Search

To determine the impact of patient age on outcome following bladder-preserving treatment for non-muscle-invasive bladder cancer (NMIBC).This study examined 491 patients treated with transurethral resection and/or intravesical bacillus Calmette-Guerin (BCG) therapy for primary NMIBC at our institution between 1985 and 2005. The patients' age at treatment was classified into categories of younger than 50, 50-59, 60-69, 70-79, and 80 years or older. Recurrence-free survival and progression-free survival were estimated by the Kaplan-Meier method and analyzed using Cox proportional hazard models.Tumors of broad-based, multiple, and higher grades were more frequent with increasing patient age. Intravesical BCG therapy was less frequently performed on elderly patients. At a median follow-up of 45 months, patients 80 years or older had the lowest recurrence-free survival and progression-free survival among the age groups (log-rank P0.001 and P = 0.019, respectively). On Cox proportional hazard model, age was an independent risk factor for tumor recurrence and progression after controlling for all confounding variables. The recurrence risk was 2.3 times higher for patients 80 years or older than those aged 60-69 years (P0.001).Older age adversely affected the outcome of patients with NMIBC, which is particularly apparent in patients 80 years or older. Further prospective studies to confirm these findings are warranted.

AIM In order to clarify the initial step of the mechanism by which bacillus Calmette-Guerin (BCG) exhibits antitumor activity via the immune response induced in the bladder submucosa after intravesical BCG therapy for human bladder cancer, various cytokines secreted in the urine after BCG instillation were measured. METHODS After transurethral resection of bladder cancer, a 6-week course of BCG instillation was performed. At the first and sixth weeks' dosings, spontaneously excreted urine was collected before and 4, 8, and 24 h after BCG instillation. The urinary cytokines were determined by Sandwich enzyme-linked immunosorbent assay using monoclonal antibodies against granulocyte-macrophage colony-stimulating factor (GM-CSF), tumor necrosis factor (TNF)-alpha, granulocyte colony-stimulating factor (G-CSF), interleukin (IL)-1beta, IL-8, interferon (IFN)-gamma, and IL-12. RESULTS After the BCG therapy, various cytokines, such as GM-CSF, TNF-alpha, G-CSF, IL-1beta, IL-8, IFN-gamma, and IL-12 were secreted, comprising the immune response cascade. The mean urinary excretions of GM-CSF and TNF-alpha 4 h after the sixth week's instillation were significantly higher than the pre-instillation levels. There were no significant increases in the urinary IFN-gamma or IL-12 levels between 4 and 24 h after the sixth week's instillation. The TNF-alpha level 4 h after the sixth week's instillation had a strong tendency towards the absence of recurrence, with a mean follow-up of 54.1 months. The Kaplan-Meier curve showed the 2, 5, and 10-year recurrence-free survival rates were 72.4%, 65.8%, and 56.4%, respectively. CONCLUSIONS We suggested that the urinary levels of TNF-alpha might be essential in antitumor activity after BCG therapy and might play an important role in the prevention of bladder tumor recurrence.

OBJECTIVES We investigated whether preoperative parameters predict pathological stage at radical prostatectomy for patients with clinically localized prostatic cancer. MATERIALS AND METHODS We studied a total of 160 men with clinically localized prostatic cancer (less than or equal to clinical T2) who underwent radical rertropubic prostatectomy at Wakayama Medical University. Clinical Ts patients are not included in this study. Preoperative parameters include patient age, Body Mass Index, preoperative serum PSA value, biopsy Gleason score, clinical stage, the percent of positive biopsy cores (%PosBx) and the percent of positive biopsy cores on the dominant side (%DomPosBx). Univariate and multivariate analysis were performed to examine the prognostic significance of these preoperative parameters. Significant independent factors were combined to create a table to predict pathologically organ confined disease. RESULTS Univariate analysis showed preoperative serum PSA value (p< 0.001), biopsy Gleason score (p =0.001), clinical stage (p = 0.026), %PosBx (p= 0.002) and %DomPosBx (p=0.003) were significantly related to the pathological stage. On multivariate analysis, serum PSA value (p< 0.01), biopsy Gleason score (p

This study evaluated the baseline patient characteristics associated with the time to biochemical progression and overall survival in patients who participated in a phase II trial on zoledronic acid combined with the initial androgen-deprivation therapy for treatment-naïve bone-metastatic prostate cancer.Patients received zoledronic acid 4 mg intravenously every 4 weeks for up to 24 months, concomitantly started with bicalutamide 80 mg orally every day and goserelin acetate 10.8 mg subcutaneously every 12 weeks.A total of 53 Japanese patients were enrolled between July 2008 and April 2010, and 52 patients were evaluable. Median follow-up period was 41.6 months. Updated median time to biochemical progression was 25.9 months (95 % confidence interval 14.5-49.9). Higher serum bone-specific alkaline phosphatase was an independent risk factor for time to biochemical progression based on multivariate analysis (hazard ratio 6.51; 95 % confidence interval 2.71-15.62; P0.001). Median time to biochemical progression for patients with serum bone-specific alkaline phosphatase level higher than 26 μg/L was 12.7 months. Multivariate analysis indicated that higher serum C-terminal telopeptide of type I collagen independently increased the risk of death (hazard ratio 9.62; 95 % confidence interval 2.11-43.89; P = 0.003). Median overall survival for patients with serum C-terminal telopeptide of type I collagen level higher than 8.0 ng/ml was 31.1 months.Baseline bone markers can be useful as predictors for disease progression and survival time in patients with bone metastasis from treatment-naïve prostate cancer treated with upfront zoledronic acid concomitantly started with androgen-deprivation therapy.

The efficacy of zoledronic acid in patients with treatment-naïve prostate cancer is unclear. We conducted a phase II study to investigate the benefits of combined zoledronic acid and androgen deprivation therapy in treatment-naïve prostate cancer with bone metastasis. The primary endpoint was skeletal-related event-free survival at 24 months.Subjects were treatment-naïve patients with histologically confirmed adenocarcinoma of the prostate and radiological evidence of bone metastasis. Treatment consisted of bicalutamide 80 mg daily, goserelin acetate 10.8 mg every 12 weeks, and zoledronic acid 4 mg every 4 weeks. Zoledronic acid was continued for 24 months.Of the patients enrolled between July 2008 and April 2010, 52 were included in the analyses. The median age of the patients was 72 years. The median baseline prostate-specific antigen level was 249.4 ng/mL. The median follow-up period was 33.3 months. The 24-month skeletal-related event-free survival rate was 84.4 % (95 % confidence interval 71.2-91.9). The median time to prostate-specific antigen progression was 25.9 months (95 % confidence interval 14.7-36.3). The median overall survival time was not reached. Improvement in pain or maintenance of no pain during the first 12 weeks was observed in 70 % of patients and the extent of bone disease was decreased in 10 % of patients at 12 months. Grade 3 osteonecrosis of the jaw was observed in three patients (5.8 %).Zoledronic acid concomitant with androgen deprivation therapy as initial treatment in patients with treatment-naïve prostate cancer with bone metastasis resulted in an encouraging skeletal-related event-free survival rate at 24 months.

We report a case of leiomyoma of the seminal vesicle in a 74-year-old man who presented with left hemilumbago. Computed tomography and magnetic resonance imaging revealed a mass containing coarse calcification and low signal intensity areas on T1- and T2-weighted images. The clinical features of previously reported cases of leiomyoma of the seminal vesicle are presented, including those of the present case. There remains a lack of consensus regarding surgical resection of leiomyoma of the seminal vesicle.

Intravesical instillation of Tokyo 172 strain bacillus Calmette-Guerin (BCG) was performed on 137 patients with superficial bladder cancer (Ta and T1) after transurethral tumor resection as a prophylaxis against tumor recurrence. The recurrence rate of tumors was compared with that of historical controls and was estimated by the person-years method. There were statistically significant decreases in recurrent tumors following BCG therapy. To clarify the efficacy of intravesical BCG therapy, prognostic significance of several factors were evaluated in 90 patients with initial bladder cancer treated with TUR and BCG instillation, and compared to those of controls. Prophylactic effects were statistically better for those with multiple tumors, grade 3 lesions or Ta lesions than for control patients. No correlation between purified protein derivative responsiveness and favorable results could detected. There were no marked side effects or fatal complications of BCG therapy during the observation periods. Our results suggest that BCG is able to change the biological behavior of superficial bladder cancers with multiple, high grade or low stage lesions. The intravesical BCG instillation seems to be effective and safe as a prophylaxis against the recurrence of superficial bladder tumors.

In order to clarify the initial step of the mechanism by which bacillus Calmette-Guérin (BCG) exhibits antitumor activity via the immune response induced in the bladder submucosa after intravesical BCG therapy for human bladder cancer, various cytokines secreted in the urine after BCG instillation were measured.After transurethral resection of bladder cancer, a 6-week course of BCG instillation was performed. At the first and sixth weeks' dosings, spontaneously excreted urine was collected before and 4, 8, and 24 h after BCG instillation. The urinary cytokines were determined by Sandwich enzyme-linked immunosorbent assay using monoclonal antibodies against granulocyte-macrophage colony-stimulating factor (GM-CSF), tumor necrosis factor (TNF)-alpha, granulocyte colony-stimulating factor (G-CSF), interleukin (IL)-1beta, IL-8, interferon (IFN)-gamma, and IL-12.After the BCG therapy, various cytokines, such as GM-CSF, TNF-alpha, G-CSF, IL-1beta, IL-8, IFN-gamma, and IL-12 were secreted, comprising the immune response cascade. The mean urinary excretions of GM-CSF and TNF-alpha 4 h after the sixth week's instillation were significantly higher than the pre-instillation levels. There were no significant increases in the urinary IFN-gamma or IL-12 levels between 4 and 24 h after the sixth week's instillation. The TNF-alpha level 4 h after the sixth week's instillation had a strong tendency towards the absence of recurrence, with a mean follow-up of 54.1 months. The Kaplan-Meier curve showed the 2, 5, and 10-year recurrence-free survival rates were 72.4%, 65.8%, and 56.4%, respectively.We suggested that the urinary levels of TNF-alpha might be essential in antitumor activity after BCG therapy and might play an important role in the prevention of bladder tumor recurrence.

Three months after an initial 6-week course ofintravesical bacillus Calmette-Guerin (BCG) given between January 1990 and March 2005, 94 (90%) out of 104 patients with carcinoma in situ (CIS) of the bladder achieved a complete response (CR). The 5- and 10-year recurrence-free rates were 67 and 60%, respectively (median follow-up 42 months). Three months after a second course ofintravesical BCG given to 23 patients who failed the initial induction course for CIS was evaluated. Of these, 96% achieved a CR, and the 5- and 10-year recurrence-free rates were 56 and 28%,respectively (median follow-up 23 months). Only one patient who received a second course of BCG therapy showed disease progression. Two of the 4 patients with BCG-refractory CIS of the bladder achieved CR after intravesical gemcitabine therapy and maintained a tumor-free status beyond 6 months. Five of the 16 patients showing disease progression had upper urinary tract cancer, 4 had recurrent or muscle invasive bladder cancer, 6 had prostatic involvement of CIS, and one patient had urethral recurrence. Three of the 16 patients died. Bladder preservation was achieved in 97 of the 104 patients, although 7 patients ultimately underwent radical cystectomy and urinary diversion for aggressive disease. In conclusion, some patients may be managed safely by repeated endoscopic resection and intravesical therapy with cystectomy postponed until objective evidence of progression exists.

A 63-year-old man underwent transurethral resection of a bladder tumor to treat superficial bladder cancer in 1995. Histological examination showed urothelial carcinoma, G2G3 with carcinoma in situ (CIS) at the bladder neck. He underwent postoperative intravesical bacillus Calmette-Guerin (BCG) therapy. In June, 2003, he complained of rubor of his external urethral meatus and visited our clinic. Biopsies at the external urethral meatus and the fossa navicularis of the urethra showed CIS. Radiological examinations, cystourethroscopy and multiple biopsies from other sites of urothelium, including bladder and urethral mucosa, did not reveal any other malignancies. Thereafter, partial penectomy and bilateral inguinal lymphadenectomy were performed. Histological examinations showed CIS at the urethral mucosa of the fossa navicularis and the skin of the glans penis. Postoperative urine cytologies were negative.

We report a rare case of inflammatory pseudotumor of the prostate. A 42-year-old man with a history of hematospermia and chronic prostatitis presented with difficulty in voiding. Cystoscopy demonstrated a large non-papillary tumor occupying the prostatic urethra along with two bladder stones. Magnetic resonance imaging (MRI) demonstrated a 7-cm prostatic mass protruding toward the bladder and the rectum. Transrectal biopsy of the prostate demonstrated a fibrous lesion containing inflammatory cells without evidence of malignancy. We performed transurethral resection of the prostatic lesion to release the bladder outlet obstruction, followed by cystolithotripsy. Histopathological examination of the surgical specimen demonstrated a benign fibromuscular lesion with spindle cell proliferation, leading to a diagnosis of inflammatory pseudotumor. Postoperatively, the patient voided normally without any signs of recurrence on follow-up at five months. Inflammatory pseudotumor is an unusual benign lesion of unknown etiology. Only 10 previous cases of the disease involving the prostate have been reported in English and Japanese literature. Prostatic involvement of inflammatory pseudotumor may show a presentation similar to malignant prostatic sarcoma. Thus, accurate identification of this benign process is important in order to avoid unnecessary radical surgery.

We report a case of carcinoma in situ (CIS) of the bladder involving the prostate with an unusual invasive pattern following Bacillus Calmette Guerin (BCG) therapy. A 41-year-old man achieved complete response after a course of intravesical instillation of BCG for diffuse CIS of the bladder. Two years later, urine cytology became positive. We performed random biopsy of the bladder and urethra three times and examined the bilateral upper urinary tract with retrograde pyelography and split urine cytology. However, none of these examinations revealed any malignant features, leading to a suspicion that the prostate was the recurrent site. Transrectal needle biopsy of the prostate revealed urothelial carcinoma (UC) at the transition between bladder and prostate. Transurethral biopsy of the prostatic urethra also detected UC in a core of the bladder neck only. Under a diagnosis of UC involving the prostate, we performed total cystectomy with ileal conduit diversion. Histopathological findings of the surgical specimen showed prostatic stromal invasion of the tumor. In this case, CIS at the bladder neck might directly and silently invade the prostatic stroma, thus transurethral biopsy contributed little to the diganosis. We recommend transrectal needle biopsy of the prostate as well as TUR biopsy in such rare cases.

Between 1995 and 2004, 43 patients underwent radical cystectomy and urinary diversion for the treatment of invasive bladder cancer at our institution. Of these patients, seven who were 75 years old or older, were considered elderly. Survival and treatment outcome of these patients were compared to younger counterparts stratified into three groups by age at diagnosis (12 patients younger than 64, 12 patients 65 to 69 years, and 12 patients 70 to 74 years). Preoperative morbidity was encountered in 57% of the elderly patients, and 42% of the elderly patients had two or more complications. There was one operative death (14%) among the elderly patients but no such deaths in the 3 younger groups. The postoperative complication rate for patients age 75 years or older was 86%, compared to 75% for patients younger than 64, 75% for those age 65 to 69 and 83% for those age 70-74. The prevalence did not differ significantly between the older and youger patients. There were no cancer deaths among the elderly patients, but 8 of the 36 younger patients died of cancer. The cancer-specific 5-year survival rate was 100% at 34 months in the elderly population. These findings suggest that radical cystectomy and urinary diversion is a relatively safe procedure and a curative operation is worth attempting in elderly patients with invasive bladder cancer, if they are in generally good health.

We here report our clinical experience with salvage therapy for patients with bacillus Calmette-Guerin (BCG)-refractory superficial bladder cancer and discuss current approaches to the disease, especially focusing on bladder preservation. First, we evaluated the efficacy of an initial 6-week course of intravesical BCG in 93 patients with carcinoma in situ (CIS) of the bladder. Of these, 91% achieved a complete response (CR) at the evaluation at 3 months. The 2- and 5-year recurrence-free rates were 71 and 67%, respectively (mean follow-up 39 months). These results support the intravesical BCG as a first-line therapy for CIS. Next, we assessed the efficacy of a second course of intravesical BCG for 16 patients who failed the initial induction course for CIS. Of these, 94% achieved CR at the evaluation at 3-month, and the 2- and 5-year recurrence-free rates were 62 and 46%, respectively (mean follow-up 28 months). None of the patients who received a second course had disease progression. Thus, a second course of BCG therapy seems to be a reasonable option for CIS patients failing the initial course. We also report our initial experience with intravesical gemcitabine therapy for 3 patients with BCG-refractory CIS of the bladder and 1 patient with recurrent multiple tumors. Gemcitabine (1500 mg in 100 ml saline) was given in the bladder for 1 hour twice weekly for a total of 12 treatments. The treatment was associated with minimal bladder irritation and systemic absorption, and was well tolerated except in a 90-year-old man who discontinued therapy because of grade 2 toxicity. Two patients achieved CR and maintained a tumor-free status beyond 14 months, suggesting that the intravesical gemcitabine is a promising salvage therapy for BCG-refractory superficial bladder cancer.

We report a case of pyoderma gangrenosum of the penis presenting as Fournier's gangrene. A 77-year-old man who had undergone radiotherapy for localized prostate cancer 16 month earlier, presented with penile pain and fever. Symptoms began with erythema and induration on the dorsal surface of the penile shaft followed by spontaneous purulent drainage with severe pain. Magnetic resonance imaging was unremarkable except for swelling of the penile skin. Biopsy of the ulcerative penile lesion demonstrated a nonspecific inflammation without vasculitis or malignancy. Despite broad-spectrum antibiotics and debridement, the penile lesion extended and new satellite lesions developed as pustules on the glans. Since cultures were negative for aerobic and anaerobic bacteria, a course of intravenous prednisolone was then initiated at 100 mg/day. Within 24 hours the temperature normalized, progression of the penile lesions stopped and became convalescent. The steroid was then tapered and discontinued. The penile lesions healed slowly during the subsequent 1-month period. Based on the clinical course and histopathological findings as well as exclusion of other ulcerative conditions, a diagnosis of pyoderma gangrenosum was made. Penile involvement of this non-infectious ulcerating skin disease has rarely been reported. Pyoderma gangrenosum affecting the penile skin, such as that in present case, may show a similar presentation as Fournier's gangrene. Prompt differential diagnosis is mandatory since effective management for each processes is markedly different.

Urachal carcinoma is a rare cancer. This is the first report of a case of squamous cell carcinoma of the urachus producing granulocyte colony-stimulating factor. The patient underwent partial cystectomy with urachal remnant resection and pelvic lymphadenectomy. No evidence of tumor recurrence or metastasis was found at 17 months after surgery.

Thirty-seven patients who had undergone radical cystectomy and pelvic node dissection for pathologic stage pT2-4 and/or N+ disease received adjuvant chemotherapy involving the injection of cis-platinum alone or in its combination from June 1982 to April 1989. Adjuvant chemotherapy was performed using the following three protocols. Protocol 1 entails the administration of cis-platinum alone. Protocol 2, involving the administration of a combination of cis-platinum, adriamycin and 5-fluorouracil (CAF), was used for deeply invasive bladder cancer. Protocol 3, consisting of cis-platinum, vp-16 and adriamycin (CVA), was employed in patients with deeply invasive bladder cancer instead of protocol 2 from July 1987. Of the 37 patients, 27 were alive with no evidence of disease for an average of 42 months. One patient died as a result of factors unrelated to cancer. Local recurrence and/or distant metastases occurred in 9 patients and all died of cancer progression. The survival rate for all 37 patients at 87 months was 64.4%. The rates were 75% in pT2, 80% in pT3a, 50.8% in pT3b, and 44.4% in pT4. Although adjuvant chemotherapy combined with radical cystectomy seemed to be effective in cases with pathological stage pT3a or less, more intensive chemotherapy is needed in an attempt to improve poor prognosis in cases with pathological stages pT3b-4 or node involvement.

Summary— Intravesical instillation of Tokyo 172 strain Bacillus Calmette-Guerin (BCG) was performed in 96 patients with initial superficial bladder cancer (Ta andT1) after transurethral resection (TUR) of tumour as a prophylaxis against tumour recurrence. The recurrence rate of tumours was estimated by the person-years method, comparing it with that of historical controls. There were statistically significant decreases in recurrent tumours following BCG therapy. To clarify the efficacy of intravesical BCG therapy, the prognostic significance of several factors was evaluated in patients with bladder cancer treated with TUR and instillation of BCG. The prophylactic effects were statistically better for those with multiple tumours, grade 3 lesions or Ta lesions than for control patients. No correlation between purified protein derivative (PPD) responsiveness and favourable results could be observed. Our results suggest that intravesical BCG instillation can alter the biological behaviour that affects the recurrence of superficial bladder cancer, especially for multiple, high grade or Ta tumours.

Partial urethrectomy (at least to the bulbous portion) was performed simultaneously in 128 consecutive male patients undergoing radical cystectomy for bladder cancer. Transitional cell carcinoma developed subsequently in the distal urethral remnant in 5 patients (4.0%) followed for 2.6 to 5.7 years (mean 4.1 years) postoperatively. These 5 patients originally had nonpapillary, multifocal and histologically high grade (5) and low stage (4) bladder cancer, 4 with associated carcinoma in situ. Our results suggest that simultaneous total urethrectomy should be considered strongly for patients with high grade nonpapillary multifocal bladder cancer associated with carcinoma in situ. Furthermore, the pattern of distal urethral recurrence in our patients may provide information regarding the appropriate management of the male urethra in potential candidates for continent urinary diversion. (J. Urol., 142: 983–987, 1989)

We treated 519 patients with primary bladder cancer, of whom 12 had upper urothelial tumor during followup. Almost all patients had superficial bladder cancer at diagnosis. All but 1 of 12 patients who underwent total cystectomy with ileal conduit diversion also underwent various transurethral procedures for treatment of the primary bladder lesions. The over-all incidence of bladder cancer patients who subsequently had upper urinary tract tumors was 2.3 per cent. Among the patients with treated bladder tumors a higher incidence (13.2 per cent) was observed in dye workers than in the general population (1.1 per cent). The interval between initial treatment of the bladder cancer and diagnosis of the upper urinary tract tumor ranged from 7 to 170 months (mean 70 months). The frequency of upper urinary tract tumors increased with time. We conclude that the appearance of upper urinary tract tumor after diagnosis of primary bladder cancer may be promoted by nonspecific irritation of the urothelium, which previously was made unstable by urinary chemical carcinogens.

Uterus didelphys with unilateral imperforate vagina is rare. Interestingly, in all reported cases in which the urinary tract was investigated renal agenesis was found on the side of the obstructed hemivagina. We report 2 cases of this unusual and interesting condition, and review the embryogenesis of mullerian duct abnormalities associated with renal agenesis, as well as the clinical findings, diagnosis and management. We stress the importance of prompt and accurate diagnosis, and treatment as a means to avoid unnecessary surgical procedures.

A case of urethral clear cell adenocarcinoma (mesonephric carcinoma) in a 62-year-old woman is reported. The patient consulted our hospital because of acute urinary retention. Fine needle aspiration cytology showed a few atypical cells; loose cluster cells with finely vacuolated cytoplasm, large nuclei and prominent nucleoli, and small cluster cells with finely vacuolated, delicate cytoplasm, small pale nuclei and small nucleoli. Cytologic diagnosis was adenocarcinoma and no diagnosis of clear cell adenocarcinoma was obtained. The neoplasia was localized at the posterior wall of the urethra and deep muscular layer of the vaginal wall. Histologically, the tumor revealed mainly small, elongated glands consisting of single-layered cuboidal or columnar cells with scanty cytoplasm and a focally hobnail appearance. In addition, a small cystic lesion resembling nephrogenic adenoma was observed. This finding raises the possibitily that clear cell adenocarcinoma may be a malignant counterpart of nephrogenic adenoma. ACTA PATHOL JPN 38: 217–223, 1988.

Summary— Intravesical instillations of Tokyo 172 strain BCG were given to 56 patients with superficial bladder cancer during the 24-month period after transurethral tumour resection as a prophylaxis against tumour recurrence. The recurrence rate of tumours was compared with that of historical controls. Results were estimated by the person-years method and there were statistically significant decreases in recurrent tumours following BCG therapy. Our results suggest that the intravesical Tokyo 172 strain BCG is effective and safe as a prophylaxis against the recurrence of superficial bladder tumours.

From June 1982 through December 1985, 25 patients who had undergone radical cystectomy with pelvic node dissection for pathologic stage-pT3 or -pT4 and/or N+ disease received adjuvant chemotherapy involving the injection of cis-platinum alone or in combination with adriamycin and 5-fluorouracil (CAF). Thirteen patients also received preoperative adjuvant chemotherapy involving the infusion of cis-platinum, adriamycin, and mitomycin C into the bilateral internal iliac arteries. Postoperative adjuvant chemotherapy was performed using the following two protocols. Protocol 1 (18 cases) consisted of cis-platinum alone being administered every week for 3 weeks and then every month for 1 year. In protocol 2 (7 cases), cisplatinum, adriamycin, and 5-fluorouracil were administered at 3-week intervals on three occasions and then every month for 1 year. Eighteen patients were still alive with no evidence of disease after an average of 26 months. One patient died as a result of factors unrelated to cancer. Local recurrence and distant metastasis occurred in 6 patients, of whom 3 were still alive for an average of 20.7 months. Three patients died of cancer progression after 9, 19, and 21 months. The survival rate for all 25 patients at 50 months was 77%. Nausea and vomiting occurred in most patients during the administration of cis-platinum. Mild myelosuppression developed in a few patients subjected to protocol 2. Our results indicate that adjuvant chemotherapy consisting of the administration of cis-platinum alone or in combination with other chemotherapeutic agents appears to be effective in patients with invasive bladder cancer.