAP in the two cases of relapse. Of these two, one patient relapsed again 7 months after MAP and was subsequently salvaged with high-dose chemotherapy. The other patient relapsed and died of the disease 30 months after receiving MAP. Of the three patients who received MAP as part of the induction chemotherapy, one with pure choriocarcinoma achieved tumor marker normalization after MAP and is still alive without disease progression. In the other two patients, MAP failed to achieve marker normalization and the patients received high-dose chemotherapy. The toxicities were mainly bone marrow suppression and mucositis, which were almost acceptable. Conclusions: The results demonstrated the limited efficacy of MAP as salvage therapy. In addition, the efficacy of MAP as part of induction chemotherapy was negligible. However, there might be some role for MAP as a salvage therapy for patients with pure choriocarcinoma.

Paclitaxel, ifosfamide and cisplatin regimen is feasible for Japanese patients with advanced germ cell cancer

K Kawai, J Miyazaki, S Tsukamoto, S Hinotsu, K Hattori, T Shimazui, H Akaza

JAPANESE JOURNAL OF CLINICAL ONCOLOGY ( OXFORD UNIV PRESS ) 33 ( 3 ) 127 - 131 2003.03 [Refereed]

Background: Paclitaxel, ifosfamide and cisplatin (TIP) has been tested with successful results on metastatic testicular cancer in Western countries. Because paclitaxel, the key drug of this regimen, has not been approved for testicular cancer in Japan, there are no established data concerning TIP. The purpose of this study was to assess the feasibility of a TIP regimen for Japanese patients with advanced germ cell cancer. Methods: Eight patients with advanced germ cell cancer were treated with TIP that was originally reported by Motzer et al (1). The treatment was used for three refractory cases and two late relapse cases as salvage therapy and for three poor-risk cases with extra-pulmonary visceral metastases as a part of induction chemotherapy. TIP consisted of paclitaxel 175 mg/m(2) by 24 h infusion on day 1, followed by ifosfamide 1.2 g/m(2) infusions over 2 h and cisplatin 20 mg/m2 given over 2 h on days 2-6. Results: Five patients (62%) achieved a disease-free status after chemotherapy and surgical resection of residual tumor. Three of five patients have remained continuously free from disease progression at a median follow-up duration of 24 months and one additional patient is currently free of evidence of disease. Most patients developed grade 3 or 4 leukocytopenia and thrombocytopenia; however, they could be managed with routine supportive care. Sensory neuropathy was frequently seen, but no patient experienced over grade 3 neurotoxicity. Conclusions: TIP regimen as salvage chemotherapy is feasible for Japanese patients with advanced germ cell cancer. TIP as a part of induction chemotherapy for poor-risk patients is also feasible; however, larger and longer-term follow-up studies are needed to define the role of TIP in this setting.

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