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PubMed1996

The management of superficial bladder cancer: an interactive seminar.

OBJECTIVES: To determine the current management of superficial bladder cancer in the United Kingdom. METHODS: An interactive seminar with a series of questions about management and hypothetical clinical scenarios was conducted at the 1995 conference of the British Association of Urological Surgeons. The responses of the audience were recorded electronically and analysed. RESULTS: The results showed that there is a wide variation in practice and some confusion over the place of intravesical treatment using cytotoxic drugs and bacille Calmette-Guérin. CONCLUSIONS: The management of superficial bladder cancer could be improved by a more widespread use of intravesical therapy, along with the introduction of local protocols and national guidelines.

Administration, Intravesical↗
PubMed2004

Role of C afferent fibers and monitoring of intravesical resiniferatoxin therapy for patients with idiopathic detrusor overactivity.

PURPOSE: Resiniferatoxin (RTX) is a specific C fiber neurotoxin which produces desensitization. In this study we performed intravesical RTX therapy in patients with idiopathic detrusor overactivity. In addition we measured the current perception threshold of C and A delta fibers before and after treatment to evaluate clinical significance. MATERIALS AND METHODS: The protocol involved an RTX solution (100 ml of 50 nM) instilled in the bladder for 30 minutes. Four men and 6 women 59 to 75 years old were treated. Effects on bladder function were evaluated before and 30 days after treatment by cystometry and Neurometer (Neurotron, Inc., Baltimore, Maryland). Subjective and objective measures included bladder diaries and quality of life before treatment, and 7, 30 and 90 days subsequently. RESULTS: Of the 10 patients 5 noted improvement and 2 of them became dry. The other 5 patients were considered to have stationary symptoms. Mean maximal cystometric capacity +/- SD increased from 229 +/- 108 ml at baseline to 271 +/- 99.5 ml at 30 days (p = 0.04). The mean number of daily episodes of urinary incontinence decreased from 3.5 +/- 2.2 to 2.0 +/- 1.6 (p = 0.008) at 7 days, to 1.9 +/- 1.6 (p = 0.018) at 30 days and to 2.5 +/- 1.7 (p = 0.018) at 90 days. Mean current perception threshold values of C and A delta fibers did not change significantly, from 46.9 +/- 35.2 to 56.4 +/- 32.1 (p = 0.161) and from 66.9 +/- 31.7 to 66.4 +/- 25.2 (p = 0.952), respectively. However, values of C fibers increased in all patients who showed improvement from 46.2 +/- 33.2 to 64.0 +/- 36.8 (p = 0.043). CONCLUSIONS: Intravesical RTX improved bladder capacity and leak episodes in patients with idiopathic detrusor overactivity. Intravesical RTX is a promising treatment for this condition.

Administration, Intravesical↗
PubMed1999

[Sepsis syndrome and bone marrow granulomatosis after intravesical instillation of BCG].

BACKGROUND: BCG therapy is an effective treatment for superficial bladder carcinoma. Exceptionally, systemic disorders including hypersensitivity reactions or infections may occur. CASE REPORT: A 70-year-old man developed septicemia with bone marrow granulomatosis with a favorable course after intravesicle administration of bacillus Calmette-Guérin for bladder carcinoma. DISCUSSION: High grade fever, septicemia, hepatitis or pulmonary granulomatosis as well as bone marrow involvement are reported in less than 1% of all cases of BCG therapy. The pathogenic mechanisms are complex. Anti-tuberculous drugs are generally given.

Administration, Intravesical↗
PubMedDate not supplied

Severe complications following intravesical BCG instillation.

In patients with urinary bladder carcinoma, the intravesical BCG instillation is widely used. We present two cases of severe pulmonary afflictions developed during this treatment. The possible mechanisms of etiology are discussed and the classification of the intravesical BCG treatment side effects is suggested.

Adjuvants, Immunologic↗
PubMed1992

Carcinoma in situ.

Carcinoma in situ is a high-grade and aggressive manifestation of transitional-cell carcinoma of the bladder that has a highly variable course. The treatment of CIS has undergone dramatic changes since this malignancy was first recognized. While cystectomy was once recommended as the initial treatment of choice, recognition of the highly variable prognosis and the uniformly high response rate to intravesical BCG has prompted a more conservative approach to management. While it is recommended that patients be offered the option of radical cystectomy, data do not currently exist to confirm that cystectomy provides a superior survival or quality of life compared with an initial trial of BCG immunotherapy followed by salvage cystectomy if needed. With current optimal BCG immunotherapy regimens, which consist of a 6-week course of BCG followed by three weekly instillations at 3 months, 6 months, and every 6 months for 3 years, the complete response rate is 82%; and it is estimated that more than 75% of patients having a complete response will remain continuously disease free for 5 or more years. Patients who fail BCG immunotherapy without evidence of progression may yet be candidates for intravesical chemotherapy, photodynamic therapy, or alternative immunotherapies such as alpha-2b interferon, bropirimine, or keyhole limpet hemocyanin.

Administration, Intravesical↗
PubMed1997

Bladder tissue pharmacokinetics and antitumor effect of intravesical 5-fluorouridine.

The present study evaluates whether intravesical 5-fluorouridine (FUR), a potent fluorinated pyrimidine, is effective against bladder cancer. The tissue and plasma pharmacokinetics of i.v. and intravesical FUR were studied in dogs to determine the tissue targeting advantage by the intravesical route. The i.v. study used a bolus FUR dose of 4 mg/kg, which is tolerated in humans. The disposition of FUR was biphasic, with a peak concentration of 8.8 microgram/ml and a clearance of 127 ml/min/kg. 5-Fluorouracil was the major circulating metabolite, reaching a peak concentration of 3.2 microgram/ml. In the intravesical study, FUR (approximately 2 mg/kg in 20 ml of water) was instilled in the dog bladder. At the end of the 2-h treatment, FUR concentration in urine decreased by about 40%, due mainly to dilution by residual and newly produced urine. The concentration at the interface between urothelium and lamina propria was 14 microgram/g, or approximately 2% of the urine concentration, and declined logarithmically to 2 microgram/g in the deep muscles. The concentrations of FUR and 5-fluorouracil in plasma were below the assay detection limit of 20 ng/ml, or > 200-fold lower than the concentration after the i.v. dose (adjusted to the difference in the i.v. and intravesical dose). These data indicate a > 200-fold advantage in the reduction of systemic exposure by the intravesical route. To determine whether the achievable tissue concentrations of FUR produced significant antitumor activity, we studied the effect of FUR against human bladder tumors maintained as 3-dimensional histocultures. The FUR concentrations (IC50s) required to produce 50% inhibition of DNA precursor ([3H]thymidine or bromodeoxyuridine) incorporation in human superficial bladder tumors (i.e., Ta and T1 tumors, n = 4) and muscle-invading tumors (i.e., T3 and T4 tumors, n = 4) were 9 and 22 microgram/ml, respectively. In conclusion, intravesical FUR therapy delivers effective drug concentration to superficial bladder tissues without resulting in appreciable systemic blood concentration. We propose that intravesical FUR represents a potentially effective treatment against superficial bladder cancer.

Administration, Intravesical↗
PubMed1990

Long-term followup of patients treated with 1 or 2, 6-week courses of intravesical bacillus Calmette-Guerin: analysis of possible predictors of response free of tumor.

We report our long-term experience with 104 patients treated for recurrent superficial bladder tumors followed for a mean of 48 +/- 2 months (range 6 to 83 months). Patients received 6 weekly intravesical bacillus Calmette-Guerin instillations, and were followed for response with urinary cytology, cystoscopy and bladder biopsy. Patients were considered treatment failures if either urinary cytology or biopsy results were positive for tumor. Of 69 patients who failed the initial treatment course 60 were given an additional 6-week course of therapy. A 6-week course of bacillus Calmette-Guerin was successful in 19 of 55 patients (35%) treated for prophylaxis, 10 of 32 (31%) treated for carcinoma in situ and 6 of 17 (35%) treated for residual tumor. The response rate for the total patient population treated with 1, 6-week course was 34% (35 of 104). Another 6-week course was successful in 32 of 60 patients (53%). The over-all response rate free of tumor for patients treated with either 6 or 12 weeks of therapy was 64%. The mean interval free of tumor was 48 months. We evaluated tumor type, stage and grade in conjunction with muscle invasion to assess potential indicators of response to a second course of bacillus Calmette-Guerin. Of 13 patients with carcinoma in situ and 45 with papillary disease 5 (38%) and 26 (58%), respectively, responded to a second course of bacillus Calmette-Guerin (not significantly different). In contrast, 5 of 8 carcinoma in situ failures (63%) had muscle invasive disease, compared to only 3 of 19 papillary nonresponders (16%) (p less than 0.02). These results suggest that intravesical bacillus Calmette-Guerin for the treatment of superficial bladder tumors is an effective long-term therapy. One 6-week course may be ineffective for some patients and another 6-week course provides long-term survival free of tumor for many course 1 failures. Patients who present with carcinoma in situ after a single 6-week course of intravesical bacillus Calmette-Guerin have a significantly higher risk for muscle invasive disease than those with recurrent papillary tumors.

Administration, Intravesical↗
PubMed2004

Long-term effects of bacille Calmette-Guérin perfusion therapy for treatment of transitional cell carcinoma in situ of upper urinary tract.

OBJECTIVES: To report our experience with bacille Calmette-Guérin (BCG) perfusion therapy for transitional cell carcinoma in situ of the upper urinary tract. BCG perfusion therapy is widely used to treat transitional cell carcinoma in situ of the upper urinary tract. However, it has not yet been established as a standard treatment. METHODS: Ten patients diagnosed with transitional cell carcinoma in situ of the upper urinary tract were treated with BCG perfusion therapy from January 1990 to May 2002. BCG was instilled weekly for 6 weeks, with a median dose of 65 mg at 1.17 mg/mL (Tokyo 172 strain, dissolved in normal saline). RESULTS: The mean follow-up period was 50.9 months (range 12 to 134). The initial response to therapy was excellent, and cytology became negative in all patients after one course of BCG perfusion. Five patients developed recurrence after 5, 11, 24, 26, and 45 months, and all died after 46, 12, 41, 134, and 79 months, respectively. The mortality rate was 50% and was 100% in those with recurrence. The mean recurrence-free period was 22.2 months (range 5 to 45). Complications included bladder irritation-related symptoms in all patients, fever greater than 38 degrees C (n = 9), hematuria (n = 2), hydronephrosis (n = 2), and lumbago (n = 1) but all were transient and did not affect long-term prognosis. CONCLUSIONS: BCG perfusion therapy for carcinoma in situ of the upper urinary tract is safe, and the short-term response is excellent. However, the long-term results were not satisfactory. Therefore, this therapy should be considered experimental, although it may have potential benefits in delaying progression and possibly providing local control for patients in poor condition. Long-term studies are required for additional evaluation of BCG therapy.

Administration, Intravesical↗
PubMed1990

Adverse impact of fibrin clot inhibitors on intravesical bacillus Calmette-Guerin therapy for superficial bladder tumors.

Although intravesical bacillus Calmette-Guerin therapy has proved to be efficacious in the treatment and prophylaxis against tumor recurrence of superficial bladder tumors, its mechanism of action has not been fully elucidated. Previous work has suggested that bacillus Calmette-Guerin organisms attach to the matrix protein, fibronectin, during fibrin clot formation at sites of urothelial disruption and that this attachment was required for the antitumor effect of bacillus Calmette-Guerin to be expressed. Furthermore, drugs inhibiting clot formation were found to abrogate the antitumor effect of intravesical bacillus Calmette-Guerin therapy in a murine bladder tumor model. To examine the effect of inhibitors of fibrin clot formation on the results of intravesical bacillus Calmette-Guerin therapy, a retrospective analysis of 149 evaluable patients receiving intravesical bacillus Calmette-Guerin for superficial bladder tumors was performed. The over-all response rate free of tumor for 29 patients who concomitantly received inhibitors of fibrin clot formation with bacillus Calmette-Guerin therapy was 48%, as compared with 67% for 120 patients who were not receiving these medications (p = 0.0655, chi-square). The most striking difference was noted for patients who failed with recurrent superficial disease. Of the patients who received fibrin clot inhibitors during intravesical bacillus Calmette-Guerin therapy 35% had recurrent superficial tumors compared to only 8% of those who did not receive these drugs during a mean followup of 29.8 plus or minus 11 months (p = 0.005, chi-square). Our study suggests that inhibitors of fibrin clot formation may have an adverse influence on the results of intravesical bacillus Calmette-Guerin therapy for superficial bladder tumors.

Administration, Intravesical↗
PubMed2002

Intravesical meglumine gamma-linolenic acid in superficial bladder cancer: an efficacy study.

OBJECTIVES: Gamma-linolenic acid (GLA) is known to be cytotoxic to malignant cells. We assessed the efficacy of the novel intravesical formulation, meglumine gamma-linolenic acid (MeGLA), in a phase II trial, in patients with recurrent, superficial bladder cancer. PATIENTS AND METHODS: Thirty patients with recurrent, superficial transitional cell carcinoma (TCC) were recruited. The tumour pattern was recorded at flexible cystoscopy. Patients received a single intravesical instillation of 50ml of either 50mg (1mg/ml) (15 patients), or 125mg (2.5mg/ml) (15 patients) of MeGLA in water, retained for one hour. At subsequent cystoscopy, the tumour patterns were recorded, prior to undertaking routine cystodiathermy. Biopsies were obtained for histological assessment. Responses were divided into complete, partial or none. RESULTS: All 30 patients retained the drug for 1 hour without significant local or systemic side effects. There were 4 (13%) complete responses, 9 (30%) partial responses, and 17 (57%) non-responders. Histology showed no evidence of damage to surrounding urothelium. CONCLUSIONS: Our data confirms the safety and tolerability of MeGLA, which is consistent with findings from a previous phase I trial. A response rate of 43% also indicates that MeGLA has a significant cytotoxic effect against TCC and the results are similar to those obtained using standard, single-dose, intravesical regimens.

Administration, Intravesical↗
PubMed1998

Intravesical chemotherapy with gamma linolenic acid becomes a realistic prospect in serum-free applications: in vitro cytotoxicity and systemic absorption studies.

PURPOSE: To assess the cytotoxicity of Meglumine gamma linolenic acid (MeGLA) in serum-free application on 2 urothelial cancer cell lines, to examine whether the instant kill action of MeGLA is retained in a serum free environment, and to study the pharmacokinetics of intravesical instillation of gamma linolenic acid (GLA). MATERIALS AND METHODS: The 2 human urothelial cancer cell lines (MGH-U1 & RT112) were utilized in classical cytotoxicity assays in which drug exposure lasted 2 hours in serum or in serum-free application. The thiozolyl blue (MTT) assay was used to quantify the residual viable biomass 5 days later. Immediate cytotoxicity was also compared in serum and serum-free application. Four Wistar rats were used to study the intravesical absorption profile of tritiated GLA (3H-GLA). RESULTS: There was a 10-fold enhancement of the lytic efficacy of MeGLA in serum-free application and this enhancement was also observed in experiments assessing instant kill. There was a similar enhancement of efficacy seen in the multi-drug resistant (MDR) clone of cells. The absorption profile showed < 2% of instilled counts were absorbed and the commonest destination for the absorbed GLA was the liver. CONCLUSIONS: The cytotoxic action of MeGLA was enhanced in serum free application. This enhancement was maintained when cells expressed the MDR phenotype. There was limited absorption from the bladder. MeGLA is a feasible intravesical agent for use in superficial bladder cancer.

Administration, Intravesical↗
PubMed2005

Adjuvant intravesical treatment of superficial bladder cancer with a standardized mistletoe extract.

PURPOSE: Adjuvant intravesical immunotherapy with bacillus Calmette-Guerin (BCG) for noninvasive superficial bladder cancer has been shown to decrease tumor recurrence significantly. However, serious local and systemic side effects of this treatment have promoted the use of other immunoactive substances, which to date have failed to show efficacy equal to that of BCG immunotherapy. MATERIALS AND METHODS: In the current phase I/II clinical trial an aqueous mistletoe extract standardized to mistletoe lectin was administered intravesically to 30 patients with superficial urothelial bladder carcinoma. About 4 weeks after transurethral resection each patient received 6 instillations at weekly intervals of 50 ml extract with mistletoe lectin concentrations between 10 and 5,000 ng/ml, which was retained in the bladder for 2 hours. Three patients per group received a dose, which was then doubled in the next group. Clinical followup consisted of examinations with cystoscopy, cytology and random biopsies. To detect cytokines and tumor necrosis factor-p75 receptor venous blood and urine samples were taken before instillation, and 2, 6 and 24 hours thereafter. RESULTS: The tolerability of intravesically administered mistletoe extract was good at all applied concentrations. None of the patients had local or systemic side effects according to WHO classification 1-4. Within the 12-month observation time study patients with pTa G2 and pT1 G2 tumors showed a recurrence rate of 33%, comparable to that in a local historical control group of patients with equal stage and grade who were treated with adjuvant BCG. Comparison of urine cytokine levels before instillation, and 2, 6 and 24 hours thereafter brought about no significant alterations in all measured cytokines. CONCLUSIONS: From these results it is concluded that standardized mistletoe extract could be a potential alternative adjuvant therapy for superficial bladder cancer. Nevertheless, the optimal intravesical treatment regimen has yet to be defined.

Administration, Intravesical↗
PubMed2004

Intravesical resiniferatoxin for patients with neurogenic detrusor overactivity.

BACKGROUND: Resiniferatoxin (RTX), a substance isolated from some species of Euphobia, is a specific C-fiber neurotoxin which produces desensitization rather than excitation. At first, we performed intravesical RTX therapy on eight patients with neurogenic detrusor overactivity. After we confirmed the safety and efficacy, a Japanese RTX study group was organized and a new protocol made. The multicenter trial was performed in Japan. However, the efficacy of the treatments was different among the institutions. Therefore, we have compared the results between the first protocol and the new one at our hospital. METHODS: The first and second protocol involved the RTX solution (30 mL of 500 nM, and 100 mL of 1 micro M, respectively) being instillated in the bladder for 30 min by almost the same procedures. Effects on bladder function were evaluated during treatment and at follow up. RESULTS: For the first and second protocols, six out of eight patients noted symptomatic improvement while two patients did not notice any change in the degree of incontinence for one month. The mean urodynamic bladder capacity had significantly increased from 138.0 +/- 64.4 mL to 227.3 +/- 112.4 mL and 133.1 +/- 43.3 mL to 247.0 +/- 102.3 mL 1 month after RTX treatment for the first and second protocols, respectively (P < 0.05). No severe side-effects were seen in either group. CONCLUSION: Intravesical RTX improved bladder capacity in patients with neurogenic detrusor overactivity in both protocols. The concentration of RTX did not exhibit any change in the effect and safety in our hospital. Intravesical RTX is a promising treatment for neurogenic detrusor overactivity.

Administration, Intravesical↗
PubMed1989

Conservative treatment of diffuse carcinoma in situ of the bladder with repeated courses of intravesical therapy.

We present a series of 13 patients with diffuse carcinoma in situ (CIS) of the bladder who failed an initial induction course of intravesical therapy with Mitomycin C, thiotepa, doxorubicin or Bacillus Calmette Guérin (BCG). Cystectomy, although indicated, was, for various reasons, not performed after the first failure of intravesical therapy and all patients were subsequently treated topically with the same or different agents. Of the 7 patients treated with 2 induction courses, 6 showed a complete response during a follow-up period of 24 to 42 months. Although 1 patient initially responded completely, he developed invasive transitional cell carcinoma (TCC) Grade IV 30 months later. Among the 3 patients who underwent 3 induction courses, 2 had a complete response at 42 and 60 months of follow-up and 1 developed TCC Grade IV with muscle invasion 18 months later. Two of the 3 patients treated with 4 induction courses are free of disease at 48 and 57 months; the third developed low grade, low stage TCC. This experience suggests that the majority of patients with CIS who fail initial treatment usually respond to further treatment with the same or a different drug. The question as to whether a second course of intravesical therapy, subsequent to failure of the first course, should be given before cystectomy requires further investigation.

Administration, Intravesical↗