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PubMed1996

Prediction of response to treatment in superficial bladder carcinoma through pattern of interleukin-2 gene expression.

PURPOSE: Superficial bladder carcinoma, treated by resection and intravesical administration of bacillus Calmette-Guérin (BCG), yields a remission rate that approaches 70%. We examined whether expression of interleukin-2 (IL-2) or interferon-gamma (IFN-gamma) genes can serve to predict response. PATIENTS AND METHODS: During BCG treatment, we analyzed induction of IL-2 and IFN-gamma mRNA in peripheral-blood mononuclear cells (PBMC) from 73 patients: 51 with papillary tumors and 22 with carcinoma-in-situ (CIS). Results were correlated with remission, relapse, or tumor persistence over a 4-year follow-up period. RESULTS: Independent of tumor type, induction of IL-2 mRNA was observed for patients who responded with remission, but not for those who relapsed (P = .0001). Multivariate logistic analysis showed that inducibility of IL-2 mRNA is the discriminating parameter, which yields a predictive value of 97% for remission. Of 23 patients with relapse/persistence, 22 lacked inducibility of IL-2 mRNA (sensitivity, 95.6%), while 35 of 50 patients in remission exhibited inducibility (specificity, 70%). For patients with carcinoma-in-situ, in which remission or failure depends solely on response to BCG, sensitivity and specificity were 88% and 86%, respectively; for patients with papillary tumors, they were 100% and 64%. IFN-gamma mRNA, by contrast, was clearly inducible in PBMC from all patients (P = .51). The disease-free interval increased progressively with inducibility of IL-2 mRNA; this trend was highly significant (P = .0001). CONCLUSION: IL-2 gene expression is essential for mounting an antitumor response in superficial bladder carcinoma. Inducibility of IL-2 mRNA is an independent prognostic parameter and useful predictive indicator of remission versus relapse.

Adjuvants, Immunologic↗

PubMed1990

Local bacillus Calmette-Guerin therapy for superficial bladder cancer: clinical, histological and ultrastructural patterns.

The effectiveness of intravesical administration of bacillus Calmette-Guerin as a prophylaxis of superficial bladder cancer has been definitely demonstrated. On the other hand, therapeutic regimens, duration effects, efficacy of either maintenance cycles or repeated courses of therapy in case of failures are still controversial. We report the results achieved in 15 cases of carcinoma in situ of the bladder and in 48 cases of superficial bladder cancer (Ta-T1 stage of disease) with bacillus Calmette-Guerin immunotherapy. Our patients underwent an initial six week cycle and a following maintenance cycle with monthly administrations for one year. Median follow-up was 19 months (range 18-21 months). Patients with carcinoma in situ are now free of disease; on the contrary, patients with Ta-T1 tumors experienced 18 recurrences (28%). There was a marked decrease of recurrence rate when compared to previous local chemotherapy. We report in detail the adverse effects encountered and both histologic and ultrastructural findings observed after immunotherapy. Bacillus Calmette-Guerin therapy can influence positively the natural history of the disease but possible adverse effects should always be considered before starting the treatment.

Administration, Intravesical↗

PubMed2004

Experimental study on the toxicity and the local and systemic tolerability of gemcitabine after topical treatment of the rabbit bladder.

This study investigated gemcitabine administered intravesically to establish the local and systemic tolerability necessary for clinical trials. Gemcitabine was directly administered via catheter into the bladders of 24 male New Zealand rabbits weighing an average of 1.9+/-0.08 kg. Three groups received weekly gemcitabine for 5 (50 mg/kg) or 8 (25 mg/kg or controls) weeks. Animals were inspected daily for signs of toxicity and distress, body weight changes, and water and food consumption; electrocardiogram, blood pressure, and urinalysis were recorded before dosing and after 4 and 8 weeks of treatment. The rabbits were euthanized, and a full necropsy was performed on day 1 after the last instillation. Principal organs (spleen, thymus, testis, and muscle) and plasma samples were analyzed for the systemic absorption of gemcitabine. The 25-mg/kg dose was well tolerated with no clinical side effects. At 50 mg/kg, signs of mild myelosuppression and severe symptomatic toxicity (leg weakness, and hair and body weight loss) was evident after 3 weeks of treatment and three of the seven animals in this group died after four doses. Necropsies revealed normal bone marrow cellularity and organ histology at both doses. No significant systemic drug absorption was seen. These findings suggest that intravesical administration of gemcitabine does not produce organ-specific toxicity, but the higher dose (50 mg/kg) may represent the threshold above which increasing morbidity may occur.

Absorption↗

PubMed2000

Intravesically administered ketoprofen in treatment of detrusor instability: cross-over study.

AIM: To evaluate the therapeutic efficacy of intravesically administered ketoprofen in patients with urodynamically verified detrusor instability. METHODS: This double-blind randomized placebo-controlled cross-over study included 30 patients with urodynamically verified detrusor instability. Their mean age was 44+/-3.6 years (range 37-49) and the median of the parity was 2 years (1-3). The mean duration of symptoms was 18.3+/-3.1 months (range 14-23). After a 6-week screening, patients were randomized to receive ketoprofen or placebo once a day for 4 weeks. Out of 30 patients, 16 started with ketoprofen, and 14 received placebo. After a week of washing period, 16 patients received placebo, and 14 received ketoprofen. The solution for intravesical application was 50 mL of saline with 2 mL (100 mg) of ketoprofen warmed to 37 degrees C. The placebo solution contained 2 mL of distilled water instead of ketoprofen. The assessment including micturition diaries, cystometric measurements, and bacteriological analysis of urine specimens was performed at the beginning of the study and after the treatment. RESULTS: The subjective cure rate was 18/30 after ketoprofen. The instability index was lower after ketoprofen than before treatment or after placebo (p<0.001). Maximal cystometric capacity and the urinary bladder volume at which the patients felt urgency to void were larger after ketoprofen than before it (p<0.001) or after placebo (p<0.001). The number of patients with uninhibited bladder contractions decreased significantly after ketoprofen, but not after placebo (p<0.001). No side effects were observed. CONCLUSION: Intravesically administrated ketoprofen is a feasible and effective treatment for detrusor instability.

Administration, Intravesical↗

PubMed2000

Intravesical therapy for superficial bladder cancer.

Intravesical therapy is a classic approach to the treatment of superficial bladder cancer. Bacillus Calmette-Guerin (BCG) has assumed the role of the most commonly administered agent, and clearly the most effective form of therapy for carcinoma in situ. Recent data quantify the advantage of "booster" treatments over a 3-year interval but suggest that current regimens are not easily tolerated by most patients. Initial studies suggest a role for intravesical interferon in potentiating the effect of BCG. Classic intravesical chemotherapy can decrease tumor recurrence by 14% to 17%, but no data exist to demonstrate any positive effect on decreasing tumor progression. Recent studies suggest a growing rationale for the intravesical administration of a single dose of a chemotherapeutic agent to decrease early tumor recurrence.

Administration, Intravesical↗

PubMed2000

Intravesical immunotoxin as adjuvant therapy to prevent the recurrence of bladder cancer.

OBJECTIVE: To assess the intravesical application of immunotoxin as adjuvant therapy to prevent recurrence after tumor resection in bladder cancer patients. METHODS: An anti-human immunotoxin against bladder carcinoma, BDI-1-RT, was prepared and its in vitro targeting cytotoxicity estimated. The immunoreactivity of BDI-1-RT with human bladder cancer tissue of different grades and stages was detected by immunohistochemical analysis. After safety test, intravesical administration of BDI-1-RT was performed in 31 patients while mitomycin C (MMC) was used in 36 patients serving as a control group. The recurrence rates and side effects in both groups were recorded. In addition, the development of human anti-mouse antibodies (HAMA) was determined by ELISA, to assess the potential safety of this immunotoxin. RESULTS: In our study, BDI-1-RT had immunoreactivity with 81.6% of bladder transitional cell carcinomas. The immunoreactivity of BDI-1-RT correlated with tumor grade. High-grade carcinoma had stronger staining than low-grade (P < 0.05). There was no significant difference between the BDI-1-RT group (10%) and MMC group (19.3%) in recurrence rate (P > 0.05). Side effects, including systemic and local, were more frequent in the MMC group (11 of 36 patients versus 2 of 31, P < 0.05). HAMA was not detected in any of 7 patients. CONCLUSION: Immunotoxin may have considerable potential in the prophylaxis of bladder transition cell carcinoma.

Administration, Intravesical↗

PubMed2001

[Lung sarcoidosis following instillation of mitomycin C in the urinary bladder].

Intravesical prophylaxis against recurrence of urinary bladder carcinomas using mitomycin C (MMC) has proved to be and effective treatment with few side effects. Previously only two cases of lung toxicity after instillation of MMC into the urinary bladder has been described. We report a 65-year-old man in whom lung sarcoidosis occurred after intravesical administration of MMC. This association has not been reported to date. The clinical picture and the pathogenesis of this lung disease are discussed.

Administration, Intravesical↗

PubMed2002

Intravesical capsaicin versus resiniferatoxin in patients with detrusor hyperreflexia: a prospective randomized study.

PURPOSE: Capsaicin and resiniferatoxin (Sigma Chemical Co., St. Louis, Missouri) administered intravesically are attractive options for treating detrusor hyperreflexia. Because the 2 agents differ in chemical structure and relative potency, possible differences in their clinical and urodynamic effects were investigated in this prospective comparative study. MATERIALS AND METHODS: A group of 24 spinal cord injured patients with refractory detrusor hyperreflexia were randomly assigned to receive a single dose of 2 mM. capsaicin in 30 ml. ethanol plus 70 ml. 0.9% sodium chloride or 100 nM. resiniferatoxin in 100 ml. 0.9% sodium chloride. Dwell time was 40 minutes with urodynamic monitoring. Urodynamics were performed at baseline before treatment, and after followups of 30 and 60 days. The frequency of daily catheterizations, incontinence episodes and side effects was recorded. RESULTS: There was no significant urodynamic or clinical improvement in the capsaicin arm at 30 and 60 days of followup. In the resiniferatoxin arm the mean uninhibited detrusor contraction threshold plus or minus standard deviation increased from 176 +/- 54 to 250 +/- 107 ml. at 30 days (p <0.05) and to 275 +/- 98 ml. at 60 days (p <0.01). Mean maximum bladder capacity increased from 196 +/- 75 to 365 +/- 113 ml. at 30 days (p <0.001) and to 357 +/- 101 ml. at 60 days (p <0.001). Daily catheterizations and incontinent episodes were significantly decreased at 30 and 60 days of followup. Autonomic dysreflexia, limb spasms, suprapubic discomfort and hematuria developed in most patients who received capsaicin but in none who received resiniferatoxin. CONCLUSIONS: Intravesical administration of resiniferatoxin is superior to that of capsaicin in terms of urodynamic results and clinical benefits in spinal cord injured patients and it does not cause the inflammatory side effects associated with capsaicin.

Administration, Intravesical↗

PubMed2005

Distribution of photosensitizers in bladder cancer spheroids: implications for intravesical instillation of photosensitizers for photodynamic therapy of bladder cancer.

PURPOSE: Uniform intratumor distribution of sufficient photosensitizer is one of the important aspects of photodynamic therapy for solid tumors. METHODS: Multicellular spheroids derived from a human transitional cell carcinoma cell line (MGHU3) were used as a surrogate system of tiny solid tumors to study intratumor distribution of photosensitizers. Photosensitizers included Photofrin, hypocrellins (HBEA-R1/R2, HBBA-R2), aluminum phthalocyanine chloride (AlPC), benzoporphyrin derivative monoacid ring A (BPD-MA), protoporphyrin-IX (PpIX), and liposomal formulations of HBBA-R2 and BPD-MA. Spheroids were incubated with various doses of the above drugs for 1-4 hours, and were examined by confocal microscopy. RESULTS: Histology showed all cells were healthy in spheroids less than 400 microm in diameter. Scanning electron microscopy showed tight cell-to-cell interdigitation in spheroids. HBEA-R1/R2 distributed more uniformly in spheroids than other drugs. Free hypocrellins and BPD-MA penetrated spheroids centripetally deeper than AlPC, Photofrin, and PpIX. Liposomal HBBA-R2 and BPD-MA penetrated less than their free formulations. CONCLUSIONS: The spheroids mimic solid tumors prior to neovascularization. Based on drug distribution in spheroids, hypocrellins and BPD-MA appear superior to Photofrin, AlPC and PpIX for intravesical administration for bladder cancer phototherapy.

Administration, Intravesical↗

PubMed1994

Successful treatment of hemorrhagic cystitis secondary to cyclophosphamide chemotherapy with intravesical instillation of prostaglandin F2 alpha.

The treatment of cyclophosphamide-induced hemorrhagic cystitis is difficult. We report a successful case of severe cyclophosphamide-induced hemorrhagic cystitis treated with intravesical instillation of prostaglandin F2 alpha. A 32-year-old woman underwent high-dose cyclophosphamide conditioning before the autologous bone marrow transplantation. She developed clot retention which required continuous irrigation with normal saline. The patient had failed to respond to continuous bladder irrigation with saline and intravesical administration of 1% alum. Fifty ml of prostaglandin F2 alpha solution (1 mg in 100 ml normal saline) was instilled into the bladder, with a dwelling time of 60 minutes, three times a day for 5 days. The hematuria cleared completely 3 days after therapy. The only adverse effect was bladder spasm which was controlled with oxybutynin chloride. The success of this therapy suggests that prostaglandin F2 alpha is a safe and useful therapy for hemorrhagic cystitis secondary to cyclophosphamide chemotherapy.

Administration, Intravesical↗

PubMed1994

[Long-term results and complications of intravesical instillation of bacillus Calmette-Guerin for prophylaxis of bladder cancer recurrence].

Since 1982, we treated 22 patients with superficial bladder cancer via intravesical bacillus Calmette-Guerin (Tokyo 172 strain) for prophylaxis against tumor recurrence. To determine the long-term efficacy and complications of BCG therapy, retrospective analysis was performed. The BCG therapy was initiated one to two weeks after complete transurethral resection of visible tumors. One hundred twenty mg or 80 mg of BCG suspended in 40 ml of 0.9% NaCl solution was instilled into the bladder once a week for 6 times, then monthly for 10 times. Of 22 patients, 10 tumor recurrences were recognized in 4 patients (mean followup 74 months). Recurrent free rate at 5 years was 78.5%. Common side effects were low grade fever and bladder irritability. Although these side effects were self-limiting, 15 patients (68%) refused instillation of BCG before completion of our protocol because of the bladder irritation. No relationship was observed between total dose of BCG instilled and tumor recurrence. Severe side effects such as permanent structural or functional alterations of the bladder or mycobacterial infection of other organs were not observed. Intravesical administration of Tokyo 172 strain of BCG seemed to be safe and useful for long-term prophylaxis of superficial bladder cancer recurrence.

Administration, Intravesical↗

PubMed1993

[Polyarthritis in 4 patients treated with intravesical BCG-therapy for carcinoma of the bladder].

Intravesical administration of Calmette-Guérin bacillus (BCG) is effective in the treatment of superficial bladder carcinoma. Transient arthritis or migratory arthralgia has been reported in 0.5% of cases. The authors report on four men (mean age 65 years), who developed an oligoarthritis in three cases after the 2nd, 5th, and 6th weekly instillation of Pasteur BCG, respectively, and symmetrical polyarthritis in one after 48 BCG instillations over a three-year period. Joints involved were the knees (3/4), ankles (3/4), shoulders (1/4), wrists, and hands (1/4). Features included morning stiffness and local evidence of inflammation. All four patients had an elevated erythrocyte sedimentation rate and negative tests for rheumatoid factor. Neutrophils were the main cell type in synovial fluid. Synovial biopsy performed in two cases revealed non-specific inflammation. Erosions of the metatarsophalangeal joints were observed in one patient. Locoregional or systemic symptoms included transient fever (3/4), cystitis (4/4), urethritis (1/4), epididymoorchitis (2/4), conjunctivitis (1/4), and pleural effusion with pericarditis (1/4). The BCG was recovered from an epididymal specimen in one patient. Two patients were positive for the HLA B27 antigen. Outcome was favorable in every case (range: 15 days-6 months) after discontinuation of BCG therapy and administration of isoniazid, rifampin, and prednisone (3 patients) or NSAID (1 patient). Various pathogenic hypotheses for BCG-induced arthritis are discussed, including infection, immune responses to heat shock proteins, and reactive arthritis.

Administration, Intravesical↗

PubMed1996

Intravesical hyaluronic acid in the treatment of refractory interstitial cystitis.

PURPOSE: Based on the assumption that interstitial cystitis results from a defective mucous lining of the bladder epithelium, we investigated the activity of hyaluronic acid in the treatment of this disease. Hyaluronic acid is an important glycosaminoglycan present in all connective tissues, including the glycosaminoglycan layer of the vesical mucosa. It exhibits a variety of pharmacological properties that enhance its appeal for the therapy of interstitial cystitis. MATERIALS AND METHODS: A total of 25 patients with characteristic findings of interstitial cystitis refractory to other medical treatments participated in a trial of intravesical hyaluronic acid at a dose of 40 mg. weekly for 4 weeks and then monthly. Response to therapy was evaluated by symptom score, voiding diaries and visual analog scales. RESULTS: An initial 56% positive (complete plus partial) response rate at week 4 increased to 71% by week 12 and response was maintained until week 20. Beyond week 24 there was a moderate decrease in the effectiveness of the medication. There was no significant toxicity attributable to hyaluronic acid in the bladder. CONCLUSIONS: The response of patients with refractory interstitial cystitis to the intravesical administration of hyaluronic acid was gratifying. In the past many therapies for interstitial cystitis which were initially considered promising failed the test of a controlled study. Such a study to determine the activity of hyaluronic acid in patients with interstitial cystitis is currently under way.

Administration, Intravesical↗

PubMed1997

[The clinical value of fluorescence cystoscopy in the detection of superficial transitional epithelial cell carcinoma of the bladder].

The prognosis of superficial bladder cancer in terms of local recurrence and transformation into invasive cancer is related to the multiplicity of tumor sites and the concomitant presence of "flat" tumours, such as dysplasia and carcinoma in situ. This study of 51 patients emphasizes the value of fluorescence cystoscopy in the early detection of superficial transitional cell carcinomas. This method is based on induction of fluorescence in carcinomatous sites which selectively accumulate an endogenous photosensitizer, protoporphyrin IX, in response to intravesical administration of its precursor, 5-aminolevulinic acid. The sensitivity of the method in the present series was close to 93%. Fluorescence cystoscopy is a simple and reliable method to map the bladder mucosa looking for areas of dysplasia and carcinoma in situ.

Administration, Intravesical↗

PubMed1998

[Recurrent urological cancer--diagnose and treatment].

Clinical efforts to spare bladder function even in the case of muscle invasive recurrent bladder cancer is taking. Early detection of recurrence is essential for bladder sparing, and both urinary NMP22 and BTA are thought to have potency to detect recurrence of bladder cancer earlier than urinary cytology. Intravesical administration of BCG for superficial bladder cancer and intraarterial injection of chemoagents (Methotrexate and Cisplatin) with radiation for muscle invasive bladder cancer are thought to play important roles in sparing the bladder. Early detection of recurrent prostate cancer is becoming easier by ultrasensitive PSA assay. Though the value of early detection of recurrence is not proven since the benefits of early hormonal treatment have not yet been established, that should be a good indicator to evaluate new and coming treatments and play a important role to develop an effective treatment for recurrent prostate cancer.

Abdomen↗

PubMed1998

Effect of tachykinin NK2 receptor blockade on detrusor hyperreflexia induced by bacterial toxin in rats.

PURPOSE: To see whether a recently characterized model of bacterial toxin-induced urinary bladder inflammation (Stein et al., J. Urol. 155, 1133-1138, 1996) is associated with detrusor hyperreflexia, and whether endogenous tachykinins acting through NK2 or NK1 receptors were involved in this model. MATERIALS AND METHODS: The bladder of urethane-anesthetized male Wistar rats was cannulated through the dome. Intravesical administration of protamine sulfate (PS, 10 mg./ml./rat) or vehicle for 1 hour was followed by the intravesical administration of E. coli lipopolysaccharide (LPS, 1 mg./ml./rat) or vehicle for 1 hour. Cystometries (50 microl./min.) were performed 3.5 hours after the exposure to LPS. MEN 11,420, a peptide tachykinin NK2 receptor antagonist, was administered before cystometries or, in a separate group of animals, during cystometries. The effect of SR 140,333, a non-peptide NK1 receptor antagonist, was also assessed in the presence or absence of MEN 11,420. The urodynamic effects of PS + LPS were also tested in capsaicin-pretreated rats. RESULTS: Unlike PS or LPS alone, the intravesical administration of PS + LPS induced detrusor hyperreflexia. In PS + LPS treated animals during nonstop cystometries, the intermicturition interval was decreased by about 50% as compared to vehicle-pretreated rats. A quantitatively similar reduction in the bladder capacity was also observed. MEN 11,420 (100 nmol./kg., i.v.) restored the intermicturition interval in PS + LPS-pretreated rats at the level of controls by increasing the bladder capacity, whereas it had no effect in vehicle-pretreated rats. SR 140,333 (1 micromol./kg., i.v.) neither modified urodynamic parameters in controls and in PS + LPS-treated rats nor altered the effect of MEN 11,420 in these groups. Capsaicin pretreatment (164 micromol./kg., s.c., 4-5 days before) induced a two-fold increase of the bladder capacity in control rats and prevented PS + LPS-induced bladder hyperreflexia. CONCLUSIONS: The intravesical administration of PS + LPS produces the activation of capsaicin-sensitive afferents. Endogenous tachykinins released from these fibers act through NK2 receptors to induce detrusor hyperreflexia.

Animals↗

PubMed1997

Intravesical electromotive drug administration for the treatment of non-infectious chronic cystitis.

Seventeen patients with non-infectious chronic cystitis (NICC) (9 with interstitial cystitis, 6 patients with radiation cystitis, 1 with chemocystitis and 1 with lupoid cystitis) were treated with electromotive administration of intravesical lidocaine and dexamethasone followed by hydrodistension of the bladder. Complete resolution of symptoms for an average of 7.5 months was observed in 11 patients (65%), partial improvement in 4 (23.5%). In this series no complications occurred. Electromotive drug administration (EMDA) and cystodistension were well tolerated by all patients. The treatment was performed on an outpatient basis, thus reducing therapeutic costs. The results presented demonstrate that the combination of EMDA and bladder hydrodistension is an effective first-line treatment for NICC patients.

Administration, Intravesical↗

PubMed1997

Preclinical evaluation of copper-67 labelled anti-MUC1 mucin antibody C595 for therapeutic use in bladder cancer.

Transitional cell carcinoma of the bladder is the fifth commonest cause of death from cancer in men in the United Kingdom. Most patients present early with superficial disease, though with current treatment up to 20% progress to invasive disease, which has a poor prognosis. Better local treatments are required to limit this tumour progression. The ease of access to the bladder via a catheter provides the ideal opportunity for antibody (Ab) targeted therapy. We have previously shown that indium-111 labelled anti-MUC1 mucin Ab C595 selectively localises to bladder tumours after intravesical administration. We have selected copper-67 as an alternative radiolabel with suitable physical characteristics for radioimmunotherapy. This communication demonstrates that C595 can be reproducibly labelled with 67Cu and that the radioimmunoconjugate is both stable and maintains high immunoreactivity. Pilot studies on cystectomy specimens in a novel ex vivo system and in one patient confirmed the ability of this conjugate to localise to tumour after intravesical administration. On the basis of these studies we are now in a position to study the intravesical administration of 67Cu-labelled C595 in patients with bladder cancer with a view to a therapeutic trial.

Administration, Intravesical↗