Isao Numata

Prospective Randomized Phase II Trial of a Single Early Intravesical Instillation of Pirarubicin (THP) in the Prevention of Bladder Recurrence After Nephroureterectomy for Upper Urinary Tract Urothelial Carcinoma: The THP Monotherapy Study Group Trial

PURPOSE We evaluated the efficacy of a single early intravesical instillation of pirarubicin (THP) in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma (UUT-UC). PATIENTS AND METHODS From December 2005 to November 2008, 77 patients clinically diagnosed with UUT-UC from 11 institutions participating in the Tohoku Urological Evidence-Based Medicine Study Group were preoperatively enrolled in this study. Patients were randomly assigned to receive or not receive a single instillation of THP (30 mg in 30 mL of saline) into the bladder within 48 hours after nephroureterectomy. Cystoscopy and urinary cytology were repeated every 3 months for 2 years or until the occurrence of first bladder recurrence. RESULTS Seventy-two patients were evaluable for efficacy analysis, 21 of whom had a subsequent bladder recurrence. Significantly fewer patients who received THP had a recurrence compared with the control group (16.9% at 1 year and 16.9% at 2 years in the THP group v 31.8% at 1 year and 42.2% at 2 years in the control group; log-rank P = .025). No remarkable adverse events were observed in the THP-treated group. Based on multivariate analysis, THP instillation (hazard rate [HR], 0.26; 95% CI, 0.07 to 0.91; P = .035) and open surgery (HR, 0.28; 95% CI, 0.09 to 0.84; P = .024) were independently predictive of a reduced incidence of bladder recurrence. CONCLUSION In this prospective randomized phase II study, a single intravesical instillation of THP seemed to reduce bladder recurrence after nephroureterectomy. A phase III, large-scale, multicenter study is needed to confirm these observations.

Clinical Evaluation of Inside Echo Patterns in Gray Scale Prostatic Echography

Improved gray scale echograms in transrectal ultrasonography clearly can visualize the anatomical structure of and pathological changes in the prostatic gland. This study includes the classification of ultrasonic findings from the prostatic gland into acoustical pattern groups--solid, cystic and mixed--as well as into pathological-anatomical pattern groups--internal gland, external gland, nodule, stone and miscellaneous. The diagnostic accuracy of prostatic diseases using pattern analysis of prostatic inside echoes was 89 per cent, a 9 per cent improvement over that provided by conventional display.

Psychological distress in Japanese men with localized prostate cancer

Objective:  To investigate: (i) the level of psychological distress; and (ii) the relationships between the level of psychological distress and general or disease‐specific HRQOL of Japanese men with localized prostate cancer following surgery or radiotherapy.

Five-year Follow-up of Health-related Quality of Life after Intensity-modulated Radiation Therapy for Prostate Cancer

OBJECTIVE We evaluated health-related quality of life (HRQOL) in patients with localized prostate cancer who underwent intensity-modulated radiation therapy (IMRT) or three-field conformal radiotherapy (3DCRT). METHODS A total of 97 patients underwent 3DCRT and 36 underwent IMRT for localized prostate cancer between 2002 and 2004. We measured the general and disease-specific HRQOL with the Medical Outcomes Study 36-Item Health Survey and University of California, Los Angeles Prostate Cancer Index, respectively. RESULTS There were no significant differences in the pre-operative characteristics of the two groups. The patients in the 3DCRT group were more likely to receive hormonal therapy compared with the IMRT group before and after radiation therapy (P < 0.001 and P = 0.011, respectively). With regard to general HRQOL domains, both the 3DCRT and IMRT group scores showed no significant difference between baseline and any of the observation periods. At 60 months after treatment, the 3DCRT group had significantly worse bowel function and bother scores than baseline (both P < 0.001). On the other hand, there were no significant differences between the baseline and any of the post-treatment time periods in the IMRT group. In the 3DCRT group, sexual function remained substantially lower than the baseline level (P = 0.023). The IMRT group tended to show a decrease in sexual function, which was not statistically significant (P = 0.11). CONCLUSIONS IMRT can provide the possibility to deliver a high irradiation dose to the prostate with satisfactory functional outcomes for long-term periods.

Health related quality of life in Japanese men after radical prostatectomy or radiation therapy for localized prostate cancer

Abstract  Background:  We performed a retrospective survey of general and disease specific health‐related quality of life (HRQOL) after radical prostatectomy (RP) and external beam radiotherapy (XRT) in Japanese men.

Intravesical Seeding of Upper Urinary Tract Urothelial Carcinoma Cells During Nephroureterectomy: An Exploratory Analysis from the THPMG Trial

OBJECTIVE The Pirarubicin Monotherapy Study Group trial was a randomized Phase II study that evaluated the efficacy of intravesical instillation of pirarubicin in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma. This study conducted further analysis of the Pirarubicin Monotherapy Study Group cohort, focusing on intravesical seeding of cancer cells. METHODS Using the data from the Pirarubicin Monotherapy Study Group trial, bladder recurrence-free survival rates and factors associated with bladder recurrence in the control group were analyzed. RESULTS Of 36 patients in the control group, 14 with positive urine cytology had more frequent recurrence when compared with the 22 patients with negative cytology (P = 0.004). Based on the multivariate analysis in the control group, voided urine cytology was an independent predictive factor of bladder recurrence (hazard ratio, 5.54; 95% confidence interval 1.12-27.5; P = 0.036). Of 72 patients in the Pirarubicin Monotherapy Study Group trial, 31 had positive urine cytology. Among the 31 patients, 17 patients who received pirarubicin instillation had fewer recurrences when compared with 14 patients who received control treatment (P = 0.0001). On multivariate analysis, pirarubicin instillation was an independent predictor of better recurrence-free survival rates in the patients with positive urine cytology (hazard ratio, 0.02; 95% confidence interval, 0.00-0.53; P = 0.018). Of 21 patients with bladder recurrence, 17 had recurrent tumor around cystotomy or in the bladder neck compromised by the urethral catheter, supporting the notion that tumor cells seeded in the injured urothelium. CONCLUSIONS Intravesical instillation of pirarubicin immediately after nephroureterectomy significantly reduced the bladder recurrence rate in patients with positive voided urine cytology. The results suggest that intravesical seeding of upper urinary tract urothelial carcinoma occurs during nephroureterectomy.

Expression of Leu-M1 Antigens in Carcinoma of the Urinary Bladder

Anti-Leu-M1 antibody, which is well known to react with a human myelomonocytic antigen, was found to react with bladder carcinoma, but never with the normal bladder epithelium. Eighty-six cases of transitional cell carcinoma of the bladder were tested in sections of formalin-fixed and paraffin-embedded tissues by using an avidin-biotin immunoperoxidase technique. Fifty per cent of these cases were positive in Leu-M1, while the other three monoclonal antibodies (HBA4, HBG9 and HBH8), which were produced against a human bladder carcinoma cell line KU-1, reacted in 17 per cent, 27 per cent and 64 per cent of these cases respectively. Reactivities of these antibodies to 33 cases of normal bladder epithelium were Leu-M1, 0 per cent; HBA4, 0 per cent; HBG9, 0 per cent and HBH8, 30 per cent, respectively. Expression of Leu-M1 antigens in bladder epithelium seems to be specific for malignant change and highly frequent in the carcinoma patients. The relation between Leu-M1 expression and a degree or stage in bladder carcinomas, however, was not significant in our studies.

Metastatic renal cell carcinoma to right ventricle without vena caval involvement

Abstract:  Cardiac metastases from renal cell carcinoma without vena caval involvement are extremely rare. We report 49‐year‐old man who presented symptoms of heart failure and thrombocytopenia. Computed tomography and echocardiography revealed a left renal tumor and a right ventricular mass without vena caval involvement. His symptoms progressed rapidly and he died at nine days following diagnosis of the right ventricular tumor.

Impact of nocturia on disease-specific quality of life for men with localized prostate cancer

ObjectivesWe assessed the impact of nocturia on the general and disease-specific health-related quality of life (HRQOL) for men with localized prostate cancer.Materials and methodsA total of 620 men with prostate cancer were enrolled to our study. All of the subjects completed the questionnaires before primary treatment. We evaluated general HRQOL with the Short Form 36-Item Health Survey (SF-36). The prostate-specific HRQOL was assessed with the University of California, Los Angeles Prostate Cancer Index (PCI). Night-time urinary frequency was assessed by the seventh score of the International Prostate Symptom Score.ResultsOf the 581 men, 47 (8%) men reported no nocturia, while 189 (32%) were categorized with one void per night and 345 (59%) with two or more voids per night. Disease-specific HRQOL, including urinary function, bowel function, and sexual function, was negatively associated with increase in frequency of nocturia. The subjects who reported two or more voids per night had significantly lower scores than those of the no nocturia or one void per night group in several domains of the SF-36 and PCI. Based on the proportion odds model, age, urinary function, bowel function, and sexual function showed a strong association with frequency of nocturia.ConclusionsWe found a strong association between the frequency of nocturia and disease-specific HRQOL as well as general HRQOL. Increased severity of nocturia is negatively correlated with overall health status and HRQOL outcomes.

Hyponatremia and thrombocytopenia associated with sorafenib treatment for renal carcinoma: an alert of an adverse event

To date, the manufacturer of sorafenib has reported that the hyponatremia and thrombocytopenia associated with its use are generally moderate and tolerable and have resulted in no mortalities. In this article we describe a Japanese patient with severe hyponatremia and thrombocytopenia that were likely related to sorafenib treatment for metastatic renal carcinoma. Oncologists should be aware of hyponatremia and thrombocytopenia as an adverse effect related to this agent.