A randomized study comparing epirubicin in a 4-weekly versus a weekly intravenous regimen in patients with metastatic, hormone resistant, prostatic carcinoma: effects on health related quality of life.

The treatment of hormone resistant prostate cancer) with epirubicin 25 mg/m(2)(Epi25) on a weekly intravenous regimen may be better in terms of health related quality of life (HRQOL) than with 100 mg/m(2)(Epi100) on a 4-weekly regimen. A total of 79 patients who filled out the EORTC-QLQ-C30 questionnaire for the assessment of HRQOL could be evaluated. Compared with the baseline, no changes in HRQOL function scales or significant changes in the following HRQOL symptom scales were found. The Epi25 group reported less pain during the first 3 months and the Epi100 group more dyspnoea after 4 weeks and less pain and less insomnia but more loss of appetite after 8 weeks. In both groups, toxicity was comparable, except for World Health Organisation grade II-III alopecia occurring in 82% in the Epi100 versus 31% in the Epi25 group. There were no significant differences between groups in response rates and survival. In this study, HRQOL was not improved which is in line with other studies using only epirubicine. Epirubicin as single agent therapy should not be used in future treatment of patients with HRPC.

Results of a randomized phase III trial of sequential intravesical therapy with mitomycin C and bacillus Calmette-Guerin versus mitomycin C alone in patients with superficial bladder cancer.

PURPOSE: We study toxicity and efficacy of sequential intravesical therapy with mitomycin C and bacillus Calmette-Guerin (BCG) in patients with intermediate or high risk superficial bladder cancer compared to the use of intravesical mitomycin C alone. MATERIALS AND METHODS: Patients with intermediate and high risk papillary superficial bladder cancer and carcinoma in situ were randomized after transurethral resection between 4 weekly instillations with 40 mg. mitomycin C followed by 6 weekly instillations with BCG (group 1, 90 patients) or 10 weekly instillations with mitomycin C (group 2, 92 patients). RESULTS: The frequency of bacterial and chemical cystitis, and other local side effects was similar in both groups. Allergic reactions, including skin rash, were more frequent in the mitomycin C only group (12 of 92 patients versus 5 of 90, p = 0.08), and other systemic side effects were more frequent in the sequential group (16 of 90 versus 8 of 92, p = 0.07). After a median followup of 32 months the number of recurrences (sequential 35 of 90 patients versus mitomycin C only 42 of 92, p = 0.36) and progression (5 of 90 versus 4 of 92 respectively, p = 0.70) were similar in both groups. CONCLUSIONS: We did not find any major differences in toxicity or treatment efficacy with intravesical mitomycin C and the sequential use of BCG or mitomycin C for intermediate and high risk superficial papillary bladder cancer.

Urodynamic and clinical effects of terazosin therapy in symptomatic patients with and without bladder outlet obstruction: a stratified analysis.

OBJECTIVES: To evaluate clinical and urodynamic changes in patients with and without bladder outlet obstruction (BOO) and to compare the clinical and urodynamic results of terazosin treatment between patients with and without BOO. METHODS: In a prospective study, 97 patients who completed a full screening program including urodynamic investigation with pressure-flow study analysis started treatment with terazosin. A total of 60 patients completed 6 months of treatment and were re-evaluated with International Prostate Symptom Scores (IPSS), uroflowmetry, and urodynamic investigation with pressure-flow study analysis. Patients were stratified using the linear passive urethral resistance relation (lin-PURR) classification according to Schäfer. Patients with a lin-PURR of 3 or more were classified as patients with BOO and patients with a lin-PURR of 2 or less were classified as patients without BOO. The clinical and urodynamic changes within and between the groups with and without BOO were evaluated. RESULTS: Terazosin resulted in significant symptomatic relief (9 points on the IPSS scale; P < 0.01) and a significant improvement of free urinary flow (3.0 mL/s; P < 0.01). In patients with BOO, a statistically significant improvement of all urodynamic obstruction variables (P < 0.01) was shown. In patients without BOO, a significant improvement of free urinary flow (4.4 mL/s; P < 0.01), a statistically significantly improved bladder capacity (increase of 70 mL; P = 0.01), and no statistically significant changes in urodynamic obstruction variables (P > 0.05) were shown. Patients with a hypoactive detrusor were more prone to early dropout. When comparing the changes of symptoms (P = 0.89), quality of life (P = 0.85), and the number of patients with improvements of free uroflow of at least 30% (P = 0.15), there appeared to be no significant difference between the groups with and without BOO. CONCLUSIONS: Although there is a statistically significant difference in urodynamic response to terazosin treatment between patients with and without BOO, we cannot recommend the use of pressure-flow studies in the selection of patients for terazosin treatment because the clinical results of treatment appear not to be significantly different between patients with and without BOO. It seems more useful, and certainly less expensive and less invasive, to start alpha 1-blocker therapy if, on clinical grounds, the urologist considers the patient to be a candidate for alpha 1-blocker therapy, and to continue therapy in those who respond.

Variability of clinical and pressure-flow study variables after 6 months of watchful waiting in patients with lower urinary tract symptoms and benign prostatic enlargement.

PURPOSE: We quantified the physiological variability of clinical and pressure-flow study variables in patients with symptomatic benign prostatic enlargement. MATERIALS AND METHODS: Symptom scores were measured, and advanced urodynamic studies with pressure-flow analysis were performed in 178 patients before and 6 months after a period a watchful waiting. RESULTS: Patients without bladder outlet obstruction experienced significant symptomatic improvement. Symptoms in patients with obvious bladder outlet obstruction did not improve significantly. The reproducibility of mean pressure-flow variables was evident. However, there was an important intra-individual variability. Patients with obvious bladder outlet obstruction showed a significant decreases in detrusor pressure at maximal flow of 14cm. water, a significant decrease in the urethral resistance factor of 7 cm. water and a significant decrease of 1 obstruction class on the linear passive urethral resistance relation nomogram, indicating less severe bladder outlet obstruction. CONCLUSIONS: Mean differences among therapy groups must be regarded critically, especially when the difference are slight and possibly within physiological variability.

Risk factors in carcinoma in situ of the urinary bladder. Dutch South East Cooperative Urological Group.

OBJECTIVES: In this article we describe the long-term follow-up of patients with carcinoma in situ (CIS) of the urinary bladder and examine whether the extent of CIS, the presence of associated papillary tumors, or the response to treatment influence the course of the disease. METHODS: Fifty-two patients with CIS of the bladder, treated in a randomized prospective study, are described. In 23 patients with concomitant papillary tumors all macroscopically visible lesions were completely resected transurethrally (TUR). CIS was histologically confirmed in all patients by biopsy, 29 of whom had primary CIS. The patients were treated with intravesical mitomycin, bacille Calmette-Guérin (BCG)-RIVM or BCG-Tice and followed regularly by urine cytology, cystoscopy, and biopsy. RESULTS: Complete response was achieved in 65% of the patients. Of these responders, 24% later had a recurrence of CIS or a superficial tumor and 18% had progressive disease (PD). In the nonresponding patients, progression occurred in 67%. In the whole group, PD was seen in 35% of the patients, and radical cystectomy was performed in 21%. The disease-related death rate was 13%. The risk for recurrence or PD was not higher in patients with more extensive CIS, defined as three or more positive biopsy results or when CIS was associated with papillary tumors compared to patients with one or two biopsy specimens positive for CIS or CIS alone. Nonresponding patients showed a significantly higher progression rate and cystectomy rate than responding patients (P = 0.0012 and 0.008, respectively). CONCLUSIONS: CIS of the bladder is a malignancy with a poor prognosis, especially in patients not responding after intravesical treatment. Early detection and adjuvant intravesical treatment after TUR of concomitant papillary tumors are required. In patients not responding after intravesical treatment, radical surgery is necessary before progression occurs. The number of biopsies positive for CIS, not the presence of concomitant superficial tumors, was an indicator for progression or recurrence.