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PubMed1999

Primary lymphoma of the bladder treated successfully with mitozantrone gel.

We describe a young man who presented with a short history of painless haematuria. Subsequent investigations and biopsy of lesions found in his bladder at cystoscopy confirmed the diagnosis of primary lymphoma of the bladder. Computed tomography studies confirmed the disease was localised to his bladder. Unfortunately, the tumour was not eradicated by radiotherapy. However, it was successfully treated with intravesical mitozantrone given in a novel gel formation. Three years after diagnosis the patient remains well with no evidence of recurrence.

Administration, Intravesical↗
PubMed2005

Intravesical heparin and peripheral neuromodulation on interstitial cystitis.

INTRODUCTION: We wanted to evaluate the therapeutic effect of intravesical heparin and peripheral neuromodulation on patients with interstitial cystitis. MATERIALS AND METHODS: From March 2002 to August 2003, 8 female and 2 male subjects conform to the NIDDK criteria and not responsive to the previous conventional treatments were included in the study. Wisconsin pain scores, maximal cystometric capacities, and night and day voiding frequencies were determined and these studies were repeated in the 2nd and 12th months of the treatment with 10,000 units intravesical heparin and peripheral neuromodulation. Frequency of the treatment was once a week during first 8 weeks, once in 2 weeks in the following 8 weeks, and once in 3 weeks four times. Then, it was decreased to once a month. RESULTS: The mean follow-up period was 13 months (12-16 months). Day and night voiding frequency were significantly better in the 2nd and 12th months, when compared to pretreatment values. The Wisconsin pain scores were 62.5 +/- 13.9% and 62.8 +/- 15.2% in the 2nd and the 12th months, respectively. The average increase in the maximum cystometric capacity was 54.8 +/- 27.4% and 52.5 +/- 31.6% in the 2nd and the 12th months, respectively. CONCLUSIONS: Intravesical heparin and peripheral neuromodulation combination seems to be an alternative for patients with interstitial cystitis not responsive to other treatments.

Administration, Intravesical↗
PubMed2002

Intravesical immunotherapy for superficial bladder cancer.

OBJECTIVE: To compare and evaluate the efficacy and tolerance of intravesical instillation of Bacillus Calmette-Guerin (BCG) and interferon alpha-2b immunotherapy for superficial transitional cell carcinoma (TCC) of the urinary bladder. METHODS: Thirty-five patients with superficial TCC of the urinary bladder, primary and recurrent tumors, stage Ta, T1, and grade 1 and 2, were prospectively enrolled for intravesical immunotherapy at the Armed Forces Hospital, Riyadh, Kingdom of Saudi Arabia between January 1992 and December 2000. The treatment regimes used were either 120 mg of BCG weekly for 6 weeks followed by a 2nd 6 week course given only on first tumor recurrence, or 50 million i.u. of interferon alpha-2b weekly for 3 months, bi-weekly for the next 3 months and monthly for 6 months. Twenty-two patients received BCG and 13 received interferon alpha-2b. Adequate blood counts, renal and hepatic function profiles, and informed consent were required. Cystoscopy was repeated every 3 months for the first 2 years, then 6 monthly for another 2 years and then yearly. RESULTS: The follow-up period ranged from 9-96 months (median 31.33 months). Twenty patients attended the follow-up and were evaluable in the BCG group and 13 in the interferon alpha-2b group. In the BCG versus interferon alpha-2b group, the rates of complete response were 80% and 41.6%, partial response were 5% and 33.3%, and progression were 15% and 8.3%. Mild side effects occurred in 5 patients and all of them completed their treatments. There was only one cancer related death in each group after 6 and 7 years of starting the treatment. CONCLUSION: Bacillus Calmette-Guerin was confirmed as a more effective intravesical immunotherapy for superficial TCC of the urinary bladder as compared to interferon alpha-2b. Both agents' treatments are well tolerated.

Adjuvants, Immunologic↗
PubMed2003

A randomized trial comparing intravesical instillations of mitoxantrone and doxorubicin in patients with superficial bladder cancer.

BACKGROUND: This randomized trial was conducted to compare the efficacy and side effects of intravesical mitoxantrone instillation with those of doxorubicin in superficial bladder cancer following transurethral resection. METHODS: Sixty-three patients were randomized into mitoxantrone and doxorubicin groups. Most of the patients enrolled were elderly people (mean age, 71 years). The instilled doses of doxorubicin and mitoxantrone were 30 and 14 mg, respectively. Disease recurrence and side effects were compared using Fisher's exact test. The interval to recurrence was shown by Kaplan-Meier survivorship curves, and the log-rank test was used to compare the time to recurrence. RESULTS: The median follow-up period was 36 months. Thirty-three patients received mitoxantrone, whereas 30 patients used doxorubicin. The recurrence rate in the doxorubicin group was 30% (95% CI: 19.8%-38.8%), while it was 27.3% (95% CI: 17.5%-36.8%) in the mitoxantrone group. The median recurrence-free survival in the mitoxantrone group and in the doxorubicin group was 22 and 20 months, respectively (p=0.580). Higher recurrence rates were found for Grade III and multiple primary tumors. There was no significant difference in response rates (p=0.784). The incidence of side effects was 20% in the doxorubicin group and 21.2% in the mitoxantrone group. However, the difference was not significant (p>0.99). CONCLUSIONS: The results revealed that the efficacy and side effects of mitoxantrone were similar to those of doxorubicin. Especially for patients with pulmonary tuberculosis or aged patients with primary bladder tumors, mitoxantrone and doxorubicin may be the tolerable and effective intravesical agents.

Administration, Intravesical↗
PubMed1990

[Clinical study of intravesical instillation therapy of superficial bladder tumor--combination therapy of mitomycin C, adriamycin, peplomycin and cytosine arabinoside].

The effect of intravesical combination chemotherapy on superficial bladder tumors was analyzed. Seventy-two patients were treated with intravesical instillation of the following anticancer drugs. MMC group: Mitomycin C (MMC) 10 mg and cytosine arabinoside (CA) 300 mg. ADM group: Adriamycin (ADM) 30 mg and CA 300 mg. PEP group: Peplomycin (PEP) 30 mg and CA 300 mg. MAC group: MMC 10 mg, ADM 30 mg and CA 300 mg. Antitumor effects in the MMC, ADM, PEP and MAC groups were evaluated in 16, 18, 17 and 21 patients and objective response (CR + PR) of tumor was observed in 87.5%, 50.0%, 35.3% and 28.6% of these patients. The papillary tumors, small tumors and low grade tumors responded better to these intravesical chemotherapies than the non-papillary tumors, the middle grade tumors and the high grade tumors. The recurrence rate in 72 patients was 6.9, 14.6 and 26.8% within 1, 2 and 3 years. No significant difference in the recurrence rate was observed between the MMC, ADM, PEP and MAC group, but the MMC group tended to have a lower recurrence rate than the other groups. The recurrence rate for the low grade tumors and the middle grade tumors was significantly lower than that for the high grade tumors and the small tumors. The major side effect of instillation therapy with these drugs was bladder irritation which appeared in 16.7% of all the patients (78 cases). In conclusion, intravesical chemotherapy is a useful approach for controlling superficial urinary bladder tumors, especially the combination of MMC and CA.

Administration, Intravesical↗
PubMed1994

Evolution of cellular and humoral response against Tuberculin and antigen 85 complex during intravesical treatment with BCG of superficial bladder cancer.

Prophylactic treatment with Bacillus Calmette-Guerin (BCG) is an established and effective therapy of bladder cancer. The antitumor effect of BCG seems to be largely related to cellular immunological mechanisms, although its precise mode of action is unknown. Antitumor response of BCG seems to be initiated by the attachment of BCG to bladder wall via Fibronectin (FN). The cellular immune response against Tuberculin PPD and the major secreted BCG antigen (Fibronectin-binding AG 85 complex) has been tested in a control group of 20 untreated bladder tumor patients and before and after 6 weekly intravesical BCG instillations in a group of 20 superficial bladder tumor patients. A major increase in the lymphoproliferative response against PPD and AG 85 was observed in respectively 66% and 57% of the treated patients. In contrast, no detectable antibody response (IgA, IgM, IgG) was observed against AG 85 complex after BCG treatment. On the other hand, antibodies against Tuberculin increased in 13 of 20 patients. This study seems to demonstrate a specific cellular immune activation against AG 85 Fibronectin-binding complex during BCG treatment of superficial bladder tumors. Humoral response against the AG 85 is not activated after BCG treatment. Further studies are needed to elucidate the role of AG 85 in the cellular intravesical penetration of BCG. Presence or absence of cellular response against this antigen could be of clinical value.

Administration, Intravesical↗
PubMed1993

[Intravesical instillations of BCG and bladder carcinoma in situ].

32 patients with bladder carcinoma in situ (CIS) were treated by intravesical instillations of BCG immun F Pasteur between 1988 and 1991. The CIS was isolated (13 cases, 40.6%) or associated with a pTa papillary tumour (10 cases, 31.2%), pT1 tumour (8 cases, 25.1%) or pT2 tumour (1 case, 3.1%). The protocol consisted of a series of weekly instillations of 150 mg of BCG for 6 weeks, repeated once in the case of persistent lesions on the first endoscopic follow-up examination. Patients were reviewed in the outpatients department every 3 months for 1 year, then every 6 months for 2 years in the absence of recurrence. Follow-up consisted of clinical examination, urine cytology and histology. The overall success rate, defined by complete resolution of the cytological and histological lesions for the total population was 81.25% (25/32) with a mean follow-up of 22.5 months. 18.75% (6/32) of cases were considered to be failures. Complications of treatment were observed in 59% of patients, but only required discontinuation of instillations in five patients (15.6%). In conclusion, intravesical BCG is the treatment of choice of bladder carcinoma in situ in the absence of detrusor invasion and contraindications to BCG.

Administration, Intravesical↗
PubMed1996

Urodynamic effects of intravesical oxybutynin chloride in conscious rats.

PURPOSE: To examine the factors of intravesical oxybutynin influencing the cystometrogram in normal conscious rats at various pH levels and concentrations of oxybutynin. MATERIALS AND METHODS: A cystostomy catheter was implanted into the bladders of male Sprague-Dawley rats. We compared the urodynamic effects of intravesical oxybutynin dissolved in pH 4.44, 6.44 and 8.44 buffer. Two concentrations of oxybutynin solution were adopted, 0.06 and 0.6 mg./ml., and were dissolved in each pH buffer. RESULTS: Although a 26% increase in bladder capacity was recognized 1 hour after instillation of pH 8.44, 0.06 mg./ml. oxybutynin, no significant difference was found in comparison with control rats. At the concentration of 0.6 mg./ml., bladder capacity markedly decreased 30 minutes to 1 hour after instillation even at pH 6.44 and 8.44. Significant decreases in detrusor contraction pressure were recognized 30 minutes to 1 hour after instillation. However, there were no significant differences among the 3 pH oxybutynin solutions. Compared with preinstillation values, significant increases in residual urine rates were observed in all pH oxybutynin solutions. Furthermore, the residual urine rate after instillation of pH 8.44 oxybutynin solution differed significantly from that of pH 4.44 oxybutynin. CONCLUSION: Our results demonstrate that pH and concentration of intravesical oxybutynin solution may play an important role in relaxation of the bladder. A high concentration of oxybutynin is considered irritating to the bladder mucosa.

Administration, Intravesical↗
PubMed1992

Long-term results of intravesical chemoprophylaxis of superficial bladder cancer: experience of the Japanese Urological Cancer Research Group for Adriamycin.

Long-term results were analyzed in terms of tumor progression and survival in patients with superficial bladder cancer who were enrolled in the second intravesical chemoprophylactic study of the Japanese Urological Cancer Research Group for Adriamycin, which was started in July 1982. This study was a prospective, randomized, controlled trial conducted on primary tumors treated with a long-term instillation regimen that involved control versus intravesical instillations of Adriamycin or mitomycin C given once a week for the first 2 weeks, once every other week for 14 weeks, once a month for 8 months, and once every 3 months for 1 year, for a total of 21 instillations in 2 years. An analysis of the prophylactic effects of such treatment on bladder tumors after TUR has previously been performed, and the results have been published elsewhere. The present study represents a follow-up of the above trial. Of the 671 cases previously analyzed with regard to tumor prophylaxis, 158 cases (23.5%) were eligible to be followed for tumor progression and survival. A detailed comparison of the background factors between these 158 patients and the other 513 cases revealed no statistically significant difference. Thus, the 158 evaluable cases might reasonably be considered to represent all patients enrolled in the second study, and the results were thought to be reasonable enough to reflect the long-term efficacy of the long-term instillation regimen adopted in this study. The median follow-up for these 158 cases was 6.6 years. Tumor progression in terms of the disease stage and/or grade occurred in 43 of 127 patients who received prophylactic instillations and in 12 of 31 control cases. No significant difference in the incidence of tumor progression was found between the treatment and the control groups. In addition, no difference in survival was observed between the treatment group and the control group. Survival was also compared between patients who showed tumor progression and those who did not. All patients whose tumors did not progress survived, whereas the 7-year survival of those exhibiting tumor progression was less than 90%.

Actuarial Analysis↗
PubMed1990

The effect of verapamil on a multi-drug resistant bladder carcinoma cell line and its potential as an intravesical chemotherapeutic agent.

A human bladder transitional cell carcinoma cell line, MGH-U1R, exhibits reproducible resistance to doxorubicin. We examined the effects on survival of this cell line caused by verapamil, which has been shown to reverse multi-drug resistance in vitro in other neoplastic cell lines. Both MGH-U1R and MGH-U1, the non-resistant parent cell line, were treated with varying concentrations of doxorubicin alone, verapamil alone, or both drugs simultaneously, all for one hour. Cells were then grown in drug-free medium for 10 days, stained, and counted. Standard survival curves were calculated. Verapamil alone had no significant cytotoxicity. Verapamil at concentrations of 16 micrograms./ml. and 32 micrograms./ml. decreased the IC50 of doxorubicin for MGH-U1R by a factor of 2.5. Using H3-verapamil, we also examined the systemic and local absorption of this drug resulting from intravesical verapamil administration in rabbits. All animals were treated for one hour, and multiple serum samples were drawn during treatment. Verapamil was found in high concentrations in the mucosa, less in the adventitia, and was absent in venous blood. Verapamil effectively reverses resistance to doxorubicin of MGH-U1R in vitro. The intravesical use of verapamil appears to be safe, and may prove to be a useful adjunct in the intravesical therapy of some bladder tumors.

Animals↗
PubMedDate not supplied

[The intravesical chemotherapy of surface tumors of the bladder].

Intravesical chemotherapy (IVC) for bladder cancer was conducted in 83 patients who had been admitted to the Moscow Cancer Research Center in 1981-1988. Farmorubicin IVC produced a complete response (CR) in 3 (21.4%) and a partial one (PR) in 6 (42.9%) of the 14 patients treated. In mytomicin C administration CR was achieved in 4 (30.8%), PR in 2 (15.4%) of the cases. For adriamycin, spirobromin, thiotef (60 mg), thiotef (20 mg), CR was registered in 4 (30.8%), 5 (17.9%), 1 (11.1%), 2 (18.2%), 2 (25%) patients, PR in 2 (15.4%), 8 (28.6%), 1, 1 (9.1%), 1 (12.5%) patients out of 13, 28, 9, 11, 8 cases, respectively. Complications of the IVC in the form of drug cystitis occurred in 57.1%, 23.1%, 46.4%, 12.5-18.1% of those treated with farmorubicin, mytomicin C, adriamycin, thiotef, respectively. Spirobromin arose no complications.

Administration, Intravesical↗
PubMed1988

Treatment schedule of intravesical chemotherapy with mitomycin C in superficial bladder cancer: short-term courses or maintenance therapy.

Intravesical chemotherapy using mitomycin C in patients with superficial bladder cancer after transurethral resection (TUR) has proved to be highly effective in preventing tumor recurrences and/or progression. No consensus has been reached on the appropriate dose and treatment schedule. This and other variable factors such as different criteria for entry and follow-up in the reported studies so far make it impossible to compare the results. There are indications that long-term mitomycin C instillation therapy improves recurrence rate, progression rate, and survival. Considering prognostic factors in patients with superficial bladder tumors, it is justified and necessary to investigate this regimen in future protocols.

Administration, Intravesical↗
PubMed1987

Acute nonlymphocytic leukemia after thiotepa instillation into the bladder: report of 2 cases and review of the literature.

We report 2 cases of acute nonlymphocytic leukemia after thiotepa instillation into the bladder for superficial bladder carcinoma and review 4 additional cases from the literature. Intravesical thiotepa is absorbed systemically in patients with bladder carcinoma and such treatment may be associated with the rare occurrence of acute nonlymphocytic leukemia and/or the myelodysplastic syndrome.

Administration, Intravesical↗
PubMed2003

Pharmacokinetics of intravesical gemcitabine: a preclinical study in pigs.

INTRODUCTION: Gemcitabine is a deoxycytidine analogue, used intravenously in the treatment of several tumours, including transitional cell carcinoma of the bladder. It has been shown to be effective and well tolerated when given systemically. We investigated the use of this agent administered intravesically in pigs for histological studies of the bladder and pharmacokinetic research. MATERIAL AND METHODS: Two groups of 5 female pigs each received once 175mg and 350mg gemcitabine intravesically for 2 hours. A third group of 5 pigs received 350mg gemcitabine weekly for 6 weeks. Animals were observed for clinical signs of toxicity. Blood was withdrawn for gemcitabine pharmacokinetics and in group 3 also for peripheral blood counts. The animals were euthanized 24 hours after (the last) instillation. Histological examination of the bladder wall was performed. RESULTS: Doses of 175 and 350mg gemcitabine were well tolerated. The animals showed no signs of deterioration of their well-being. Peripheral blood counts showed no signs of immunosuppression in the third group. In none of the pigs systemic absorption was seen, up to 4 hours after the beginning of instillation. Histology showed in all cases normal bladder wall histology, except for some cases with mild signs of infection (mainly group 3). CONCLUSION: The use of gemcitabine as an intravesical agent in pigs is well tolerated, has no bladder toxicity and is not absorbed systemically.

Administration, Intravesical↗
PubMed2000

Type III and type IV hypersensitivity reactions due to mitomycin C.

A 71-year-old man developed an exfoliative dermatitis of the palms of the hands and soles of the feet, and a generalized itch, during treatment with intravesical instillations of mitomycin C for an undifferentiated carcinoma of the bladder. Patch tests with mitomycin C 0.03%, 0.1% and 0.3% aq. were positive. Because of the serious consequences of this finding, the patient was retested with mitomycin C in pet. (same concentrations), a more stable preparation. This showed clear positive reactions. During this last series of patch tests, he developed palpable purpura on the legs. We postulated that this reaction was an immune-complex-mediated reaction, caused by the 2nd series of patch tests with mitomycin C. To prove this, we performed histopathological and immunofluorescence investigations, and these showed the reaction to be consistent with Henoch-Schonlein-type purpura. We therefore conclude that this patient developed systemic reactions to mitomycin C, characterized by an eczematous dermatitis as well as purpuric reactions. The intravesical installations with mitomycin C have been stopped. The patient's skin problems (the purpura as well as the eczema) have completely resolved and have not recurred.

Administration, Intravesical↗
PubMed1996

Combined cytotoxic effects of tamoxifen and chemotherapeutic agents on bladder cancer cells: a potential use in intravesical chemotherapy.

OBJECTIVE: To evaluate whether tamoxifen enhances the cytotoxicity of chemotherapeutic agents on bladder cancer cells, and the possible mechanism(s) of action. MATERIALS AND METHODS: The in vitro inhibition of cell growth was examined in a model simulating intravesical chemotherapy using two bladder cancer cell lines (TSGH-8301, HTB9) and three commonly used intravesical cytotoxic agents (doxorubicin, mitomycin C, and thiotepa) in the presence or absence of tamoxifen or verapamil as modulators. The expression of the multi-drug resistance-related gene mdr-1 was evaluated by reverse-transcription polymerase chain reaction and Southern blotting (RT-PCR-SB) to determine its transcript level, by flow cytometric analysis of the P-glycoprotein (P-gp) product level with C-219 monoclonal antibody and by the rhodamine-123 retention and efflux assay for P-gp activity. Transforming growth factor beta-1 (TGF beta-1) levels in tamoxifen-conditioned culture medium were determined with enzyme-linked immunosorbant assay (ELISA). RESULTS: Tamoxifen at concentrations > or = 30 microM significantly enhanced the cytotoxicity of the three chemotherapeutic agents to both cell lines, as shown by a marked reduction in the drug concentration which inhibited growth by 50% (IC50). The enhancement of cytotoxicity was significantly dependent on the concentration of tamoxifen. However, tamoxifen alone caused significant toxic effects to TSGH-8301 at > or = 40 microM and to HTB9 at > or = 30 microM. Median-effect analysis showed additive or less-than-additive combination effects between tamoxifen and chemotherapeutic agents and only a minimal synergism in a narrow range of maximal cytotoxicity (fraction affected > 0.9). Thus, the reduction of IC50s by tamoxifen was mostly because it was cytotoxic to the bladder cancer cells used. No enhancement of cytotoxicity was observed in verapamil-modulated cells. Transcripts of mdr-1 could not be detected by RT-PCR-SB, nor was P-gp detected by flow cytometric analysis in the two cell lines. Furthermore, no active P-gp function was detected by the rhodamine-123 retention and efflux study, indicating that the primary chemoresistance mechanisms of the two cell lines were not mediated by mdr-1, nor could tamoxifen or verapamil act through modulation of the mdr-1 pathway in the two cell lines. Tamoxifen at 3 and 10 microM down-regulated the secretion of TGF beta-1 from TSGH-8301 in a concentration-dependent manner, in contrast to the findings that tamoxifen was cytotoxic to the bladder cancer cells used and that tamoxifen up-regulated TGF beta-1 in a breast cancer model, suggesting that there may be a different mechanism of response to TGF beta-1 in these bladder cancer cells. CONCLUSION: Tamoxifen enhanced the cytotoxicity of chemotherapeutic agents largely through its toxic effects on the bladder cancer cells. The mode of action of tamoxifen was not through the regulation of TGF beta-1 or the function of mdr-1. Although cytotoxic levels of tamoxifen (> 50 microM) can be achieved easily in the intravesical model, further study is necessary before tamoxifen can be used clinically in intravesical chemotherapy.

ATP Binding Cassette Transporter, Subfamily B, Mem↗
PubMed1992

Outcome in carcinoma in situ of bladder treated with intravesical bacille Calmette-Guérin.

Fifty-three patients with carcinoma in situ of the bladder were treated with Evans strain BCG given intravesically. Complete remission was achieved after either one or two 6-weekly courses in 53% of patients. The median duration of remission was 32 months. Treatment-related bladder symptoms were minor during the first course, more severe during the second. There was no relation between severity of symptoms and likelihood of response. With a median follow-up of 32 months, disease progression has occurred in 10% of complete responders, whereas failure to respond on either cystoscopic, histological or cytological grounds was associated with a 48% progression rate. Although intravesical BCG produces impressive responses in carcinoma in situ of the bladder, managed conservatively the condition remains a dangerous one.

Administration, Intravesical↗