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PubMed2000

Prospective phase II trial of alternating intravesical Bacillus Calmette-Guérin (BCG) and interferon alpha IIB in the treatment and prevention of superficial transitional cell carcinoma of the urinary bladder: preliminary results.

BACKGROUND AND OBJECTIVE: Evaluate the efficacy and toxicity of alternating intravesical instillation of Bacillus Calmette-Guerin(BCG) and Interferon alpha2-b (IFN) in the treatment and prevention of recurrence of superficial transitional cell carcinoma (TCC) of the urinary bladder. METHODS: Patients with Ta, T1 tumors and carcinoma in situ, either recurrent (TaG1, T1G1) or primary/recurrent TaG2 TaG3, T1G2, T1G3 and Tis (T: Tumor stage, G: grade) are eligible. All patients received intravesical BCG 81 mg on Weeks 1, 3, 5 and 7 and IFN 100 million units on Weeks 2, 4, 6 and 8. Cystoscopy performed 4 weeks after completion of therapy, and every 3 months thereafter. RESULTS: There was a total of 37 patients. Thirteen had TaG2, 13 T1G2, 1 T1G1, 4 TaG1, 1 TaG3, 3 T1G3 and 7 Tis (5 concurrent with other above tumors). Index lesion cleared in 7/10 patients. With a median follow-up of 26.2 month, 22 patients (59%) failed above therapy. Median time to treatment failure was 7 months. Seven, 6 and 9 patients recurred at a higher, lower and same stage or grade respectively. No grade 3 or 4 toxicity was encountered. CONCLUSIONS: Alternating intravesical BCG and IFN is effective and well tolerated therapy for superficial TCC of urinary bladder.

Administration, Intravesical↗
PubMed1999

Urodynamics in acetone-induced cystitis of anesthetized rats.

We examined the bladder function of cystitis models induced by intravesical acetone instillation in urethane-anesthetized rats. Acetone (0.35 ml) at 10, 30, or 50% concentration or deionized water (sham-treatment) was instilled into the bladder via the cannula which was inserted into the lumen. Acetone was withdrawn 90 sec after instillation and the bladder lumen was washed with saline after 15 min. One hour later, the cystometrogram induced by transvesical infusion of saline (3.3 ml/hr) was measured. During cystometrography of normal (non-treated) or sham-treated group, the time required to cause micturition, reflecting bladder capacity, was 9.6 +/- 0.9 (n = 7) or 10.0 +/- 0.8 min (n = 6), respectively. In the 10% acetone-treated group, the bladder capacity was similar to that in the normal or sham group. In the 30% acetone group, the time to micturition was 4.4 +/- 0.4 min (n = 7), indicating decreased bladder capacity, although the micturition pressure and the threshold pressure were not significantly different from those in the normal or sham group. However, in the 50% acetone group, the micturition reflex disappeared. In isolated rat bladder strips, contractile responses to carbachol or electrical field stimulation in the sham and 30% acetone group were similar. While, both responses in isolated strips from the 50% acetone group were reduced. The degree of damage from degeneration and desquamation of epithelium and hemorrhage in the bladder tissue from the 30% acetone group was less prominent than in the 50% acetone group. Additionally, some tissue from the 50% acetone group showed degeneration of muscle layer. The effects of three drugs were investigated in the 30% acetone group which showed increased urinary frequency. Baclofen (100 microg/kg, i.v.) and morphine (100 microg/kg, i.v.) increased significantly the bladder capacity and the threshold pressure. Atropine (10 microg/kg, i.v.) decreased the micturition pressure. These results suggest that cystitis models induced by intravesical instillation of 30% acetone may be valuable for evaluating drugs for the treatment of urinary frequency.

Acetone↗
PubMed1998

Is gamma-linolenic acid an effective intravesical agent for superficial bladder cancer? In vitro cytotoxicity and in vivo tolerance studies.

The essential fatty acid gamma-linolenic acid (GLA) is an effective cytotoxic agent when applied topically and for prolonged periods to tumour cells. Topical application, by intravesical therapy, is firmly established in the treatment of superficial bladder cancer. However, this form of therapy is limited to a maximum duration of 2 h. At such a short drug exposure time, does GLA retain its cytotoxicity? We have examined this question by exposing the superficial bladder cancer cell lines MGH-U1 and RT112 to meglumine-GLA (MeGLA) for time intervals ranging from 30 min to 2 h, at drug concentrations ranging from 1000 to 1.95 microg/ml. The MTT viable biomass assay was used to assess cell kill. Greater than 90% inhibition was observed at a concentration of 125 microg/ml (IC > 90), at 2 h drug exposure. At shorter drug exposure times, higher drug concentrations were needed to induce the same effect. At 1 h drug exposure, the IC > 90 was recorded at 500 microg/ml. In vivo intravesical tolerance studies were conducted in rats. Rats exposed to 2.5 mg/ml MeGLA intravesically for 2 h or less remained well and bladder histology showed minimal changes. This study confirms that GLA retains its cytotoxicity at short drug exposure times and is well tolerated by normal bladder mucosa in vivo. Bladder mucosa tolerated > 10x the concentration required for the IC > 90 in vitro. MeGLA is therefore a feasible intravesical agent for superficial bladder cancer.

Administration, Intravesical↗
PubMed1993

Intravesical formalin for hemorrhagic cystitis following irradiation of cancer of the cervix.

OBJECTIVE: To determine the effectiveness of intravesical formalin instillation in hemorrhagic cystitis following irradiation of cancer of the cervix. METHOD: Records were reviewed for 35 patients with hemorrhagic radiation cystitis who underwent treatment with 1% (n = 22), 2% (n = 10), and 4% formalin (n = 4), using Fair's technique. RESULT: Complete response was seen in 31 patients (89%) and partial response in 3 patients (8%) after a single instillation. Minor complications were seen in 19 patients (54%). Major complications occurred in 11 patients (31%), with 5 cases requiring subsequent urinary diversion. One patient died of persistent bleeding and probable formalin toxicity. Hematuria recurred in 7 patients achieving complete response at a mean period of 8 months after treatment. A 1% solution was as effective in controlling hematuria as higher concentrations and was associated with significantly less morbidity. CONCLUSION: Intravesical instillation of 1% formalin is an effective treatment for intractable hematuria secondary to radiation cystitis.

Administration, Intravesical↗
PubMed1993

Intravesical oxybutynin chloride: experience with 42 patients.

To evaluate the efficacy of intravesical oxybutynin chloride, 42 patients who were incontinent secondary to uninhibited detrusor contractions and had failed oral anticholinergic therapy were begun on intravesical oxybutynin chloride. Indications for intravesical therapy were detrusor hyperreflexia (N = 20), detrusor instability (N = 19), and bowel/bladder overactivity after augmentation cystoplasty (N = 3). A 5-mg tablet dissolved in 30 cc of sterile water was instilled into the bladder two to three times daily via clean self intermittent catheterization. With a mean follow-up of 18.4 months, no patient reported side effects as a result of the intravesical therapy. Nine patients (21%) dropped out of the study due to inability to tolerate the catheterization or difficulty retaining the solution in the bladder. Eighteen of the 33 patients (55%) who followed the protocol experienced elimination or significant improvement of their incontinence. The results of the current study confirm the safety and usefulness of intravesical oxybutynin in treating uninhibited detrusor contractions in a difficult patient population.

Administration, Intravesical↗
PubMed2004

Intravesical gemcitabine: a phase 1 and pharmacokinetic study.

INTRODUCTION: Superficial bladder cancer can be treated by transurethral resection and additional intravesical therapy. Although agents like Mitomycin C, Epirubicin and BCG are routinely used, there is a need for more potent and/or less toxic agents. Gemcitabine is a deoxycytidine analogue, used systemically for several tumours, such as non-localised bladder cancer, where it is effective and well tolerated. We investigated the use of three dose levels of gemcitabine when given intravesically in humans for safety and pharmacokinetic research. MATERIAL AND METHODS: Patients with superficial bladder cancer, except pT1G3 or CIS were included. Six weekly instillations of 1000, 1500 or 2000 mg gemcitabine were given in 50 ml saline for one hour. Dose modifications were defined in case of dose limiting toxicities. Blood samples were taken before, and 5, 30, 60 (= evacuation) and 120 minutes after instillations 1, 3 and 6. Samples were used for blood counts and pharmacokinetics. Side effects were noted. RESULTS: 3, 4 and 3 patients were treated with 1000, 1500, and 2000 mg gemcitabine respectively, of which 2, 3 and 1 patients had highly recurrent tumours before treatment. Seven patients experienced side effects: 2 with dysuria after the first instillation, 2 after instillations 3-6 and 4-6 and in 3 patients headache, fatigue and heavy legs were experienced once. All side effects were reversible, non-limiting and WHO 1. No macroscopic hematuria was seen. Haematology showed only one case of drop in white blood cell count (lowest dose level, after the first instillation). Gemcitabine plasma levels were immeasurable or low, with peak levels between 30 and 60 minutes, decreasing after more instillations. The metabolite difluorodeoxyuridine reached levels of at most 5 microM, indicating a very low passage of the drug to the systemic circulation. CONCLUSION: Intravesical gemcitabine in the dose used has minimal and reversible side effects. Plasma evaluation indicates that its intravesical use is safe.

Administration, Intravesical↗
PubMed2004

Antineoplastic effect of gemcitabine in an animal model of superficial bladder cancer.

OBJECTIVES: To evaluate the safety and efficacy of gemcitabine in an animal model of superficial bladder cancer because of the promising results for treatment of patients with advanced urothelial carcinoma using gemcitabine. The substantial failure rate and toxicity of currently available intravesical agents for treating superficial bladder cancer emphasize the need for alternative drugs. METHODS: The mouse bladder tumor (MBT-2) model was used in female C3H/eb mice to evaluate gemcitabine toxicity (n = 45) and efficacy (n = 402). RESULTS: Treatment with varying doses (0.5, 2.5, and 10 mg) of intravesical gemcitabine was well tolerated with no demonstrable side effects. No statistically significant differences in the histologic changes in the bladder wall were observed among the various treatment groups. The efficacy of the drug was tested in two sets of experiments and showed a statistically significant decrease in the bladder weight of the animals treated with gemcitabine compared with those treated with phosphate-buffered saline or untreated controls (61.4 +/- 24.1 mg versus 106.2 +/- 50 mg and 105.5 +/- 46 mg, respectively [P = 0.0001], for an aggressive tumor variant). In the second set of experiments, gemcitabine was given both intraperitoneally and intravesically and resulted in a lower bladder weight (44.5 +/- 15.75 mg and 59.71 +/- 22.5 mg, respectively) compared with the control groups (116.43 +/- 53.91 mg and 122.29 +/- 50 mg, respectively, P = 0.0004). CONCLUSIONS: The results of the present study indicate that repeated doses of gemcitabine can be safely administered intravesically to C3H/eb mice. This drug displayed significant antineoplastic activity against superficial bladder cancer.

Administration, Intravesical↗
PubMed2000

The best management of superficial bladder tumours: comparing TUR alone versus TUR combined with intravesical chemotherapy modalities?

To compare retrospectively the recurrence rates of TUR alone versus different intravesical chemotherapy modalities in superficial bladder cancer cases, 187 patients with stage Ta and T1 bladder tumours were treated with transurethral resection followed by adjuvant intravesical chemotherapy with mitomycin, BCG or epirubicin or by transurethral resection alone. All patients in this study had historically proven transurethrally resectable primary, category Ta and T1 transitional cell carcinoma (TCC) of the bladder. Group I included transurethral resection alone, and the other groups included intravesical mitomycin-C (Group II), BCG (Group III) and epirubicin (Group IV) therapies after transurethral resection. 146 male and 41 female patients (78% male and 22% female patients) in this study were diagnosed as primary TCC bladder tumours. Only 52 of them were stage Ta and 135 of them were stage T1 bladder tumours. Examining the histological grade of the bladder tumours, 88 (47%) of the patients had grade I, 53 (28%) had grade IIa, 30 (16%) had grade IIb and remaining 16 (9%) had grade III bladder cancers. The recurrence rates were 25% for Group I, 23.8% for Group II, 26.2% for Group III and 22.7% for Group IV. These values were given with disregarding the grade and volume of the bladder tumours. For solitary, less than 3 cm low grade tumours (grade I, IIa) recurrence rates were 16% for Group I, 15.4% for Group II, 17.8% for Group III, 17.2% for Group IV (p > 0.05). As a result of this retrospective study, for patients with low grade, stage Ta and T1 tumours TUR alone may be the best treatment modality. Although intravesical chemotherapy is effective in decreasing short-term incidences of tumour recurrence, it has not decreased long-term incidences of tumour recurrence. The high cost and adverse side effects of intravesical chemotherapy should also be taken into consideration in superficial, single, low grade tumours of bladder.

Administration, Intravesical↗
PubMed2004

The influence of intravesical therapy on progression of superficial transitional cell carcinoma of the bladder: a metaanalytic comparison of chemotherapy versus bacilli Calmette-Guerin immunotherapy.

OBJECTIVE: Currently, the true impact of intravesical chemotherapy or immunotherapy (bacilli Calmette-Guerin [BCG]) on the rate of progression of superficial transitional cell carcinoma of the bladder to muscle invasive disease is unclear. A metaanalysis was performed to statistically compare the efficacy of these treatments in preventing tumor progression in this disease setting. METHODS: A prospective protocol outlining the metaanalysis noted here was developed followed by a thorough search of the existing published literature using strict eligibility criteria. Eight randomized, controlled trials were found that met protocol specifications. These reports contained data on 2427 patients who were statistically pooled using a fixed-effects model (Peto). The outcome of interest was the proportion of patients progressing to muscle invasive or metastatic disease expressed as a summary odds ratio (ORp). An ORp greater than unity favored BCG versus chemotherapy. RESULTS: Initial pooling of these 8 trials gave a nonstatistically significant summary odds ratio of 1.24 (0.95-1.61) without evidence of statistical heterogeneity. Analysis by drug type showed significant attenuation of the ORp when the effects of mitomycin C were compared with BCG, ie, 1.04 (0.76-1.42) suggesting that: 1) mitomycin is probably more active than the other chemotherapeutics used in the available trials and 2) BCG is not clearly superior to mitomycin C. Sensitivity analyses also demonstrated that failure to control for prior intravesical drug treatment in all but 2 of the analyzed studies produces a spurious result favoring BCG over intravesical chemotherapy. CONCLUSION: The available data fail to support a clear superiority of intravesical BCG over intravesical chemotherapy in preventing progression of superficial transitional cell carcinoma of the bladder. Mitomycin C appears more effective than the other commonly used drugs, and failure to control for prior intravesical chemotherapy in most of available studies results in a spurious finding of greater clinic effect of BCG over chemotherapy.

Administration, Intravesical↗
PubMed1994

Intravesical BCG therapy of superficial bladder cancer: study of adverse effects.

Immunotherapy with intravesical bacillus Calmette-Guérin (BCG) has proved to be more effective than most chemotherapeutic agents in the prophylaxis and treatment of superficial bladder tumours. Side-effects, both local and systemic, are the main limitations against its use. With the aim of lowering the incidence and severity of side-effects, we started to use two vials of BCG, Connaught type, per instillation, instead of three vials, as recommended by the manufacturer. We prospectively reviewed adverse effects of BCG treatment at the lower dosage in 92 patients. Compared with other series, we found a similar incidence of adverse effects except for some local effects as haematuria which showed a higher incidence, but we also found a lower rate of tumour relapse. Four primary tumours were recorded during the study period. In our open study, a lower BCG intravesical dosage is not followed by a reduction in side-effects.

Administration, Intravesical↗
PubMed2005

Intravesical nitric oxide delivery for prevention of catheter-associated urinary tract infections.

The use of indwelling urinary catheters is a major risk factor for urinary tract infection; and despite the availability of numerous preventive regimens, this condition is still extremely common. In earlier studies we have demonstrated the inhibitory effects of nitrite and ascorbic acid on bacterial growth in urine. When combined, these compounds generate antibacterial reactive nitrogen species, including the gas nitric oxide. We have now tested in a laboratory model of the urinary bladder whether filling of the catheter retention balloon with nitrite and ascorbic acid would generate measurable amounts of NO outside the membrane and whether this would affect bacterial growth in the surrounding urine. Two strains of Escherichia coli, one strain isolated from a patient (U1106024) and one reference strain (ATCC 25922), were tested. Nitric oxide gas was generated in the silicone balloon and readily diffused into the urine. When control catheters with ascorbic acid but without nitrite were used, bacterial counts increased from 9.0 x 10(5) to 2.0 x10(8) CFU/ml (strain U1106024) and from 2.5 x 10(6) to 2.7 x 10(8) CFU/ml (strain ATCC 25922) after 24 h. In contrast, in test catheters with ascorbic acid and nitrite, both strains tested were effectively killed. The NO donor {DETA NONOate, (Z)-1-[N-(2-aminoethyl)-N-(2-ammonioethyl)amino]diazen-1-ium-1,2-diolate} also showed antibacterial activity in the same model, thereby supporting a central role of NO in achieving the observed effects. Future clinical trials will reveal whether this novel approach for the intravesical delivery of an antibacterial gas could be used to prevent catheter-associated infections.

Administration, Intravesical↗
PubMed2000

No generalized skin phototoxicity after intravesical application of 5-aminolevulinic acid for fluorescence diagnosis of superficial bladder cancer.

INTRODUCTION: A prospective monocenter open study was carried out to evaluate if generalized phototoxic skin reactions occur after intravesical application of 5-aminolevulinic acid (ALA) for fluorescence diagnosis of superficial bladder carcinomas. PATIENTS AND METHODS: On 21 patients, skin phototoxicity was determined prior to as well as 4, 8 and 28 h after intravesical instillation of a 3% ALA solution by exposing small skin areas to a progressively graded series of defined UVA-light doses (n = 9; 5-80 J/cm(2)). RESULTS: Prior to ALA instillation, erythema or pigmentation as signs of cutaneous phototoxicity occurred at an UVA-light dose of 28 +/- 1.5 J/cm(2) (mean +/- SEM). A reduction of the minimal phototoxic dose (MPD) was not detected 4 (28 +/- 1.9 J/cm(2)), 8 (28 +/- 1.6 J/cm(2)) and 28 h (28 +/- 1.5 J/cm(2)) after ALA instillation. Consequently phototoxic reactions were not observed. CONCLUSIONS: A reduction of MPD for UVA was not detected. Therefore, it is not necessary to protect the skin of patients from ambient or daylight after intravesical instillation of ALA for fluorescence diagnosis.

Administration, Intravesical↗
PubMed2001

Intravesical valrubicin in the treatment of carcinoma in situ of the bladder.

The propensity of patients with carcinoma in situ (CIS) of the bladder to progress to invasive and metastatic disease is clearly established. Today, the standard therapy in treating patients with CIS of the bladder is intravesical bacillus Calmette-Guerin (BCG). Nevertheless, patients who fail intravesical BCG have few viable options except to undergo a radical cystectomy. Valrubicin (N-trifluoroacetyladriamycin-14-valerate) is a new semisynthetic derivative of the anthracycline antibiotic doxorubicin that has been shown to benefit patients with BCG-refractory CIS of the bladder. Intravesical instillation of valrubicin is well-tolerated, safe and can be durable. Early non-randomised studies show promise and the current utilisation of this drug is limited to patients with BCG-refractory CIS of the bladder who are not good surgical candidates. Randomised studies of intravesical valrubicin for the treatment of superficial bladder cancer are ongoing.

Administration, Intravesical↗
PubMed1999

Intravesical chemotherapy for maximum prophylaxis of new early phase superficial bladder carcinoma treated by transurethral resection: a combined analysis of trials by the Japanese Urological Cancer Research Group using smoothed hazard function.

BACKGROUND: The effect of intravesical instillation of doxorubicin or epirubicin after transurethral resection (TUR) was estimated from the data of five randomized clinical trials in Japan. The authors provided the estimated hazard function plots with a smoothing technique, to evaluate the prophylactic effect of an intravesical therapy over time and to estimate the natural history of superficial bladder carcinoma. METHODS: Data on a total of 1732 patients from 5 studies of the Japanese Urological Cancer Research Group who were eligible to receive doxorubicin and epirubicin were analyzed. The patients were divided into four subgroups based on their background characteristics. Their tumors were categorized as "primary and solitary," "primary and multiple," "recurrent and solitary," or "recurrent and multiple." RESULTS: Multivariate analysis revealed that intravesical instillation reduced the risk of recurrence to about one-half to two-thirds compared with the controls. The shapes of the graphs that estimated the hazard function for patients with no prophylaxis indicated that multiple tumors showed an earlier peak of recurrence than solitary tumors and recurrent tumors had a higher hazard of recurrence than primary tumors. Graphic presentation of the hazard function in each subgroup suggested that the effect of prophylaxis continued for 500 days after TUR but not for longer. CONCLUSIONS: This analysis indicated that there are two patterns of tumor recurrence of superficial bladder carcinoma after TUR, namely, early phase and late phase. Intravesical chemotherapy may be effective mainly in reducing the hazard for recurrence in the early phase.

Administration, Intravesical↗
PubMed1992

[Intravesical BCG, mitomycin-C and thiotepa in the prevention of bladder tumor recurrence after operation].

We observed the effects of intravesical irrigation with BCG (group B), Mitomycin-C (group M), and Thiotepa (group T) in prophylaxis of bladder tumor recurrence after surgical treatment. Follow-up for 1-10 years showed that the recurrence rate of bladder tumor was 12.5% (3/24) in group B, 46.9% (15/33) in group M, and 61.8% (21/34) in group T respectively. The effect of BCG was far better than that Mitomycin-C and Thiotepa (P < 0.01). In 5 cases, who failed to Thiotepa, also showed satisfactory results after use of intravesical BCG. Considering the side-effects of intravesical BCG, Thiotepa or Mitomycin-C should be used as the first choice of drugs in preventing the tumor recurrence.

Administration, Intravesical↗
PubMed1991

[Clinical effect on tumor regression and tissue concentration of peplomycin treated with peplomycin emulsion in hydroxypropylcellulosum].

Peplomycin emulsified in hydroxypropyl cellulosum (HPC-PEP) was prepared for intravesical chemotherapy. Clinical efficacy of HPC-PEP and tissue concentration of peplomycin (PEP) were studied in 12 patients with bladder tumor. Histopathology showed transitional cell carcinoma; 2 in grade 1,8 in grade 2, and 2 in grade 3. The total volume of 30 ml HPC-PEP was prepared from a mixture of 2% HPC and 90 mg PEP in 15 ml saline, and was intravesically administered through a urethral catheter and retained for two hours. Clinical evaluation 7 days after the initial instillation demonstrated good tumor regression in 2, good response in 5, and no change in 5. The mean PEP level in tumor tissue was 0.36 microgram/gr after 7 days and 0.19 microgram/gr even after 14 days. These clinical observations and tissue levels of PEP suggest that HPC-PEP might be useful as an intravesical instillation agent for bladder tumor.

Administration, Intravesical↗