Michiyuki Usami

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

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.

Long-term results of a randomized trial for the treatment of stages B2 and C prostate cancer: radical prostatectomy versus external beam radiation therapy with a common endocrine therapy in both modalities

OBJECTIVES To improve the treatment of locally advanced prostate cancer (Stages B2 and C), a prospective randomized trial was conducted to compare radical prostatectomy versus external beam radiotherapy with the combination of endocrine therapy in both modalities. METHODS One hundred patients were enrolled and 95 were evaluated. Forty-six patients underwent radical prostatectomy with pelvic lymph node dissection, and 49 were treated with radiation by linear accelerator with 40 to 50 Gy to the whole pelvis and a 20-Gy boost to the prostatic area. For all patients, endocrine therapy was initiated 8 weeks before surgery or radiation, and continued thereafter. The living patients were asked to respond to a quality-of-life questionnaire. RESULTS The follow-up period ranged from 6.0 to 94.4 months (median 58.5). The progression-free and cause-specific survival rates at 5 years were 90.5% and 96.6% in the surgery group and 81.2% and 84.6% in the radiation group, respectively. The surgery group had better progression-free and cause-specific survival rates (P = 0.044 and 0.024, respectively). More patients in the surgery group complained of urinary incontinence. The questionnaire revealed that quality of life was less disturbed in the radiation group. CONCLUSIONS Radical prostatectomy combined with endocrine therapy may contribute to the survival benefit of patients with locally advanced prostate cancer. External beam radiotherapy in combination with endocrine therapy can be used in selected patients because of its low morbidity.

Impact of tumor size on the clinical outcomes of patients with Robson Stage I renal cell carcinoma

In the TNM classification of renal cell carcinoma released in 1997, T1 tumors were defined as organ‐confined tumors 7.0 cm or less in size, and T2 as those larger than 7.0 cm. The consideration of tumor size should be predicated on its prognostic value in predicting survival, because the goal of clinical staging is to separate patients into similar classes of survival based on the extent of disease at presentation. The authors examined the impact of tumor size on the clinical outcomes of patients with Robson Stage I disease to determine a size cutoff that would maximize the predictive value of the TNM staging system.

Prognostic significance of bone metastases in patients with metastatic prostate cancer

Background. The distribution of bone metastases on a bone scan has not been duly considered when assessing the prognosis of metastatic prostate cancer.

Efficacy of primary hormone therapy for localized or locally advanced prostate cancer: results of a 10‐year follow‐up

To evaluate the efficacy of primary hormone therapy for localized or locally advanced prostate cancer, by analysing the 10‐year survival rates for men with localized or locally advanced prostate cancer treated with primary hormone therapy or prostatectomy.

Analysis of the Arterial Blood Flow Patterns of Normal and Allografted Kidneys by the Directional Ultrasonic Doppler Technique

AbstractThe arterial blood flow of the allotransplanted kidney was examined 52 times in 40 recipients and that of the normal kidney 6 times in 6 donors by means of the directional ultrasonic Doppler technique.The blood flow patterns showed a rapid forward phase in systole and a slow forward phase in diastole but nothing indicative of a reverse flow was found. A significant correlation was observed between the acceleration time of flow component and graft function, while there were no correlations among diastole/systole ratio, appearance time and graft function. The arterial blood flow patterns of the grafts were classified into 3 groups based on acceleration time: I—excellent, II—intermediate and III—poor graft functions.Additionally, in pursuit of possible relationships between the ultrasonic Doppler flow patterns of the grafts and their morphological features, histopathology and angiography were done for 20 and 15 recipients, respectively. As a result the histologic vascular changes with interstitial da...

Phase III Trial of Everolimus in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from RECORD-1

Objective To assess the efficacy and safety of everolimus in Japanese patients with metastatic renal cell carcinoma. Methods A subgroup analysis of the pivotal Phase III, randomized, double-blind, placebo-controlled trial of everolimus 10 mg/day in patients with disease progression after treatment with sorafenib, sunitinib or both assessed outcomes in Japanese participants. Results were compared with those for the overall study population. Results The final trial analysis included 24 Japanese patients (everolimus, n= 15; placebo, n = 9). Median progression-free survival in the Japanese subpopulation was 5.75 months (95% confidence interval, 4.90 months to not reached) with everolimus and 3.61 months (95% confidence interval, 1.91–9.03 months) with placebo (hazard ratio, 0.19; 95% confidence interval, 0.05–0.83). Median overall survival was not reached with everolimus and was 14.9 months (95% confidence interval, 11.0–16.8 months) with placebo (hazard ratio, 0.30; 95% confidence interval, 0.07–1.27). Overall, efficacy and safety were similar when comparing the Japanese and overall populations. In the Japanese subpopulation, the most common adverse events with everolimus were stomatitis, infections and rash. Four Japanese subjects (27%) developed Grade 1 (n = 2) or 2 (n = 2) pneumonitis (all reversible and allowing for continuation of therapy, after interruption, steroids and dose reduction for both Grade 2 cases), with a lower pneumonitis incidence of 14% in the overall population (albeit associated with a Grade 3 incidence of 4%). Conclusions These findings suggest that the demonstrated benefits of everolimus in the overall trial population are similar in Japanese patients with metastatic renal cell carcinoma.

Efficacy of primary hormonal therapy for patients with localized and locally advanced prostate cancer: A retrospective multicenter study

Aim: A retrospective review of patients with localized and locally advanced prostate cancer was performed to evaluate the efficacy of primary hormonal therapy and predict long‐term prognosis in these patients.

A prospective and randomized study of primary hormonal therapy for patients with localized or locally advanced prostate cancer unsuitable for radical prostatectomy: results of the 5-year follow-up

To evaluate the effect of primary hormonal therapy for patients with localized and locally advanced prostate cancer.

Maintenance intravesical bacillus Calmette-Guérin instillation for Ta, T1 cancer and carcinoma in situ of the bladder: Randomized controlled trial by the BCG Tokyo Strain Study Group

Objectives:  We carried out a prospective, randomized, controlled trial to investigate the efficacy and safety of both induction and maintenance therapy with intravesical instillation of bacillus Calmette‐Guérin (BCG) for high‐risk non‐muscle invasive bladder cancer (NMIBC).