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Intravesical application of bacillus of Calmette-Guérin (BCG) has proved to be an effective form of treatment for some stages of bladder cancer. Infrequent, serious complications of this treatment have become apparent as its use has become more widespread. We report a case of Mycobacterium bovis mycotic abdominal aortic aneurysm and a case of M. bovis mycobacteremia that developed as complications of intravesical BCG therapy. These cases are discussed in the context of a review of reported complications of intravesical BCG therapy and a review of measures currently advocated to prevent them.
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OBJECTIVE: To report a serious side-effect of intravesical instillations of neomycin in patients with end-stage renal disease. PATIENTS AND METHODS: Three patients (two men and a woman, aged 51.71 and 54 respectively) with end-stage renal disease who had undergone bladder irrigation with neomycin sulphate solution suffered complete irreversible deafness, which was assessed by audiogram. RESULTS: All three patients developed complete perception deafness after 3, 4 and 10 months, with characteristic changes in the audiogram. The severe progressive hearing loss was maximal in the high-frequency range. A high-pitched tinnitus was the first sign of impending hearing difficulty and two patients developed a spontaneous nystagmus. CONCLUSION: In view of the doubtful efficacy and, most importantly, the risk of severe disabling side-effects such as ototoxicity, we recommend the avoidance of intravesical instillation with neomycin whenever possible.
OBJECTIVE: To examine the effectiveness and tolerability of multiple intravesical instillations of 10 nmol/L resiniferatoxin in patients with detrusor overactivity (DO) refractory to anticholinergic agents, as not all these patients are successfully treated by one such instillation. PATIENTS AND METHODS: The study included 53 patients with DO from neurogenic (NDO, 10), previous bladder outlet obstruction (BOO, 20) or idiopathic cause (IDO, 23) and who were refractory to anticholinergic agents. Patients received three to four instillations of 10 nmol/L resiniferatoxin, as outpatients. The International Prostate Symptom Score and quality-of-life index were recorded, and a video-urodynamic study conducted at baseline and 3 months after treatment. The therapeutic results and urodynamic variables were compared among patients with different causes of DO. RESULTS: Four patients withdrew from the study after the first instillation because of urinary tract infection or severe pain on urination, leaving 49 who completed at least three instillations. The overall results were an excellent response in 17 patients (35%), improvement in 13 (27%) and failure in 19 (39%); the treatment was deemed a success (excellent or improved) in 16 of 20 with previous BOO, 11 of 19 with IDO, and only three of 10 with NDO (P = 0.011). Patients had significant improvements in the storage symptom score, total symptom score and quality-of-life index after treatment. The cystometric capacity and the postvoid residual were significantly greater and voiding efficiency significantly less after treatment. DO during the urodynamic study was absent in 12 patients after treatment. CONCLUSIONS: Multiple intravesical instillations of 10 nmol/L resiniferatoxin are effective in treating patients with DO refractory to anticholinergics.
OBJECTIVE: To determine the probability and risk factors of recurrence and progression (to T2 or worse) after a long tumor-free period in patients with superficial (stage Ta and T1) bladder cancer. PATIENTS AND METHODS: A consecutive series of 100 patients with superficial bladder cancer who remained tumor-free for longer than 4 years after initial treatment were reviewed. The rates of recurrence and progression were statistically assessed and the significance of risk factors was determined. RESULTS: Of the 100 patients, 24 (24. 0%) recurred within 15 years after the initial treatment. The 10- and 15-year recurrence-free rates were 76.0 and 59.6%, respectively. Among the clinicopathological variables examined, intravesical chemotherapy was determined by a log-rank test to be a significant unfavorable risk factor for late recurrence (p < 0.001). Progression of the tumor occurred in 5 patients. Four variables including presence of multiple tumors, involvement of the bladder neck, positive urine cytology, and intravesical chemotherapy were found by a univariate analysis to be significant risk factors for late progression (p < 0.05). Among these factors, initial presence of multiple tumors (3 or more) was determined by a multivariate analysis to be an independent risk factor for late progression. CONCLUSION: Recurrence and progression continue to occur in patients with superficial bladder cancer even after long periods of dormancy. Regular follow-up urological assessments should be continued until at least 15 years of tumor-free existence, especially in patients treated by intravesical chemotherapy or those initially having multiple tumors.
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The depth of drug penetration into the wall of the urinary bladder in intravesical ionophoresis (IVIP), IVIP influence on functional condition of the lower urinary tracts were studied on 15 female dogs. Functional condition of the lower urinary tracts was characterized by pressure in the urinary bladder, "volume-pressure" index, bioelectric activity of the urethra. The pressure was registered by electromanometry. Bioelectric activity of the urethra was studied with electromyography and tetrapolar rheography. The above indices were registered synchroneously on a multichannel recorder. Intraoperative cystomanometry was made in 7 tyopental narcotized animals. Samples of blood and vesicular tissue were taken for immunofluorescent study before and after IVIP. Medicines were accumulated best in mucous and submucous layers (0.039 +/- 0.0012 and 0.0338 +/- 0.0050 mcm/mg tissue, respectively). After IVIP intravesical pressure was, on the average, lower in the same filling volumes as before IVIP. A mean amplitude of spontaneous fluctuations of pressure in the urinary bladder in its filling after IVIP was also lower than the baseline. After IVIP, pressure in the urinary bladder in voiding was much lower than before the procedure, maximal capacity of the urinary bladder and elasticity of the wall increased. Bioelectrical activity of the urethral wall was registered in the same mean pressure and capacity as before IVIP. Intensity of micturition after IVIP course decreased both at rest and in diuretic load with lasix. Time to micturition was increased with an increase in the number of procedures of IVIP. Thus, the experimental study showed pathogenetic validity of intravesical ionophoresis of medicines in the treatment of chronic recurrent cystitis.
BACKGROUND: We evaluated whether p53 and bcl-2 expression has any predictive value on the outcome of postoperative adjuvant intravesical chemotherapy for superficial bladder transitional cell carcinoma (TCC). MATERIALS AND METHODS: Immunostaining for p53 and bcl-2 was performed on paraffin-embedded tumor tissues obtained from 100 patients with superficial bladder TCC. 56 had solitary and 44 had multiple tumors; 36 were grade I, 53 grade II and 11 grade III; 50 were stage pTa and 50 stage pT1. They all received transurethral resection (TUR) and weekly intravesical instillation chemotherapy with either Thiotepa (70 patients) or Epirubicin (30 patients) for consecutive 8 doses postoperatively. RESULTS: Overall, 7 (7%) tumors were p53+ and 12 (12%) tumors were bcl-2+. Of these, only one tumor was combined p53+ and bcl-2+. The status of tumor p53 and bcl-2 positivity was found to be not significantly correlated with either tumor grade or stage. After adjuvant intravesical chemotherapy, tumor recurrence is significantly correlated with tumor multifocality (p = 0.0002) but not with tumor grade and stage. Compared with p53- or bcl-2- tumors, patients with p53+ or bcl-2+ tumors do not show a higher tumor recurrence rate. The number of recurrence-free patients was also not significantly different in p53+ versus p53- tumors, bcl-2+ versus bcl-2- tumors. Six (6%) patients eventually developed disease progression, and none stained positively for either p53 or bcl-2. CONCLUSIONS: We conclude that in superficial bladder TCC the status of tumor p53 and bcl-2 expression is not correlated with stage and grade. Their expression, either alone or combined, has no predictive role on the outcome of post-TUR intravesical chemotherapy on tumor recurrence.
At the Institute of Urology, University of Padova, 125 patients with multifocal superficial bladder cancer underwent treatment with intravesical Mitomycin C (MMC; 1 weekly instillation of 40 mg for 8 consecutive weeks) between January 1982 and December 1988. Eighty-four patients had multifocal papillary tumors (stages Ta-T1) and 41 patients had carcinoma in situ of the bladder. At 6 and 36 months the tumor free percentage in the group with papillary tumors was 69 and 36%, respectively; for carcinoma in situ the complete response percentage at the same intervals was 80 and 36%. Thirty-one patients previously unsuccessfully treated with adriamycin did not show any difference compared to untreated ones. The authors emphasize the efficacy and low toxicity of intravesical MMC in multiple superficial bladder cancer. The possibility of long-term relapse suggests maintenance therapy.
OBJECTIVES: To estimate and compare recurrence rates, index of recurrence, and disease-free interval in patients with superficial recurrent bladder cancer receiving bacille Calmette-Guérin (BCG) or interferon (IFN) for immunoprophylaxis. METHODS: One hundred twenty-two patients with recurrent superficial Stage pT1, grade 1 to 3 tumors were enrolled in a randomized, prospective, multicenter trial with two treatment arms of endovesical immunoprophylaxis: 150 mg of BCG versus 54 MU of recombinant IFN-alpha-2a. Administration was weekly during the first month, biweekly for 2 months, and monthly for 9 months. Both groups were similar with regard to tumor stage, grade, size, and number. RESULTS: Sixty-one patients were evaluable in the BCG group and 49 in the IFN group. Tumors recurred in 34 (69.4%) of 49 patients in the IFN group (890 months of follow-up) and in 24 (39.3%) of 61 in the BCG group (1272 months of follow-up). The total number of recurrences (28 for BCG, 47 for IFN), disease-free interval (mean 19.3 months for BCG, 15.3 months for IFN), and index of recurrence (2.2 for BCG, 5.5 for IFN) were statistically significant (P = 0.001) in favor of BCG. Progression to invasive carcinoma was similar in both study arms. Neither systemic nor local side effects were seen in the IFN group. However, the previously reported toxicity of BCG was confirmed. CONCLUSIONS: According to our trial, BCG remains the most efficacious agent for immunoprophylaxis of recurrent superficial bladder tumors.
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PURPOSE: Intravesical instillation of bacillus Calmette-Guerin (BCG) induces various immunological reactions and decreases the recurrence rate of superficial bladder tumors. To determine whether additional immune stimulation with concomitant intradermal BCG applications could further lower the recurrence rate, 154 patients with superficial bladder tumors at high risk for recurrence were randomized to receive either 6 intravesical instillations of 120 mg. Pasteur strain BCG alone or combined with intradermal application. MATERIALS AND METHODS: A total of 76 patients received intravesical and intradermal BCG, while 78 received intravesical BCG only. Median followup was 41 months (range 2 to 89) and 36 months (range 2 to 86), respectively. Both treatment groups were comparable regarding patient age and number of previous transurethral bladder tumor resections, as well as tumor recurrence rate, stage and grade before BCG therapy. RESULTS: A highly significant decrease in the monthly tumor recurrence rate was observed in both arms after BCG compared to the pretreatment recurrence rates (p < 0.0001). Recurrence rate decreased from 0.73 +/- 1.07 (standard deviation) to 0.06 +/- 0.13 in the combined treatment group and from 0.71 +/- 0.90 to 0.074 +/- 0.17 in the intravesical treatment only group. However, we were unable to find any difference between the 2 groups regarding interval to initial recurrence or recurrence rates after BCG treatment. Changes in the purified protein derivative skin test performed before and after BCG therapy were not useful to predict response to treatment because 44% of our patients already had a positive test before treatment. Also, interpretation of the skin test was difficult and not always reliable. In the multivariate analysis, however, fever was an important prognostic factor. Patients with increased body temperature greater than 37.5C had a significantly lower recurrence rate than those without fever (37.5C or less) after BCG instillation (p = 0.009). Moreover, fever after BCG instillation was observed significantly more frequently in patients with a positive purified protein derivative skin test before treatment (p = 0.021). CONCLUSIONS: The therapeutic benefit from intravesical BCG apparently was not substantially improved by simultaneous intradermal BCG vaccination. Fever following intravesical BCG instillation is an important prognostic factor regarding superficial bladder tumor recurrence. Fever occurs predominantly in patients who were previously sensitized to mycobacteria (by BCG vaccination or infection) as shown by a positive pretreatment purified protein derivative skin test. This finding suggests that previously sensitized patients respond significantly better to a single course of intravesical BCG.
This study was designed to evaluate the interaction of photodynamic therapy (PDT) and intravesical drugs (thiotepa, adriamycin, mitomycin C and BCG) in a murine transitional cell carcinoma (MBT-2) model. C3H/He mice with implanted MBT-2 flank tumors were treated with either thiotepa (TT), adriamycin (ADM), mitomycin C, Bacillus Calmette-Guerin (BCG), photodynamic therapy (PDT) or a combination of the drug and PDT. The MBT-2 tumor showed sensitivity to adriamycin, MMC or PDT compared to control. PDT combined with either adriamycin, MMC or BCG, produced a greater retardation in the growth of the MBT-2 tumor than monotherapy with adriamycin, MMC, BCG or PDT. PDT combined with the anticancer agents currently used in intravesical therapy for bladder cancer is well tolerated. The combination of PDT and intravesical drugs may enhance the tumoricidal effect of either treatment used alone.
OBJECTIVES: To evaluate the correlation between the overexpression of mutant protein p53 and disease recurrence and progression in patients treated with bacillus Calmette-Guérin (BCG) intravesical therapy for T1G3 bladder cancer. METHODS: We analyzed the outcome of 29 consecutive patients treated for T1G3 bladder tumor with transurethral resection. Patients previously treated for a bladder tumor, those who underwent incomplete resection, and those in whom no assessment of the muscle cell layer was possible were excluded from the study. p53 overexpression was determined using monoclonal p53-DO7 antibody, with a 20% cutoff for definition of positivity. After the initial transurethral resection, all patients were treated with Pasteur BCG (75 mg in 50 mL saline), weekly for 6 weeks. The correlation between p53 overexpression and disease recurrence and progression was assessed by the Fisher exact test. RESULTS: The median follow-up was 36.7 months (range 1 to 108). Of the 29 patients, 18 (62.1%) were p53 positive and 11 (37.9%) were p53 negative. Both groups were similar according to age, tumoral substage (T1a/T1b), association with carcinoma in situ, multifocality, and length of follow-up. The recurrence rate was 54.4% in the p53-negative group versus 38.9% in the p53-positive group (P = 0.47). The progression rate was 18.2% in the p53-negative group versus 33.3% in the p53-positive group (P = 0.67). CONCLUSIONS: These findings suggest that overexpression of p53, as determined immunohistochemically, has no predictive value for recurrence and progression in T1G3 bladder cancers treated with intravesical BCG.
A 71-year-old man with a history of rheumatoid arthritis was treated with intravesical bacillus Calmette-Guérin (BCG) instillation of 80 mg once-a-week for carcinoma in situ. He developed low-grade fever followed by dyspnea and severe hypoxemia. Radiological and laboratory studies revealed bilateral diffuse reticulonodular infiltrates and hypereosinophilia. A lymphocyte stimulation test for BCG was strongly positive. From these findings, a pulmonary hypersensitivity reaction to immunotherapy was suspected, and therefore, methylprednisolone (500 mg per day) was started. After that, the fever and dyspnea disappeared, the hypereosinophilia was normalised and chest radiography results were clear. The present case is the first reported case of eosinophilic pneumonia following intravesical BCG therapy.