ALKALINE PHOSPHATASE REPRESSION BY INORGANIC PHOSPHATE IN BACILLUS ANTHRACIS AND BACILLUS CEREUS.
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Alkaline Phosphatase↗
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Clinical evidence of systemic persistence of bacillus Calmette-Guerin: long-term pulmonary bacillus Calmette-Guerin infection after intravesical therapy for bladder cancer and subsequent cystectomy.
A patient with urothelial bladder carcinoma is reported who suffered from culture proved pulmonary bacillus Calmette-Guerin (BCG) infection 14 months after a single course of intravesical BCG and 11 months after subsequent radical cystectomy for progressive cancer. This unusual case raises the question of the ultimate fate of intravesically instilled BCG and the possible persistence of these mycobacteria in remote organs. Systemic spread and dormant survival at least in some cases are suggested, and therapeutic and diagnostic consequences are discussed.
Administration, Intravesical↗
Prospective randomized comparison of intravesical with percutaneous bacillus Calmette-Guerin versus intravesical bacillus Calmette-Guerin in superficial bladder cancer.
Conflicting reports of the necessity for percutaneous bacillus Calmette-Guerin (BCG) administration with intravesical BCG prompted us to evaluate its benefit in a randomized prospective comparison of intravesical versus intravesical with percutaneous BCG therapy. Intravesical Tice BCG was given in a dose of 50 mg. with or without percutaneous BCG weekly for 6 weeks, at 8, 10 and 12 weeks, at 6 months and every 6 months thereafter. Tumor recurrence was documented in 13 of 30 patients (43%) receiving only intravesical BCG and in 15 of 36 patients (42%) receiving intravesical plus percutaneous BCG. The addition of percutaneous BCG to intravesical therapy did not increase treatment efficacy in this study.
Administration, Intravesical↗
Expression of Bacillus circulans Teri-42 xylanase gene in Bacillus subtilis.
The xylanase gene of Bacillus circulans Teri-42 was cloned in both B. subtilis and Escherichia coli. The enzyme activity was almost 87% higher in B. subtilis (pBA7) than in E. coli (pAQ4). No cellulase activity was detected in the clones, B. subtilis (pBA7) and E. coli (pAQ4). Approximately 1120 U (80%) of the xylanase was secreted extracellularly by the clone B. subtilis (pBA7) as compared to 79 U (88%) excreted in E. coli (pAQ4). In B. subtilis (pBA7) the optimal xylanase activity was at pH 7.0 and 50 degrees C, which was the same as that of the parent B. circulans Teri-42. The recombinant xylanase in B. subtilis was more stable at higher temperatures than the parent B. circulans Teri-42. Purification of xylanase from the clone B. subtilis (pBA7) showed a 71 kDa polypeptide similar to that observed in B. circulans Teri-42.
Journal Article↗
Intravesical instillation of epirubicin, bacillus Calmette-Guerin and bacillus Calmette-Guerin plus isoniazid for intermediate and high risk Ta, T1 papillary carcinoma of the bladder: a European Organization for Research and Treatment of Cancer genito-urinary group randomized phase III trial.
PURPOSE: After transurethral resection, we compared the efficacy and side effects of weekly intravesical instillations of epirubicin, bacillus Calmette-Guerin (BCG), and BCG plus isoniazid during a 6-week interval followed by 3 weekly maintenance instillations at months 3, 6, 12, 18, 24, 30 and 36 in patients with intermediate and high risk Ta, T1 bladder cancer. MATERIALS AND METHODS: A total of 957 patients were randomized at 44 institutions in a phase III multicenter trial. RESULTS: The time to first recurrence was significantly longer in patients treated with BCG and BCG plus isoniazid compared to epirubicin (p = 0.0001) but there was no difference between the 2 BCG regimens (p = 0.27). Progression to muscle invasive cancer was rare (5%) and did not differ significantly among the 3 arms (p = 0.12). Drug induced cystitis was observed in 31% of the patients treated with epirubicin, 42% BCG and 45% BCG plus isoniazid. Systemic side effects, such as fever and malaise, were not observed in patients treated with epirubicin, but were noted in 31% BCG and 36% BCG plus isoniazid. CONCLUSIONS: Intravesical BCG with or without isoniazid provokes more side effects than epirubicin. Prophylactic isoniazid does not reduce the side effects of BCG, while BCG with or without isoniazid prolongs the time to first recurrence compared to epirubicin. Further followup is required before long-term conclusions can be made for progression-to-muscle invasive disease and survival.
Administration, Intravesical↗
Tuberculosis in Bacillus Calmette-Guérin-immunized and unimmunized children in Sweden: a ten-year evaluation following the cessation of general Bacillus Calmette-Guérin immunization of the newborn in 1975.
An analysis was made of childhood tuberculosis in Sweden between 1969 and 1984 which included the 6.25 years before and the 9.75 years after the cessation of general Bacillus Calmette-Guérin (BCG) immunization of the new-born on April 1, 1975. The annual incidence of tuberculosis per 100,000 children ages 0 to 4 years increased from an average of 1.1 cases in the period 1970 to 1974 to 1.3 cases in the period 1975 to 1979 and to 2.1 cases in the period 1980 to 1984, including both children born in Sweden and those born abroad. Among children born in Sweden after April 1, 1975, tuberculosis occurred in 58 (57 unimmunized and one BCG-immunized), or 1.3 cases per 100,000 person years up to and including 1984. Eighteen of the 58 children were asymptomatic. Minor symptoms were reported in 13 and clinical illness in 27 children, 2 of whom developed meningitis and 1 of whom died of miliary infection. The relative increase of tuberculosis in the mainly unimmunized cohorts born in Sweden after April 1, 1975, compared with the mainly BCG-immunized cohorts born in Sweden in the period 1969 to 1974 was, by the end of 1984, estimated at 6.0 (95% confidence interval, 2.3, 16.1). Tuberculosis was about 10 times more common in non-BCG-immunized children born in Sweden of foreign parents than in those born of Swedish parents.(ABSTRACT TRUNCATED AT 250 WORDS)
Adolescent↗
Resistant Mycobacterium bovis Bacillus Calmette-Guérin disease: implications for management of Bacillus Calmette-Guérin Disease in human immunodeficiency virus-infected children.
Guidelines for the diagnosis and management of Bacillus Calmette-Guérin (BCG) disease in children are lacking, and there are limited data on drug resistance of Mycobacterium bovis BCG. A 6-month-old HIV-infected infant presented with right axillary adenitis ipsilateral to the site of BCG immunization. M. tuberculosis complex was cultured from axillary lymph nodes and gastric aspirates, and M. bovis BCG was isolated. Susceptibility testing before initiation of therapy demonstrated inherent resistance to isoniazid. The organism acquired rifampin resistance during therapy. This was confirmed by the presence of a mutation in codon 531 (Ser531Tyr) of the rpoB gene. Treatment guidelines for BCG disease with consideration of inherent and possible acquired drug resistance should be established in settings with high rates of vertical HIV transmission and routine BCG vaccination.
Animals↗
Elongation factor T from Bacillus stearothermophilus and Escherichia coli. Purification and some properties of EF-Tu and EF-Ts from Bacillus stearothermophilus.
Homogeneous preparations of elongation factors EF-Tu and EF-Ts from Bacillus stearothermophilus have been obtained with specific activities of 20000 +/- 2000 and 500000 +/- 50000 units/mg, respectively. By dodecylsulphate-polyacrylamide gel electrophoresis the molecular weight of EF-Tu was found to be 49000 +/- 2000 and of EF-Ts 35500 +/- 1000. Nucleotide-free EF-Tu was prepared by using ITP as a GDP-binding-site-directed analogue. EF-Tu was shown to contain two sulphydryl groups, one reacting fast and one slowly with N-ethylmaleimide and 5,5'-dithio-bis(2-nitrobenzoic acid) under non-denaturing conditions. The same reagents were shown to react with the three sulphydryl groups of EF-Ts in the native state. The heat stabilities of EF-Tu and EF-Ts are reversed with respect to the Escherichia coli factors, EF-Tu being the more stable protein; even nucleotide-free EF-Tu is relatively stable with a half-life at room temperature of about 35 h.
Amino Acids↗
Systemic bacillus Calmette-Guérin infection, 'BCGitis', in patients treated by intravesical bacillus Calmette-Guérin therapy for bladder cancer.
Among 169 patients treated for supeficial bladder tumor with 150 mg Pasteur-strain bacillus Calmette-Guérin (BCG) intravesical instillation, 5 cases of 'BCGitis' were observed, i.e. a severe systemic BCG infection with bronchopulmonary lesions and granulomatous hepatitis. In 4 cases, the complications appeared at the early stage of treatment (after the 3rd, 6th, 6th and 8th instillations, respectively). In 1 case, treated with monthly maintenance therapy for 2 years, BCGitis appeared 6 months after treatment had been completed and, in addition to pulmonary basal infiltrate and granulomatous hepatitis, intramedullary granulomatosis was observed. In 3 patients, trauma must be taken into consideration as BCGitis appeared after traumatic instillation with bleeding. All patients were cured by treatment with rifampicin, isoniazid and prednisone.
Administration, Intravesical↗
Experience with bacillus Calmette-Guérin in patients with superficial bladder tumors. Value of monocyte activation in intravesical bacillus Calmette-Guérin therapy.
Twenty-four patients with transitional cell carcinoma of the bladder, who had failed thiotepa therapy, were subjected to immunotherapy with intravesical bacillus Calmette-Guérin (BCG) by a modification of the Morales protocol. The results show a marked decline in the number of recurrent tumors following BCG immunotherapy. From a cumulative recurrence of 1 in 8.3 months, recurrences declined to 1 in 82 months. In parallel with the clinical follow-up, the level of the in vivo activation of peripheral blood monocytes of the treated patients, as a result of immunostimulation with BCG, was monitored by the quantitation of oxidative burst products released by the cells. The oxidative burst capacity of peripheral blood monocytes were found to undergo an increase of 80-140% in 5 of 10 patients tested. The patients with a high level of activation of peripheral blood monocytes did not have tumor recurrence while 3 of the 5 patients who did not show an increase in the oxidative burst had recurrent tumors. The possibilities for utilizing the oxidative burst test as an early indicator for distinction between patients who will respond to BCG immunotherapy and nonresponders is discussed.
Adult↗
[Intravesical instillation of bacillus Calmette-Guerin for superficial bladder carcinoma: study on significance of additional maintenance instillations of bacillus Calmette-Guerin].
The efficacy of maintenance bacillus Calmette-Guerin (BCG) instillations for superficial bladder tumors was studied by prospective randomized trial. From June 1985 to October 1988, 42 newly diagnosed patients with superficial bladder carcinoma (pTa or pT1) were treated by transurethral tumor resection and subsequent five daily instillations of mitomycin C. Then they were divided into non-maintenance group (22 patients) and maintenance group (20 patients) by randomization. The patients received six weekly instillations of 80 mg of BCG. Tokyo strain (Japan BCG manufacturing Co., Tokyo, Japan), suspended in 40 ml of physiological saline, and the patients in the maintenance group received four additional instillations of BCG every three months. We could not complete the six-week course of BCG instillations in three patients due to adverse effects (two in non-maintenance group and one in maintenance group) and we lost six patients from follow-up within one year (one in non-maintenance group and five in maintenance group). The mean follow-up period of the remaining 33 patients was 28.1 months. Of these 33 patients, six patients had been found to have recurrent tumors, and the over-all three-year non-recurrence rate was 82%. Before employing BCG, when we used only mitomycin C after TUR-Bt, the three year non-recurrence rate was 58%. This indicates prophylactic effect of BCG instillations. The stage of the initial tumor of the six recurrent cases were all pT1b. The non-recurrence rate of the patients with pT1b tumor was significantly lower than that of the patients with pTa and pT1a tumor. However, multiplicity and grade of tumors did not affect the non-recurrence rate.(ABSTRACT TRUNCATED AT 250 WORDS)
Administration, Intravesical↗
Sequential bacillus Calmette-Guerin and epirubicin versus bacillus Calmette-Guerin alone for superficial bladder tumors: a randomized prospective study.
PURPOSE: This study was designed to find a new therapeutic modality that may have the same efficacy and lower toxicity than bacillus Calmette-Guerin (BCG) for the treatment of superficial transitional cell carcinoma of the bladder. MATERIALS AND METHODS: Between January 1993 and July 1997 a prospective randomized trial was conducted on 139 patients with stages pTa and pT1 bladder transitional cell carcinoma to compare the prophylactic efficacy and toxicity of sequential BCG and epirubicin (group 1) versus BCG alone (group 2). Group 1 comprised 69 patients who received alternating doses of 150 mg. BCG and 50 mg. epirubicin (1 drug at a time), while 70 patients in group 2 received 150 mg. BCG at each instillation. Treatment was continued for 6 weeks followed by 10 monthly instillations. RESULTS: Therapy was discontinued permanently in 3 group 1 and 12 group 2 patients due to severe side effects, and they were excluded from the study. Among the 124 evaluable patients (96 men and 28 women, mean age 58.2 years) mean followup was 30.4 months (range 12 to 50). Recurrence and progression rates were statistically comparable in both groups. Interval to first recurrence with or without progression was longer in group 1 than in group 2 (log rank p = 0.05). Toxicity and complications were significantly lower with sequential treatment than with BCG alone at rates of 27.3% (18 patients) and 70.7% (41), respectively (p = 0.001). CONCLUSIONS: Sequential BCG and epirubicin are comparable to BCG alone in efficacy and superior in terms of toxicity.
Adjuvants, Immunologic↗
Weekly mitomycin C followed by monthly bacillus Calmette-Guerin or alternating monthly interferon-alpha2B and bacillus Calmette-Guerin for prophylaxis of recurrent papillary superficial bladder carcinoma.
PURPOSE: We evaluated alternatives to bacillus Calmette-Guerin (BCG) monotherapy using a new combination of chemotherapy and immunotherapy for recurrent superficial bladder carcinoma. MATERIALS AND METHODS: A total of 236 patients with frequently recurrent stage Ta or T1 bladder tumors were enrolled in our prospective, randomized, multicenter Finnbladder IV study. The initial mitomycin C instillation was instilled in all patients perioperatively after transurethral resection, followed by 4 weekly instillations of mitomycin C. Thereafter patients were randomized to receive monthly for up to 1 year BCG only or interferon-alpha2b and BCG alternating monthly. Primary end points were time to initial recurrence, recurrence rate (number of recurrences per patient-year) and recurrence index (number of recurrent tumors per patient-year). RESULTS: Of the 236 randomized patients 205 were eligible for study with a median overall followup of 30.7 months. Monthly BCG was superior to alternating monthly interferon-alpha and/or BCG with respect to time to initial recurrence (log rank test p <0.00001) as well as recurrence rate (0.4 versus 0.9, p <0.00001) and index (0.9 versus 3.0, p <0.00001). Side effects were limited. CONCLUSIONS: Monthly BCG given for up to 1 year preceded by perioperative and an additional 4 weekly mitomycin C instillations is a well tolerated mode of instillation therapy, providing excellent tumor control comparable to that of the best reported instillation regimens. No benefit was obtained by alternating interferon-alpha2b with BCG.
Adjuvants, Immunologic↗
Salvage intravesical therapy with interferon-alpha 2b plus low dose bacillus Calmette-Guerin is effective in patients with superficial bladder cancer in whom bacillus Calmette-Guerin alone previously failed.
PURPOSE: We determined whether combining low dose bacillus Calmette-Guerin (BCG) interferon-alpha 2B would be effective for patients in whom previous BCG failed. MATERIALS AND METHODS: A total of 40 patients in whom 1 (19) or more (21) previous induction courses of BCG failed received 6 to 8 weekly treatments of 1/3 dose (27 mg.) BCG plus 50 million units interferon-alpha 2B. Additional 3 week miniseries of further decreased BCG (1/10, 1/30 or 1/100) titrated to symptoms without changing the interferon-alpha 2B dose were given at 5, 11 and 17 months. In 12 patients a second induction course was given with 1/10 BCG plus 100 million units interferon-alpha 2B. There was multifocal disease in 39 patients, previous BCG had failed within 6 months in 34, disease was aggressive (stage T1, grade 3 or carcinoma in situ in 31, there had been 2 or more previous recurrences in 25 and disease history was greater than 4 years in 13. RESULTS: At a median followup of 30 months 63% and 53% of patients were disease-free at 12 and 24 months, respectively. Patients in whom 2 or more previous BCG courses had failed fared as well as those with 1 failure. Of the 18 failures 14 occurred at the initial cystoscopy evaluation. Of 22 patients initially counseled to undergo cystectomy 12 (55%) are disease-free with a functioning bladder. Combination therapy was well tolerated. CONCLUSIONS: While longer followup and larger multicenter studies are required to validate these encouraging findings, intravesical low dose BCG plus interferon-alpha 2B appears to be effective in many cases of high risk disease previously deemed BCG refractory. However, early failure while on this regimen should be aggressively pursued with more radical treatment options.
Adjuvants, Immunologic↗
Prevention of the Recurrence of Superficial Bladder Cancers: Intravesical Instillation of Bacillus Calmette-guerin Versus Bacillus Calmette-guerin Plus Epirubicin.
Purpose The short-term effects of intravesical chemoimmunotherapy with epirubicin and Bacillus Calmette-Guerin (BCG) administered repeatedlly for prophylaxis of recurrence of superficial bladder cancer (pTa, pT1) were investigated in 22 patients with a median of 70 years between March, 1995 and February, 1999, and were compared with those of BCG monotherapy in 50 patients between March, 1995 and February, 1999. Patients and Methods The patients underwent intravesical instillation of Tokyo-strain BCG with or without epirubicin after transurethral resection (TUR) of bladder cancer. For the combined treatment, at 1~2 weeks after TUR, epirubicin (40 mg) and BCG (80 mg) were instilled into the bladder by turn once a week for 12 weeks. For the BCG alone group, 80 mg instillation were performed with the same schedule. Thereafter, the patients were followed by cystoscopy and urinary cytology every 3 months for up to 3 years after intravesical therapy. Results and Conclusions The simple recurrence rate was 22.7% (5/21) in patients with chemoimmunotherapy and 32.0% (16/50) in BCG-treated patients. Adverse reactions, including increased frequency of urination, urgency and miction pain, were observed in 18 patients (85.7%) undergoing chemoimmunotherapy and 58.0% undergoing BCG monotherapy. One patient receiving chemoimmunotherapy was withdrawn from treatment because of severe bladder-irritation symptoms due to instillation. Intravesical chemoimmunotherapy using epirubicin and BCG was inferior in comparison with BCG monotherapy for prophylaxis of recurrence of superficial bladder cancer.
Journal Article↗
Intravesical and intradermal Bacillus Calmette-Guérin application. A phase I study to the toxicity of a Dutch Bacillus Calmette-Guérin preparation in patients with superficial bladder cancer.
In 30 patients toxic side effects of Bacillus Calmette-Guérin (BCG) were evaluated after intradermal and intravesical administration. The BCG preparation (BCG-RIVM) was produced in a homogeneously dispersed culture yielding a relatively high number of culturable particles per milligram dry weight BCG. All patients had a history of recurrent multiple noninvasive superficial transitional cell carcinoma of the bladder, and were previously unsuccessfully treated with intravesical chemotherapy (epodyl and/or adriamycin). BCG-RIVM (1 X 10(9) culturable particles) was instilled in the bladder, in combination with intradermal BCG-RIVM (8 X 10(7) culturable particles) administration once a week for 6 consecutive weeks. BCG was applied intradermally by a multiple-puncture technique. During and after therapy, subjective and objective side effects and toxicity were registered. Hematology and blood chemistry, including hepatic and renal function, was monitored. Only minor toxicity and/or side effects were observed during therapy and for a period of 6 months after treatment. After a period of 7 days no significant amount of BCG bacteria could be detected in the urine of 24 investigated patients.
Administration, Intravesical↗
Intravesical Bacillus Calmette-Guérin therapy for murine bladder tumors: initiation of the response by fibronectin-mediated attachment of Bacillus Calmette-Guérin.
Intravesical Bacillus Calmette-Guérin (BCG) is considered to be one of the most effective treatments for superficial bladder cancer. Although the mechanisms by which BCG inhibits tumor growth are not known, previous studies have shown that systemic immunization to BCG and the local expression of the immune response in the bladder are associated with a favorable response to BCG therapy. We have investigated the conditions required for the initiation of an immunological response after the intravesical instillation of BCG. Initial histological studies showed that BCG attached to the bladder wall only in areas where the urothelium was damaged by electrocautery and suggested that attachment was associated with the fibrin clot. Quantitative studies verified the histological observations. Minimal BCG attachment (mean less than 10(2) colony forming units) was observed in normal bladders in contrast with a mean of 1.42 X 10(4) colony forming units/bladder in bladders damaged by electrocautery (10 separate experiments). BCG attachment to the bladder wall was durable since organisms were observed in bladders 48 h after instillation. To investigate the proteins to which BCG attached, we tested the binding of BCG to extracellular matrix and inflammatory proteins which comprise a significant portion of the fibrin clot. BCG bound in vitro to coverslips coated in vivo with extracellular matrix proteins but did not bind to control albumin-coated coverslips. BCG also bound to coverslips coated with purified plasma fibronectin but not to coverslips coated with other purified extracellular matrix proteins including laminin, fibrinogen, and type IV collagen. BCG attachment to coverslips coated with either extracellular matrix proteins or purified fibronectin was inhibited by antibodies specific for fibronectin. Moreover, BCG attachment to cauterized bladders in vivo was inhibited by antifibronectin antibodies. These results demonstrate that fibronectin mediates the attachment of BCG to surfaces and suggest that it is the primary component mediating attachment within the bladder. Moreover, the data suggest that the BCG-fibronectin interaction may be a requisite first step for the initiation of the antitumor activity in intravesical BCG for bladder cancer.
Animals↗
Reduction of bladder tumor growth in mice treated with intravesical Bacillus Calmette-Guérin and its correlation with Bacillus Calmette-Guérin viability and natural killer cell activity.
The effect of intravesical Bacillus Calmette-Guérin (BCG; Pasteur strain) treatment on the frequency of implantation and growth rate of the murine transitional cell carcinoma of the bladder, MBT-2, was studied. MBT-2 cells were instilled into the bladder immediately after electrocauterization, and BCG instillations (40, 80, and 160 micrograms/instillation) were initiated 24 hr later and continued on a weekly basis for 4 weeks. BCG treatment significantly (p less than 0.0002) reduced the incidence of tumor implantation in a dose-dependent manner and resulted in significantly (p less than 0.0001) smaller tumors when they appeared in BCG-treated mice. The therapeutic effect of BCG correlated with augmentation of natural killer cell (NK) activity and positive purified protein derivative (PPD) footpad reactions. In experiments in which treatment was initiated with rapidly growing BCG organisms (10(7) colony-forming units/mg), tumor implantation was inhibited, there was a dose-dependent increase in NK activity, and mice had positive footpad reactions in PPD. In experiments in which BCG with reduced viability (10(6) colony-forming units/mg) and slower growth rates was used for treatment, no significant inhibition of tumor implantation was observed, NK activity was depressed, and PPD footpad tests were uniformly negative. The results suggest that the therapeutic effects of BCG therapy in this murine model correlate with augmentation of NK activity and positive footpad reactions to PPD and further suggest that the viability and growth rate of BCG organisms are important factors in determining the efficacy of intravesical BCG therapy.
Animals↗