A total of 62 patients at high risk for recurrence of superficial bladder cancer were selected for a study designed to compare the prophylactic efficacy of different doses and schedules of sequential intravesical instillations of epirubicin and interferon-alpha-2b and to evaluate which sequence could enhance the release of cytokines in the urine. Our investigations showed a significant increase in urinary concentrations of interleukins in patients who received the sequential intravesical administration of epirubicin and interferon-alpha-2b. Higher urinary concentrations of interleukins and a lower recurrence rate were detected in patients who received interferon-alpha-2b 24 h after epirubicin instillation.
– After TUR of superficial bladder tumours (G1-G3, Ta-T1), 121 patients were randomized in three groups of intravesical treatment: mitomycin C alone, mitomycin C plus epirubicin, mitomycin C plus interferon-alpha-2. At a mean follow-up of 53 months, 64 patients (52.8%) showed a recurrence. A trend (p < 0.02) in favour of the combination of mitomycin C and epirubicin was evident. The higher efficacy of this association was particularly evident when patients with primary tumours were excluded from the statistical analysis.
– Intravesical iontophoresis should permit higher intratumoral concentrations of a drug administered intravesically for the treatment of superficial bladder tumours. Iontophoresis was performed with mitomycin C (30 mg in 60 ml) for 20 minutes using a pulsating electric current of 20 mA. Ten patients, with a papillary marker lesion left after TUR, were treated for ablative purposes. Sixteen other patients were submitted to intravesical prophylaxis after complete TUR. Toxicity was purely local. A complete response was obtained in 6 of the 10 patients with a marker lesion.
Objectives. To evaluate a selected population of 50 consecutive patients with primary T1, G3 bladder transitional cell carcinoma in the absence of carcinoma in situ (Tis) treated with a bladder-sparing approach.Methods. Between January 1983 and December 1992, all patients were treated by transurethral resection (TUR) plus adjuvant intravesical chemotherapy over 1 year. In most cases, doxorubicin, epirubicin, and mitomycin were used alone or in combination.Results. At a mean follow-up period of 52 months (range, 18 to 126), 16 of 50 patients (32%) showed a recurrent superficial tumor. The recurrent lesion was of Stage T1 in 11 (22%) cases, but was a T1, G3 tumor only in 5 cases (10%). In 2 additional patients (4%) a Tis developed during the observation period after TUR. The mean interval between TUR and first recurrence was 14.6 months (range, 3 to 38). At a mean time of 17 months after the initial TUR, 5 patients (6%) underwent a radical cystectomy due to a progression in T category and 5 additional patients (6%) developed distant metastases at a mean time of 23 months after TUR. In brief, 84% of the patients are alive and tumor-free. Five patients (10%) died of bladder cancer with a mean follow-up of 52 months.Conclusions. If no concomitant Tis exists, a conservative approach is a legitimate option as an initial treatment of patients with primary T1, G3 bladder tumors.
Clinical use of recombinant tumor necrosis factor‐alpha is strongly limited by its severe toxicity, mainly cardiovascular, when systemically administered. Recent studies suggest that topical (intrapleural, intraperitoneal, intratumoral) administration is free of significant toxicity. Human recombinant tumor necrosis factor‐alpha was administered intravesically, at a dose of 500 mg dissolved in 30 ml of phosphate buffer (pH 7.6–7.8) plus 0.25% human albumin, weekly for two months to 18 patients with papillary transitional cell carcinoma of the bladder. Of the 15 evaluable patients, four (26%) achieved a complete response. Systemic and local tolerability were excellent.
The main aim of this multicenter observational study was to assess the impact on quality of life (QoL) of 3 months' treatment with an al-blocker, alfuzosin, 2.5 mg t.i.d., in patients suffering from symptomatic benign prostatic hyperplasia (BPH). Safety and efficacy evaluations were secondary objectives.Nine hundred and ninety patients were enrolled; 940 were evaluable for per-protocol analysis. On day 84, all the three indices of the QoL self-questionnaire were significantly improved in comparison with baseline: mental health +0.4 (2.0%; p < 0.01); general health +0.6 (5.4%; p < 0.01, and, especially, activity +1.4 (13.4%; p < 0.01). Improvement was more marked in patients with severe symptoms at baseline (activity index: +25.6%).Alfuzosin also significantly relieved BPH symptoms according to the Maine Medical Assessment Program (total mean score: day 28 -3.07; day 84 -4.44) and Madsen-Iversen indexes (total mean score: day 28 -5.29; day 84 -7.98). Improvement was more marked in patients with severe symptoms at baseline. Subjective improvement was confirmed by objective measurements (uroflowmetry and residual volume).Fifty-two patients (5.2%) experienced one or more drug-related adverse medical events, mainly within the first 4 weeks of treatment (n = 46; 4.6%). Twenty-seven (2.7%) patients dropped out prematurely from the study for safety reasons. Forty vasodilatory events and 45 nonvasodilatory events were reported. Slight, not clinically significant decreases of blood pressure were observed but heart rate was not modified.In this study, 3 months' treatment with alfuzosin had a positive impact on patients' QoL by relieving their symptoms. As expected, this beneficial effect was more evident on the day-to day activities of patients with moderate to severe symptoms, suggesting a positive impact on their social functioning.
Preliminary results are given of the topical endovesical use of idarubicin for superficial bladder urotheliomas. Its toxicity toward the urothelium is underlined; a fact which strongly compromises its endovesical chemotherapeutic use.
A case of spontaneous rupture of the urinary tract is described. This clinical picture is uncommon and the subsequent conservative therapeutic management is therefore emphasised.
Local recurrences of superficial transitional cell carcinoma of the bladder (TCCB) can be significantly reduced by intravesical treatment following transurethral resection (TUR) but they are not fully abolished. There is a need to gain experience with new agents. Anthracyclines, such as doxorubicin and epirubicin, have been clearly demonstrated to be active against superficial TCCB by intravesical route. Idarubicin is an anthracycline, much more lipophilic than doxorubicin, inhibiting tumour cell growth at lower concentrations. The aim of this study was to evaluate the tolerability and the ablative efficacy on a marker lesion of weekly intravesical instillations of idarubicin given at different doses and concentrations. Seventeen patients, affected by superficial TCCB, Ta-T1 G1-G2, after TUR of all tumours except one, that was used as a 'marker lesion', were treated intravesically with idarubicin weekly for two months. The drug, in the first 4 patients, was administered at the dose of 15 mg diluted in 30 mi of normal saline solution and maintained in the bladder for one hour. Because of severe chemical cystitis, the dose was reduced to 10 mg in 40 mi in the following 13 patients. The study was closed because of the severe local toxicity. In eight (47%) patients the treatment was interrupted for local toxicity between the first and sixth week and in 5 more patients pharmacological therapy was required because of severe chemical cystitis. No systemic toxicity was evident. Three patients achieved a complete response. Our experience shows that idarubicin is not indicated in the intravesical therapy of superficial TCCB because of severe chemical cystitis limiting the administration of doses able to explicate a relevant antitumoral action.
The Authors present their experience with TUR plus adjuvant intravesical chemotherapy in 50 patients affected by primary T1 G3 bladder tumours without previous or concomitant carcinoma in situ. At a mean follow-up of 36 months, 84% of the patients are alive and tumour-free. Cystectomy was performed in three patients due to locally invasive disease. Five patients (10%) died of bladder cancer.
A case of unusual appendiceal pathology presenting as an advanced bladder cancer is reported. The difficulties in clinical and radiological diagnosis are emphasized. Correct diagnosis was possible only upon surgical exploration.
A phase I-II trial of intravesical immunotherapy with tumor necrosis factor (TNF)-alpha in 24 patients affected by superficial bladder tumors is herein presented. Of these, 11 patients were submitted, at weekly intervals, after complete TUR, to 8 instillations of TNF-alpha at increasing doses from 50 to 600 micrograms. Tolerability was excellent, even at the highest dose. In a second group of 13 patients with a histologically proved papillary marker lesion, TNF-alpha was instilled at weekly intervals at the dose of 500 micrograms for 8 weeks. Three complete responses (23%) were obtained.
La resezione endoscopica delle neoplasie vescicali, se include la sottomucosa e gli stadi più superficiali della muscolare, è insostituibile nella valutazione dello stadio di infiltrazione del tumora.